health research project example

Social Media Use Linked to Tobacco Initiation among Youth

Permanent Contraception Procedures Surge Among Young Adults After Dobbs

Global health research projects ..

Global Health research spans a wide range of interrelated and complex public health topics. Please explore our current projects by their primary theme listed below. Be sure to investigate more detailed descriptions of projects that have hyperlinked project titles .  Many project areas overlap, so please explore them all.

Academic Interests of the DGH Faculty

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Point of Care Diagnostics

Technology to improve decision making and neonatal outcomes in special neonatal care units (sncus) in india.

There have been major improvements in childhood mortality around the world over the last 20 years, but it has been more difficult to reduce mortality of babies in the first month of life. The study is evaluating how to optimize design and use of medical equipment and point of care diagnostics to improve care of newborns in India.

Patricia Hibberd

Diagnostic and Prognostic Biomarkers for Bacterial Infection in Pediatric Clinical Pneumonia

Bacterial pneumonia is one of the leading causes of childhood mortality, particularly in resource-limited countries. The disease burden can be partially attributed to the lack of an accurate and reliable diagnostic test to allow promptly starting antibiotic therapy. Lack of a diagnostic test also results in accelerated resistance to available antibiotics. Previously, we identified a combination of blood inflammatory proteins that could accurately diagnose bacterial infection in Mozambican children with clinical pneumonia. We are currently validating and improving upon this combinations in Gambian children with clinical pneumonia to further start development of a point-of-care diagnostic test with partners.

Clarissa Valim

Emerging Infectious Disease Surveillance and Research

Geosentinel – the global research and surveillance network of the international society of travel medicine in partnership with the cdc.

This is an emerging infectious global surveillance and research network consisting of 72 sites in 30 countries, which uses travelers, immigrants, and refugees as sentinel indicators of disease outbreaks worldwide. GeoSentinel research major projects include studies of fever etiology and outcomes among travelers, artemisinin resistance, mpox, neurocognitive impact of malaria, and COVID-19.

Davidson Hamer

BU-UL Partnership to Enhance Emerging Epidemic Virus Research in Liberia (BULEEVR)

This grant supports a training program is for Liberian Researchers to combat emerging infectious disease outbreaks, such as Ebola. Faculty at BUMC/BUSPH and the University of Liberia co-mentor trainees.

Andrew Henderson

Global Health Research Training

Fogarty global health training fellowship.

This program provides mentored research opportunities to train and prepare a new cadre of health professionals in the US and LMICs in global health research by enhancing the trainees’ ability to independently plan, implement, and assess innovative clinical or operations research focused on reducing mortality and morbidity associated with HIV/AIDS and associated co-infections, NCDs including cardiovascular disease and diabetes, mental health, and MCHN. Academic partners include Harvard University (Harvard T. H. Chan School of Public Health, Harvard Global Health Institute), Boston University (Schools of Public Health and Medicine), Northwestern University (Center for Global Health, Feinberg School of Medicine) and the University of New Mexico (School of Medicine, Center for Global Health).

Bangladesh, Botswana, Ghana, India, Kenya, Nigeria, Mali, Peru, South Africa, Thailand, Uganda, Zambia

Health Services Research

Indlela: a nudge unit to build capacity in behavioral economics and increase hiv program effectiveness in south africa.

Indlela is the first-of-its-kind unit focused specifically on improving the effectiveness of the public sector in delivering health care and achieving better health outcomes in South Africa. In the unit’s first 3 years it will focus specifically on building capacity to expand the use of behavioral economics within HIV prevention and treatment programs in South Africa and strengthen the ability of health service delivery providers and key research institutions to develop and test contextually appropriate interventions that are informed by behavioral insights. In future years, the scope will expand beyond HIV to include other public health issues in South Africa.

Lawrence Long

South Africa

Providence/Boston Center for AIDS Research (CFAR)

The major goals of this project are to foster HIV Research and collaborations between Brown and Boston University Developing young investigators.

Matthew Fox

US, Ukraine, Kenya, South Africa, the Philippines

Dartmouth-Boston University HIV-TB Research Training for the Infectious Disease Institute at Muhimbili University of Health and Allied Sciences (MUHAS)

The major goals of this project are to train Tanzanian citizens in clinical HIV/AIDS research and to estaqblish san Infectious Dsieases Institute at MUHAS.

Robert Horsburgh

Boston University’s Contributions to the Enhanced Mentor Mother Program (EMMA) Study for USG FY2021-22.

During 2014-2019, BU collaborated with the Walter Reed Project and the Kenya Medical Research Institute to complete a study titled: “Evaluating the effectiveness of implementing Option B+ under routine conditions with and without the PMTCT Patient Coordinator Program: A site-randomized impact evaluation among maternal and child health centers supported by the South Rift Valley PEPFAR program in Kenya.” The focus of this additional grant is to complete final data extraction and analysis for infant HIV testing outcomes (testing and HIV status at 18 months of age).

Bruce Larson

AMBIT: Alternative Models of ART Delivery: Optimizing the Benefits 

Many high HIV-prevalence countries are scaling up differentiated service delivery (DSD) models for providing antiretroviral treatment for HIV. DSD models adjust the location, frequency, provider cadre, and other aspects of service delivery to make HIV treatment more patient-centric and more efficient. Little is known about the true impact of DSD models on the health system or patients, however. AMBIT is a research project in sub-Saharan Africa comprising synthesis of existing data, new data collection, data analysis, and modeling activities aimed at generating information for near- and long-term decision making for scaling up DSD models in Malawi, Zambia, and South Africa.

Sydney Rosen

Malawi, Zambia, South Africa

Evaluating the Cost of Scaling PrEP Access through Novel Delivery (EXPAND). 

Blurb: This is an economic evaluation of three demonstration projects that are testing different service delivery approaches for PrEP in South Africa. Each of the demonstration projects uses a different delivery model to reach populations at increased risk for HIV acquisition to offer them oral PrEP. These models will also be adapted for the delivery of long-acting injectable PrEP as soon as this becomes available in South Africa. The economic evaluation includes qualitative work, baseline assessment, patient costs, and the cost of delivery PrEP from the provider perspective. We also include a cross-cutting component focused on local capacity building in costing and economic evaluations.

Retain6: Models of care for the first 6 months of lo treatment

For HIV-positive patients in sub-Saharan Africa and globally, the first six months after initiating lifelong antiretroviral therapy (ART) pose the greatest risk of loss to follow up. Patients who make it through the first six months have a good chance of being retained on ART for the long term, but many drop out before reaching the six-month point. The Retain6 project aims to develop new models of differentiated service delivery for patients in their first six months on ART, in an effort to improve retention in care during this period.

Zambia, South Africa

CAB-RPV LA Implementation Strategies for High-Risk Populations.

This will be an evaluation of a new injectable antiretroviral treatment for HIV-positive individuals receiving care at the Boston University Medical Center and its associated community-based outreach clinics. It includes qualitative research on preferences of patients and providers and a randomized controlled trial to assess feasibility and impact.

Mari-Lynn Drainoni (BMC)

The SUpporting Sustained HIV Treatment Adherence after INitiation ( SUSTAIN study)

Early detection of poor adherence to antiretroviral treatment (ART) and linkage to support for new patients is critical. The objective of this study is to improve ART adherence, retention and viral outcomes in people commencing ART in the South African public sector, a low-resource setting, over 24 months using five evidence-based adherence strategies to enable rapid identification and management of people with poor adherence. We will test the combinations of these components using a Multiphase Optimization STrategy (MOST) design, which allows us to explore the benefit of various combinations of these five effective and feasible ART adherence monitoring or support components.

Faculty/PI: Lora Sabin (PI), Nafisa Halim (Co-I), Bill MacLeod (Co-I), Allen Gifford (Co-I)

Location: South Africa

Zambia Infant Cohort Study

The ZICS study will determine if antiretroviral regimens used to successfully prevent mother to child transmission of HIV have also decreased morbidity and mortality among the children born to these mothers but who, themselves, have escaped infection with HIV. If not, then further investigation of the cause of poor outcomes in these children will be necessary. We will also determine if the mother’s immune status is a determinant of poor health outcome in their uninfected children, and in their infants early immune status.

Donald Thea

Zambia Infant Cohort Study: Brain Optimized to Survive and Thrive (ZICS-BOOST)

Children exposed to HIV in-utero but uninfected (CHEUs) number 14.8 million globally. In Zambia, an estimated 56,000 CHEUs are born annually, a staggering fraction of the national birth cohort. Multiple studies establish that CHEUs are more neurodevelopmentally vulnerable than HIV-unexposed peers. In Zambia, there are existing effective early childhood developmental (ECD) interventions that target other vulnerable populations, but never trialed specifically for CHEUs. GAP: Research is needed to evaluate the effectiveness of a scalable early childhood development (ECD) intervention for CHEUs. Zambia is scaling up ECD as part of its national strategy, but CHEUs are not currently targeted. There is need to better understand the scope and mechanism of HEU-related neurodevelopmental differences and what interventions are most effective. HYPOTHESIS #1: An ECD intervention delivered by community health workers via bi-weekly home visits will improve neurodevelopmental outcomes in CHEUs. HYPOTHESIS #2: CHEUs have significantly worse neurodevelopmental outcomes than unexposed peers at 24 months, mediated by preterm birth, disease stage or ARV exposure. METHODS: In order to observe differences in neurodevelopment between HIV-exposed and HIV-unexposed children, we will build upon an existing Zambian birth cohort by extending follow-up from 6 months to 2 years (n=450). Neurodevelopmental assessments will be measured by multiple context-validated tools at 12 and 24 months. In addition, a randomized control trial of a bi-weekly community health worker-delivered ECD intervention for CHEUs will be conducted to assess its impact on CHEU neurodevelopment. RESULTS: Pending. IMPACT: Despite growing evidence, HIV-exposure is not currently prioritized as a risk factor for poor development by policy makers or ECD programs. By capitalizing on the wealth of prenatal and infant data collected in our ‘parent’ study, we can investigate the mechanism that links HEU to neurodevelopment and test a potential therapy. Addressing developmental vulnerability in CHEUs is paramount to ensuring that future generations of children are school ready, and able to reach their full developmental potential.

Julie Herlihy

EVIDENCE: Evaluation to Inform Decisions using Economics and Epidemiology

EVIDENCE is a 5-year HIV/AIDS project funded by PEPFAR through USAID. With the project lead in South Africa, the Health Economics and Epidemiology Research Office (HE2RO), we conduct health economics and epidemiology evaluations and provide technical assistance in support of the goals of the South African National Strategic Plan for HIV, TB and STIs (NSP) and the PEPFAR Country Operational Plan. BU faculty and staff work closely with HE2RO on project evaluations, cost modeling, outcomes research, and financial management to improve guidelines, policies, programs, and resource allocation.

Economic Impact of HIV Policy Briefs

This project synthesises the evidence on the economic impact of HIV into a series of 17 policy briefs that can help decision-makers in ministries of finance and health in low- and middle-income countries (LMIC) decide on the future financing of their country’s HIV programme. The project incorporates a series of seminars with an academic and LMIC government staff audience aimed at refining the content and presentation of the briefs, the presentation of the evidence base to LMIC decision makers during a comprehensive workshop, and the publication of the briefs on a website and in peer-reviewed journals.

Gesine Meyer-Rath

infectious disease

Vaccine impact modelling consortium (vimc) 2.0  .

VIMC   is an international community of modelers providing high-quality estimates of the public health impact of vaccination to inform and improve decision making. This project contributes to the estimation of cervical cancer disease burden and human papillomavirus (HPV) vaccine impact in low- and middle-income countries. In addition, this project examines policy-relevant research questions for HPV vaccines in order to advance the research agenda in the field of vaccine impact modeling.

 Allison Portnoy

Low- and middle-income countries worldwide

INSECT: Implementing Novel Strategies for Education and Chagas Testing  

This project, funded by a CDC cooperative agreement, aims to increase Chagas knowledge in the medical community and to roll out screening programs for high-risk populations (such as women of childbearing age from endemic areas) nationwide.

Boston, Massachusetts

Chagas disease biorepository

We have developed a biorepository using biological samples from a cohort of Chagas disease patients at Boston Medical Center. The primary goal of the biorepository is to develop and maintain a large, geographically diverse collection of well-characterized samples to be used as a resource for future Chagas diagnostics research.

Incorporating Behavioral Feedback in the Infectious Disease Transmission Modeling

Transmission dynamic modeling is a powerful tool to understand the epidemiology of infectious diseases and evaluate the impact of control measures. However, the lack of empirical data on human behavior and its temporal variation has hindered the progress and application of these models. Therefore, this project aims to 1) understand how people experiencing acute infections change their social contact patterns over the course of their illness and 2) develop mechanistic models that incorporate these data to generate more reliable estimates of key transmission parameters and intervention impacts. Our project aims to provide policy makers and public health officials with more informed decision-making tools to develop interventions, ultimately leading to improved health outcomes.

Kayoko Shioda

United States

EPISTORM: Real-time Evaluation of Vaccine Effectiveness and Safety

Real-time monitoring of the effectiveness and safety of vaccines is essential for controlling infectious diseases. However, there are both practical and methodological hurdles. Our project aims to address two key challenges: 1) issues with linking public health data from different sources, and 2) analytic challenges associated with evaluating multi-dose vaccines, using causal inference techniques. Boston University has been selected to be part of the national network for outbreak and disease modeling led ( CDC Insight Net ), and this project will be conducted through this network.

Cryptococcal Meningitis Screening in South Africa

Cryptococcal meningitis (CM) is a fungal infection that causes infection in the brain and spinal cord. CM is a leading cause of AIDS-related deaths globally, mainly among patients with low CD4 cell counts. Through screening HIV patients with low CD4 cells counts for cryptococcal antigen (CrAg), it is possible to identify CrAg-positive patients before they develop meningitis. Treating these patients with antifungal medications can then substantially reduce risks of progression to CM and death. Through support from the CDC Foundation (May 2015 – June 2021), the purpose of this program of research has been to evaluate costs and effectiveness of alternative CrAg screening strategies and CM treatment regimens.

Using Behavioral Economics to Improve the Uptake of and Persistence on Pre-exposure Prophylaxis in Men Who Have Sex With Men to Prevent HIV Infection

South Africa’s HIV incidence remains high, in particular amongst populations such as men who have sex with men (MSM) who may be at increased risk. HIV pre-exposure prophylaxis (PrEP) is considered key to reducing incidence in these populations, yet pilot studies show sub optimal uptake and poor persistence amongst those most at risk. This research will focus on understanding why PrEP uptake and persistence amongst MSM in South Africa is low and how the delivery of PrEP to this population could be altered to encourage those most at risk to start treatment using behavioral insights.

Impact of Undernutrition on Immunity Elicited by Vaccines in the Gambia

Moderate and severe undernutrition are highly prevalent in several resource-limited countries. There is conflicting evidence on the impact of undernutrition on the immunity elicited by childhood vaccines, as well as the specific supplements that could be used to overcome vaccine hypo-responses associated with undernutrition. In a pilot project in The Gambia, we are comparing antibody vaccine responses against a panel of EPI vaccines of children with severe wasting and stunting with well-nourished children. Furthermore, through a metabolomics assay, we will assess whether specific amino acid deficiencies are associated with decreased responses in undernourished children.

IPV (intimate partner violence)

Testing the effectiveness of an evidence-based transdiagnostic cognitive behavioral therapy approach for improving hiv treatment outcomes among violence-affected and virally unsuppressed women in south africa.

This study will evaluate the impact of the Common Elements Treatment Approach (CETA), an evidence-based intervention comprised of cognitive-behavioral therapy elements, at improving HIV treatment outcomes among women with HIV who have experienced intimate partner violence (IPV) and have an unsuppressed viral load on HIV treatment. To evaluate CETA, we will conduct a randomized controlled trial of HIV-infected women, with or without their partners, who have experienced IPV and have an unsuppressed viral load to test the effect of CETA in increasing viral suppression and reducing violence.

The Intransigence of Malaria in Malawi: Understanding Hidden Reservoirs, Successful Vectors and Prevention Failures

Under the aegis of the Malawi International Center of Excellence of Malaria Research (ICEMR) program, several cohort studies have been conducted focused on studying malaria control measures and understanding why measures such as bed nets have failed to control malaria in Malawi. Examples of these studies are the one led by Dr. Valim aiming to identify the transmission reservoir group(s) for malaria in Malawi and to assess the impact of current interventions on these human reservoirs. Another study conducted under the aegis of ICEMR aims to assess the effectiveness of the RTS,S malaria vaccine in conjunction with other malaria prophylactic measures.

Maternal and Child Health

Global network for women’s and children’s health research.

The Global Network conducts observational studies and clinical trials in 8 locations in low and middle income countries in Asia, Africa and Central America. The goals of the research are (1) to evaluate whether low-cost, sustainable interventions improve maternal and child health; and (2) build local research capacity and infrastructure. Whenever possible common protocols are implemented in all 8 locations. The Boston University site works with the Lata Medical Research Foundation in Nagpur, India. The grant funds several studies.

Synbiotics for the Early Prevention of Severe Infections in Infants (SEPSIS)

SEPSIS, a collaboration between icddrb (Dhaka), Hospital for Sick Kids (Toronto), and BU consists of a few related studies including an observational cohort of severe infections and the intestinal microbiome in young infants in Dhaka, Bangladesh and a phase II randomized, placebo-controlled trial of the efficacy, safety, and tolerability of neonatal administration of Lactobacillus plantarum ATCC 202195 with or without fructooligosaccharide for one or seven days

Antimicrobial Resistance

A-plus trial: multi-site efficacy and safety trial of intrapartum azithromycin in lmics – amr sub-study and effect of azithromycin on the developing microbiome ..

The Global Network is conducting a trial to evaluate whether Azithromycin given during labor reduces maternal and neonatal infections and mortality. This grant supports studying the effect of azithromycin on development of antimicrobial resistance and the gut and airway microbiome.

Sequencing of Klebsiella pneumoniae isolates from Zambia

Bloodstream isolates (K. pneumoniae and E. coli) from the Sepsis Prevention in Neonates in Zambia study are being sequenced to determine serotypes and antibiotic resistance characteristics.

Non-communicable Diseases

World health organization. global ncd reporting mechanism..

Veronika Wirtz & Peter Rockers

In 2021, the World Health Organization introduced the Global Diabetes Compact, targeting equitable and affordable access to diabetes care, particularly in low- and middle-income countries. Acknowledging the support from the private sector, WHO formulated a list of 31 asks to prioritize expansion of access to essential insulin and related health technologies. Boston University is now supporting WHO in developing a Global Reporting Mechanism (GRM) to encourage the reporting and tracking of industry commitments aligned with the 31 WHO Asks.

Noncommunicable Disease Management in South Africa: Insights from the National Health Laboratory Services (NHLS) Multi-morbidity Cohort.

The K01 Award (K01DK116929) addresses the growing challenge of Type 2 Diabetes Mellitus (T2DM), focusing on care disparities and treatment efficacy, particularly among populations living with and without HIV in low- and middle-income countries. Central to this project is the innovative application of a probabilistic record-linking algorithm to develop a patient cohort from the National Health Laboratory Services (NHLS) database in South Africa, which contains over 68 million laboratory records from more than 30 million individuals and covers conditions like HIV, tuberculosis, diabetes, kidney disease, and cardiovascular disorders from April 1, 2004, to March 31, 2017.

The creation of the NHLS Multi-morbidity Cohort has facilitated in-depth analysis of data including anonymized patient identifiers, demographics, test specifics, and geographic information. This cohort is instrumental for the project’s aims to examine examining the T2DM care cascade in populations with and without HIV, evaluate the Integrated Chronic Disease Management (ICDM) model’s impact on diabetes care using quasi-experimental methods, studying chronic kidney disease progression , and evaluating compliance with national diabetes guidelines . These efforts aim to enhance understanding and improve management of noncommunicable diseases in South Africa.

Alana Brennan

World Bank Global compendium of primary care service delivery models for non-communicable diseases

(link to report should be available in June 2024)

Addressing the challenges within non-communicable disease programs and primary healthcare centers, the World Bank embarked on a project to gather a comprehensive collection of primary care service delivery models for non-communicable diseases. This initiative highlighted the critical need for a cohesive approach to primary healthcare, which includes the promotion, prevention, and management of non-communicable diseases, aiming to improve care across the entire spectrum, from reducing risk factors to managing chronic conditions at the primary care level effectively. The project’s goal was to develop an online, action-oriented collection for the World Bank, filled with innovative design solutions and digital enhancements to boost access, efficiency, effectiveness, and the quality of care for non-communicable diseases. This collection intended to present a wide array of primary healthcare models designed for chronic conditions, supporting countries in their shift towards integrated, chronic care services and moving away from a reliance on acute, episodic care.

The project culminated in a comprehensive matrix featuring 158 models, alongside 60 concise two-page case reports and 15 detailed five-page case reports. These documents collectively highlight a diverse range of primary care service delivery models for non-communicable diseases, spanning various geographic regions and income categories. Sub-Saharan Africa was prominently featured, accounting for 26.6% of the models, with East Asia and the Pacific at 22.8%, and South Asia at 20.2%. Most of these models were found in upper-middle-income and lower-middle-income countries, making up 45.6% and 42.4% of the implementations, respectively. Diabetes stood out as the most common focus, being the target of 50.0% of the models, followed by hypertension at 41.8% and mental health disorders at 38.0%. The main strategies highlighted in these models were task-shifting/task-sharing (40.5%), the integration of new services or conditions (35.4%), and educational or training initiatives (33.5%). The implementation settings varied, with mixed areas being the most common at 41.8%, and rural and urban areas following at 24.7% and 22.1%, respectively. The scale of implementation predominantly ranged from small to medium, accounting for 55.1% of the models, but there were also notable instances of large-scale and national-scale projects at 20.2% and 10.1%, respectively, highlighting the extensive reach and potential impact of these initiatives.

Alana Brennan, Nancy Scott , Sydney Rosen

low-and middle-income countries

Opportunistic screening for hypertension and type 2 diabetes mellitus using COVID-19 infrastructure

South Africa continues to grapple with a substantial burden of non-communicable diseases, particularly type 2 diabetes and hypertension. However, these conditions are often underdiagnosed and poorly managed, further exacerbated by the strained primary healthcare system and the disruptive impact of the COVID-19 pandemic. Integrating non-communicable disease screening with large-scale healthcare initiatives, such as COVID-19 testing and vaccination campaigns, offers a potential solution, especially in low- and middle-income countries. We investigated the feasibility and effectiveness of this integration in two separate cohorts.

Study 1: Integration of point-of-care screening for type 2 diabetes mellitus and hypertension with COVID-19 rapid antigen screening in Johannesburg, South Africa

In a prospective cohort study at the Germiston taxi rank in Johannesburg, South Africa, we assessed the integration of screenings for type 2 diabetes mellitus and hypertension with rapid antigen tests for COVID-19. The study involved 1,169 participants and included measurements of blood glucose, blood pressure, waist circumference, smoking status, height, and weight. Participants showing elevated blood glucose levels (fasting levels equal to or greater than 7.0 or random levels equal to or greater than 11.1 millimoles per liter) and/or elevated blood pressure readings (diastolic pressure equal to or greater than 90 and systolic pressure equal to or greater than 140 millimeters of mercury) were directed to receive clinical follow-up. Our results indicated an overall diabetes prevalence of 7.1%, incorporating both previously diagnosed individuals and those newly identified with elevated blood glucose measurements. We also observed a hypertension prevalence of 27.9%, which included both known cases and new detections of elevated blood pressure during the study. However, the rates of connecting these individuals to subsequent medical care were low, with only 30.0% of those with elevated blood glucose and 16.3% with elevated blood pressure engaging in follow-up care. This opportunistic approach to screening helped identify potential new diagnoses in 22% of participants, yet it also underscored the necessity for better strategies to ensure these individuals receive the necessary ongoing care, highlighting the critical need for additional research to determine the feasibility and effectiveness of such integrated screening programs on a larger scale.

Study 2: Integration of point-of-care screening for type 2 diabetes mellitus and hypertension into the COVID-19 vaccine programme in Johannesburg, South Africa

In a prospective cohort study at four health facilities in Johannesburg, South Africa, we screened 1,376 participants for hypertension and type 2 diabetes mellitus during COVID-19 vaccination campaigns. This integration aimed to address the significant problem of undiagnosed conditions in a strained healthcare system. We measured blood glucose, blood pressure, waist circumference, smoking status, height, and weight, referring individuals with elevated blood glucose (fasting levels equal to or greater than 7.0 or random levels equal to or greater than 11.1 millimoles per liter) and/or blood pressure (diastolic pressure equal to or greater than 90 and systolic pressure equal to or greater than 140 millimeters of mercury) for further medical evaluation. Our findings showed a 4.1% prevalence of diabetes, combining known cases and new detections of elevated blood glucose levels. The hypertension prevalence was 19.4%, including both existing and newly identified cases of elevated blood pressure. Notably, 46.1% of participants exhibited waist circumferences indicative of metabolic syndrome, more frequently observed in females. Additionally, 7.8% of the screened individuals were potentially newly diagnosed with diabetes or hypertension, emphasizing the importance of integrated screening initiatives. Approximately half of the individuals with newly identified risk factors successfully sought follow-up care within a month, highlighting the effectiveness of using routine healthcare interactions for extensive screenings, particularly vital in settings with limited resources, and underscoring the need to improve linkage to care for efficient management of non-communicable diseases.

Alana Brennan, Gesine Myer-Rath

Assessing the effects of HIV disease on dysglycemia in a cohort of tuberculosis patients in South Africa’s Western Cape

Our planned research will focus on compare rates of dysglycemia (both hyperglycemia and hypoglycemia) in people living with HIV (PLWH) and HIV-uninfected persons receiving tuberculosis (TB) treatment using pilot data from the The Impact of Alcohol Consumption on TB Treatment Outcomes (TRUST) Study . HbA1c’s were only collected at enrollment the TRUST. As such, we will collect blood samples to measure HbA1c and blood glucose levels at patients 18-month study visit. This will allow us to assess changes in blood glucose levels from study enrollment by HIV status. Second, we will assess the role stress and inflammation play in relation to blood sugar levels in PLWH and HIV-uninfected individuals. Research suggests that the hosts immune response to active TB and/or HIV disease results in a prolonged state of systemic inflammation which can have negative metabolic effects. We will collect samples to measure markers of stress and inflammation at the 18-month study visit when all patients will be one year post TB treatment completion and when transient hyperglycemia due to TB infection should be resolved. This will be preliminary data to assess if there are differences in these specific stress and inflammatory markers post TB treatment amongst PLWH and HIV-uninfected individuals and potentially identify underlying mechanism(s) causing abnormal blood sugar levels.

Programme Evaluation of Timor-Leste PEN-HEARTS Intervention

This project will evaluate early implementation in Timor-Leste of PEN-HEARTS, a community-based intervention supported by the WHO designed to improve health outcomes among individuals with non-communicable diseases such as diabetes. Building on a similar evaluation in Bhutan, a BU team of faculty and students will design and implement the evaluation with WHO and Ministry of Health officials in Timor-Leste. The evaluation will use mixed methods and involve data collection in both intervention and comparison sites in four districts of Timor-Leste.

Timor-Leste

Pharmaceutical Policy

Medicines, technologies, and pharmaceutical services.

The Medicines, Technologies and Pharmaceutical Services (MTaPS) project aims to strengthen pharmaceutical systems in low and middle income countries. Boston University is a core partner of the USAID funded MTaPS project led by Management Sciences for Health. The objectives are (1) to generate evidence on the development, implementation and strengthening of data management that can support decision-making in pharmaceutical systems; (2) to develop, implement and evaluation accountability mechanisms in pharmaceutical systems.

Veronika Wirtz

Tuberculosis

Methods to estimate the impact of interventions on the transmission and incidence of tuberculosis.

The major goals of this project are to develop models that can be used to monitor the success of TB interventions. This project is a collaboration with Dr. Helen Jenkins and Dr. Leo Martinez and is led by Dr. Laura White of the BUSPH Department of Biostatistics

Intensified patient-finding intervention to increase the detection of children with tuberculosis

Children with tuberculosis are vastly under detected and under diagnosed. An intensified patient-finding intervention using systematic verbal screening at health facilities was undertaken in two locations to increase the detection of children who may be at high risk for tuberculosis disease. These projects aim to identify gaps along the pediatric tuberculosis care cascade; understand age-specific clinical presentation and risk factors for tuberculosis disease, extrapulmonary presentations, and poor treatment outcomes; refine clinical algorithms to expedite decision-making for treatment initiation; and explore other topics related to pediatric tuberculosis epidemiology.

Meredith Brooks

Pakistan and Bangladesh

SAIA-TB: Using the Systems Analysis and Improvement Approach to Prevent TB in rural South Africa

Description: South Africa estimates 80% of their population has TB infection, and 14% of the population lives with HIV, with an estimated 5-15% of South Africans at high risk of developing TB disease from recent infection or immunocompromised status. Therefore, utilization of routinely collected data to optimize the comprehensive TB care cascade – screening, evaluation, diagnosing, linkage to care, treatment, and TB-free survival – is important to assess at the clinic level to improve clinic flow and patient outcomes. This study—funded by NINR/NIH—will leverage an evidence-based implementation science strategy, the Systems Analysis and Improvement Approach (SAIA), and recent TB cascade analyses piloted in the proposed site, to adapt and evaluate the effectiveness of SAIA-TB using a stepped wedge crossover cluster randomized trial across 12 clinics in rural Eastern Cape, South Africa.

Improving Childhood Tuberculosis Treatment Outcomes and Post-TB Lung Functioning and Quality of Life in Rural South Africa

Description: We will assess the TB care cascade in children, expanding it to include a child-specific definition of post-TB lung disease (PTLD), among children in a high TB/HIV burden setting in Eastern Cape South Africa, and identify risk-factors for completing each step of the newly expanded TB care cascade. Additionally, we will collect rich data regarding nutritional status, air pollutant exposure, lung capacity, and quality of life to estimate their effect on TB disease outcomes and PTLD in children. Funded by the Charles H. Hood Foundation.

Household Contact Tuberculosis Preventive Therapy Programs in Rural Eastern Cape, South Africa (KWIT-TB)

Description: We will assess the geospatial components, including access to care and population-level characteristics to gaps in the TB preventive therapy care cascade.

Adaptive Design to Aid in the Planning of community-based Tuberculosis screening services (ADAPT-TB)

Description: Community-based screening via mobile units can close gaps in missed diagnoses by bringing screening services into communities, making screening more convenient for individuals with limited access to appropriate services. Questions remain, however, about how to efficiently operate these mobile units. Leveraging longstanding relationships in Lima, Peru, including existing collaborations involving mobile screening units, I will collect data from health facilities and mobile screening units to [Aim 1] establish spatial and temporal trends of the local tuberculosis burden and [Aim 2] build neighborhood-level models reflecting local risk of tuberculosis. I will then [Aim 3] develop a baseline decision model via a restless multi-armed bandit framework to make data-driven decisions about where, when, and how long to place the mobile units in the community. The overall goal is to optimize the real-time movement of these units throughout a community to increase the detection of individuals with TB and allocate resources more efficiently. Funded by a Carlin Foundation Award for Public Health Innovation and a Population Health Data Science (PHDS) Seed Funding Award.

Optimizing tuberculosis elimination initiatives for high-risk populations

Certain populations are at increased risk of tuberculosis infection and progression to tuberculosis disease. In Mexicali, Mexico, we are assessing the impact of novel diagnostics for tuberculosis infection testing in three high-risk populations–people who use drugs, household contacts of people with tuberculosis, and people confined to a penitentiary setting–to inform tailored algorithms for tuberculosis testing and initiation of tuberculosis preventive treatment. We also assess gaps identified along the tuberculosis comprehensive care cascade to guide local tuberculosis prevention and management guidelines.

Tuberculosis in teens: a geospatial approach to predict community transmission

Description: Adolescents are a unique population that have been routinely neglected from tuberculosis guidelines. However, due to their ability to spread tuberculosis and their high number of social contacts, adolescents may be a key node fueling cycles of local community tuberculosis transmission in high incidence settings. Through a K01 Award from NIAID, NIH, we use geospatial and genotypic analyses to complete the following objectives: (1) To characterize the spatial heterogeneity of tuberculosis transmission events in adolescents. (2) To predict the spatial distribution of tuberculosis transmission events in adolescents. (3) To estimate and compare, through simulation, the impact of adolescent-tailored screening and treatment interventions on reducing community tuberculosis transmission.

Predictors of Resistance Emergence Evaluation in MDR-TB Patients on Treatment.

Dr. Horsburgh and Dr. Tim Sterling of Vanderbilt are leading a prospective cohort study of patients with MDR-TB. The aims of the study are to determine if decreased TB drug levels predispose to the development of additional drug resistance on treatment and to develop early indicators of such emergence of resistance.

US, India, Brazil

RePORT India Consortium

The major goal of this project is to collaborate with partners in India in clinical studies of tuberculosis infection and disease.

Akshay Gupte

Transmission of Tuberculosis among illicit drug use linkages

The goal of this project is to assess the risk for TB transmission between persons who smoke drugs. This is a prospective cohort study of persons with and without drug use in South Africa.

Karen Jacobson

US, South Africa

Prevention Policy Modeling Lab

The Goal of this Project is to develop cost-effectiveness models for TB prevention. This project is a collaboration with Dr. Nick Menzies at Harvard School of Public Health and Dr. Josh Solomon at Stanford School of Medicine.

DRAMATIC Phase 2 Duration Randomized MDR-TB Treatment Trial

The major goal of this project is to identify a shorter, less toxic treatment for MDR-TB.  This project is a collaboration with Dr. Payam Nahid at University of California, San Francisco. It is randomizing patients with fluoroquinolone-susceptible MDR-TB in Vietnam and the Philippines to four different durations of a 5-drug regimen.

US, Vietnam, the Philippines

Phenotype, Progression and Immune Correlates of Post-Tuberculosis Lung Disease

Pulmonary tuberculosis (PTB) is associated with lung injury which can persist despite successful therapy. Lung sequelae of treated PTB are increasingly recognized as an independent risk factor for chronic obstructive pulmonary disease (COPD) and, an important contributor of excess morbidity and mortality. This project aims to: 1) characterize the early natural history of post-TB lung disease (PTLD) and provide rationale for long-term monitoring and bronchodilator therapy in affected cases, 2) characterize the functional and morphological phenotype of PTLD by serial pulmonary function testing and multi-detector computed tomography, 3) identify immune profiles measured during early, late and post-therapy associated with PTLD.

RePORT-India Lung Health Study

Pulmonary tuberculosis (PTB) is the most common form of TB disease and is characterized by granuloma formation, necrosis, and cavitation in the lung tissue. This lung injury in PTB may affect tuberculosis treatment outcomes. Granulomatous lesions, fibrosis, and cavitation impair drug penetration in affected lung tissue and may lead to persistent foci of bacterial replication and drug resistance. The overall goal of this project is to identify clinical and imaging markers of lung injury that are associated with unfavorable treatment outcomes in PTB.

Multiomic signatures of Lung Injury in Tuberculosis

Pulmonary tuberculosis (PTB) is associated with lung injury which can persist despite successful therapy. Lung sequelae of treated PTB are increasingly recognized as an independent risk factor for chronic obstructive pulmonary disease (COPD) and, an important contributor of excess morbidity and mortality. Furthermore, PTB is characterized by granuloma formation, necrosis, and cavitation in the lung tissue which can impair drug penetration in affected lung tissue leading to persistent foci of bacterial replication, drug resistance and poor treatment outcomes. The overall goal of this study is to explore host metabolomic and genetic signatures associated with lung injury in PTB patients with and without diabetes and HIV.

Point-of-care Questionnaire and mHealth Assisted Diagnosis of Post-TB Lung Disease

Pulmonary tuberculosis (PTB) is associated with lung injury which can persist despite successful therapy. Lung sequelae of treated PTB are increasingly recognized as an independent risk factor for chronic obstructive pulmonary disease (COPD) and, an important contributor of excess morbidity and mortality. Spirometry is the gold standard for diagnosing lung function defects, however it is technically challenging and expensive to perform, and may not be available at the point-of-care in many TB-endemic settings. The overall goal of this project is to develop and validate a questionnaire-based screening algorithm, assisted by machine learning analysis of cough sounds and lung auscultation data, to identify individuals with a high probability of having Post-TB Lung Disease for referral and confirmatory testing.

Effectiveness of Anti-Fibrotic Therapy for Preventing Pulmonary Impairment in COVID-19

COVID-19 is associated with persistent pulmonary impairment despite successful management of acute disease. Of particular interest is pulmonary fibrosis, with several studies reporting reduced FVC, DLCO and anterior reticulation on chest CT. The overall goal of this project is to conduct a retrospective analysis of medical records to measure the association between receipt of antifibrotic therapy (Pirfenidone and/or Nintedanib) and lung impairment following hospital discharge among adults with COVID-19.

Veterans health

Bridging the care continuum for vulnerable veterans across va and community care (bridgecc) queri program.

Led by investigators at the Bedford VA, this project is implementing three evidence-based practices (EBPs) that aim to improve coordinated care between VA and non-VA providers to improve the health of veterans. The EBPs focus on 1) homeless overdose prevention expansion; 2) maintaining independence and sobriety through systems integration and outreach; and 3) post-incarceration engagement to increase social support. Dr. Sabin is guiding the costing components for each EBP.

Browse all our research projects by topic We have funded more than 150 external research projects across a range of themes over the last five years

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How to Conduct Research in Healthcare in 9 Steps

• March 13, 2023

Table of Contents

Conducting research is a complex and multi-step process. This guide will provide an overview of how to conduct healthcare research, including the steps involved and key considerations for each stage.

1: Define the Objectives of Your Research Study

The objectives of the research study should include both short-term and long-term goals . It is essential to have a solid plan with well-defined objectives and the right methods to ask the right questions to the right people. 

Research should also consider ethical issues and the steps needed to minimize harm to those who take part. Furthermore, potential benefits to users must be considered, and it’s important to include time frames, milestones, and communication strategies.

Analyze and interpret data collected from surveys or interviews to identify trends related to the impact on desired outcomes, such as changes in attitudes or behaviors over time and changes in policies or practices.

2: Identify Relevant Studies and Sources

Searching the literature helps ensure that the research will address an appropriate gap in the evidence and help refine the research question and choice of methods. Critiquing the methodology of other people’s work is key to building up a better understanding and justification for a research approach.

The search strategy can be developed and enriched using relevant terms and literature from MeSH , Medline Plus , Ovid MEDLINE, EMBASE , CINAHL , HMIC , and Oxford Academic’s Research Evaluation databases. 

Screen all retrieved citations for eligibility based on your inclusion criteria and discard any that do not meet them (e.g., non-English language articles). Review the remaining articles for quality using appropriate assessment tools (e.g., QUADAS ).

Lastly, apply systematic review methodology (e.g., PRISMA ) to ensure transparency in reporting findings from each study reviewed in your review article or paper report.

? Learn more: Common Data Sources in HEOR

3: Consider Ethical Approval and Consent Requirements

Research teams should follow ethical guidelines and seek approval from a research ethics committee for their plan. The research should not involve any unnecessary harm or risk to the participants, and all possible measures should be taken to ensure their welfare and safety during the study period.

In addition, studies involving new medicines should have gone through a process to ensure they are ready for use with people before being tested on humans or animals in clinical trials or laboratory experiments, respectively.

Consent should also be obtained from all participants before they take part in the study, outlining what they can expect from it as well as any potential risks involved in taking part in it (if any).

4: Create a Study Plan and Timeline

After identifying the topic and research question, you would like to explore and review the eligibility criteria for each registry or study , as well as any additional requirements, such as consent forms or surveys, to determine which ones are suitable for your project goals and needs. 

Select one or more registries or studies that fit your needs best, then register with them if necessary by following their instructions on how to participate in their study.

Don’t forget to create a timeline for how long you will be involved in each study so you can keep track of progress toward completion of the project goals.

5: Construct a Questionnaire or Survey

Identify the purpose of the research and the target population and determine what information you are trying to gather, as well as who will be most affected by your research.

Create a survey or questionnaire that includes questions that are relevant to your purpose and can be answered by respondents in a way that is meaningful to them. Make sure it is clear, concise, and easy to understand for all ages and levels of education and language abilities.

Pilot-test your survey with a small group of people from your target population before rolling it out across the board for full use in research activities (e.g., interviews).

Finally, analyze responses using descriptive statistics (e.g., mean scores) or inferential statistics (for example, t-tests) as needed depending on what questions are being asked of participants in order to understand their experiences better or make comparisons between groups if applicable.

? Related: Biostatistics in HEOR

6: Write Your Research Proposal

The process of writing a research proposal can be broken down into six manageable steps.

• Introduce an educated idea arising from a clinical practice issue . The research topic should be rooted in a problem that affects medical practice; it should also provide motivation for completing the research and relevance for affecting medical practice changes and improvements.
• Conduct a systematic literature review before starting to write . This will help to inform the research idea and provide evidence to support the project from the beginning.
• Develop a conceptual framework . This will help to clarify the research question and ensure the proposed project is feasible and efficient.
• Seek advice from clinical experts, experienced researchers, relevant stakeholders , and even patients. This will enhance the research question’s relevance, feasibility, and efficiency in your document.
• Structure the research proposal . It should include background, objectives, methodology, outcomes, and dissemination. Additionally, include a section on ethical issues, service user involvement, and project management.
• Proofread the proposal carefully before submitting it to a funding body or ethical review panel. Consider having the proposal read by a consumer of health, colleague, or friend to ensure clarity and that jargon would be understood by a wider audience.

7: Collect Data Manually or Electronically

Determine the end goal of your research project and decide whether qualitative or quantitative data collection methods would be most beneficial for achieving your goal.

Select appropriate data collection methods, such as interviews, focus groups, observation for qualitative research, multiple choice surveys, or structured data analysis for quantitative research.

Analyze the collected data using specific tools and methods relevant to each data collection method (e.g., qualitative analysis software). This step should be done thoroughly to draw valid conclusions from the findings.

8: Elaborate on Conclusions and Report Results

First, identify the purpose of the research study and determine which outcomes are most relevant . Next, plan how to communicate results to study participants , including what information to provide, when it should be provided, and how it should be presented.

When possible, involve patients or other individuals who have participated in the study in developing feedback mechanisms that are meaningful to them.

At a minimum, provide participants with a summary of findings from their records that are clinically relevant (as determined by researchers) as well as an explanation of these findings in an understandable format.

In addition, you can consider providing additional information, such as data tables or graphs showing trends over time if applicable; this may help individuals better understand their healthcare situation more clearly. You can also provide opportunities for further discussion if needed.

9. Disseminate Your Findings

Depending on the size and scope of your research, disseminating your research could include media releases and interviews, conference presentations and posters, white papers, policy briefs, infographics, or other formats.

Follow best practices when communicating your findings. Consider the National Institutes of Health Guide, A Checklist for Communicating Science and Health Research to the Public , for tips on making research results accessible to a broad audience. 

Additionally, the Rural Health Research Gateway’s Dissemination Toolkit provides examples of fact sheets, policy briefs, and other dissemination formats, as well as general guidelines for sharing rural health research findings.

By taking the previous steps, you can ensure that your research is accurate and comprehensive and can be communicated thoroughly to all stakeholders. This will give you the confidence to present your findings in a meaningful way and disseminate them to the appropriate audiences.

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Research Topics & Ideas: Mental Health

100+ Mental Health Research Topic Ideas To Fast-Track Your Project

If you’re just starting out exploring mental health topics for your dissertation, thesis or research project, you’ve come to the right place. In this post, we’ll help kickstart your research topic ideation process by providing a hearty list of mental health-related research topics and ideas.

PS – This is just the start…

We know it’s exciting to run through a list of research topics, but please keep in mind that this list is just a starting point . To develop a suitable education-related research topic, you’ll need to identify a clear and convincing research gap , and a viable plan of action to fill that gap.

If this sounds foreign to you, check out our free research topic webinar that explores how to find and refine a high-quality research topic, from scratch. Alternatively, if you’d like hands-on help, consider our 1-on-1 coaching service .

Overview: Mental Health Topic Ideas

• Mood disorders
• Anxiety disorders
• Psychotic disorders
• Personality disorders
• Obsessive-compulsive disorders
• Post-traumatic stress disorder (PTSD)
• Neurodevelopmental disorders
• Eating disorders
• Substance-related disorders

Mood Disorders

Research in mood disorders can help understand their causes and improve treatment methods. Here are a few ideas to get you started.

• The impact of genetics on the susceptibility to depression
• Efficacy of antidepressants vs. cognitive behavioural therapy
• The role of gut microbiota in mood regulation
• Cultural variations in the experience and diagnosis of bipolar disorder
• Seasonal Affective Disorder: Environmental factors and treatment
• The link between depression and chronic illnesses
• Exercise as an adjunct treatment for mood disorders
• Hormonal changes and mood swings in postpartum women
• Stigma around mood disorders in the workplace
• Suicidal tendencies among patients with severe mood disorders

Anxiety Disorders

Research topics in this category can potentially explore the triggers, coping mechanisms, or treatment efficacy for anxiety disorders.

• The relationship between social media and anxiety
• Exposure therapy effectiveness in treating phobias
• Generalised Anxiety Disorder in children: Early signs and interventions
• The role of mindfulness in treating anxiety
• Genetics and heritability of anxiety disorders
• The link between anxiety disorders and heart disease
• Anxiety prevalence in LGBTQ+ communities
• Caffeine consumption and its impact on anxiety levels
• The economic cost of untreated anxiety disorders
• Virtual Reality as a treatment method for anxiety disorders

Psychotic Disorders

Within this space, your research topic could potentially aim to investigate the underlying factors and treatment possibilities for psychotic disorders.

• Early signs and interventions in adolescent psychosis
• Brain imaging techniques for diagnosing psychotic disorders
• The efficacy of antipsychotic medication
• The role of family history in psychotic disorders
• Misdiagnosis and delayed treatment of psychotic disorders
• Co-morbidity of psychotic and mood disorders
• The relationship between substance abuse and psychotic disorders
• Art therapy as a treatment for schizophrenia
• Public perception and stigma around psychotic disorders
• Hospital vs. community-based care for psychotic disorders

Personality Disorders

Research topics within in this area could delve into the identification, management, and social implications of personality disorders.

• Long-term outcomes of borderline personality disorder
• Antisocial personality disorder and criminal behaviour
• The role of early life experiences in developing personality disorders
• Narcissistic personality disorder in corporate leaders
• Gender differences in personality disorders
• Diagnosis challenges for Cluster A personality disorders
• Emotional intelligence and its role in treating personality disorders
• Psychotherapy methods for treating personality disorders
• Personality disorders in the elderly population
• Stigma and misconceptions about personality disorders

Obsessive-Compulsive Disorders

Within this space, research topics could focus on the causes, symptoms, or treatment of disorders like OCD and hoarding.

• OCD and its relationship with anxiety disorders
• Cognitive mechanisms behind hoarding behaviour
• Deep Brain Stimulation as a treatment for severe OCD
• The impact of OCD on academic performance in students
• Role of family and social networks in treating OCD
• Alternative treatments for hoarding disorder
• Childhood onset OCD: Diagnosis and treatment
• OCD and religious obsessions
• The impact of OCD on family dynamics
• Body Dysmorphic Disorder: Causes and treatment

Post-Traumatic Stress Disorder (PTSD)

Research topics in this area could explore the triggers, symptoms, and treatments for PTSD. Here are some thought starters to get you moving.

• PTSD in military veterans: Coping mechanisms and treatment
• Childhood trauma and adult onset PTSD
• Eye Movement Desensitisation and Reprocessing (EMDR) efficacy
• Role of emotional support animals in treating PTSD
• Gender differences in PTSD occurrence and treatment
• Effectiveness of group therapy for PTSD patients
• PTSD and substance abuse: A dual diagnosis
• First responders and rates of PTSD
• Domestic violence as a cause of PTSD
• The neurobiology of PTSD

Neurodevelopmental Disorders

This category of mental health aims to better understand disorders like Autism and ADHD and their impact on day-to-day life.

• Early diagnosis and interventions for Autism Spectrum Disorder
• ADHD medication and its impact on academic performance
• Parental coping strategies for children with neurodevelopmental disorders
• Autism and gender: Diagnosis disparities
• The role of diet in managing ADHD symptoms
• Neurodevelopmental disorders in the criminal justice system
• Genetic factors influencing Autism
• ADHD and its relationship with sleep disorders
• Educational adaptations for children with neurodevelopmental disorders
• Neurodevelopmental disorders and stigma in schools

Eating Disorders

Research topics within this space can explore the psychological, social, and biological aspects of eating disorders.

• The role of social media in promoting eating disorders
• Family dynamics and their impact on anorexia
• Biological basis of binge-eating disorder
• Treatment outcomes for bulimia nervosa
• Eating disorders in athletes
• Media portrayal of body image and its impact
• Eating disorders and gender: Are men underdiagnosed?
• Cultural variations in eating disorders
• The relationship between obesity and eating disorders
• Eating disorders in the LGBTQ+ community

Substance-Related Disorders

Research topics in this category can focus on addiction mechanisms, treatment options, and social implications.

• Efficacy of rehabilitation centres for alcohol addiction
• The role of genetics in substance abuse
• Substance abuse and its impact on family dynamics
• Prescription drug abuse among the elderly
• Legalisation of marijuana and its impact on substance abuse rates
• Alcoholism and its relationship with liver diseases
• Opioid crisis: Causes and solutions
• Substance abuse education in schools: Is it effective?
• Harm reduction strategies for drug abuse
• Co-occurring mental health disorders in substance abusers

Choosing A Research Topic

These research topic ideas we’ve covered here serve as thought starters to help you explore different areas within mental health. They are intentionally very broad and open-ended. By engaging with the currently literature in your field of interest, you’ll be able to narrow down your focus to a specific research gap .

It’s important to consider a variety of factors when choosing a topic for your dissertation or thesis . Think about the relevance of the topic, its feasibility , and the resources available to you, including time, data, and academic guidance. Also, consider your own interest and expertise in the subject, as this will sustain you through the research process.

Always consult with your academic advisor to ensure that your chosen topic aligns with academic requirements and offers a meaningful contribution to the field. If you need help choosing a topic, consider our private coaching service.

You Might Also Like:

Good morning everyone. This are very patent topics for research in neuroscience. Thank you for guidance

What if everything is important, original and intresting? as in Neuroscience. I find myself overwhelmd with tens of relveant areas and within each area many optional topics. I ask myself if importance (for example – able to treat people suffering) is more relevant than what intrest me, and on the other hand if what advance me further in my career should not also be a consideration?

This information is really helpful and have learnt alot

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Home > Public Health > IPH_CAPSTONE

Public Health Capstone Projects

Capstone projects from 2024 2024.

PrEP Inequities Among Black and Latino MSM in the United States: Identifying Barriers and Opportunities Using a Social Ecological Model (SEM) Framework , Ryan Fisher

The Association between Oral Contraceptives and Cardiovascular Disease: A Biomarker Analysis using Total Cholesterol, Low-Density Lipoprotein, and High-Sensitivity C-Reactive Protein , Maryam Z. Kenning

The Relationship between Mental and Environmental Health in Urban Salvador Brazil: Development of a Research Protocol , Rashad Parmer

Analyzing the Associations between Pre- and Post-COVID-19 Pandemic Childhood ADHD Prevalence, Demographics and Environmental Factors in the United States , Reisha Rhodenbaugh

The Most Diverse Square Mile in America: Sociodemographic, Health Profiles, and Access to Healthcare among the Refugee, Immigrant, and Migrant Population in Clarkston, Georgia , Win Min Thein

Capstone Projects from 2023 2023

Positive Behavior Support Parent Academy Curriculum - An Additional Approach , Lupe Arteaga

Association between Socio economic Factors and Contraceptive Use among Married Women in Guinea and Mali: An Examination of the Demographic and Health Survey Data 2018 , Mamadou Abdoulaye R Diallo

Fall Risk Assessment of Elderly Community-Dwelling Individuals , Jha'Meisheia Griffin

Reducing Health Disparities for U.S. Hispanics by Increasing the Cultural Literacy of Nutrition Professionals , Norma Esther Guardado López

The Associations between Selected Demographic, Socioeconomic, and Health Factors for Depression in Elderly Americans , Pema Lhewa

Epigenetic Changes and Health Disparities: An Evaluation Plan for Mamatoto Village Programming , Diamond T. Robinson

Adapting the International Protocol for Sexual Violence within the Department of Defense: Sexual Assault Prevention & Response Office , Tehnyat Sohail

Stigma, Social Norms, and Culture as Mediators of HIV and AIDS Incidence in South Africa , Skyeisha Swain

Capstone Projects from 2022 2022

Survival of Anthrax Patients with Fluid Collections by Treatment Status , Sophie Binney

A Review of Economic Policies to Reduce and Prevent Child Maltreatment and Other Adverse Childhood Experiences , Kaila Farmer

Behavioral and Epidemiological factors behind Vaccine Hesitancy in The United States , Maggie Hanusek

The Evaluation Plan for the LGBTQ+ Runaway & Homelessness Youth (LRHY) Outreach Program , Jade Matthews

Analysis of the Association between Physical and Mental Health in Adults: Understanding the Literature and Developing a Plan for Future Research , Max Moskowitz

Health Insurance Status and Severe Maternal Morbidity Outcomes in the United States - A Policy Review , Adejumobi Otekunrin

The Associations Between Overweight/Obesity Among Children and Select Social and Economic Predictors , Lauren A. Powell

“We Really are Seeing Racism in the Hospitals”: Racism and Doula Care , Ayeesha Sayyad

Concepts for Antiracist Policy Formulation , Sophia Steinberg

“a Doula Is Not a Visitor...a Birth Doula Is an Essential Part of the Birth Team”: Interprofessional Dynamics among Doulas, Doctors, and Nurses , Kaniya Williamson

Capstone Projects from 2021 2021

Challenges and Prospects of Implementing Mobile Health in Angola: Lessons Learned from Kenya and Denmark. , Maria da Graca Ambrosio

Evaluating Funding Structures of Federally Qualified Health Centers (FQHCs) in Metropolitan Atlanta: A Basis for Public Policy , Mamta Sanam Chaudhary

Levels of Engagement in a Comprehensive Parenting Intervention to Reduce Child Neglect Among Mothers without a High School Diploma: A Profile Examination , De Gao

The Need for Speed: Broadband Access as a Social Determinant of Health , Mwoddah Habib

An Evaluation Plan for Georgia's Injury Prevention Program , Joy Ngene

Examining United States Drug Policy from 2010-2021: A Qualitative Summation Using PEST Framework Model , Izadora A. Nunes

U.S. Rural Healthcare Shortage: A Review of Strategies in the U.S., Canada, and Colombia. , Carlos Perez

Comparing Water Quality Data of Atlanta's Sewage Overflows and Spills , Bonnie M. Pirlot

Policy Recommendations to Address Disproportionate Health Outcomes Caused by Healthy Food Access in Relation to Housing Districts Segregated by Class and Race , Roselyn Quarcoo

Characterization of Hand Hygiene Techniques Among Intensive Care Nurses: A Descriptive Study , Ashley L. Reyes

Analysis of Loss of Work during the COVID-19 Pandemic in the United States , Mira Shah

Research Proposal: COVID-19 Pandemic and Birth Experiences: Describing the Relationship Between Policies and the Birth Experiences of Georgia Mothers , Katherine Thornburgh

Georgia Commercial Sexual Exploitation of Children (CSEC) Resource and Protocol Guide , Sanon Williams

Developing and Disseminating the Children’s Environmental Health Index with Web GIS , Allegra Yeley

Branched Chain Amino Acids and Risk of Type 2 Diabetes Mellitus: A Literature Review , Alina Yemelyanov

Capstone Projects from 2020 2020

The Role of Policy in Preventing Adverse Childhood Experiences (ACEs) and Childhood Trauma in Georgia , Hallie Andrews

StayNeighbor: Community Platform for Essential Supplies and Services During the COVID-19 Pandemic , Samuel Archbold

Strategies in Maintaining Financial Sustainability of National Health Insurance Under A Single-payer System in Indonesia, Taiwan, and Canada: A Comparative Study , Arif Budiman

Aligning the Georgia Child Abuse & Neglect Prevention Plan with Governor Kemp's Priorities and Initiatives , Taylor Jennings

Healthcare for All: Achieving Universal Health Coverage (UHC) through the Strengthening of Health Systems , Diene Kaba

Youth Vaping: An Analysis of an Epidemic , Tina Kilpatrick

Georgia’s Child Sexual Abuse and Exploitation Prevention Technical Assistance Resource Guide (TARG) Evaluation Report , Maureen Oginga

U.S. Opioid Epidemic: Challenges and Opportunities for Evidence-based Policies , Imoh S. Okon

The Association between Mental Illness and Incarceration Among the African American/Black Population in the United States , Brittany Oladipupo

Capstone Projects from 2019 2019

A Cross-Sectional Study to Identify Factors Associated with Extrapulmonary Tuberculosis Among Foreign-Born In DeKalb County Georgia During 2008-2018 , Chinedu F. Egbuonu

WHO Drinking Water Guidelines , Aja Jagne

Evaluating Strategies for Community-sourced Photography for Mapping Alcohol Adverts in the Urban Slums in Kampala, Uganda , Joseph Madden

Community Organizing as a Vehicle to Promote Public Health in Clarkston, GA: A Literature Review & Case Study of Georgia Refugee Health and Mental Health , Maylott Mulugeta

The Use of Art to Increase Awareness about Mental Well-being and Promotion of Mental Health among the African American Community , Andromada Murden

Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Opt-out Testing in a Southern Federally Qualified Health Center (FQHC) , Leah Pinholster

A Resource Guide on the Epidemiology, Prevention, and Treatment of Opioid and Other Substance Use. , Anthony F. Rotoloni

Promoting an Urban Utopia: The Role of Community Gardens on Community Vitality , Kayla Danielle Staley

Augmenting Coastal Georgia’s Fresh-Water Supply while Reducing Local Salt-Water Intrusion into Groundwater Reservoirs , Forrest A. Strickland

Capstone Projects from 2018 2018

A Resource Guide To Empower Older Adults to Make Informed Health Decisions About Prescription Opioids And The Potential For Misuse , Kandia S. Al-Haddad

Program Evaluation Aspects of Atlanta Streets Alive , Rebecca A. Ament

A Systematic Analysis of Hepatitis C Virus Screening Trends and Linkage to Care Program in the United States , Ijeoma Azih

Understanding Educational Vulnerability in the Context of Disasters Using Visualizations , Cherish Caldwell

Tobacco-free Campus Post-implementation Program , Ashley Campbell

Examining the Relationship between Drought and Mental Health Outcomes of Depression and Anxiety in the U.S. , Robyn J. Cathey

Urban Water Planning in Lagos, Nigeria: An Analysis of Current Infrastructure Developments and Future Water Management Solutions , Adaure Chiori

A Review of Childhood Obesity Prevention Efforts among Evidence-Based Home Visiting Programs , Olga Costa

Prevention Messages to Reduce the Risk of Shigellosis among Men who have Sex with Men , Steve Evener

A Baseline Comparison of PATSCH and Parent as Teachers , Irasema Garcia-Rosales

A Mobile Initiative for Waste Disposal in Bringing Awareness to the Damage Littering Behavior Has on Storm Drains , Kimberly Hung

Examining the Community Outreach Efforts of Local African American Religious Organizations in Relation to Drug Use and HIV Transmission , Alyshia Jackson

A Qualitative Analysis of the Environmental and Personal Factors which Influence the Help-Seeking Behaviors of Men who have Sex with Men in Light of the Emerging Threat of Antimicrobial Resistance to Shigella Bacteria , Kathleen Jacobson

Alcohol Use among Orphans in Sub-saharan Africa: a Literature Review , Megan M. Mallett

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• Research article
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• Published: 01 December 2006

Describing the impact of health research: a Research Impact Framework

• Shyama Kuruvilla 1 ,
• Nicholas Mays 2 ,
• Andrew Pleasant 3 &
• Gill Walt 4  

BMC Health Services Research volume  6 , Article number:  134 ( 2006 ) Cite this article

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Researchers are increasingly required to describe the impact of their work, e.g. in grant proposals, project reports, press releases and research assessment exercises. Specialised impact assessment studies can be difficult to replicate and may require resources and skills not available to individual researchers. Researchers are often hard-pressed to identify and describe research impacts and ad hoc accounts do not facilitate comparison across time or projects.

The Research Impact Framework was developed by identifying potential areas of health research impact from the research impact assessment literature and based on research assessment criteria, for example, as set out by the UK Research Assessment Exercise panels. A prototype of the framework was used to guide an analysis of the impact of selected research projects at the London School of Hygiene and Tropical Medicine. Additional areas of impact were identified in the process and researchers also provided feedback on which descriptive categories they thought were useful and valid vis-à-vis the nature and impact of their work.

We identified four broad areas of impact:

I. Research-related impacts;

II. Policy impacts;

III. Service impacts: health and intersectoral and

IV. Societal impacts.

Within each of these areas, further descriptive categories were identified. For example, the nature of research impact on policy can be described using the following categorisation, put forward by Weiss:

Instrumental use where research findings drive policy-making;

Mobilisation of support where research provides support for policy proposals;

Conceptual use where research influences the concepts and language of policy deliberations and

Redefining/wider influence where research leads to rethinking and changing established practices and beliefs.

Researchers, while initially sceptical, found that the Research Impact Framework provided prompts and descriptive categories that helped them systematically identify a range of specific and verifiable impacts related to their work (compared to ad hoc approaches they had previously used). The framework could also help researchers think through implementation strategies and identify unintended or harmful effects. The standardised structure of the framework facilitates comparison of research impacts across projects and time, which is useful from analytical, management and assessment perspectives.

Researchers are increasingly, and regularly, requested to describe the impact of their work in:

Grant proposals, especially sections on research users, beneficiaries, communication and expected impact;

Research project evaluations and reports, particularly to provide accountability for funds invested in research;

Publicity information e.g. for institutional annual reports and press releases that highlight "success stories";

Research dissemination and implementation strategies;

Assessments of the impact of research on policy, practice and public opinion;

Individual and institutional research assessment exercise (RAE) submissions.

However, researchers are often hard-pressed to come up with coherent and comprehensive narratives of actual or potential research impacts and produce ad hoc accounts that do not facilitate comparison across time or learning across cases. More specialised research impact assessment studies can be difficult to replicate and may require resources and skills not available to individual researchers [ 1 , 2 ]. Further, the specialised focus of these models, for example on publications and economic benefits, may not cover a range of other areas where research could have impact. For example with regards to health research, environmental effects and social capital are increasingly associated with health outcomes and are areas where research can have impact [ 3 – 5 ], but are often neglected in existing health research impact assessment models and frameworks. A research impact scoping exercise at the London School of Hygiene and Tropical Medicine (LSHTM) identified some additional areas in which health research can have impact, such as on policy networks and on other sectors such as energy, that are also often missing in existing frameworks and models of health research impact [ 6 ].

In this paper we take a practical approach to help researchers describe the impact of their work. We present the Research Impact Framework , which is designed as a 'DIY' approach with descriptive categories that prompt researchers to systematically think through and describe the impact of their work. The framework was also designed with some additional goals in mind: to develop a standardised framework to help describe impacts across research topics and methods and facilitate comparison across time and cases; to guide researchers in planning research implementation and evaluation strategies; to facilitate researchers in looking at the broader influences and effects on and of their work in society; to promote research accountability in relation to the use of resources and the consequences of research; to help in the attribution of effects to health research given the range of other determinants of health and societal impacts; and to contribute to more extensive or specialised evaluations of research impact.

Researchers' narratives of the impact of their work could also serve as building blocks for a variety of more specialised analytical purposes. For example, researchers' accounts are considered a starting point for more specialised research impact assessments and can provide similar findings, though the level of detail and analysis may differ [ 7 ]. In analysing the role of research in diffusion of innovations, Greenhalgh et al. [ 8 ] found that "researchers in different traditions had conceptualised, explained and investigated diffusion of innovations differently and had used different criteria for judging the quality of empirical work. Moreover, they told very different over-arching stories of the progress of their research." Thus researchers' narratives also facilitate analysis of differences in the 'doing', diffusion and impact of research within and across research fields [ 8 ].

While the Research Impact Framework provides a simple, practical approach to developing research impact narratives, it is important to recognise that these narratives are generated and assessed in the context of historically rich and complex, often contending, views on the role of science and its relationship with society. Some may align with Bacon's [ 9 ] utopian vision wherein wise and benevolent rulers coordinate and disseminate research for the good of the state. Others take a 'Republic of Science' view, espoused by Polyani [ 10 ] and Vannevar Bush [ 11 ], where science is idealised as an independent enterprise, separate from societal concerns and having intrinsic value in and of itself. However, researchers on the sociology of scientific knowledge posit that science and society are interlinked and mutually influential [ 12 , 13 ]. Further, Kuhn [ 14 ] and Callon [ 15 ] among others, discuss how science itself is a social enterprise with researchers interacting within specific scientific cultures and communities.

There may also be different types of impact expected from different types of research, for example basic, applied, action, clinical, user driven, translational or curiosity-driven research. Then there are contesting and complementary theories and models of causal pathways of research impacts associated with different levels and types of impact on research, policy and practice [ 16 – 19 ]. Several academic disciplines including communication, diffusion of innovation studies, policy science, sociology of scientific knowledge and organisational research all offer valuable perspectives on different aspects of assessing the production, communication, utilisation and impact of research [ 20 ]

Further considerations in describing research impacts include questions of accountability, for example, whether there is a different standard of accountability for researchers compared with practitioners with regards to impact [ 21 ]. There are also concerns about whether research impacts are positive or negative (and for whom) and what individual or institutional biases and incentives may operate in describing impact. Prioritisation of impact is another assessment issue, though priorities may vary in accordance with different funders' priorities, in different research fields and in different socio-political contexts.

Researchers may variously ascribe to different worldviews and may take into account various assessment considerations, either knowingly or unknowingly, when describing the impact of their work. However, the Research Impact Framework presented in this paper is not aligned with any particular philosophy, is not in itself evaluative and does not prioritise impacts or propose causal pathways. The Research Impact Framework was primarily designed as a practical tool to help researchers think through and describe the impact of their work; this could then serve a range of practical and analytical purposes as required.

While much of the framework presented in this paper could apply to research impact narratives in general, specific considerations warrant a topical focus on health research, which is defined as "the generation of new knowledge using the scientific method to identify and deal with health problems" [ 22 ]. While health research is nested within the larger science and technology enterprise, there are a multitude of social, governmental, academic, service, manufacturing and legal institutions specifically in place to deliver the products of health research to society [ 23 ]. Further, a systematic review on the diffusion of innovations, including research, emphasized the need for "building up a rich picture of process and impact" in health services [ 24 ].

To address the gaps in existing approaches to and models of health research impact assessments, we first drew from the literature on health research impact assessment models and criteria to map out a framework of health research impacts. This framework was then tested and modified against impacts identified by LSHTM researchers working on a wide range of health research topics. Using the Research Impact Framework allowed individual researchers to identify and select impacts relevant to their work and develop impact narratives without requiring specialised skill in the field of research impact assessment. The standardised descriptive categories also facilitated analysis across the narratives. The methods used to develop the Research Impact Framework are described in the following section.

Our objective was to develop a conceptual framework to help health researchers think through and describe the possible outcomes of their work. A framework is a way of setting out a range of possible variables related to the issue of interest, but does not necessarily identify the relationships between them [ 25 ] or provide an evaluative judgement of the variables. For example, the fallout from the controversy of research linking the MMR vaccine with autism received substantial coverage in scientific journals and in the media and had various adverse effects such as a drop in immunisation rates [ 21 ]; a framework would include these areas of impact, but would not evaluate the nature of this impact. We developed a conceptual framework that covered a wide range of potential areas of health research impact, and standardised ways of describing them, so that individual researchers without any specific training in research impact assessment could use the framework to describe the impact of their work, selecting descriptive categories as per relevant purposes, priorities and assessment criteria.

To develop the Research Impact Framework, we first mapped out potential research impact areas based on a review of the main health research impact assessment approaches. The goal was not to conduct an exhaustive review of the literature, or to analyse the causal claims of different impact assessment models, but only to identify and map out the scope and coverage of potential areas of health research impact across a range of models, frameworks and criteria. The approaches we drew on to map the health research impact areas, and there were was overlap between them, were the Payback Model of health research benefits [ 18 ], a framework to analyse Health Research Systems [ 23 ], a 'knowledge transfer' approach to assessing the impact of research [ 26 ], a model of the path from evidence generation to clinical application [ 27 ] as well as economic approaches to assessing health research impact, such as the Funding First approach, which includes calculations of the economic value of increased life expectancy resulting from investments in research [ 28 ]. We also drew on frameworks that did not explicitly focus on health research, but explicated the links between globalization and health [ 3 ], pathways of communication and social change [ 29 ] outcomes of health promotion [ 30 ] and the non-financial constraints in health systems [ 31 ] as these are all areas where health research potentially could have impact. Research assessment criteria, for example, as proposed in the OECD's Oslo Manual [ 32 ], criteria for the initiation and evaluation of National Institutes for Health (NIH) Extramural Center Programs [ 33 ] and the UK Research Assessment Exercise [ 34 ], further informed the development of the Research Impact Framework by highlighting contemporaneous criteria against which the significance and impact of research are judged.

We turned this initial mapping of potential research impact areas into a semi-structured interview guide, designed to be used in interviews with researchers to develop narratives, or case studies of research impact (See Table 1 ). LSHTM-based projects were purposefully selected for maximum variation [ 35 ] with reference to project topics and with regards to the familiarity of the principal investigators with research impact assessment concepts. The study was initially developed in the Department of Public Health and Policy (PHP) at LSHTM and included primary analysis of the impact of seven research health services and policy research projects and secondary analysis of four other research projects based on impact assessments previously conducted [ 6 ]. These projects covered a wide range of topics: health care financing reform, bilingual young people's agency in facilitating health care access for their families, climate change and health, primary care-led commissioning in the NHS, a clinical audit of sino-nasal surgery, epidemiological analysis of cold-related morbidity and mortality, the public health implications of the trafficking of women and adolescents, the UK National Prospective Tonsillectomy Audit and HIV/AIDS-related research [ 6 ]. The study was then expanded beyond PHP to further develop the Research Impact Framework based on analysis of four 'basic' or 'technical' research projects selected from the departments of Epidemiology and Public Health (EPH) and Infectious and Tropical Disease (ITD). These research projects focused on insecticide treated bed nets to prevent malaria, handwashing with soap to prevent diarrhoeal diseases, morbidity and mortality related to road traffic injuries, and the use of epidemiological methods in genomics research.

The principal investigators (or LSHTM focal points in collaborative projects) of the selected research projects were interviewed using the semi-structured interview guide that was structured according to the mapping of research impact areas (See Table 1 ). Principal investigators were selected as the main interviewees because they were primarily responsible for drawing up descriptions of research impact in grant proposals as well as in final project reports. In addition, LSHTM colleagues whose expertise included research impact assessment as well as the heads of the research units were interviewed, not on the substance of the individual projects per se, but on the development of the Research Impact Framework. One investigator conducted all the interviews that took around 45 minutes each, and took contemporaneous notes. Information was also gathered from research project documents including reports, published papers and correspondence. The data were analysed based on a thematic analysis using the descriptive categories of the framework as the main themes.

This process helped to both test and further develop the framework, for example, through the identification of additional areas of impact, such as intersectoral services related to vector control, road safety and climate change, that were not included in the initial mapping based on the literature review alone. These data were used to further develop and refine the initial mapping of health research impact areas to produce a final version of the Research Impact Framework (See Table 2 ).

Within each impact area in the Research Impact Framework, we also identified descriptive categories in the literature, discussed in following sections, to support and help standardise the development of research impact narratives to enable comparative analysis across projects. Through an iterative and consultative process with LSHTM researchers involved in the selected projects, we determined which terms and categories were most useful to help researchers structure narratives of research impact.

The Research Impact Framework was thus validated through congruence with the literature on health research impact assessment, as well as through empirical analysis of research projects. Researchers in the LSHTM study found the approach more systematic than the more usual ad hoc and guess work-based process. The framework also provided new perspectives on potential and actual health research impacts and allowed for comparison of impact and assessment-related issues across the selected projects [ 6 ].

In this paper, the Research Impact Framework is presented, including the main health research impact areas and the descriptive categories within them. Examples from the LSHTM study and from the research impact assessment literature are used to illustrate key points.

Results: the Research Impact Framework

We identified four broad areas to structure a framework of health research impacts, based on a literature review as well as an empirical analysis of selected LSHTM research projects:

Research-related impacts

Policy impacts

Services impacts: health and intersectoral

Societal impacts

Within each of these areas, key descriptive categories were identified (See Table 2 ). By listing this broad range of health research impact areas, we do not propose that all these impacts should be expected or targeted all the time. Neither do we suggest that these are necessarily mutually exclusive categories. Rather, the framework offers an overview of potential, and sometimes overlapping, research impact areas that can serve as a series of prompts or a checklist that researchers can select from or modify, as appropriate to the research being described and taking into account, for example, funders' priorities or research assessment criteria.

I. Research-related impacts

Research can have impacts within the research field itself that can be described using the following categories:

Type of problem/knowledge

Research methods

Publications and papers, products, patents and translatability potential.

Research networks

• Leadership and awards

Research management

Communication

Type of problem/knowledge addressed.

The type of problems addressed and knowledge generated through research are primary areas in which to describe impact. The following adaptation of a categorization by Nutley, Walter and Davies [ 16 ] helps think through this area of research impact and research projects may address more than one of these categories.

Data about a problem/phenomenon: e.g. statistics and trends showing declining vulnerability to temperature-related mortality in London over the 20th century [ 36 ].

Definitions and concepts: e.g. the concept of equity in health care financing.

Rationale for action/possible solutions: e.g. rationale for health promotion strategies based on evidence that hand washing with soap helps prevent diarrhoeal diseases [ 37 ].

Evidence of effectiveness of interventions: e.g. through clinical audits of different surgical techniques.

Information on how to implement solutions: e.g. methods to promote the purchase and treatment of bed nets with insecticide by communities themselves, an effective, equitable and sustainable strategy to prevent malaria [ 38 – 40 ].

New research topics in a field: e.g. public health research has been extended to topics such as the public health implications of climate change [ 41 ] or road traffic injuries [ 42 ] and new knowledge on the determinants of health is continually produced.

Addressing research gaps and testing new hypotheses: e.g. gaps in existing research can be identified through systematic reviews of the literature on a topic and studies may be designed to address these gaps or to test new hypotheses.

Ethical debates and guidelines: e.g. the development of new ethical guidelines for research on violence against women [ 43 ].

Responsiveness/public interest: e.g. research responding to topics of public interest or on government and media agendas, such as research on obesity or teenage pregnancy; or research that contributes to issues becoming topical in the media or in policy and analysis of the same.

This area of impact covers the mode of research employed or a researcher's methodological contribution to the overall study. Knowledge evolves along a continuum that ranges from applying models that have worked elsewhere to trying out something completely new [ 16 ]. Thus, in addition to describing the actual methods used (e.g. survey research, face-to-face interviews, case studies, multi-variate analysis) categories to describe methodological impact include:

Replication of a study.

Application of established methods.

Further development / extension of methods, such as the application of Bayesian modeling techniques in emerging genomics research to study genotype-phenotype associations around a causative site, including relative risk of a causative allele and mode of inheritance [ 44 ].

Innovation in terms of developing new research methods, for example, new methods for accessing "hard-to-reach" groups, and the use of new technologies such as GIS in research.

Synthesis of research involves review and appraisal across several research projects and can help determine whether theories are adequately tested before applying them to practice and policy, indicates if resources are being wasted on new research on topics previously and conclusively studied, facilitates analysis of new evidence in the context of previous evidence, and highlights gaps in current knowledge. There are a variety of methods used to synthesise diverse forms of qualitative and quantitative evidence, for example systematic reviews as set out by the Cochrane [ 45 ] and Campbell Collaborations [ 46 ]; methodological development in the area of research synthesis is ongoing [ 47 ].

This is the perhaps most familiar part of the framework for researchers, as the impact of research is commonly described based on publications, in tenure and performance reviews to research utilisation analysis and research assessment exercised, using measures such as [ 33 , 34 , 48 ]:

Publications in scientific journals and the 'impact factors' of the journals

Technical reports , project reports, position statements etc, which while often considered as 'grey literature', can sometimes be more rigorously peer-reviewed than scientific publications and are widely read.

Citations of research publications by other researchers.

Products and processes . The OECD Oslo Manual [ 32 ] classifies technological innovation as comprising:

◦ Introduction of a new product

◦ Qualitative change in an existing product, for example improved technologies, sometimes referred to as 'better mousetrap' solutions

◦ Process innovation that is new to an industry

◦ Opening of a new market

◦ Development of new sources of supply for raw materials or other inputs; and changes in industrial organisation.

Other specific examples of research products include vaccines and drugs, decision algorithms, mathematical models, information tools and resources e.g. geographical information systems; training manuals, databases, health education materials etc.

Patents of research information or products and citations of patents by other researchers, are another area of potential research impact [ 32 ]. For example, an analysis of citations of U.S. industry patents showed a strong national linkage with "each country's inventors preferentially citing papers authored in their own country, by a factor of between two and four" [ 49 ].

Commercial development of scientifically developed products including commercial licences and spin off companies. This may also include the influence of research on product development and marketing processes [ 32 ].

Translatability potential of research refers to the potential for the translation of research findings, particularly in basic science, to clinical applications [ 33 ] or to technological opportunities and outcomes [ 32 ]. Indicators of translatability potential include publications in clinically oriented journals, patent applications, licenses issued and clinical trials underway or completed [ 33 ]. The term is also used to discuss the extent to which the research can be applied in other study contexts as well as in other disciplinary fields. This area of research impact is receiving increased attention as new, and at times controversial, partnerships between industry and business, government and non-governmental organizations and university-based research units and researchers continue to develop [ 50 ].

Research networks and user involvement

Developing and maintaining research collaborations as well as client and user involvement in research are increasingly desired goals as they are seen to increase the reach, responsiveness, relevance, dissemination and impact of research [ 19 , 51 , 52 ]. Research partnerships usually involve researchers, research groups and institutes who jointly submit a research grant application, for example, and work together on a research project. Other partners as well as potential research clients and users may be involved at various stages of the research process from ethics review processes to research commissioning, collaborative research and project evaluation. For example, the Canadian Health Services Research Foundation specifically focuses on building 'linkage and exchange' between researchers and policy-makers in research priority setting, funding, proposal assessment and in the conduct and communication of research, in order to enhance the utilisation and impact of research on policy as well as to evaluate this impact [ 53 ]. Listing research collaborators, other partners, clients and users, as well as their specific involvement in the research, provides a useful description of this area of research impact.

Research leadership

Leadership in research, is often a key area of interest in research assessment exercises [ 34 ] and may be related to a specific project or to a body of work. Research leadership can be documented by referring to:

Role in setting the agenda or standards for a field of research or setting out a vision for the same.

Leadership in coordinating and managing research projects and multi-institutional research collaborations.

Public recognition of leadership including prestigious fellowships, named lectures and keynote addresses, awards that mark significant achievement in research, or membership in honorary scientific societies.

Membership of regional, national or international research bodies , review boards and funding bodies.

Editorship of journals or membership on journal editorial boards and advisory committees.

Research system management

A health research system is defined as the people, institutions, networks and activities whose primary purpose is to generate, communicate and promote the utilization of scientifically validated knowledge that can be used to enhance, restore and/or maintain the health status of populations [ 23 ]. Research can have an impact on research system management by:

Expanding health research system linkages for multidisciplinary and cross-sectoral research [ 33 ]. For example, the advantages of coordinating health and environmental impact assessments are increasingly recognized [ 54 ].

Changing research priority setting, investment strategies, resource allocation and accounting processes . Research can highlight gaps in resource allocation for research, for example in relation to health research priorities and in terms of equitable allocation of research resources to address the needs of different populations [ 33 , 55 ].

Developing capacities to conduct research and providing opportunities for training and development of researchers [ 23 , 33 , 56 ].

Changing the research environment in relation to working conditions, incentives, job retention rates, recruiting and retaining women in science and overall researcher satisfaction [ 23 , 33 ].

Influencing health research system performance and assessing comparative advantages of different research systems [ 23 , 32 ].

Studies have long shown that researchers feel handicapped in their involvement in research communication due to lack of time, resources and incentives and that research is disseminated mainly through existing networks within the scientific community [ 52 ]. This is not only due to limited capacity, but also because the 'popularisation' of research has been perceived to be in conflict with the norms and standards of science [ 57 ]. These findings were reflected in the LSHTM study as well [ 6 ]. Nevertheless, as found in the LSHTM study, researchers do employ various modes of research dissemination, often on their own initiative. Potential target audiences and modes of dissemination for research are listed below.

Target audiences

Academic/research institutions and programmes

Donor government/bilateral agencies (e.g. DFID, USAID)

Public/consumer organisations and groups

Government offices/agencies

Health insurance organizations

Hospitals and clinics, practising physicians, nurses, allied health professionals etc.

International organisations (e.g. UN, WHO, World Bank)

Media and entertainment groups

Non-governmental organisations (NGOs)

Other private sector companies/institutes

Pharmaceutical companies

Professional associations

Research funding councils/foundations/charities

Other research networks e.g. with more informal structures, sometimes termed epistemic communities [ 58 ]

Modes of research dissemination and implementation strategies [ 16 , 59 ]

Audit and feedback processes

Books: textbooks; technical; 'popular'

Conferences and workshops

Decision aids/algorithms/computer reminder systems

E-mail/list serve discussions

Face-to-face interaction/meetings

Films, documentaries

Health education and health promotion

Incentive systems (financial/professional) for use of research products

Interventions targeting health that apply research findings, for example social marketing of soap to promote hand washing and prevent diarrhoeal disease

Mass media: press releases and newspapers – articles and op eds; television; radio; magazine; and Internet

Opinion leaders

Organisational/systems-level strategies

Policy briefs/recommendations

Public engagement activities

Formal academic talks/presentations

Translation of research for different users

Beyond listing of research communication activities, specific impacts of research communication could also be usefully described [ 29 ], for example in curricular use or media coverage as described below.

Curricular/educational use

The use of research findings and papers in educational curricula and courses is a key area of research impact [ 19 ]. In the LSHTM study, researchers noted as impacts in this area feedback from other researchers and institutions about the inclusion of publications on the selected research projects in course curricula or being invited as guest speakers on courses.

Media coverage

Research effects relating to media coverage include [ 60 , 61 ]:

Media coverage on a research project's findings; descriptive details including dates and any attribution or mention of a particular research project or researcher.

The nature of the coverage in terms of scientific accuracy and whether the research was viewed favourable or unfavourably; e.g. using headlines or quotes to illustrate the nature of media coverage.

Media coverage of individual researchers, e.g. their work, profile or personality; including whether researchers are depicted as being average everyday individuals or somehow different than the social norm; i.e. whether scientists are considered part of society or separate from it.

The long-term trends in covering health research in the mass media; e.g. the extent individual researchers are used as sources of information in the media, the position of health research within the news agenda; and the representation of health research and researchers in entertainment content.

II. Policy impacts

Increasingly, one of the main objectives of health research is to inform and influence policy and there are several potential impacts in this area:

Level of policy-making

Type of policy.

Nature of policy impact

Policy networks

Political capital.

Research can have an impact on policy-making at different levels and including different groups, for example, national and local politicians, health services administrators and managers/directors, representatives of local, national and international professional groups, NGOs and business leaders. In describing impact, the geopolitical level of policy impact, i.e. whether at international, national, or sub-national level, can be described as well as if the changes were localised to a particular organisation or network of organisations within those levels.

The type of policy influenced by research is another way that impact can be described. For example, Black [ 62 ] endorses a distinction made between: practice policies, service policies and governance policies. Type of policies may also be described in relation to particular types of policy institutions, for example, researchers in the LSHTM study discussed how findings on home temperature-related morbidity and mortality [ 63 ] were used in the UK parliament in support of the Housing Bill (2004). The publication of WHO guidelines on ethics related to research on women and adolescents who had been trafficked [ 43 ] that had been developed on the basis of a research project was cited another example of policy impact in the LSHTM study [ 6 ].

Nature of policy influence

There are several ways in which research can influence policy and Weiss (1998) identified four main modes of influence listed below [ 64 ]. There are a wide range of other categorisations of research to policy impact [ 65 ], including in Weiss's earlier work [ 17 ], describing rational, tactical and symbolic use of research in policy-making. In the LSHTM study, the following categories were found to be conceptually clear and relevant to policy impacts identified by researchers:

Instrumental use where research findings directly drive or define policy.

Mobilisation of support [supportive evidence] where research findings provide persuasive evidence to back ongoing and proposed policy activities or raise awareness and support for new policy-making, for example through writing policy briefs. As one LSHTM researcher noted, "Writing policy briefs gives us the opportunity to discuss the wider policy implications of our research and to anticipate and rehearse policy arguments ... Our work adds weight to policy deliberations." [ 6 ]

Conceptual use where research leads to new ideas and language that influence the nature and substance of policy discourse, for example the concept of equity is increasingly used in considerations of health care financing [ 66 , 67 ].

Redefining/wider influence refers to research impact that leads to a wide change or transformation of accepted beliefs and practices. This may involve overturning orthodoxies, as in the revolutionary shift in eighteenth century medical science from the concepts of vapours and humours to the constructs of anatomy and pathology [ 68 ]. More contemporary examples also indicate how research can lead to the changes in existing beliefs and practices. For instance, a multi-country randomised control trial found that widely accepted practice of administering corticosteroids after head injury could be harmful [ 69 ] with implications for both policy and practice on this topic.

In relation to a specific policy problem, networks of actors and institutions with particular interests and perspectives on that issue may pre-exist or form and interact in policy-making [ 70 ]. At times, these networks are referred to as epistemic communities and extend across normally disparate elements of research, policy, practice and the public, but are based on a common research-based understanding of the issue [ 63 ]. As with the dissemination of research through research networks, policy ideas and interests are often developed through policy networks. The extent to which researchers are part of, or inform, policy networks is, therefore, an important aspect of research impact. Collaborations with policy advocacy groups, think tanks and government institutions can be listed as part of this description. In the LSHTM study, researchers emphasised the importance of establishing networks that extended beyond the formal bureaucracy as "knowledge users include policy-makers as well as the range of civil society organisations." [ 6 ]

Research impact on political capital takes into account the value of research evidence and researchers themselves in policy negotiations, in reaching in high quality agreements and improvements to the policy-making process, in the ability in societies to achieve agreed-upon ends, in the socio-political prestige resulting from innovations, and in increased national security [ 71 ]. For example, research on negotiation and consensus building methods on health issues could contribute to improving the quality of deliberations and reaching agreements that are reliable and satisfactory to the parties involved [ 72 , 73 ].

III. Service impacts

The following categories help describe the impact of research on both health and intersectoral services.

Type of services: health/intersectoral

Evidence-based practice

Quality of care, information systems.

Services management

Cost-containment and cost-effectiveness

Type of services.

Health research, often primarily targeted at improving clinical and public health services, can have a range of impacts in this area that are detailed in the following sections on evidence based practice, quality of care, health information systems and on health services and systems management, including cost-effectiveness and cost-containment. Research on prevention and control measures for newly emerging diseases such as avian flu is another example of an area in which research can have an impact on health services [ 74 ].

In addition, health research can influence a range of other service sectors that contribute to public health. For example, in the LSHTM study researchers described how the WHO ethical guidelines, developed on the basis of a research project, for research on women and adolescents who were trafficked [ 43 ], were now being used to train journalists who conduct interviews on this topic and were also used in police training courses in several countries [ 6 ].

Living and work environments are associated with negative or positive effects on human health and are, therefore, critical areas for health research impact assessment [ 75 ]. For example, research on the health benefits of well-lit and safe places to work and exercise can contribute to reducing injury and promoting physical activity [ 76 ]. Impacts can also be described in the areas of measures undertaken, as a result of research, to reduce indoor and outdoor air pollution as well as in the use of more energy efficient devices [ 77 ].

Road traffic injuries are increasingly recognised as a major public health problem. Research could influence road safety and health, for example by highlighting issues for the regulation of vehicular use to facilitate safe walking and cycling, particularly for children [ 42 ] or by showing how the growth in sales of SUVs and pick-up trucks in the US contributed to a slower decline in road fatality rates there than in other industrialised countries [ 78 ].

Health research may also have an impact on vector control services, for example as related to studies on the cost-effectiveness of different types of insecticides to prevent malaria as well as on their safety for humans [ 39 ]. Additionally, clean drinking water and soil fertility are critically important to human health [ 79 ]. Thus, if applicable, research impact narratives could include descriptions of research impacts on food production and safety, water access and quality.

The impact of climate change and weather events on public health is another intersectoral area that is receiving increasing attention in health research. For example, in 2003, a heat wave resulted in numerous deaths across Europe, in France alone there were around 14,000 deaths [ 41 ]. This event raised the profile of climate change as a public health issue in Europe. Changes in forecasting and early warning systems as well as on related response mechanisms and guidelines, informed by research findings, are examples possible health research impacts in this area.

The use of research evidence by different groups involved in clinical diagnosis and decision-making is an indicator of research impact in health services [ 27 ]. Studies also indicate that in clinical decision-making and interviews between patients, their families and health professionals, the use of decision aids that are based on research evidence, can have significant effects on treatment decisions, choices and costs [ 80 , 81 ].

Research can also influence clinical practice and service delivery through [ 19 , 24 , 59 ]:

Adoption of research findings and health technologies by health service providers

Adherence to research-informed policies and guidelines and

Addressing barriers to the use of research-informed interventions in the health system. Potential barriers include inflexible organisational workflows, inadequate resources and staff training as well as staff and patient attitudes and beliefs.

Research-influenced changes in health services can lead to improved information on quality of care and improvements in quality of care itself. Quality of health care addresses [ 82 ]:

Efficacy of health interventions. For example, one of the studies included in the LSHTM analysis was a clinical audit of tonsillectomy surgical techniques where the findings were that that 'hot' surgical techniques – diathermy or coblation – had a higher risk of complication than cold steel tonsillectomy methods [ 83 ].

Availability of services, for example in different geographical regions.

Accessibility of services, especially for disadvantaged and vulnerable individuals and groups.

Acceptability of services provided, for example in terms of quality and cultural appropriateness.

Utilisation and coverage of health services. Research can inform strategies to improve the coverage of health services and can also have impact through the development of methods to assess coverage. For example, availability and accessibility of services or interventions are often used as a proxy of health services coverage. However, it has been proposed that coverage should be assessed by estimating the probability that those who need a particular intervention will actually receive it, the probability of their requiring the intervention in the future and the probability of receiving effective health services based on previous experience [ 84 ].

Responsiveness of health services to population health needs is a further area that can have impact vis-à-vis the quality of services.

A portion of health research is also directed toward improving the quality and efficiency of public health monitoring, reporting and evaluation. Possible indicators of the effects of research in this area include the accuracy, completeness, efficiency, relevance and timeliness of health monitoring and reporting systems, e.g. health information systems and GIS tools. For example, research in Turkey compared health information systems across 729 hospitals run by either the Ministry of Labor and Social Security or the Ministry of Health [ 85 ]. The study highlighted several differences in the use of health information systems across the two ministries that would need to be addressed given a proposed merger of the hospitals. This type of research could have an impact on the way health information systems are developed and used.

Health systems and services management

The extent to which research contributes to changes in health systems management and administration is therefore another important area of potential impacts. For example, management of health services procurement and provisioning in both private and public sectors can also be influenced by research [ 86 ]. In assessing the impact of research on the management of health systems and markets, there is a broad range of considerations including health care financing and insurance. In addition, Hanson et al. [ 31 ] provide a conceptual framework to analyse non-financial constraints in health systems including sociopolitical changes, intersectoral issues, such as transport to health facilities and planning for long-term outcomes such as improving health by promoting female education.

Cost-containment , while obviously related to health systems management is often a particular focus for assessing the impact of research on health services provision and health system management. This can have far-reaching implications for how health systems resources are allocated and used [ 87 ].

Cost-effectiveness of health services is another common focus in health research impact assessment and can be studied by analysing research-related changes in health systems in terms of both expenditure and related health outcomes [ 87 ]. In the LSHTM study, some research projects specifically included economic evaluations of the interventions being researched, for example the cost-effectiveness of social marketing of insecticide treated bed nets [ 88 ].

IV. Societal impacts

Finally, research impacts can be described in terms of impacts at a societal level with reference to:

Knowledge, attitudes and behaviour

Health literacy

Health status, equity and human rights, macroeconomic/related to the economy, social capital and empowerment, culture and art.

Sustainable development outcomes

Knowledge, attitude and behaviour impacts

As a result of research dissemination and implementation strategies, various research impacts on knowledge, attitudes and behaviour could be expected or targeted. For example, research information could lead to changes in:

Knowledge about and attitudes toward health risks and resources including the development of health self-efficacy. For example, in a study that was part of the LSHTM analysis, researchers had found that bilingual young people, while previously mainly viewed as an at risk group also served as a resource, often playing the role of translators and mediators in promoting their families' access to health care services [ 89 ]. These findings also led to changes in service institutions working with bilingual young people, to focus on both risks and resources in strategies aimed at improving access to health care [ 6 ].

Healthy behaviours e.g. nutrition and diet, physical activity, safe sex, immunisations and improved hygiene practices can be promoted and adopted as a result of health research being disseminated, for example through health education and health promotion activities.

However, care must be taken in predicting or describing direct effects from research-based information being communicated and the desired effects occurring. There are a host of intermediary effects and influences that complicate that process, including culture, local and socio-historical contexts, the framing and relevance of the issues as well as perceived benefits and risks related to the research, so these should be noted if possible [ 29 , 90 ].

Health literacy encompasses the wide range of skills and competencies required to find, understand, evaluate and use health information and concepts to make informed choices, reduce health risks and increase quality of life [ 91 ]. As such, health literacy is a key component of the complex relationship between knowledge, attitudes, decision-making, behaviour and health outcomes [ 30 , 92 ]. Thus, health literacy is a potential impact of health research. In addition health literacy can facilitate successful communication of health research or can be a potential roadblock in situations when health research is communicated in a manner not commensurate with the health literacy skills of the intended audience.

As one example of research that can have an impact on health literacy, traditionally malaria control strategies rely on the free distribution of insecticide treated bed nets through public health and donor agencies. However, research shows that approaches to malaria control approaches that raise awareness in communities about the causes and prevention of malaria and promote community skills and capacities to purchase and treat bed nets on their own, provide a more sustainable and equitable method of malaria control and significantly improve health outcomes [ 39 , 40 ].

Research can contribute to improvements in health status by contributing to interventions that reduce morbidity, mortality and disability and promote health as well as by developing methods to measure and monitor health status. However, the attribution of health status effects to research can be challenging given the range of other influencing factors and there are ongoing efforts to address this challenge [ 18 , 28 ]. There are various measures for assessing health outcomes such as Quality Adjusted Life Years (QALYs); Disability Adjusted Life Years (DALYs); and Health Adjusted Life Expectancy (HALE) and a host of specific measures related to particular diseases/conditions. As is the case for assessment in general, the choice of measure usually reflects researchers' preferences, decision-makers' needs and the focus of assessment. Research can therefore also have impact by elucidating the values and assumptions underlying health status assessment measures so that these can be deliberated on by a broad range of stakeholders [ 93 ]. Research impact on health outcomes can thus be assessed both in terms of changes in health outcomes as well as in methods of measuring health outcomes.

Health equity and the realisation of human rights are increasingly discussed as desired health research outcomes and need be taken into account at different levels of assessment, be they related to structure, process or outcome [ 94 , 95 ]. Research can also influence health equity outcomes by explicitly focusing on the needs of disadvantaged and vulnerable populations [ 96 ] as well as through the application of research to facilitate more equitable access to health care [ 67 ]. For example, there is concern that by focussing on mass interventions and targets set at the overall population level, the Millennium Development Goals may fail to address the needs of the most vulnerable and marginalised groups such as indigenous communities [ 97 ].

Human rights also include the right of individuals to participate in decisions that influence their lives and the right to information on the same. Additionally, the impact of participation on health outcomes is increasingly recognised. For example a randomised control trial showed that birth outcomes in a poor rural population in Nepal improved greatly through a low cost, potentially sustainable community-based participatory intervention with women's groups [ 98 ]. This type of research potentially has equity, human rights, methodological and health impacts.

There are several areas in which the economic outcomes of health research can be assessed [ 87 ]. The term 'macroeconomic' is used here to distinguish between impact on the overall economy (though the scale of impact may vary) and impact in terms of cost-savings and cost-effectiveness in the health care system, which was described in an earlier section.

There are various ways in which health research can have impact on the economy. The extent to which individual researchers have access to this level of economic analysis may vary, but some multidisciplinary research collaborations explicitly include an economic analysis of the proposed research-based intervention or technology and others may rely on post hoc economic evaluations.

Commercial outcomes can result from research in terms of monetary returns on investments in product development and marketing as well as from new or more efficient industrial processes [ 32 , 87 ].

The impact of research on private markets, particularly with regard to the distribution of health interventions, needs to be further understood and assessed. For example, research evidence indicating that the distribution of soap to promote hygiene and nets to prevent malaria is more effective and as equitable when done through local markets than through the public health system, including to poor populations [ 38 , 99 ]. These findings have influenced how some public health programmes implement related strategies.

Healthy workforce outcomes can also impact the economy. For example, analyses of the economic impact of health services research combine cost savings in health care provision with the economic value of a research intervention in terms of working days lost and produce a single metric of economic impact [ 100 ].

The value of health gain (or loss) from research to societies in monetary terms. For example, the Funding First approach calculates the economic value of improved health and life expectancy resulting from investment in and application of research-based health interventions, e.g. to treat cardiovascular disease [ 28 ]. Evaluation of health outcomes in economic terms, however, is subject to criticism even from those who use the approach, as evaluating human life in monetary terms is ethically controversial. Other potential problems include the equity implications of such approaches, for instance, evaluating the impact of health research in terms of productivity could favour research primarily focused on those of working age and/or those with higher incomes [ 101 ].

Social capital is increasingly viewed as a desired resource in societies and studies also find that there are links between social capital and health outcomes [ 4 , 5 ]. Therefore the contribution of research to the development of social capital and its assessment is a key area of impact. Social capital is measured through a variety of social research techniques and the context of the assessment is an important consideration, but many authors seem to agree on the importance of the following as measures of social capital [ 4 , 5 ]:

Civic engagement and social cohesion (through social interaction, mobilisation and connections as well as the development of shared knowledge and concepts).

Self-efficacy and collective efficacy (the ability and resources for problem solving at individual and societal levels).

Trust (in other individuals and groups in society). For example, in a series of surveys in the UK on who people generally trusted to tell them the truth, doctors and teachers were listed first, scientists and the 'ordinary man/woman in the street' were near the middle and politicians and journalists were at the bottom of the list [ 102 ]. Similar surveys have been carried out in other countries [ 103 ]. Research can generate information that affects peoples' trust of different groups. In addition, trust in researchers themselves is associated with the support and use of science.

Research that empowers communities to access, understand and use health research informed interventions, as earlier discussed with reference to the malaria control example, and to take ownership of health promotion efforts [ 30 ] is another key area of health research impact.

Culture refers to patterns of human learning and activity that lead to shared communication, artefacts and characteristics in societies; including language, patterns of behaviour, beliefs, identity, customs, traditions and other modes of expression [ 104 ]. These learned characteristics enable group members to hold and communicate shared meanings. The ability to influence culture is the also the ability to influence conceptions and categories that guide behaviour [ 105 ], including health behaviour. Health research generates new concepts and knowledge that influences societal culture (though the relationship works both ways). Health researchers are also constantly renegotiating the boundaries between what is considered traditional medicinal practice and research-based evidence as well as on what constitutes health and ill health. For instance, Maori researchers in New Zealand found that they were able to apply the methods and values of both indigenous and scientific knowledge in order to reach more comprehensive understandings of health and illness [ 106 ].

Arts and entertainment is a particular area where the influence of and on health research has generated interest in 'lay' society [ 107 ]. Some scientists serve as advisors on movies and TV shows. For example, the Journal of Public Health Policy reviewed the film The Constant Gardener . The film was based on John le Carre's book of the same title, in which the author mentions talking with Peter Godfrey-Faussett, a senior researcher at LSHTM, among others, in doing background research for the book. The review concludes with an observation of the potential impact of such work noting that,

This one production will be seen by millions of people around the world [and] will have done more to present the pharmaceutical industry's obstacles to improving health in developing countries ... than all health and science journals can in a year [ 108 ].

The influence of science on art and of art on science as well as on health and wellbeing certainly bears further research [ 109 ]. However, the interpretation and communication of science through art is increasingly considered an important means of science communication, not only in the mass media and movies, but also in museum collections on art and health as well as the art collections and programmes of major health research funders, such as the Wellcome Trust [ 110 ].

Sustainable development

Sustainable development outcomes depend on a combination of several of the earlier described impacts. One commonly encountered conceptualization of sustainable development is that it enables all people throughout the world to satisfy their basic needs and enjoy a better quality of life without compromising the quality of life of future generations, for example as defined in the Rio Declaration on Environment and Development [ 111 ].

The UK was one of the first countries to establish a set of indicators to review sustainable development in 1996 and these have been reported on regularly and reviewed in annual reports [ 77 ]. Key elements of the UK sustainable development strategy are:

Living within environmental limits

Ensuring a strong, healthy and just society

Achieving a sustainable economy

Promoting good governance

Using sound science responsibly.

Additionally, the continued ability to learn and adapt to new knowledge as it is produced is a key aspect of sustainable development. Thus, research may have a direct impact on sustainable development outcomes through the production of new knowledge on a range of topics, but can also help further develop concepts and assessment methods and help collect, validate and analyse data to guide sustainable development.

Researchers are often hard pressed to come up with coherent accounts of the significance and impact of their work as regularly required in a range of situations, from writing grant proposals to designing implementation strategies and in submissions to research assessment exercises. Increasingly health research funders expect measurable outcomes from their investment in research. While some may decry this as neglecting the inherent value of science, others point out to the underutilisation or misutilisation of health research or to the need to prioritise research funding based on identified societal needs [ 16 – 19 ]. There is also evidence that researchers' accounts of the impact of their work provide a reliable starting point for more in-depth analyses and can provide similar information to more specialised assessments, although the scope and level of analysis may vary [ 7 ].

In this light, we pragmatically set out to identify the areas where health research could be expected to have an impact and then organized these areas into a framework. The validity and usefulness of the Research Impact Framework was tested at the London School of Hygiene and Tropical Medicine. The framework categories were finalised based on feedback from researchers working on a wider range of health research topics as to which areas they thought provided a valid indication of the impact of their work and which categories they found most useful to describe the same.

While initially sceptical, LSHTM researchers found that using the Research Impact Framework prompted them to identify a wide range of impacts related to their work in a relatively systematic manner (compared to the ad hoc approaches they had previously used) [ 6 ]. Researchers' narratives contained specific and verifiable evidence and the standardized structure of the narratives facilitated analysis across projects that could inform research management, practice and assessment [ 6 ]. One caution we offer is to be aware of various biases that may influence identification and description of research impact. For instance there may be strong historical and institutional biases and incentives to identify only positive impacts from research. However, researchers interviewed in the LSHTM study were aware of potential negative impacts of their research, for example, stigma that could arise with the publication of research findings related to a particular group or community. We will continue to learn as much, if not more, about the relationship of science and society and research impacts by maintaining focus on scientific controversies as well as scientific developments.

The Research Impact Framework provides a useful set of descriptive categories to help researchers identify and describe the impact of their work. It could also help researchers think through strategies to enhance the use of research-informed interventions as well as to identify unintended or harmful effects. The standardised structure of the framework also facilitates comparison of impact across projects, which is useful from an analytical and research management perspective. In addition, the framework should help health researchers systematically present the value of the work they have done as well as the work they wish to conduct in the future. This approach will further enable researchers to better explain what it is that they do and why they do it, not only to funders and governments, but also to review boards, colleagues, journalists and family and friends. This paper contributes to ongoing efforts seeking to understand, assess and explain the role, relevance and impact of health research.

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Acknowledgements

We acknowledge that this paper has been influenced by many discussions with colleagues over the years and insights from collaborative projects on the topic of assessing the impact of research, for example in consultations on a research utilisation project at WHO. We thank the two peer reviewers, Mark Petticrew and Liz Farmer for valuable comments and suggestions that have strengthened the paper. Special thanks also to Steve Hanney from the Health Economics Research Group (HERG) at Brunel University and to Andy Haines, Nick Black and Jo Lines at the London School of Hygiene and Tropical Medicine for their ongoing advice and support. We also thank John Browne, Val Curtis, Hazel Dockrell, Pat Doyle, Lucy Gilson, Judith Green, Sari Kovats, Anne Mills, Ian Roberts, Charlotte Watts, John Whittaker, Paul Wilkinson, Cathy Zimmerman, the LSHTM Senior Management Team and other colleagues who contributed to the development and testing of the Research Impact Framework at the London School of Hygiene and Tropical Medicine.

This project received no external funds and was supported by the authors' institutions in that the authors worked and consulted with colleagues there: the London School of Hygiene and Tropical Medicine for SK, NM and GW and Rutgers University for AP. The research ethics committee at the London School of Hygiene and Tropical Medicine approved the study that informed the development of the Research Impact Framework.

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Shyama Kuruvilla

Nicholas Mays

Department of Human Ecology and Department of Family and Community Health Sciences, Rutgers University, New Brunswick, USA

Andrew Pleasant

Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK

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Correspondence to Nicholas Mays .

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The author(s) declare that they have no competing interests.

Authors' contributions

All the authors were involved in developing the Research Impact Framework described as well as in writing the paper and approving the final version. SK, NM and GW also applied and tested the framework in a study to analyse the impact of selected research projects at the London School of Hygiene and Tropical Medicine.

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Kuruvilla, S., Mays, N., Pleasant, A. et al. Describing the impact of health research: a Research Impact Framework. BMC Health Serv Res 6 , 134 (2006). https://doi.org/10.1186/1472-6963-6-134

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Received : 22 July 2006

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151+ Public Health Research Topics [Updated 2024]

The important area of public health research is essential to forming laws, influencing medical procedures, and eventually enhancing community well-being. As we delve into the vast landscape of public health research topics, it’s essential to understand the profound impact they have on society.

This blog aims to provide a comprehensive guide to selecting and understanding the diverse array of public health research topics.

Overview of Public Health Research Topics

Table of Contents

Public health research encompasses a wide range of subjects, reflecting the interdisciplinary nature of the field. From epidemiology and health policy to environmental health and infectious diseases, researchers navigate through various dimensions to address complex health challenges.

Each category holds its own significance, contributing to the overall understanding of public health dynamics.

Key Considerations in Selecting Public Health Research Topics

• Current Relevance: Assess the timeliness of potential topics by considering recent health trends, emerging issues, and societal concerns.
• Impact on Public Health: Evaluate the potential impact of the research on improving health outcomes, addressing disparities, or influencing policy and interventions.
• Feasibility and Resources: Gauge the practicality of conducting research on a particular topic, considering available resources, data accessibility, and research infrastructure.
• Ethical Considerations: Scrutinize the ethical implications of the research, ensuring it aligns with ethical standards and guidelines, especially when dealing with vulnerable populations or sensitive topics.

Top 151+ Public Health Research Topics

Epidemiology.

• The Impact of Social Determinants on Disease Outcomes
• Patterns and Trends in Emerging Infectious Diseases
• Investigating Health Disparities among Different Ethnic Groups
• Childhood Obesity and its Long-Term Health Consequences
• Assessing the Effectiveness of Contact Tracing in Disease Control

Health Policy

• Universal Healthcare: Comparative Analysis of Global Models
• The Role of Telemedicine in Improving Healthcare Access
• Evaluating Mental Health Policies and Their Impact on Communities
• Assessing the Impact of Affordable Care Act on Public Health
• Vaccine Policies and Public Perception: A Comprehensive Study

Environmental Health

• Climate Change and Health: Adapting to the Challenges
• Air Quality and Respiratory Health in Urban Environments
• Waterborne Diseases and Strategies for Safe Water Supply
• Occupational Health Hazards: A Comprehensive Workplace Analysis
• The Impact of Green Spaces on Mental Health in Urban Areas

Infectious Diseases

• Antimicrobial Resistance: Strategies for Mitigation
• Vaccination Strategies and Herd Immunity
• Global Health Security: Preparedness for Pandemics
• The Impact of Vector-Borne Diseases on Public Health
• Emerging Trends in Antibiotic-Resistant Infections

Chronic Diseases

• Lifestyle Interventions for Preventing Cardiovascular Diseases
• Genetic Factors in the Development of Cancer: A Comprehensive Study
• Aging and Health: Addressing the Healthcare Needs of the Elderly
• Diabetes Prevention Programs: Efficacy and Implementation
• Mental Health in Chronic Disease Patients: Bridging the Gap

Maternal and Child Health

• Maternal Mortality: Understanding Causes and Prevention
• The Impact of Breastfeeding on Infant Health and Development
• Childhood Immunization: Barriers and Strategies for Improvement
• Teenage Pregnancy and Its Long-Term Health Consequences
• Mental Health Support for Postpartum Women: Current Gaps and Solutions

Health Behavior and Promotion

• Smoking Cessation Programs: Effectiveness and Challenges
• Physical Activity Promotion in Schools: Strategies for Success
• Nutrition Education and Its Impact on Healthy Eating Habits
• Mental Health Awareness Campaigns: Assessing Public Perceptions
• The Role of Social Media in Health Promotion

Global Health

• Assessing the Impact of International Aid on Global Health
• Water, Sanitation, and Hygiene (WASH) Programs in Developing Countries
• The Role of Non-Governmental Organizations in Global Health
• Communicable Disease Control in Refugee Populations
• Global Access to Essential Medicines: Challenges and Solutions

Community Health

• Community-Based Participatory Research: Best Practices and Challenges
• The Impact of Community Health Workers on Health Outcomes
• Health Literacy and its Relationship to Health Disparities
• Assessing the Effectiveness of Mobile Health (mHealth) Interventions
• Community Resilience in the Face of Public Health Crises

Healthcare Quality and Patient Safety

• Hospital-Acquired Infections: Strategies for Prevention
• Patient Safety Culture in Healthcare Organizations
• Quality Improvement Initiatives in Primary Care Settings
• Healthcare Accreditation: Impact on Patient Outcomes
• Implementing Electronic Health Records: Challenges and Benefits

Mental Health

• Stigma Reduction Programs for Mental Health Disorders
• Integrating Mental Health into Primary Care Settings
• The Impact of COVID-19 on Mental Health: Long-Term Implications
• Mental Health in the Workplace: Strategies for Employee Well-being
• Suicide Prevention Programs: Effectiveness and Outreach

Health Disparities

• Racial Disparities in Healthcare: Addressing Systemic Inequities
• LGBTQ+ Health Disparities and Inclusive Healthcare Practices
• Socioeconomic Status and Access to Healthcare Services
• Geographical Disparities in Health: Rural vs. Urban
• The Impact of Gender on Health Outcomes and Access to Care

Public Health Education

• Evaluation of Public Health Education Programs
• Innovative Approaches to Teaching Public Health Concepts
• Online Health Education Platforms: Opportunities and Challenges
• Interdisciplinary Training in Public Health: Bridging Gaps
• Continuing Education for Public Health Professionals: Current Landscape

Digital Health

• The Role of Wearable Devices in Health Monitoring
• Telehealth Adoption: Barriers and Opportunities
• Health Apps for Chronic Disease Management: User Perspectives
• Blockchain Technology in Healthcare: Privacy and Security Implications
• Artificial Intelligence in Disease Diagnosis and Prediction

Health Economics

• Cost-Effectiveness of Preventive Health Interventions
• The Impact of Healthcare Financing Models on Access to Care
• Pharmaceutical Pricing and Access to Essential Medicines
• Economic Evaluation of Health Promotion Programs
• Health Insurance Coverage and Health Outcomes: A Global Perspective

Innovations in Public Health

• 3D Printing in Healthcare: Applications and Future Prospects
• Gene Editing Technologies and their Ethical Implications
• Smart Cities and Public Health: Integrating Technology for Well-being
• Nanotechnology in Medicine: Potential for Disease Treatment
• The Role of Drones in Public Health: Surveillance and Intervention

Food Safety and Nutrition

• Foodborne Illness Outbreaks: Investigating Causes and Prevention
• Sustainable Food Systems: Implications for Public Health
• Nutritional Interventions for Malnutrition in Developing Countries
• Food Labeling and Consumer Understanding: A Critical Review
• The Impact of Fast Food Consumption on Public Health

Substance Abuse

• Opioid Epidemic: Strategies for Prevention and Treatment
• Harm Reduction Approaches in Substance Abuse Programs
• Alcohol Consumption Patterns and Public Health Outcomes
• Smoking and Mental Health: Exploring the Connection
• Novel Psychoactive Substances: Emerging Threats and Strategies

Occupational Health

• Workplace Stress and Mental Health: Intervention Strategies
• Occupational Hazards in Healthcare Professions: A Comparative Analysis
• Ergonomics in the Workplace: Improving Worker Health and Productivity
• Night Shift Work and Health Consequences: Addressing Challenges
• Occupational Health and Safety Regulations: A Global Overview

Disaster Preparedness and Response

• Pandemic Preparedness and Lessons from COVID-19
• Natural Disasters and Mental Health: Post-Traumatic Stress
• Emergency Response Systems: Improving Timeliness and Efficiency
• Communicating Health Risks During Emergencies: Public Perception
• Collaborative Approaches to Disaster Response in Global Health

Cancer Research

• Precision Medicine in Cancer Treatment: Current Advancements
• Cancer Screening Programs: Efficacy and Challenges
• Environmental Factors and Cancer Risk: Exploring Connections
• Survivorship Care Plans: Enhancing Quality of Life after Cancer
• Integrative Therapies in Cancer Care: Complementary Approaches

Sexual and Reproductive Health

• Access to Contraception in Developing Countries: Challenges and Solutions
• Comprehensive Sex Education Programs: Impact on Teen Pregnancy
• Reproductive Health Rights: Global Perspectives and Challenges
• Infertility Treatment: Ethical Considerations and Societal Impact
• Maternal and Child Health in Conflict Zones: Addressing Challenges

Cardiovascular Health

• Hypertension Prevention Programs: Strategies and Effectiveness
• Cardiovascular Disease in Women: Gender-Specific Risk Factors
• Innovations in Cardiac Rehabilitation Programs
• Artificial Heart Technology: Advancements and Ethical Implications
• Impact of Air Pollution on Cardiovascular Health: A Global Concern

Social Determinants of Health

• Educational Attainment and Health Outcomes: Exploring Links
• Income Inequality and its Impact on Population Health
• Social Support Networks and Mental Health: A Comprehensive Study
• Neighborhood Environments and Health Disparities
• Employment and Health: The Interplay of Work and Well-being

Genomics and Public Health

• Population Genomics and its Implications for Public Health
• Genetic Counseling and Education: Empowering Individuals and Families
• Ethical Issues in Genetic Research: Privacy and Informed Consent
• Pharmacogenomics: Tailoring Drug Therapies to Individual Genotypes
• Gene-Environment Interactions in Disease Risk: Unraveling Complexities

Public Health Ethics

• Informed Consent in Public Health Research: Current Practices
• Ethical Challenges in Global Health Research: Balancing Priorities
• Confidentiality in Public Health Reporting: Striking the Right Balance
• Research with Vulnerable Populations: Ethical Considerations
• Ethical Implications of Emerging Technologies in Healthcare

Health Communication

• The Role of Media in Shaping Public Health Perceptions
• Health Literacy Interventions: Improving Understanding of Health Information
• Social Media Campaigns for Public Health Promotion: Best Practices
• Tailoring Health Messages for Diverse Audiences: Cultural Competency
• Risk Communication in Public Health Emergencies: Lessons Learned

Nutrigenomics

• Personalized Nutrition Plans based on Genetic Makeup
• Impact of Nutrigenomics on Chronic Disease Prevention
• Ethical Considerations in Nutrigenomics Research
• Public Perceptions of Nutrigenomic Testing: A Qualitative Study
• Integrating Nutrigenomics into Public Health Policies

Public Health and Artificial Intelligence

• Predictive Analytics in Disease Surveillance: Harnessing AI for Early Detection
• Ethical Considerations in AI-Driven Health Decision Support Systems
• Machine Learning in Epidemiology: Predicting Disease Outbreaks
• Natural Language Processing in Public Health: Text Mining for Insights
• Bias in AI Algorithms: Implications for Health Equity

Health Disparities in Aging

• Geriatric Health Disparities: Bridging the Gap in Elderly Care
• Ageism in Healthcare: Addressing Stereotypes and Discrimination
• Social Isolation and Health Consequences in Aging Populations
• Access to Palliative Care for Older Adults: A Global Perspective
• Alzheimer’s Disease and Ethnic Disparities in Diagnosis and Treatment
• Loneliness and Mental Health in the Elderly: Interventions and Support

Research Methodologies in Public Health

Public health research employs various methodologies, including quantitative, qualitative, and mixed-methods approaches. Each method brings its own strengths to the research process, allowing researchers to gain a comprehensive understanding of the complex issues they investigate. 

Community-based participatory research is another valuable approach, emphasizing collaboration with communities to address their specific health concerns.

Challenges and Opportunities in Public Health Research

While public health research is immensely rewarding, it comes with its own set of challenges. Funding constraints, ethical dilemmas, the need for interdisciplinary collaboration, and the integration of technology pose both obstacles and opportunities. 

Researchers must navigate these challenges to ensure their work has a meaningful impact on public health.

In conclusion, public health research topics are diverse and dynamic, reflecting the complex nature of the field. As researchers embark on their journeys, they must carefully consider the relevance, impact, and ethical implications of their chosen topics. 

The collaborative and interdisciplinary nature of public health research positions it as a powerful tool in addressing the health challenges of our time. By exploring the depths of these topics, researchers contribute to the collective effort to build healthier and more equitable communities. 

As we move forward, a continued exploration of relevant public health research topics is essential for shaping the future of healthcare and improving the well-being of populations worldwide.

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📕 Studying HQ

30+ reproductive and sexual health research topics: a guide for nursing scholars, carla johnson.

• September 8, 2023
• Essay Topics and Ideas

Reproductive and sexual health is significant in healthcare, impacting individuals across their lifespans. For nursing scholars, comprehending these topics is vital for holistic patient care and overall well-being. This article delves into reproductive and sexual health research topics, giving nursing scholars insights into these sensitive subjects adeptly.

What You'll Learn

Understanding Reproductive and Sexual Health

Reproductive and sexual health covers various subjects, from family planning to sexually transmitted infections. It encompasses physical, emotional, and social aspects, demanding nursing scholars’ adeptness in offering respectful, compassionate care .

10 PICOT Questions in Reproductive and Sexual Health

• P: Adolescents seeking contraception knowledge; I: Introducing comprehensive sexual education; C: Traditional education; O: Lower teen pregnancies ; T: 2 years. Teens often lack contraceptive knowledge. Can comprehensive education reduce unintended pregnancies?
• P: Menopausal women; I: Offering hormone replacement therapy choices; C: No therapy; O: Better life quality, fewer symptoms; T: 6 months. Menopausal symptoms can disrupt life. Can hormone therapy choices alleviate these symptoms?
• P: Couples planning conception; I: Using fertility tracking apps; C: Traditional methods; O: Accurate fertile period identification; T: 1 year. Can fertility apps aid couples in conceiving?
• P: STI-diagnosed individuals; I: Partner notification strategies; C: No notification; O: Improved STI management, reduced transmission; T: 3 months. How effective is notifying and testing partners of STI-diagnosed individuals?
• P: Postpartum women; I: Offering contraception counseling ; C: Standard care; O: Increased contraception use; T: 6 weeks. Postpartum contraception is vital. Can counseling enhance postpartum contraception rates?
• P: LGBTQ+ youth in schools; I: Integrating inclusive sexual education; C: Traditional curriculum; O: Better understanding of diverse sexualities; T: 1 school year. Can inclusive education improve LGBTQ+ sexual education experiences?
• P: Elderly in care homes; I: Implementing sexual health discussions; C: No structured talks; O: Enhanced sexual well-being, reduced stigma; T: 6 months. Elderly sexual health needs attention. Can open discussions improve well-being?
• P: Individuals with disabilities; I: Providing accessible sexual health resources; C: Limited resources; O: Empowered choices, better sexual health; T: 1 year. Disabilities limit resources. Can tailored materials improve sexual health understanding?
• P: Reproductive-age women; I: Introducing telehealth for reproductive care; C: In-person consultations; O: Enhanced access, improved outcomes; T: 6 months. Reproductive care access is limited. Can telehealth bridge the gap?
• P: Inconsistent contraceptive users; I: Dual contraceptive method counseling; C: Single method advice; O: Fewer unintended pregnancies; T: 1 year. Inconsistent contraception usage can lead to pregnancies. Can counseling on dual methods help?

20 Reproductive and Sexual Health Research EBP Topics

• Assess online sexual education effectiveness for adolescents.
• Implement a peer-led contraception campaign on campuses.
• Evaluate cultural sensitivity training for sexual health discussions.
• Investigate postpartum sexual dysfunction’s mental health impact.
• Develop sexual education for long-term care.
• Compare contraceptives in preventing STIs.
• Examine religious beliefs and contraception choices.
• Explore telehealth for remote STI counseling.
• Assess reproductive health issues among transgender individuals.
• Investigate rural reproductive care barriers.
• Analyze sex education’s teenage pregnancy impact.
• Develop elder sexual health provider training.
• Evaluate mobile apps for youth sexual health awareness.
• Investigate knowledge’s effect on student behaviors.
• Assess comprehensive sexual education’s STI impact.
• Investigate reproductive health in marginalized communities.
• Develop school nurse adolescent sexual health training.
• Explore LGBTQ+ reproductive healthcare experiences.

20 Nursing Capstone Project Ideas for Reproductive and Sexual Health 

• Designing college sexual consent education.
• Creating diverse cultural sexual health guides.
• Intervention to reduce STI stigma.
• Investigating prenatal sex education’s impact.
• Sexual health toolkit for foster care adolescents.
• Linking sexual education to partner violence prevention.
• Support for fertility-challenged individuals.
• Sexual health education for intellectual disabilities.
• Empowering marginalized populations’ sexual health.
• Inclusive LGBTQ+ youth sexual health resources.
• Elder sexual health in nursing homes.
• Inclusive sexual education educator training.
• Online sexual health forum impact.
• Media influence on body image and satisfaction.
• Nurses discussing sexual health with chronic patients.
• Telehealth for remote sexual health services.
• Campus campaign for healthy relationships.
• Refugee reproductive healthcare access.
• Parent-adolescent sexual health communication.
• Nursing advocacy in comprehensive sexual education.

20 Reproductive and Sexual Health Research Topics

• Pornography’s impact on adolescent body perceptions.
• Cultural influences on immigrant contraceptive choices.
• Factors delaying STI treatment-seeking in young adults.
• Nurse practitioners’ LGBTQ+ sexual healthcare role.
• Sexual education impact on unintended pregnancies.
• Low-income women’s preconception care access.
• Transgender reproductive healthcare experiences.
• Parental views on school sexual education.
• Aging population sexual health discussions.
• Marginalized community reproductive health disparities .
• Hormonal contraception’s mental health implications.
• Abstinence-only education’s effects on youth behavior.
• Disabilities and sexual health understanding.
• Media influence on sexual attitudes.
• Ethics of older fertility treatments.
• Reproductive healthcare disparities and marginalized groups.
• Socioeconomics affecting contraception access.
• Reproductive healthcare in conservative societies.
• Intimate partner violence’s impact on sexual health .
• Media portrayal of sexuality’s societal effects.

30 Reproductive and Sexual Health Essay Topics for In-Depth Discussions

• Ethics of compulsory sexual education.
• Media’s effect on adolescent sexuality.
• Sexual autonomy and healthcare.
• Healthcare policies shaping access.
• Disabilities and reproductive care.
• Cultural norms influencing contraception .
• Abstinence-only education debate.
• Gender identity in reproductive care.
• Evolution of reproductive rights .
• Nursing elderly sexual health.
• Sexual education and violence prevention.
• Religion’s influence on healthcare.
• Media’s effect on body image.
• Ethical older fertility treatments.
• Healthcare policies and disparities.
• Access in conservative societies.
• Socioeconomic factors in contraception.
• Chronic illnesses and sexual health.
• Reproductive health in marginalized groups.
• Aging population’s sexual well-being.
• LGBTQ+ sexual education needs.
• STI transmission and education.
• Gender norms and behavior.
• Sexuality portrayal in media.
• Ethical implications of reproductive technology.
• Disabilities’ impact on sexual health.
• Media’s effect on sexual perceptions.
• Medical tourism’s reproductive impact.
• Intersection of sexuality and disabilities.
• Nursing advocacy in sexual education.

Nursing scholars possess the potential to influence reproductive and sexual health. By exploring projects, capstones, research, and essays, you contribute to a comprehensive understanding of these essential topics. Seek assistance from our expert writing services to ensure your academic success. Embrace your role as an advocate for sexual well-being, working towards a future where reproductive and sexual health is respected and promoted for all.

FAQs: Exploring Reproductive and Sexual Health for Nursing Students

Q1: What is the role of a nurse in sexual and reproductive health?

A1: Nurses play a pivotal role in providing comprehensive education, counseling, and care related to sexual and reproductive health. They empower individuals to make informed decisions and promote overall well-being.

Q2: What are the 4 pillars of reproductive health?

A2: The four pillars of reproductive health include the right to reproductive choices, access to quality reproductive healthcare services, sexual education , and eliminating discrimination and stigma surrounding reproductive and sexual health.

Q3: Why is reproductive health and sexual health important?

A3: Reproductive and sexual health is crucial for individual well-being, gender equality, and public health. It encompasses physical, emotional, and social aspects and is essential for family planning, disease prevention, and overall quality of life.

Q4: What is the concept of reproductive health and sexual health?

A4: Reproductive health focuses on the physical, emotional, and social well-being in all matters related to the reproductive system, while sexual health includes the physical, emotional, and psychological aspects of sexual well-being and relationships. Both concepts encompass rights, choices, and access to healthcare services.

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Institute of Medicine (US) Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule; Nass SJ, Levit LA, Gostin LO, editors. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington (DC): National Academies Press (US); 2009.

Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research.

• Hardcopy Version at National Academies Press

3 The Value, Importance, and Oversight of Health Research

The previous chapter reviewed the value of privacy, while this chapter examines the value and importance of health research. As noted in the introduction to Chapter 2 , the committee views privacy and health research as complementary values. Ideally, society should strive to facilitate both for the benefit of individuals as well as the public.

In addition to defining health research and delineating its value to individuals and society, this chapter provides an overview and historical perspective of federal research regulations that were in place long before the Privacy Rule was implemented. Because a great deal of medical research falls under the purview of multiple federal regulations, it is important to understand how the various rules overlap or diverge. The chapter also explains how the definition of research has become quite complex under the various federal regulations, which make a distinction between research and some closely related health practice activities that also use health data, such as quality improvement initiatives.

The chapter also reviews the available survey data regarding public perceptions of health research and describes the importance of effective communication about health research with patients and the public.

• CONCEPTS AND VALUE OF HEALTH RESEARCH

Definitions

Under both the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Common Rule , “research” is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” This is a broad definition that may include biomedical research, epidemiological studies, 1 and health services research, 2 as well as studies of behavioral, social, and economic factors that affect health.

Perhaps the most familiar form of health research is the clinical trial, in which patients volunteer to participate in studies to test the efficacy and safety of new medical interventions. But an increasingly large portion of health research is now information based. A great deal of research entails the analysis of data and biological samples that were initially collected for diagnostic, treatment, or billing purposes, or that were collected as part of other research projects, and are now being used for new research purposes. This secondary 3 use of data is a common research approach in fields such as epidemiology, health services research, and public health research, and includes analysis of patterns of occurrences, determinants, and natural history of disease; evaluation of health care interventions and services; drug safety surveillance; and some genetic and social studies ( Lowrance, 2002 ; Lowrance and Collins, 2007 ).

The Importance of Health Research

Like privacy, health research has high value to society. It can provide important information about disease trends and risk factors, outcomes of treatment or public health interventions, functional abilities, patterns of care, and health care costs and use. The different approaches to research provide complementary insights. Clinical trials can provide important information about the efficacy and adverse effects of medical interventions by controlling the variables that could impact the results of the study, but feedback from real-world clinical experience is also crucial for comparing and improving the use of drugs, vaccines, medical devices, and diagnostics. For example, Food and Drug Administration (FDA) approval of a drug for a particular indication is based on a series of controlled clinical trials, often with a few hundred to a few thousand patients, but after approval it may be used by millions of people in many different contexts. Therefore, tracking clinical experience with the drug is important for identifying relatively rare adverse effects and for determining the effectiveness in different populations or in various circumstances. It is also vital to record and assess experience in clinical practice in order to develop guidelines for best practices and to ensure high-quality patient care.

Collectively, these forms of health research have led to significant discoveries, the development of new therapies, and a remarkable improvement in health care and public health. 4 Economists have found that medical research can have an enormous impact on human health and longevity, and that the resulting increased productivity of the population contributes greatly to the national economy ( Hatfield et al., 2001 ; Murphy and Topel, 1999 ) in addition to the individual benefits of improved health. If the research enterprise is impeded, or if it is less robust, important societal interests are affected.

The development of Herceptin as a treatment for breast cancer is a prime example of the benefits of research using biological samples and patient records ( Box 3-1 ) ( Slamon et al., 1987 ). Many other examples of findings from medical records research have changed the practice of medicine as well. Such research underlies the estimate that tens of thousands of Americans die each year from medical errors in the hospital, and research has provided valuable information for reducing these medical errors by implementing health information technology, such as e-prescribing ( Bates et al., 1998 ; IOM, 2000b ). This type of research also has documented that disparities in health care and lack of access to care in inner cities and rural areas result in poorer health outcomes ( Mick et al., 1994 ). Furthermore, medical records research has demonstrated that preventive services (e.g., mammography) substantially reduce mortality and morbidity at reasonable costs ( Mandelblatt et al., 2003 ), and has established a causal link between the nursing shortage and patient health outcomes by documenting that patients in hospitals with fewer registered nurses are hospitalized longer and are more likely to suffer complications, such as urinary tract infections and upper gastrointestinal bleeding ( Needleman et al., 2002 ). These findings have all informed and influenced policy decisions at the national level. As the use of electronic medical records increases, the pace of this form of research is accelerating, and the opportunities to generate new knowledge about what works in health care are expanding ( CHSR, 2008 ).

Examples of Important Findings from Medical Database Research. Herceptin and breast cancer: Data were collected from a cohort of more than 9,000 breast cancer patients whose tumor specimens were consecutively received at the University (more...)

Advances in health information technology are enabling a transformation in health research that could facilitate studies that were not feasible in the past, and thus lead to new insights regarding health and disease. As noted by the National Committee on Vital and Health Statistics, “Clinically rich information is now more readily available, in a more structured format, and able to be electronically exchanged throughout the health and health care continuum. As a result, the information can be better used for quality improvement, public health, and research, and can significantly contribute to improvements in health and health care for individuals and populations” ( NCVHS, 2007a ). The informatics grid recently developed with support from the National Cancer Institute (Cancer Biomedical Informatics Grid, or caBIG) is an example of a how information technologies can facilitate health research by enabling broader sharing of health data while still ensuring regulatory compliance and protecting patient privacy ( Box 3-2 ).

caBIG (Cancer Biomedical Informatics Grid). The National Cancer Institute’s caBIG Data Sharing and Intellectual Capital Workspace’s mission is to enable all constituencies in the cancer community—including researchers, physicians, (more...)

Science today is also changing rapidly and becoming more complex, so no single researcher or single site can bring all the expertise to develop and validate medical innovations or to ensure their safety. Thus, efficient sharing of information between institutions has become even more important than in previous eras, when there were fewer new therapies introduced. The expansion of treatment options, as well as the escalating expense of new therapies, mandates greater scrutiny of true effectiveness, 5 once efficacy has been demonstrated. This requires registries of patient characteristics, outcomes, and adverse events. Large populations are required to facilitate comparison of patient populations and to calculate risk/benefit estimates. For example, INTERMACS 6 (Interagency Registry for Mechanically Assisted Circulatory Support) is a national registry for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. This registry was devised as a joint effort of the National Heart, Lung and Blood Institute, Centers for Medicare & Medicaid Services, FDA, clinicians, scientists and industry representatives. Analysis of the data collected is expected to facilitate improved patient evaluation and management while aiding in better device development. Registry results are also expected to influence future research and facilitate appropriate regulation and reimbursement of such devices. Similarly, the Extracorporeal Life Support Organization (ELSO), 7 an international consortium of health care professionals and scientists who focus on the development and evaluation of novel therapies for support of failing organ systems, maintains a registry of extracorporeal membrane oxygenation and other novel forms of organ system support. Registry data are used to support clinical practice and research, as well as regulatory agencies. Another example is the database developed by the United Network for Organ Sharing (UNOS) for the collection, storage, analysis and publication of data pertaining to the patient waiting list, organ matching, and transplants. 8 Launched in 1999, this secure Internet-based system contains data regarding every organ donation and transplant event occurring in the United States since 1986.

Information-based research, such as research using health information databases has many advantages (reviewed by Lowrance, 2002 ). It is often faster and less expensive than experimental studies; it can analyze very large sets of data and may detect unexpected phenomena or differences among subpopulations that might not be included in a controlled experimental study; it can often be undertaken when controlled trials are simply not possible for ethical, technical, or other reasons, and it can be used to study effectiveness of a specific test or intervention in clinical practice, rather than just the efficacy as determined by a controlled experimental study. It can also reexamine data accrued in other research studies, such as clinical trials, to answer new questions quickly and inexpensively. However, information-based research does have limitations. Often it has less statistical rigor than controlled clinical studies because it lacks scientific control over the original data collection, quality, and format that prospective experimental research can dictate from the start. In addition to these scientific limitations, because of its relational and often distant physical separation from the data subjects, and the sheer volume of the records involved, obtaining individual consent for the research can be difficult or impossible.

Advances in information-based medical research could also facilitate the movement toward personalized medicine, which will make health research more meaningful to individuals. The goal of personalized medicine is to tailor prevention strategies and treatments to each individual based on his/her genetic composition and health history. In spite of the strides made in improving health through new treatments, it is widely known that most drugs are effective in only a fraction of patients who have the condition for which the drug is indicated. Moreover, a small percentage of patients are likely to have adverse reactions to drugs that are found to be safe for the majority of the population at the recommended dose. Both of these phenomena are due to variability in the patient population. Revolutionary advances in the study of genetics and other markers of health and disease are now making it possible to identify and study these variations, and are leading to more personalized approaches to health care—that is, the ability to give “the appropriate drug, at the appropriate dose, to the appropriate patient, at the appropriate time.” Achieving the goals of personalized medicine will lead to improvements in both the effectiveness and the safety of medical therapies.

Public Perceptions of Health Research

A number of studies have been undertaken to gauge the public’s attitude toward research and the factors that influence individuals’ willingness to participate in research. The surveys reviewed in this chapter focus on interventional clinical trials. A review of survey questions to gauge the public willingness to allow their medical records to be used in research can be found in Chapter 2 .

The Public Values Health Research

A number of studies suggest that most Americans have a positive view of medical research and believe that research is beneficial to society. A recent Harris poll found that nearly 80 percent of respondents were interested in health research findings, consistent with previous survey results ( Westin, 2007 ). A study in 2005 compiled data from 70 state surveys and 18 national surveys and found that the majority of Americans believe maintaining world leadership in health-related research is important. Seventy-eight percent of respondents said that it is very important, and 17 percent said that it is somewhat important. Only 4 percent of Americans reported that maintaining world leadership in health-related research is not impor tant ( Woolley and Propst, 2005 ). Similar results were found in a 2007 survey—76 percent of respondents reported that science plays a very important role in our health, and 78 percent reported that science plays a very important role in our competitiveness ( Research!America, 2007 ).

The Virginia Commonwealth University 2004 Life Sciences Survey also found that most Americans have a positive view of research. In this study, 90 percent of respondents agreed that developments in science have made society better; 92 percent reported that “scientific research is essential for improving the quality of human lives”; and 84 percent agreed that “the benefits of scientific research outweigh the harmful results” ( NSF, 2006 ).

Overall Experience When Participating in Research

Little is known about the attitudes of individuals who have actually participated in medical research. However, the available evidence suggests that most research participants have positive experiences. A recent Harris Poll found that 13 percent of respondents had participated in some form of health research, and 87 percent of those felt comfortable about their experience ( Westin, 2007 ). In a study focused on cancer, 93 percent of respondents who participated in research reported it as a very positive experience; 76 percent said they would recommend participation in a clinical trial to someone with cancer. Most physicians surveyed in this study stated that they believe clinical trial participants receive the best possible care, and have outcomes at least as good as patients receiving standard cancer treatment ( Comis et al., 2000 ). Another study found that 55 percent of individuals who participated in a research study would be willing to participate again in a future research study ( Trauth et al., 2000 ).

Willingness to Participate in Research

Public opinion surveys indicate that a majority of Americans are willing to participate in clinical research studies. In 2001, a compilation of studies commissioned by Research !America found that 63 percent of Americans would be willing to participate in a clinical research study ( Woolley and Propst, 2005 ). This percentage has remained stable over time. A 2007 Research!America survey also found that 63 percent of Americans would be very likely to participate in a clinical research study if asked ( Research!America, 2007 ); 68 percent of respondents reported that their desire to improve their own health or the health of others was a major factor in deciding whether to participate in a clinical research project ( Research!America, 2007 ).

Other surveys also suggest that willingness to participate in research focused on specific diseases is quite high. In one survey, the percentage of respondents indicating a willingness to participate in a medical research study was 88 percent for cancer, 86 percent for heart disease, 83 percent for a noncurable fatal disease, 79 percent for addiction, 78 percent for depression, and 76 percent for schizophrenia ( Trauth et al., 2000 ). Respondents with greater knowledge of how research is conducted were more willing to participate ( Trauth et al., 2000 ). Another study found that 8 of 10 Americans would consider participating in a clinical trial if faced with cancer. More than two-thirds of respondents said they would be willing to participate in a clinical trial designed to prevent cancer ( Comis et al., 2000 ).

Americans also seem to be very supportive of medical research that relies on genetic data. A 2007 survey found that 93 percent of Americans supported the use of genetic testing if the information collected is used by researchers to find new ways to diagnose, prevent, or treat disease ( Genetics & Public Policy Center, 2007 ). Two separate surveys found that 66 percent of Americans would be willing to donate their genetic material for medical research ( Genetics & Public Policy Center, 2007 ; Research!America, 2007 ). However, despite this apparent positive view of genetic research, 92 percent of Americans reported they were concerned about their genetic information being used in a “harmful way” ( Genetics & Public Policy Center, 2007 ).

Many factors, in addition to concerns about privacy and confidentiality ( Genetics & Public Policy Center, 2007 ; Research!America, 2007 ), may influence an individual’s willingness to participate in a medical research study. The Trauth survey found that individuals with higher income levels, with a college or graduate degree, or with children were more likely to participate in research. Age affected willingness to participate: 57 percent of respondents ages 18–34 were willing to participate in research, but only 31 percent of respondents ages 65 or older were willing ( Trauth et al., 2000 ).

Other factors that potentially influence an individual’s willingness to participate in research are race and ethnicity. It is well documented that minorities participate in health research at a much lower percentage than white Americans. Many cultural, linguistic, and socioeconomic barriers could be responsible for this difference ( Giuliano et al., 2000 ), and study results have been variable on this issue. Several studies suggest that the low participation rates by racial and ethnic minority groups are due to their strong distrust of the medical research community compared to the general population ( Braunstein et al., 2008 ; Corbie-Smith et al., 1999 ; Farmer et al., 2007 ; Grady et al., 2006 ; Shavers et al., 2002 ).

However, other evidence suggests that the low percentage of minorities participating in research is related to minority groups’ lack of access to the research community ( Brown et al., 2000 ; Wendler et al., 2006 ; Williams and Corbie-Smith, 2006 ). Thus, it is likely that the low number of minority individuals participating in medical research is at least partly due to recruitment techniques that are ineffective for minority populations.

The survey that focused on cancer research suggests that one of the main reasons why individuals do not participate in research is lack of knowledge about the availability of clinical trials. In a survey of nearly 6,000 cancer patients, 85 percent said they were unaware of the opportunity to participate in a clinical trial. Respondents who did participate said they did so because of one of the following beliefs: (1) trials provide access to the best quality of care (76 percent), (2) their participation would benefit future cancer patients (72 percent), (3) they would receive newer and better treatment (63 percent), and (4) participation would get them more care and attention (40 percent) ( Comis et al., 2000 ).

A recommendation from a physician can also impact participation. In the United States, 48 percent of respondents to one survey reported that a physicians’ recommendation would be a major factor in deciding whether to take part in a research study. Nearly three-fourths of respondents also cited an institution’s reputation as a key factor to consider when deciding whether to participate in a study ( Research!America, 2007 ). Twenty percent of respondents in an Italian public survey indicated that the presence of a physician as a reference during a research study influenced their willingness to participate ( Mosconi et al., 2005 ).

In sum, surveys indicate that the vast majority of Americans have a positive view of medical research, believe that research is beneficial to society, and are interested in health research findings. Although little is known about the attitudes of individuals who have actually participated in medical research, the available evidence suggests that most research participants have positive experiences. Surveys also suggest that a majority of Americans are willing to participate in clinical research studies. Similar to the findings in Chapter 2 , surveys indicate that many factors, in addition to concerns about privacy and confidentiality, can potentially influence an individual’s willingness to participate in medical research, including the type of research and personal characteristics such as health status, age, education, and race. Notably, respondents with greater knowledge of how research is conducted were more willing to participate in research.

• OVERSIGHT OF HEALTH RESEARCH

Historical Development of Federal Protections of Health Information in Research

The development of international codes, federal legislation, and federal regulation of human subjects often occurred in response to past abuses in biomedical experiments (reviewed by Pritts, 2008 ) ( Box 3-3 ). The most well-known examples included (1) reported abuses of concentration camp prisoners in Nazi experiments during World War II, and (2) the Tuskegee syphilis study begun in 1932, in which researchers withheld effective treatment from affected African American men long after a cure for syphilis was found. Most of the current principles and standards for conducting human subjects research were developed primarily to protect against the physical and mental harms that can result from these types of biomedical experiments. Therefore, they focus on the principles of autonomy and consent. Although the standards apply to research that uses identifiable health information, research based solely on information is not their primary focus.

The Basis for Human Subjects Protections in Biomedical Research. Nuremberg Code The Nuremberg Code, created by the international community after the Nazi War Crimes Trials, is generally seen as the first codification (more...)

In the United States, perhaps the most influential inquiry into the protection of human subjects in research was the Belmont Report. The Belmont principles have been elaborated on in many settings, and served as the basis for formal regulation of human subjects research in the United States. In general, states do not directly regulate the activity of most researchers ( Burris et al., 2003 ). However, the Belmont Commission’s recommendations were reflected in the Department of Health and Human Services’ (HHS’s) Policy for Protection of Human Subjects Research , Subpart A of 45 C.F.R. 46 (“Subpart A”) in 1979. 9 These protections were considered a benchmark policy for federal agencies, and in December 1981, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended 10 that all federal departments and agencies adopt the HHS regulations. 11

In 1982, the President’s Office of Science and Technology Policy appointed a Committee for the Protection of Human Research Subjects to respond to the recommendations of the President’s commission. The committee agreed that uniformity of federal regulations on human subjects protection is desirable to eliminate unnecessary regulations and to promote increased understanding by institutions that conduct federally supported or regulated research. As a result, in 1991, other federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects of research, identical to Subpart A of 45 C.F.R. 46, which is now informally known as the “ Common Rule .” Eighteen federal agencies have now adopted the Common Rule as their own respective regulations.

Overview of the Common Rule

The Common Rule governs most federally funded research conducted on human beings and aims to ensure that the rights of human subjects are protected during the course of a research project. The Common Rule stresses the importance of individual autonomy and consent; requires independent review of research by an Institutional Review Board (IRB); and seeks to minimize physical and mental harm. Privacy and confidentiality protections, although not defined in a detailed and prescriptive manner, are included as important components of risk in research.

The framework for achieving the goal of protecting human subjects is based on two foundational requirements: the informed consent of the research participant and the review of proposed research by an IRB. This section describes some of the basic parameters of the Common Rule (reviewed by Pritts, 2008 ). Particular provisions that interact with the HIPAA Privacy Rule are described in more detail in Chapter 4 .

Scope of the Common Rule

In general, the Common Rule applies only to research on human subjects that is supported by the federal government. 12 As noted previously, research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” 13

Under the Common Rule , a “human subject” is defined as “a living individual about whom an investigator … conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.” Private information is considered to be personally identifiable if the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

The Common Rule applies to most human subjects research conducted using federal funds, but its influence is broader because most institutions that accept federal funds sign an agreement (a Federalwide Assurance or FWA) with HHS to abide by the Common Rule requirements in all research, regardless of funding source. Nonetheless, some privately funded human subjects research is conducted outside the purview of federal regulation ( Goldman and Choy, 2001 ; Williams, 2005 ). Companies and other organizations may voluntarily choose to apply the Common Rule to their research projects, and many do. However, research projects in which compliance is voluntary are not subject to oversight or disciplinary action by HHS ( Goldman and Choy, 2001 ; Williams, 2005 ).

Informed Consent 14

The Common Rule requires that a researcher obtain informed consent (usually in writing) from a person before he/she can be admitted to a study ( Williams, 2005 ). Informed consent is sought through a process in which a person learns key facts about a research study, including the potential risks and benefits, so that he/she can then agree voluntarily to take part or decide against it.

The Common Rule informed consent regulations focus primarily on the elements and documentation of informed consent rather than on the process used to obtain it. As to the process, the regulations require that informed consent be sought only under circumstances that provide the prospective subject with adequate opportunity to consider whether to participate. The Common Rule requires that information pertaining to informed consent be given in language understandable to the subject, and that the consent does not imply that the subject is giving up his/her legal rights or that the investigator is released from liability for negligence during the conduct of the study. 15

The Common Rule also specifies a number of elements that must be provided when informed consent is sought. These elements include:

• an explanation of the purposes of the research,
• the expected duration of the subject’s participation,
• the potential risks and benefits of the research,
• how confidentiality will be maintained,
• the fact that participation is strictly voluntary, and
• who the subject can contact to answer questions about the study or about his/her rights as a research participant.

In certain limited circumstances, the Common Rule allows an informed consent to be for unspecified future research. For example, under the Common Rule an informed consent can be used to obtain a person’s permission to study personally identifiable information maintained in a repository for future, unspecified research purposes ( HHS, 2003 ).

For the most part, the required elements of an informed consent address all types of research, although some are more relevant to biomedical research (e.g., the consent must include a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject). One required element of informed consent is particularly relevant to research involving personally identifiable health information. The Common Rule requires an informed consent to include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. 16

Institutional Review Boards

Adopting the principles of the Belmont Report, the Common Rule requires that protocols for human subjects research be reviewed by an IRB ( Box 3-4 ) before research may begin. 17 The IRB must meet certain membership requirements, including having members with different expertise and at least one member who is not affiliated with the investigator’s institution. The Common Rule specifies which level of IRB review is needed for various types of research and provides criteria for the IRB to consider during the review. Although the Common Rule does not specify the procedures an IRB must follow in its review of protocols, it does require the IRB to have written procedures for how it will review protocols and document IRB decisions.

Institutional Review Boards. According to the Department of Health and Human Services (HHS) Institutional Review Board (IRB) guidebook, “the IRB is an administrative body established to protect the rights and welfare of human research subjects (more...)

The Common Rule requires that an IRB determine the following factors are satisfied to approve proposed research:

• Risks to subjects are minimized;
• Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result;
• The selection of subjects is equitable;
• Informed consent will be sought in accordance with the rules and will be documented;
• When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects; and
• When appropriate, adequate provisions are in place to protect the privacy of subjects and to maintain the confidentiality of data. 18

An IRB may waive the requirement to obtain informed consent or approve an alteration of the consent form for some minimal risk research. The IRB may also waive the requirement for signed consent in certain circumstances. 19

Anonymized Data

As noted above, the Common Rule considers use of “private identifiable information” to be human subjects research. Data are considered personally identifiable if the identity of the subject is or may be readily ascertained by the investigator or associated with the information accessed by the researcher. 20 However, the Common Rule exempts from its requirements research that involves:

[T]he collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. 21

Otherwise identifiable data may be deidentified or “anonymized” for purposes of the Common Rule if it is coded and certain other conditions are met ( HHS, 2004 ). Under Guidance issued by the Office for Human Research Protection, information is “coded” if identifying information (such as name or Social Security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (the code), and a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimen.

Research involving only coded private information or specimens is not considered to involve human subjects under the Common Rule if the following conditions are met:

• The private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and
• —The key to decipher the code is destroyed before the research begins;
• —The investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased;
• —IRB-approved written policies and operating procedures for a repository or data management center prohibit the release of the key to investigators under any circumstances, until the individuals are deceased; or
• —Other legal requirements prohibit the release of the key to the investigators, until the individuals are deceased.

Under this standard, when a researcher accesses or receives data that have been coded and does not have access to the identifying key, the research is not considered human subjects research and is not subject to the Common Rule ’s requirements of informed consent or IRB review and approval of protocol.

Enforcement of the Common Rule

The Common Rule requirements for informed consent do not preempt any applicable federal, state, or local laws that require additional information to be disclosed to a subject in order for informed consent to be legally effective. 22

Federal funding can be suspended or withdrawn from an institution when it is found to be in material violation of the Common Rule . 23 There is no authority to impose penalties directly on individual researchers for violations. Neither does the Common Rule expressly provide a research participant with a private right of action. It should be noted, however, that recent cases indicate that courts may be willing to hold an institution liable under common law negligence theories where the approved informed consent form is determined to be less than adequate ( Shaul et al., 2005 ). 24

FDA Protection of Human Research Subjects

Some health research is also subject to FDA regulations. The FDA is charged by statute with ensuring the protection of the rights, safety, and welfare of human subjects who participate in clinical investigations 25 involving articles subject to the Federal Food, Drug, and Cosmetic Act 26 (the Act), as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including drugs, medical devices, and biological products for human use ( Box 3-5 ).

FDA Protection of Human Subjects Regulations. The Food and Drug Administration (FDA) Protection of Human Subjects Regulations aim to protect the rights of human subjects enrolled in research involving products that the FDA regulates (i.e., drugs, medical (more...)

In January 1981, the FDA adopted regulations governing informed consent of human subjects 27 and regulations establishing standards for the composition, operation, and responsibilities of IRBs that review clinical investigations involving human subjects. 28 At the same time, HHS adopted the Common Rule regulations on the protection of human research subjects. 29 The FDA’s regulations were harmonized with the Common Rule in 1991 to the extent permitted by statute. Key differences between FDA and HHS regulations include that the FDA does not allow for waiver or alteration of informed consent and requires that subjects be informed that the FDA may inspect their medical records. In addition, studies of efficacy based solely on medical records research are not permitted to support registration. Remaining differences in the rules are due to differences in the statutory scope or requirements ( Lee, 2000 ).

• DISTINGUISHING HEALTH RESEARCH FROM PRACTICE

The Common Rule and Privacy Rule make a somewhat artificial distinction between health research and some closely related health care practices, such as public health practice, quality improvement activities, program evaluations, 30 and utilization reviews, 31 all of which may involve collection and analysis of personally identifiable health information. However, determining which activities meet the definition of “research” is a major challenge for IRBs, Privacy Boards , 32 investigators, and health care practitioners because neither the regulations nor their interpretations by HHS provide clear guidance on how to distinguish research from activities that use similar techniques to analyze health information ( IOM, 2000a ).

It is important for IRBs and Privacy Boards to correctly distinguish among activities that are or are not subject to the various provisions of the Privacy Rule and the Common Rule . Only research requires formal IRB or Privacy Board review and informed consent. 33 Inappropriate classification of an activity as research can make it difficult or impossible for important health care activities, such as public health practice and quality improvement, to be undertaken. On the other hand, failure to correctly identify an activity as research could potentially allow improper disclosure of personally identifiable health information without sufficient oversight.

Thus, standard criteria are urgently needed for IRBs and Privacy Boards to use when making distinctions between health research and related activities, and the committee recommends that HHS consult with relevant stake holders to develop such standard criteria. HHS is aware of this need, and created a working document titled “What Is Research ?” However, the work on this project apparently has been delayed for unknown reasons ( NCURA, 2007 ). 34 As described below, a number of other models have already been proposed to help determine whether activities should be classified as research in the fields of public health and quality improvement, and these could be instructive for developing HHS guidance. Any criteria adopted by HHS should be regularly evaluated to ensure that they are helpful and producing the desired outcomes.

The following sections describe some ongoing efforts to develop such criteria in the fields of public health and quality improvement. The intent of the committee is not to endorse these particular models, but rather to illustrate the challenges associated with making these distinctions and establishing standard criteria.

Public Health Practice Versus Public Health Research

The Belmont Report defined health practice as “interventions designed solely to enhance the well-being of the person, patient or client, and which have reasonable expectation of success” ( CDC, 1999 ). To apply this definition to “public” health practice, the targeted beneficiary of the intervention must be expanded to include benefit to the community, rather than just a particular person. Neither the Common Rule nor the Privacy Rule provides a specific definition for public health research; rather public health research is included in the general definition of research. However, the Privacy Rule regulates public health practice differently from public health research (see Chapter 4 ).

An early model for distinguishing public health research from public health practice focused on the intent for which the activity was designed, noting that the intent of public health research is to “contribute to or generate generalizable knowledge,” while the intent of public health practice is to “conduct programs to prevent disease and injury and improve the health of communities” ( Snider and Stroup, 1997 ). The Centers for Disease Control and Prevention developed a similar method with an expanded assessment of intent. For example, the model posits that in public health research, the intended benefits of the project extend beyond the study participants, and the data collected exceed the requirements for the care of the study participants. But for public health practice, the intended benefits of the project are primarily for the participants in the activity, or for the participants’ community, and the only data collected are those needed to assess or improve a public health program or service, or the health of the participants and their community. The model also assumes that public health practice is based on well-established medical interventions and is nonexperimental ( CDC, 1999 ). However, these models both have been criticized as too subjective and too dependent on the opinion of the person conducting the activity ( Gostin, 2008 ; Hodge, 2005 ).

A new, more comprehensive model incorporating much of the previous two was recently proposed as a more objective checklist to be used by IRBs, Privacy Boards , and interested parties ( Hodge, 2005 ; Hodge and Gostin, 2004 ). The foundations for this model are specific definitions of public health research: “the collection and analysis of identifiable health data by a public health authority for the purpose of generating knowledge that will benefit those beyond the participating community who bear the risks of participation,” and public health practice: “the collection and analysis of identifiable health data by a public health authority for the purpose of protecting the health of a particular community, where the benefits and risks are primarily designed to accrue to the participating community.”

The model is based on two primary assumptions. First, the actor performing the activity in question is a governmental public health official, agent, agency, or entity at the federal, tribal, state, or local level. Second, the activity in question involves the acquisition, use, or disclosure of personally identifiable health data. The model is then divided into two stages. Stage 1 is applied to all activities, and can be used to distinguish practice from research in the easiest cases. Stage 2 is only applied to those cases that are hard to distinguish, and where Stage 1 failed to lead to a definitive IRB/ Privacy Board decision ( Box 3-6 ).

A Model for Distinguishing Public Health Practice from Research. Stage 1 Public health practice:

Quality Improvement Versus Health Research

Quality improvement has been defined as “systematic, data-guided activities designed to bring about immediate, positive change in the delivery of health care in a particular setting” ( Baily, 2008 ). Quality improvement activities do not require IRB or Privacy Board approval under the Common Rule or the Privacy Rule, which classify quality improvement as a component of health care operations. 35

However, in many cases, it is difficult for health care providers, IRBs, and Privacy Boards to determine whether a particular activity is purely for quality improvement, or whether it also entails research. One survey 36 exploring opinions in the health care community about the need for IRBs to review various quality-related activities found that physicians conducting quality improvement were less likely than IRB chairs to believe that IRB review was required for a given hypothetical activity, or that informed consent was necessary ( Lindenauer et al., 2002 ). Recently, a highly publicized case has again brought the issue to the forefront for all the stakeholders ( Box 3-7 ).

A Case Study of Quality Improvement and Research. Peter Pronovost of Johns Hopkins University (JHU) led a quality improvement effort at 103 intensive care units (ICUs) in Michigan hospitals to reduce the number of catheter-related bloodstream infections. (more...)

Some members of the health care community have proposed requiring that all prospective quality improvement activities go through external review ( Bellin and Dubler, 2001 ), while others have outlined specific criteria to differentiate quality improvement activities from research.

For example, Casarett and colleagues developed a two-part test to identify quality improvement activities. The first test is whether the majority of patients are expected to benefit directly from “the knowledge to be gained” from the initiative. This means that the patients must actually benefit from the knowledge learned during the evaluation, not just from being a recipient of the protocol itself. If the patients are generally expected to directly benefit from the knowledge gained during the activity, then the activity is quality improvement. If not, the activity is research. The second test is whether the participants would be subjected to additional risks or burdens, including the risk of privacy breach, beyond the usual clinical practice in order to make the results of the initiative generalizable. If yes, then the initiative should be reviewed as research ( Casarett et al., 2000 ).

More recently, the Hastings Center published a report exploring the similarities and differences between research and quality improvement. The report emphasized three fundamental characteristics of quality improvement and three fundamental characteristics of research. The authors argue that individuals have a responsibility to participate in the quality improvement activities because all patients have an interest in receiving high-quality medical care, and the success of a quality improvement activity depends on the cooperation of all patients. In addition, the report notes that quality improvement activities are a low risk to the patient, so there is little justification for not participating. The report also assumes that quality improvement activities are based on existing knowledge about human health and should lead to immediate local improvements in the provision of medical care.

In contrast, the report notes that participation in research should be voluntary, and decisions to participate should be based on researchers’ full disclosure of all the potential risks and benefits. In addition, the authors assert that research is designed to create new knowledge about human health, rather than relying solely on existing knowledge, and that most research does not result in any direct benefit to the institution where the research is being conducted.

The authors concluded that IRBs are not the appropriate body for the ethical oversight of quality improvement activities. They argue that IRBs unnecessarily impose high transaction costs on these activities because of the difference in the way they are conducted compared to research. For example, in research, any changes in methodology require further IRB approval. In contrast, quality improvement activities involve frequent adjustments in the intervention, measurement, and goals of the activity based on the experience of the investigators. Requiring the investigator to revisit an IRB every time a small adjustment is needed in such an activity significantly increases the amount of time and effort required to conduct the initiative and to produce meaningful data. Also, the investigators involved in quality improvement activities ordinarily are already involved in the clinical care of participants and bear responsibility for the quality and safety of an intervention. Thus, the authors argue that there is no need for the additional oversight by an IRB to protect participant safety.

Rather, the report recommended integrating the ethical oversight of quality improvement activities into the ongoing management of an institution’s health care delivery system, suggesting that oversight of quality improvement could be left with the managers of clinical care organizations, and that consent to receive treatment should include consent to participate in any quality improvement project that is minimal risk. However, the report stated that if a project has the characteristics of both quality improvement and research, the project should be reviewed as both human subjects research and quality improvement ( Baily et al., 2006 ; Lynn et al., 2007 ).

In response to the ongoing confusion over when quality improvement rises to the level of research and requires IRB review, the IOM jointly hosted a meeting with the American Board of Internal Medicine in May 2008 to discuss this issue. Key members of the quality improvement community attended, and short- and long-term solutions to this problem were proposed. However, no written report from this meeting was produced and no general consensus was reached.

• THE IMPORTANCE OF EFFECTIVE COMMUNICATION WITH THE PUBLIC

As noted previously in this chapter, surveys indicate that the vast majority of Americans believe that health research is important and are interested in the findings of research studies. The majority of patients also appear to be willing to participate in health research, either by volunteering for a study to test a medical intervention or by allowing access to their medical records or stored biospecimens, under certain conditions. Their willingness to participate depends on trust in researchers to safeguard the rights and well-being of patients, including assurance of privacy and confidentiality, and the belief that it is a worthwhile endeavor that warrants their involvement. Yet patients often lack information about how research is conducted, and are rarely informed about research results that may have a direct impact on their health. The committee’s recommendations in this section are intended to address both the public’s desire for more information about health research and to help fulfill two of the committees overarching goals of the report: (1) improving the privacy and security of health information, and (2) improving the effectiveness of health research.

Disseminating Health Research Results

Ethicists have long suggested greater community involvement in health research studies, including more communication about research results (reviewed by Shalowitz and Miller, 2008a , b ). In addition, the IOM committee identified transparency—the responsibility to disclose clearly how and why personally identifiable information is being collected—as an important component of comprehensive privacy protections. A previous IOM report also recommended improved communication with the public and research participants to ensure that the protection process is open and accessible to all interested parties ( IOM, 2002 ). Effective communication would build the public’s trust of the research community and is consistent with the principles of fair information practices.

When patients consent to the use of their medical records in a particular study, health researchers should make greater efforts at the conclusion of the study to inform study participants about the results, and the relevance and importance of those results. Learning about clinically relevant findings from a study in which a patient has participated could make patients feel more integrated into the process and could encourage more to participate in future studies. A recent United Kingdom report on the use of personal data in health research concluded that public involvement in research is necessary for the success of information-based research, and that a public informed about the value of research is likely to have greater enthusiasm and confidence in research and the research community ( AMS, 2006 ). Moreover, direct feedback with study participants could lead to improved health care for the individuals if the results indicate that an altered course of care is warranted.

Nonetheless, there are multiple impediments, beyond cost, to providing meaningful feedback to participants. A summary of the results alone, while necessary and reasonable, can be seen as a token, and also raises questions about issues such as how best to write summaries, the stage at which results should be disseminated, and how to present research with uninformative outcomes. For example, one recent study found that sharing results directly with study participants was met with overwhelmingly favorable reactions from patients, but the study also revealed some obstacles ( Partridge et al., 2008 ). In a survey of women who had participated in a randomized trial of breast cancer therapy and had received a summary of the study results by mail, 95 percent reported that they were glad they received the results. Most respondents interpreted the results correctly, although incorrect interpretation of the results was associated with increased anxiety, as was dissatisfaction with treatment.

Although some guidelines for providing and explaining study results to research participants have been proposed, they differ in details because limited data are available on this subject, and thus standards are lacking ( Partridge and Winer, 2002 ; Partridge et al., 2008 ; Shalowitz and Miller, 2008b ; Zarin and Tse, 2008 ). Because transparency is best achieved by providing graded levels of information and guidance to interested parties ( IOM, 2002 ), it will be important to develop effective and efficient ways to communicate with various sectors of the population. A commitment to the principles of “plain language” 37 will be important. Broader adoption of electronic medical records may also be helpful in accomplishing this goal.

Research Registries

One way to make information about research studies more broadly available to the public is through registration of trials and other studies in public databases. HHS should encourage such registration of trials and other studies, particularly when research is conducted with an IRB/ Privacy Board approved waiver of consent or authorization (see Chapter 4 ). Numerous clinical trial registries already exist, and registration has increased in recent years (reviewed by Zarin and Tse, 2008 ). In 2000, the National Library of Medicine established a clinical trials registry ( ClinicalTrials.gov ), which has expanded to include information from several other trial registries and to serve as the FDA-required site for submissions about clinical trials subject to the FDA databank requirement. The FDA Amendments Act of 2007 38 expanded the scope of required registrations at ClinicalTrials.gov and provided the first federally funded trials results database. It mandates registrations of controlled clinical investigations, except for Phase I trials, of drugs, biologics, and devices subject to FDA regulation.

A policy of the International Committee of Medical Journal Editors (ICMJE), adopted in fall 2005, also requires prospective trial registration as a precondition for publication ( DeAngelis et al., 2004 ). This policy led to a 73 percent increase in trial registrations of all intervention types from around the world ( Zarin et al., 2005 ). Nearly 45,000 trials had been registered by fall 2007.

However, although the development of such registries is an important first step toward providing high-quality clinical trial information to the public, no centralized system currently exists to disseminate information about clinical trials of drugs or other interventions, making it difficult for consumers and their health care providers to identify ongoing studies. The current statutory requirements for registration and data reporting in the United States are not as broad as the transnational policies of the ICMJE or the World Health Organization, which call for the registration of all interventional studies in human beings regardless of intervention type ( Laine et al., 2007 ; Sim et al., 2006 ). Moreover, noninterventional studies, such as observational studies that play an increasingly critical role in biomedical research, are not generally included in these databases. Because many noninterventional studies are conducted with an IRB/ Privacy Board approved waiver of consent or authorization, including those studies in a registry could be an important method for increasing public knowledge of such studies.

Informing the Public About the Methods and Value of Research

As noted previously, clinical trials are the most visible of the various types of health research, but a great deal of information-based health research entails analysis of thousands of patient records to better understand human diseases, to determine treatment effectiveness, and to identify adverse side effects of therapies. This form of research is likely to increase in frequency as the availability of electronic records continues to expand. As we move toward the goal of personalized medicine, research results will be even more likely to be directly relevant to patients, but more study subjects will be necessary to derive meaningful results.

However, many patients probably are not aware that their medical records are being used in information-based research. For example, the recent study that used focus groups to examine the views of veterans toward the use of medical records in research found that the majority of participants (75 percent) were not aware that “under some circumstances, [their] medical records could be used in some research studies without [their] permission,” despite the fact that a notice of privacy practices, which included a statement that such research could occur, had been mailed to all participants less than a year prior to the study ( Damschroder et al., 2007 ).

Moreover, surveys show that many patients desire not only notice, but also the opportunity to decide whether to consent to such research with medical records. Those surveys further indicate that patients who wish to be asked for consent for each study are most concerned about the potentially detrimental affects of inappropriate disclosure of their personally identifiable health information, including discrimination in obtaining health or life insurance or employment.

As noted in Chapter 2 , strengthening security protections of health data should reduce the risk of security breaches and their potential negative consequences, and thus should help to alleviate patient concerns in this regard. But educating patients about how health research is conducted, monitored, and reported on could also help to ease patient concerns about privacy and increase patients’ trust in the research community, which as noted above is important for the public’s continued participation in health research. For example, datasets are most often provided to researchers without direct identifiers such as name and Social Security number. Furthermore, identifiers are not included in publications about research results. Also, under both the Privacy Rule and the Common Rule , a waiver of consent and authorization is possible only under the supervision of an IRB or Privacy Board , and a waiver is granted only when the research entails minimal risk and when obtaining individual consent and authorization is impracticable (see the previous section and also Chapter 4 ). Finally, professional ethics dictate that researchers safeguard data and respect privacy.

Conveying the value of medical records research to patients will be important. Surveys show that people are more supportive of research that is relevant to them and their loved ones. At the same time, educational efforts should stress the negative impact of incomplete datasets on research findings. Representative samples are essential to ensure the validity and generalizability of health research ( Box 3-8 ), but datasets will not represent the entire population if some people withhold access to their health information.

Selection Bias in Health Research. When researchers are required to obtain consent or authorization to access each individual’s medical record for a research study, it is likely that individuals’ willingness to grant access will not be (more...)

In addition, an educated public could also decrease the potential for biased research samples. A universal requirement for consent or authorization in medical records research leads to incomplete datasets, and thus to biased results and inaccurate conclusions. Some large medical institutions with a strong research history and reputation (e.g., Mayo Clinic) can obtain authorization and consent rates as high as 80 percent, but the 20 percent who refuse have distinct demographic and health characteristics. In fact, even a refusal rate of less than 5 percent can create selection bias in the data ( Jacobsen et al., 1999 ; see Chapter 5 for more detail). Conveying to the public the importance of health care improvements derived from medical records research and stressing the negative impact of incomplete datasets on research findings may increase the public’s participation in research and their willingness to support information-based research that is conducted with IRB or Privacy Board oversight, under a waiver of patient consent or authorization.

Numerous examples of important research findings from medical records research would not have been possible if direct patient consent and authorization were always required ( Box 3-1 ). For example, analysis of medical records showed that infants exposed to diethylstilbesterol (DES) during the first trimester of pregnancy had an increased risk of breast, vaginal, and cervical cancer as well as reproductive anomalies as adults. Similarly, studies of medical records led to the discovery that folic acid supplementation during pregnancy can prevent neural tube defects.

Thus, HHS and the health research community should work to edu cate the public about how research is done and the value it provides. All stakeholders, including professional organizations, nonprofit funders, and patient organizations, have different interests and responsibilities to make sure that their constituencies are well informed. For example, the American Society of Clinical Oncology and the American Heart Association already have some online resources to help patients gather information about research that may be relevant to their conditions. But coordination and identification of best practices by HHS would be helpful, and research is needed to identify which segments of the population would be receptive to and benefit from various types of information about how research is done and its value in order to create and implement an effective plan.

Greater use of community-based participatory research, in which community-based organizations or groups bring community members into the research process as partners to help design studies and disseminate the knowledge gained, 39 could help achieve this goal. These groups help researchers to recruit research participants by using the knowledge of the community to understand health problems and to design activities that the community is likely to value. They also inform community members about how the research is done and what comes out of it, with the goal of providing immediate community benefits from the results when possible.

• CONCLUSIONS AND RECOMMENDATIONS

Based on its review of the information described in this chapter, the committee agreed on a second overarching principle to guide the formation of recommendations. The committee affirms the importance of maintaining and improving health research effectiveness. Research discoveries are central to achieving the goal of extending the quality of healthy lives. Research into causes of disease, methods for prevention, techniques for diagnosis, and new approaches to treatment has increased life expectancy, reduced infant mortality, limited the toll of infectious diseases, and improved outcomes for patients with heart disease, cancer, diabetes, and other chronic diseases. Patient-oriented clinical research that tests new ideas makes rapid medical progress possible. Today, the rate of discovery is accelerating, and we are at the precipice of a remarkable period of investigative promise made possible by new knowledge about the genetic underpinnings of disease. Genomic research is opening new possibilities for preventing illness and for developing safer, more effective medical care that may eventually be tailored for specific individuals. Further advances in relating genetic information to predispositions to disease and responses to treatments will require the use of large amounts of existing health-related information and stored tissue specimens. The increasing use of electronic medical records will further facilitate the generation of new knowledge through research and accelerate the pace of discovery. These efforts will require broad participation of patients in research and broad data sharing to ensure that the results are valid and applicable to different segments of the population. Collaborative partnerships among communities of patients, their physicians, and teams of researchers to gain new scientific knowledge will bring tangible benefits for people in this country and around the world.

Surveys indicate that the majority of Americans believe that health research is important, are interested in the findings of research studies, and are willing to participate in health research. But patients often lack information about how research is conducted and are rarely informed about research results that may have a direct impact on their health. Effective communication could build the public’s trust of the research community, which is important because trust is necessary for the public’s continued participation in research. Moreover, direct feedback could lead to improved health care for study participants if the results indicate that an altered course of care is warranted.

Thus, the committee recommends that when patients consent to the use of their medical records in a particular study, health researchers should make greater efforts when the study ends to inform study participants about the results, and the relevance and importance of those results. Broader adoption of electronic health records may be helpful in accomplishing this goal, but standards and guidelines for providing and explaining study results to research participants or various sectors of the public are needed.

HHS should also encourage registration of trials and other studies in public databases, particularly when research is conducted with an IRB/ Privacy Board approved waiver of consent or authorization, as a way to make information about research studies more broadly available to the public. Numerous clinical trial registries already exist, and registration has increased in recent years, but no centralized system currently exists for disseminating information about clinical trials of drugs or other interventions, making it difficult for consumers and their health care providers to identify ongoing studies. Moreover, noninterventional studies, such as observational studies that play an increasingly critical role in biomedical research, are not generally included in these databases. Because many noninterventional studies are conducted with an IRB/Privacy Board approved waiver of consent or authorization, including such studies in a registry could be an important method for increasing public knowledge of those studies.

Interventional clinical trials are the most visible of the various types of health research, but a great deal of information-based health research entails analysis of thousands of patient records to better understand human diseases, to determine treatment effectiveness, and to identify adverse side effects of therapies. This form of research is likely to increase in frequency as the availability of electronic health records continues to expand. As we move toward the goal of personalized medicine, research results will be even more likely to be directly relevant to patients, but more study participants will be necessary to derive meaningful results.

However, many patients are likely not aware that their medical records are being used in information-based research, and surveys show that many patients desire not only notice, but also the opportunity to decide about whether to consent to such research with medical records. As noted in Chapter 2 , strengthening security protections of health data should reduce the risk of security breaches and their potential negative consequences, and thus should help to alleviate patient concerns in this regard. But educating patients about how health research is conducted, monitored, and reported could also increase patients’ trust in the research community. Thus, HHS and the health research community should work to educate the public about how research is done.

It will also be important for HHS and researchers to convey the value of health care improvements derived from medical records research, and to stress the negative impact of incomplete datasets on research findings. Representative samples are essential to ensure the validity and generalizability of health research, but datasets will not be representative of the entire population if some people withhold access to their health information. A universal requirement for consent or authorization in information-based research may lead to incomplete datasets, and thus to biased results and inaccurate conclusions. Numerous examples of important research findings from medical records research would not have been possible if direct patient consent and authorization were always required.

To ensure that beneficial health research and related activities continue to be undertaken with appropriate oversight under federal regulations, it will be important for HHS to also provide more guidance on how to distinguish the various activities. The Privacy Rule makes a distinction between health research and some closely related endeavors, such as public health and quality improvement activities, which also may involve collection and analysis of personally identifiable health information. Under the Privacy Rule (as well as the Common Rule ), these activities, which aim to protect the public’s health and improve the quality of patient care, are considered health care “practice” rather than health research. Therefore, they can be undertaken without consent or authorization, or an IRB/ Privacy Board waiver of consent or authorization. However, it can be a challenge for IRBs and Privacy Boards to distinguish among activities that are or are not subject to the various provisions of the Privacy Rule and the Common Rule, and inappropriate decisions may prevent important activities from being undertaken or could potentially allow improper disclosure of personally identifiable health information.

To address these difficulties, a number of models have been proposed that outline the criteria IRBs and Privacy Boards should use to distinguish practice and research. For example, one recent model provides a detailed checklist for IRBs and Privacy Boards to use in determining whether an activity is public health research and required to comply with the research provisions of the Privacy Rule, or public health practice that does not need IRB/Privacy Board review. The committee believes that standardizing the criteria is essential to support the conduct of these important health care activities.

Thus, HHS should convene the relevant stakeholders to develop standard criteria for IRBs and Privacy Boards to use when making decisions about whether protocols entail research or practice. There should be flexibility in the regulation to allow important activities to go forward with appropriate levels of oversight. Also, it will be important to evaluate whether these criteria are effective in aiding IRB/Privacy Board reviews of proposed protocols, and whether they lead to appropriate IRB/Privacy Board decisions.

These changes suggested above could be accomplished without any changes to HIPAA by making them a condition of funding from HHS and other research sponsors and by providing some additional funds to cover the cost.

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Epidemiology is the study of the occurrence, distribution, and control of diseases in populations.

Health services research has been defined as a multidisciplinary field of inquiry, both basic and applied, that examines the use, costs, quality, accessibility, delivery, organization, financing, and outcomes of health care services to increase knowledge and understanding of the structure, processes, and effects of health services for individuals and populations ( IOM, 1995 ).

The National Committee on Vital and Health Statistics has noted that “secondary uses” of health data is an ill-defined term, and urges abandoning it in favor of precise description of each use ( NCVHS, 2007a ). Thus, the committee chose to minimize use of the term in this report.

See Standards for Privacy of Individually Identifiable Health Information , 64 Fed. Reg. 59918, 59967 (preamble to rule proposed November 3, 1999) for a discussion on the benefits of health records research.

Effectiveness can be defined as the extent to which a specific test or intervention, when used under ordinary circumstances, does what it is intended to do. Efficacy refers to the extent to which a specific test or intervention produces a beneficial result under ideal conditions (e.g., in a clinical trial).

See http://www ​.intermacs.org .

See http://www ​.elso.med.umich.edu .

See http://www ​.unos.org/Data .

The Department of Health, Education and Welfare (now HHS) had previously issued policy and guidance on the protection of human subjects. See Williams (2005) .

In its report “First Biennial Report on the Adequacy and Uniformity of Federal Rules and Policies, and their Implementation, for the Protection of Human Subjects in Biomedical and Behavioral Research , Protecting Human Subjects.”

45 C.F.R. part 46 (2005).

See 45 C.F.R. § 46.101 (2005).

See 45 C.F.R. § 46.102(d) (2005).

This section on informed consent is based largely on a Congressional Research Service report ( Williams, 2005 ), as adapted by Pritts (2008) .

See 45 C.F.R. § 46.116 (2005).

See 45 C.F.R. § 46.116(b) (2005).

See 45 C.F.R. § 46.103 (2005).

See 45 C.F.R. § 46.111 (2005). There are additional factors if the study includes subjects who are likely to be vulnerable to coercion or undue influence.

See 45 C.F.R. § 46.116(d); 46.117(c) (2005).

See 45 C.F.R. § 46.102(f) (2005).

See 45 C.F.R. § 46.101(b)(4) (2005).

See 45 C.F.R. § 46.116(e) (2005).

See 45 C.F.R. § 46.123 (2005).

See also Grimes v. Kennedy Krieger Institute , 782 A. 2d 807 (Md. Ct. App. 2001); Gelsinger v. University of Pennsylvania (Philadelphia County Court of Common Pleas filed September 18, 2000), available at http://www ​.sskrplaw.com ​/links/healthcare2.html .

The FDA has defined “clinical investigation” to be synonymous with “research.”

The Food, Drug, and Cosmetic Act Section 505(i), 507(d), or 520(g) of 21 U.S.C. 355(i), 357(d), or 360j(g) (1972).

See 21 C.F.R. part 50 (2008); 46 Fed. Reg. 8942 (1981).

See 21 C.F.R. part 56 (2008); 46 Fed. Reg. 8958 (1981).

See 45 C.F.R. part 46 (2005); 46 Fed. Reg. 8366 (1981).

The Centers for Disease Control and Prevention defines program evaluation as the “systematic investigation of the merit, worth, or significance of organized public health action,” noting that such evaluations are “systematic ways to improve and account for public health actions by involving procedures that are useful, feasible, ethical, and accurate.” They can be based on goals, processes, outcomes, or value ( http://www ​.cdc.gov/mmwr ​/preview/mmwrhtml/rr4811a1.htm ).

The Utilization Review Accreditation Commission defines utilization review as “the evaluation of the medical necessity, appropriateness, and efficiency of the use of health care services, procedures, and facilities under the provisions of the applicable health benefits plans” ( http://www ​.urac.org/about/ ).

Another type of oversight board defined by the Privacy Rule. See Chapter 4 .

Under the Privacy Rule, consent is referred to as authorization. See Chapter 4 .

Personal communication, C. Heide, Office for Civil Rights, HHS, May 29, 2008.

The Privacy Rule defines the term “health care operations” by listing a number of specific activities that qualify as health care operations. These include “conducting quality assessment and improvement activities, population-based activities relating to improving or reducing health care costs, and case management and care coordination.” See 45 C.F.R. § 164.501 (2006).

A total of 444 surveys were mailed to the medical directors of quality improvement and IRB chairs at hospitals with 400 or more beds that belong to the Council of Teaching Hospitals of the Association of American Medical Colleges, and to the editors of all U.S.-based medical journals that publish original research and appear in the Abridged Index Medicus. 236 surveys were returned, for a 53 percent response rate. The survey consisted of six brief scenarios that asked respondents to determine whether the described project needed IRB review and informed consent.

See http: ​//plainlanguage.gov/index.cfm .

FDA, Public Law 110–85 § 801 (2007).

See http://www ​.ahrq.gov/research/cbprrole ​.htm .

• Cite this Page Institute of Medicine (US) Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule; Nass SJ, Levit LA, Gostin LO, editors. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington (DC): National Academies Press (US); 2009. 3, The Value, Importance, and Oversight of Health Research.
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