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  • Ethical Theory and Principles (23)
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A woman's face showing stress.

Case Study – Moral Culpability for Respecting Patients’ Autonomy

A ball of twine on a red background.

Case Study – Decisional Capacity of the Patient’s Surrogate

Close up of a stethoscope draped around a doctor's neck wearing a white lab coat.

Case Study – A Multidisciplinary Healthcare Team Disagrees

A man's legs.

Case Study – Whose Decision?

ICU monitor.

Case Study –Too little, too late… almost

Case Study – Trying to Honor Johnny’s Wishes

Case Study – Trying to Honor Johnny’s Wishes

Man standing high up.

Case Study – “God will restore his leg. The doctors will see.” Patient Nonadherence.

Nurse looking distressed.

Case Study – Moral Dimensions of Medical Negligence

Nurse resting on a sofa.

Case Study – Moral Distress of Hospital Workers

Research Cases for Use by the NIH Community

Theme 23 – authorship, collaborations, and mentoring (2023).

  • Case 1: Transfer of a Project and Scientific Disagreement
  • Case 2: Authorship or Acknowledgement of a Post-baccalaureate Trainee
  • Case 3: Collaboration and Outside Activities
  • Case Study Facilitator Notes
  • 2023 Ethics Case Facilitator Training with Dr. David Resnik (NIEHS)
  • 2023 Ethics Case Discussion Make-up Session
  • Note: IC submission of ethics case completion data is due by 02/29/2024

Theme 22 – Use of Human Biospecimens and Informed Consent (2022)

  • Case Study: Use of Human Biospecimens and Informed Consent
  • 2022 Ethics Case Facilitator Training with Dr. David Resnik (NIEHS)
  • Note: IC submission of ethics case completion data is due by 3/31/2023

Theme 21 – Science Under Pressure (2021)

  • Case 1: Science Under Pressure
  • Case 1 Facilitator Notes
  • 2021 Ethics Case Facilitator Training with Dr. David Resnik (NIEHS)

Theme 20 – Data, Project and Lab Management, and Communication (2020)

  • Case 1: Data Access, Analysis and Reporting within a Research Group
  • Case 2: Postdoc Leaving NIH Lab
  • Cases 1 and 2 for Facilitators
  • 2020 Ethics Case Facilitator Training with Dr. David Resnik (NIEHS)

Theme 19 – Civility, Harassment and Inappropriate Conduct (2019)

  • Case 1: Gender Harassment, Sexual Harassment, and Consenting Relationships
  • Case 2: Freedom of Expression and Civility in the Laboratory
  • Case 3: Biases in Mentoring of Fellows and Sexual Harassment
  • Study Guide (2019)

Theme 18 – Implicit and Explicit Biases in the Research Setting (2018)

  • Case 1: Gender Bias in Academia
  • Case 2: Responsible and Equitable Mentoring of Fellows
  • Case 3: Diversity and Bias – Approach to Disabilities
  • Case 4: Implicit/Unconscious Biases?

Theme 17 – Socially Responsible Science (2017)

  • Case 1: Deciding What Study Results to Publish and Transparency in Research Publication
  • Case 2: Handling Select Agents
  • Case 3: Research Competition and Reproducibility
  • Case 4: Societal Aspects of the Responsible Conduct of Research

Theme 16 – Research Reproducibility (2016)

Because this important topic is both broad and provocative, with issues that could be discussed for hours, discussion leaders and participants will need to identify ways to keep the discussion on schedule. Three potential alternative approaches to this are: (a) keep discussion of the entire case concise and well-paced; (b) discuss a selected subset of the sections, labeled by Roman numerals, that are the most relevant to the particular IC and audience, and/or use only selected questions; or, (c) dedicate more than one hour to discussing this case.

  • Case 1: Research Reproducibility

Theme 15 – Authorship and Collaborative Science (2015)

  • Case 1: Intellectual Input, Core Facilities and Authorship
  • Case 2: Authorship Disputes in Multi-Team Collaborations
  • Case 3: Clinical Collaborations
  • General Guidelines for Authorship Contributions

Theme 14 – Differentiating Between Honest Discourse and Research Misconduct and Introduction to Enhancing Reproducibility (2014)

  • Case 1: Handling of Images and Graphs
  • Case 2: A Technically Challenging Method Collides With a Hot Topic
  • Case 3: Handling of Clinical Data
  • Case 4: Sources of Potential Bias and Data Sharing
  • Case 5: Research Reproducibility I: Sample Composition and Reproducibility
  • Case 6: Research Reproducibility II: Prostate Cancer Serum Biomarker Study

Theme 13 – Data Management, Whistleblowers, and Nepotism (2013)

  • Case 1: Whistleblowers
  • Case 2: CLUES: Research Misconduct or Sloppy Science?
  • Case 3: Data Management in Clinical Studies
  • Case 4: Nepotism in the Training and Research Setting

Theme 12 – Mentoring (2012)

  • Case 1: Different Mentoring Styles
  • Case 2: Non-Academic Staff
  • Case 3: Intellectual Property
  • Case 4: Personal Relationships

Theme 11 – Authorship (2011)

  • Case 1: Co-Authorship – When Changing Labs, Have You Done Enough to Be Included?
  • Case 2: Criteria for Authorship and Attribution
  • Case 3: Multiple Publications
  • Case 4: First Authorship, Publicity, and Multiple Institutions
  • NIH IRP Authorship Conflict Resolution Process

Theme 10 – Science and Social Responsibility, Continued (2010)

  • Case 1: Potential Consequences of Epidemiological Studies
  • Case 2: Scientific Research and the Press
  • Case 3: Intellectual Property – Why Use an MTA

Theme 9 – Science and Social Responsibility – Dual Use Research (2009)

  • Case 1: Streptococcus pneumoniae Membrane Pump Sequence
  • Case 2: Pandemic Influenza Genomic Sequence
  • Case 3: An Unusual Wrinkle to Translational Research
  • Case 4: Cell-matrix Interaction and Tumor Growth & Metastasis

Theme 8 – Borrowing – Is It Plagiarism? (2008)

  • Case 1: Borrowing Results
  • Case 2: Borrowing Ideas
  • Case 3: Borrowing English

Theme 7 – Data Management and Scientific Misconduct (2007)

  • Case 1: Data Management of Computer-generated Files
  • Case 2: Handling of Images and Graphs
  • Case 3: Appropriate Use of Statistics
  • Case 4: Appropriate Sources of Data and Decision to Publish
  • Case 5: Handling of Clinical Data

Theme 6 – Ethical Ambiguities (2006)

  • Ethical Ambiguities

Theme 5 – Data Management (2005)

  • Figure 1 (Image File)
  • Epidemiological and Clinical Data Management
  • What’s in a Picture? The Temptation of Image Manipulation
  • Three Retractions Published in Cell (2004)

Theme 4 – Collaborative Science (2004)

  • Case 1: Basic-Clinical Collaboration
  • Case 2: When Does a Collaborator Deserve Authorship
  • Case 3: Equipment Sharing and Authorship
  • Case 4: Assays and Authorship
  • Case 5: Collaboration and Credit
  • Case 6: The Statute of Limitations

Theme 3 – Mentoring (2003)

  • Case 1: Different Supervising and Mentoring Styles
  • Case 2: Equal Treatment of Postdoctoral Fellows Sharing of Job Ads
  • Case 3: Work Hours and Schedules
  • Case 4: Mentoring of Technicians
  • Case 5: Intellectual Property Mentor’s Use of Fellow’s Research Proposal
  • Case 6: Future Collaborations for Tenuretrack Investigators
  • Case 7: Issues Related to CRADA Funding of Trainees
  • Case 8: Confirmation of Lab Results Request for Secrecy
  • Case 9: Handling of Personal Relationships in the Laboratory
  • Case 10: Dealing with A Substance Abuse Problem in the Laboratory
  • A Guide to Training and Mentoring in the Intramural Research Program at NIH
  • SD Policy Updates for Mentors and Trainees (May 2002)

Theme 2 – Authorship (2002)

  • Case 1: Authorship and the Role of the Absent Researcher
  • Case 2: To Be or Not To Be Included
  • Case 3: Student Publishes
  • Case 4: Criteria for Authorship and Attribution
  • http://www.stanford.edu/dept/DoR/rph/2-8.html
  • http://www.responsibility.research.umich.edu/casematerialsdir.html
  • http://www.apa.org/journals/amp/kurdek.html
  • http://www.councilscienceeditors.org/services_ATF.shtml
  • http://www.ed.gov/databases/ERIC_Digests/ed410318.html

Theme 1 – Scientific Misconduct (2001)

  • Case 1: Scientific Misconduct in the Laboratory
  • Case 2: Suspicions of Misconduct in Clinical Research
  • Case 3: Ownership of Ideas
  • A Guide to the Handling of Scientific Misconduct Allegations in the Intramural Research Program at the NIH
  • Intramural Research Program Policies & Procedures for Research Misconduct Proceedings

This page was last updated on Friday, January 26, 2024

Case report

BMC Medical Ethics welcomes well-described reports of cases that include the following: • Unreported or unusual side effects or adverse interactions involving medications. • Unexpected or unusual presentations of a disease. • New associations or variations in disease processes. • Presentations, diagnoses and/or management of new and emerging diseases. • An unexpected association between diseases or symptoms. • An unexpected event in the course of observing or treating a patient. • Findings that shed new light on the possible pathogenesis of a disease or an adverse effect.

Case reports submitted to BMC Medical Ethics should make a contribution to medical knowledge and must have educational value or highlight the need for a change in clinical practice or diagnostic/prognostic approaches. BMC Medical Ethics will not consider case reports describing preventive or therapeutic interventions, as these generally require stronger evidence. We will not consider reports on topics that have already been well characterised or where other, similar, cases have already been published. 

Authors should describe how the case report is rare or unusual as well as its educational and/or scientific merits in the covering letter that will accompany the submission of the manuscript. Case report submissions will be assessed by the Editors and will be sent for peer review if considered appropriate for the journal.

Case reports should include relevant positive and negative findings from history, examination and investigation, and can include clinical photographs, provided these are accompanied by a statement that written consent to publish was obtained from the patient(s). Case reports should include an up-to-date review of all previous cases in the field. Authors should follow the CARE guidelines and the CARE checklist should be provided as an additional file.

Authors should seek written and signed consent to publish the information from the patient(s) or their guardian(s) prior to submission. The submitted manuscript must include a statement that this consent was obtained in the consent to publish section as detailed in our editorial policies .

Professionally produced Visual Abstracts BMC Medical Ethics will consider visual abstracts. As an author submitting to the journal, you may wish to make use of services provided at Springer Nature for high quality and affordable visual abstracts where you are entitled to a 20% discount. Click here to find out more about the service, and your discount will be automatically be applied when using this link.

Preparing your manuscript

The information below details the section headings that you should include in your manuscript and what information should be within each section.

Please note that your manuscript must include a 'Declarations' section including all of the subheadings (please see below for more information).

Title page 

The title page should:

  • "A versus B in the treatment of C: a randomized controlled trial", "X is a risk factor for Y: a case control study", "What is the impact of factor X on subject Y: A systematic review, A case report etc."
  • or, for non-clinical or non-research studies: a description of what the article reports
  • if a collaboration group should be listed as an author, please list the Group name as an author. If you would like the names of the individual members of the Group to be searchable through their individual PubMed records, please include this information in the “Acknowledgements” section in accordance with the instructions below
  • Large Language Models (LLMs), such as ChatGPT , do not currently satisfy our authorship criteria . Notably an attribution of authorship carries with it accountability for the work, which cannot be effectively applied to LLMs. Use of an LLM should be properly documented in the Methods section (and if a Methods section is not available, in a suitable alternative part) of the manuscript
  •  indicate the corresponding author

The Abstract should not exceed 350 words. Please minimize the use of abbreviations and do not cite references in the abstract. The abstract must include the following separate sections:

  • Background: why the case should be reported and its novelty
  • Case presentation: a brief description of the patient’s clinical and demographic details, the diagnosis, any interventions and the outcomes
  • Conclusions: a brief summary of the clinical impact or potential implications of the case report

Keywords 

Three to ten keywords representing the main content of the article.

The Background section should explain the background to the case report or study, its aims, a summary of the existing literature.

Case presentation

This section should include a description of the patient’s relevant demographic details, medical history, symptoms and signs, treatment or intervention, outcomes and any other significant details.

Discussion and Conclusions

This should discuss the relevant existing literature and should state clearly the main conclusions, including an explanation of their relevance or importance to the field.

List of abbreviations

If abbreviations are used in the text they should be defined in the text at first use, and a list of abbreviations should be provided.

Declarations

All manuscripts must contain the following sections under the heading 'Declarations':

Ethics approval and consent to participate

Consent for publication, availability of data and materials, competing interests, authors' contributions, acknowledgements.

  • Authors' information (optional)

Please see below for details on the information to be included in these sections.

If any of the sections are not relevant to your manuscript, please include the heading and write 'Not applicable' for that section. 

Manuscripts reporting studies involving human participants, human data or human tissue must:

  • include a statement on ethics approval and consent (even where the need for approval was waived)
  • include the name of the ethics committee that approved the study and the committee’s reference number if appropriate

Studies involving animals must include a statement on ethics approval and for experimental studies involving client-owned animals, authors must also include a statement on informed consent from the client or owner.

See our editorial policies for more information.

If your manuscript does not report on or involve the use of any animal or human data or tissue, please state “Not applicable” in this section.

If your manuscript contains any individual person’s data in any form (including any individual details, images or videos), consent for publication must be obtained from that person, or in the case of children, their parent or legal guardian. All presentations of case reports must have consent for publication.

You can use your institutional consent form or our consent form if you prefer. You should not send the form to us on submission, but we may request to see a copy at any stage (including after publication).

See our editorial policies for more information on consent for publication.

If your manuscript does not contain data from any individual person, please state “Not applicable” in this section.

All manuscripts must include an ‘Availability of data and materials’ statement. Data availability statements should include information on where data supporting the results reported in the article can be found including, where applicable, hyperlinks to publicly archived datasets analysed or generated during the study. By data we mean the minimal dataset that would be necessary to interpret, replicate and build upon the findings reported in the article. We recognise it is not always possible to share research data publicly, for instance when individual privacy could be compromised, and in such instances data availability should still be stated in the manuscript along with any conditions for access.

Authors are also encouraged to preserve search strings on searchRxiv https://searchrxiv.org/ , an archive to support researchers to report, store and share their searches consistently and to enable them to review and re-use existing searches. searchRxiv enables researchers to obtain a digital object identifier (DOI) for their search, allowing it to be cited. 

Data availability statements can take one of the following forms (or a combination of more than one if required for multiple datasets):

  • The datasets generated and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS]
  • The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
  • All data generated or analysed during this study are included in this published article [and its supplementary information files].
  • The datasets generated and/or analysed during the current study are not publicly available due [REASON WHY DATA ARE NOT PUBLIC] but are available from the corresponding author on reasonable request.
  • Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.
  • The data that support the findings of this study are available from [third party name] but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of [third party name].
  • Not applicable. If your manuscript does not contain any data, please state 'Not applicable' in this section.

More examples of template data availability statements, which include examples of openly available and restricted access datasets, are available here .

BioMed Central strongly encourages the citation of any publicly available data on which the conclusions of the paper rely in the manuscript. Data citations should include a persistent identifier (such as a DOI) and should ideally be included in the reference list. Citations of datasets, when they appear in the reference list, should include the minimum information recommended by DataCite and follow journal style. Dataset identifiers including DOIs should be expressed as full URLs. For example:

Hao Z, AghaKouchak A, Nakhjiri N, Farahmand A. Global integrated drought monitoring and prediction system (GIDMaPS) data sets. figshare. 2014. http://dx.doi.org/10.6084/m9.figshare.853801

With the corresponding text in the Availability of data and materials statement:

The datasets generated during and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS]. [Reference number]  

If you wish to co-submit a data note describing your data to be published in BMC Research Notes , you can do so by visiting our submission portal . Data notes support open data and help authors to comply with funder policies on data sharing. Co-published data notes will be linked to the research article the data support ( example ).

All financial and non-financial competing interests must be declared in this section.

See our editorial policies for a full explanation of competing interests. If you are unsure whether you or any of your co-authors have a competing interest please contact the editorial office.

Please use the authors initials to refer to each authors' competing interests in this section.

If you do not have any competing interests, please state "The authors declare that they have no competing interests" in this section.

All sources of funding for the research reported should be declared. If the funder has a specific role in the conceptualization, design, data collection, analysis, decision to publish, or preparation of the manuscript, this should be declared.

The individual contributions of authors to the manuscript should be specified in this section. Guidance and criteria for authorship can be found in our editorial policies .

Please use initials to refer to each author's contribution in this section, for example: "FC analyzed and interpreted the patient data regarding the hematological disease and the transplant. RH performed the histological examination of the kidney, and was a major contributor in writing the manuscript. All authors read and approved the final manuscript."

Please acknowledge anyone who contributed towards the article who does not meet the criteria for authorship including anyone who provided professional writing services or materials.

Authors should obtain permission to acknowledge from all those mentioned in the Acknowledgements section.

See our editorial policies for a full explanation of acknowledgements and authorship criteria.

If you do not have anyone to acknowledge, please write "Not applicable" in this section.

Group authorship (for manuscripts involving a collaboration group): if you would like the names of the individual members of a collaboration Group to be searchable through their individual PubMed records, please ensure that the title of the collaboration Group is included on the title page and in the submission system and also include collaborating author names as the last paragraph of the “Acknowledgements” section. Please add authors in the format First Name, Middle initial(s) (optional), Last Name. You can add institution or country information for each author if you wish, but this should be consistent across all authors.

Please note that individual names may not be present in the PubMed record at the time a published article is initially included in PubMed as it takes PubMed additional time to code this information.

Authors' information

This section is optional.

You may choose to use this section to include any relevant information about the author(s) that may aid the reader's interpretation of the article, and understand the standpoint of the author(s). This may include details about the authors' qualifications, current positions they hold at institutions or societies, or any other relevant background information. Please refer to authors using their initials. Note this section should not be used to describe any competing interests.

Footnotes can be used to give additional information, which may include the citation of a reference included in the reference list. They should not consist solely of a reference citation, and they should never include the bibliographic details of a reference. They should also not contain any figures or tables.

Footnotes to the text are numbered consecutively; those to tables should be indicated by superscript lower-case letters (or asterisks for significance values and other statistical data). Footnotes to the title or the authors of the article are not given reference symbols.

Always use footnotes instead of endnotes.

Examples of the Vancouver reference style are shown below.

See our editorial policies for author guidance on good citation practice

Web links and URLs: All web links and URLs, including links to the authors' own websites, should be given a reference number and included in the reference list rather than within the text of the manuscript. They should be provided in full, including both the title of the site and the URL, as well as the date the site was accessed, in the following format: The Mouse Tumor Biology Database. http://tumor.informatics.jax.org/mtbwi/index.do . Accessed 20 May 2013. If an author or group of authors can clearly be associated with a web link, such as for weblogs, then they should be included in the reference.

Example reference style:

Article within a journal

Smith JJ. The world of science. Am J Sci. 1999;36:234-5.

Article within a journal (no page numbers)

Rohrmann S, Overvad K, Bueno-de-Mesquita HB, Jakobsen MU, Egeberg R, Tjønneland A, et al. Meat consumption and mortality - results from the European Prospective Investigation into Cancer and Nutrition. BMC Medicine. 2013;11:63.

Article within a journal by DOI

Slifka MK, Whitton JL. Clinical implications of dysregulated cytokine production. Dig J Mol Med. 2000; doi:10.1007/s801090000086.

Article within a journal supplement

Frumin AM, Nussbaum J, Esposito M. Functional asplenia: demonstration of splenic activity by bone marrow scan. Blood 1979;59 Suppl 1:26-32.

Book chapter, or an article within a book

Wyllie AH, Kerr JFR, Currie AR. Cell death: the significance of apoptosis. In: Bourne GH, Danielli JF, Jeon KW, editors. International review of cytology. London: Academic; 1980. p. 251-306.

OnlineFirst chapter in a series (without a volume designation but with a DOI)

Saito Y, Hyuga H. Rate equation approaches to amplification of enantiomeric excess and chiral symmetry breaking. Top Curr Chem. 2007. doi:10.1007/128_2006_108.

Complete book, authored

Blenkinsopp A, Paxton P. Symptoms in the pharmacy: a guide to the management of common illness. 3rd ed. Oxford: Blackwell Science; 1998.

Online document

Doe J. Title of subordinate document. In: The dictionary of substances and their effects. Royal Society of Chemistry. 1999. http://www.rsc.org/dose/title of subordinate document. Accessed 15 Jan 1999.

Online database

Healthwise Knowledgebase. US Pharmacopeia, Rockville. 1998. http://www.healthwise.org. Accessed 21 Sept 1998.

Supplementary material/private homepage

Doe J. Title of supplementary material. 2000. http://www.privatehomepage.com. Accessed 22 Feb 2000.

University site

Doe, J: Title of preprint. http://www.uni-heidelberg.de/mydata.html (1999). Accessed 25 Dec 1999.

Doe, J: Trivial HTTP, RFC2169. ftp://ftp.isi.edu/in-notes/rfc2169.txt (1999). Accessed 12 Nov 1999.

Organization site

ISSN International Centre: The ISSN register. http://www.issn.org (2006). Accessed 20 Feb 2007.

Dataset with persistent identifier

Zheng L-Y, Guo X-S, He B, Sun L-J, Peng Y, Dong S-S, et al. Genome data from sweet and grain sorghum (Sorghum bicolor). GigaScience Database. 2011. http://dx.doi.org/10.5524/100012 .

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The following summary describes the peer review process for this journal:

Identity transparency: Single anonymized

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BMC Medical Ethics

ISSN: 1472-6939

MIT Press

On the site

Basic bioethics, case studies in biomedical research ethics.

Case Studies in Biomedical Research Ethics

by Timothy F. Murphy

ISBN: 9780262632867

Pub date: February 27, 2004

  • Publisher: The MIT Press

360 pp. , 7 x 10 in ,

ISBN: 9780262134378

  • 9780262632867
  • Published: February 2004
  • 9780262134378
  • MIT Press Bookstore
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  • Description

This textbook for instruction in biomedical research ethics can also serve as a valuable reference for professionals in the field of bioethics. The 149 cases included in the book are grouped in nine chapters, each of which covers a key area of debate in the field. Some of the case studies are classics, including the famous cases of the Tuskegee Syphilis Study (in which subjects with syphilis were not given treatment) and the Willowbrook hepatitis studies (in which institutionalized subjects were intentionally exposed to hepatitis). Others focus on such current issues as human embryonic stem cell research, cloning by somatic nuclear transfer, and the design and function of institutional review boards. Each chapter begins with a brief introduction that places the issues raised in context; this is followed by a number of cases (each of which is no more than a few pages). Study questions meant to encourage further discussion follow each case. After an introductory discussion of the history and tenets of ethics in medical research, the book's chapters cover the topics of oversight and study design; informed consent; the selection of subjects; conflicts of interest; the social effects of research; embryos, fetuses, and children; genetic research; the use of animals; and authorship and publication. Following these chapters are appendixes with the texts of the Nuremburg Code and the World Declaration of Geneva, two key documents in the establishment of bioethical standards for research. Also included are a glossary, a table of cases by general category, and an alphabetical listing of cases.

Timothy F. Murphy is Professor of Philosophy in the Biomedical Sciences at the University of Illinois College of Medicine at Chicago. He is the author of Case Studies in Biomedical Research Ethics (MIT Press, 2004), Gay Science: The Ethics of Sexual Orientation Research , and other books.

Tim Murphy has created a wonderful new book. It has been sorely needed for a long time and has promise of being a classic in the field. I am amazed by the breadth, number, and depth of the cases. Gregory Pence, Department of Philosophy, University of Alabama at Birmingham
Timothy Murphy has produced a thought-provoking collection of cases in biomedical research ethics that is astonishing in its breadth, and will prove highly useful in education. Mark H. Waymack, Department of Philosophy and Co-Director of Graduate Programs in Health Care Ethics, Loyola University Chicago

Additional Material

Related books.

Re-Reasoning Ethics

medical research ethics case studies

  • Cases in Medical Ethics: Student-Led Discussions
  • Markkula Center for Applied Ethics
  • Focus Areas
  • Bioethics Resources

Cases in Medical Ethics

Student-led discussions.

A selection of medical ethics cases designed to help determine whether medicine is the correct calling for pre-medical students.

I was a Hackworth Fellow for the Markkula Center for Applied Ethics at Santa Clara University. I was also a pre-medical student, and am currently attending the Loyola University Chicago Stritch School of Medicine. During my senior year at Santa Clara, I led discussions on medical ethics with students interested in medicine. The purpose of these discussions was two-fold. First, they were created to help bring current ethical issues onto our campus. Second, they were intended to help students who were interested in a career in the health sciences determine whether or not medicine is their correct calling. Most of the discussions followed a simple format. One to two cases were formulated for the students to read. Then I presented the students with various questions related to some of the ethical issues contained in the situations described. The following cases are the ones that I presented to the groups. Each case also has a short history and summary of the ethical issues being reviewed. The questions I asked of the students are included as well. These cases and questions are public domain, and can be re-used or modified for educational purposes. I hope that you find them useful, and that they spawn the same thoughtful enjoyment in you as they did in me.

Note: The cases were not based on specific events. However, it is possible that they share similarities with actual events. These similarities were not intended.

Autonomy essentially means "self rule," and it is a patient's most basic right. As such, it is a health care worker's responsibility to respect the autonomy of her patients. However, at times this can be difficult because it can conflict with the paternalistic attitude of many health care professionals. The following two cases address patient autonomy. The first involves the rights of an individual to decide her own fate, even against her physicians' judgments. The second case involves the rights of a parent to care for her child in the manner that she sees fit.

A woman enters the emergency room with stomach pain. She undergoes a CT scan and is diagnosed with an abdominal aortic aneurysm, a weakening in the wall of the aorta which causes it to stretch and bulge (this is very similar to what led to John Ritter's death). The physicians inform her that the only way to fix the problem is surgically, and that the chances of survival are about 50/50. They also inform her that time is of the essence, and that should the aneurysm burst, she would be dead in a few short minutes. The woman is an erotic dancer; she worries that the surgery will leave a scar that will negatively affect her work; therefore, she refuses any surgical treatment. Even after much pressuring from the physicians, she adamantly refuses surgery. Feeling that the woman is not in her correct state of mind and knowing that time is of the essence, the surgeons decide to perform the procedure without consent. They anesthetize her and surgically repair the aneurysm. She survives, and sues the hospital for millions of dollars. Questions for Case 1:

Do you believe that the physician's actions can be justified in any way?

Is there anything else that they could have done?

Is it ever right to take away someone's autonomy? (Would a court order make the physicians' decisions ethical?)

What would you do if you were one of the health care workers?

You are a general practitioner and a mother comes into your office with her child who is complaining of flu-like symptoms. Upon entering the room, you ask the boy to remove his shirt and you notice a pattern of very distinct bruises on the boy's torso. You ask the mother where the bruises came from, and she tells you that they are from a procedure she performed on him known as "cao gio," which is also known as "coining." The procedure involves rubbing warm oils or gels on a person's skin with a coin or other flat metal object. The mother explains that cao gio is used to raise out bad blood, and improve circulation and healing. When you touch the boy's back with your stethoscope, he winces in pain from the bruises. You debate whether or not you should call Child Protective Services and report the mother.

Questions for Case 2:

Should we completely discount this treatment as useless, or could there be something gained from it?

When should a physician step in to stop a cultural practice? (If someone answers "when it harms the child" remind that person that there is some pain in many of our medical procedures, for example, having one's tonsils removed)

Should the physician be concerned about alienating the mother and other people of her ethnicity from modern medicine?

Do you think that the physician should report the mother?

Autonomy Part 2 Maintenance of patient autonomy is one of the major ethical focuses of physicians. Therefore, a second discussion was also held that focused primarily on patient autonomy. This discussion also took a superficial look at euthanasia. For this discussion, a 58 minute video, Dax's Case (produced by Unicorn Media, for Concern for Dying ; produced by Donald Pasquella, Keith Burton ; directed by Donald Pasquella New York : Filmmakers Library, c1984) was used. The video tells the story of Dax Cowart, a man who was severely burned by an accidental propane explosion. The burns disabled Dax, and the physicians forced treatment on him. Though he survived the treatment, he still argues that he should have been allowed to refuse it so that he could die. The video is very useful; however, the videos of Dax's burn treatments are very graphic and the video should be reviewed before it is shown to a group of students.

In the video, one of the physicians says that burn patients are incompetent to make decisions when they first enter the hospital because they are in such a great deal of pain. However, patients such as Dax can be in a great deal of pain for a very long time. In such cases, what should be done to determine competence, and when should this be done?

Do you think the fact that Dax could not see a future for himself should have been taken into account when determining his competency? Could this have clouded his judgment? (He thought that he would end up on the street corner selling pencils)

Do you think that the fact that Dax was going to recover, and had the possibility of living a happy life, made not treating Dax like suicide… or murder? What if he did not have this possibility?

After his recovery, Dax attempted suicide. Should the physicians have let him die? Is it ever correct for a doctor to allow a patient to kill himself?

Do you ever think that it is correct for a physician to break a competent patient's autonomy? If so, is this one of those cases?

Do you think that in this case, that the ends justified the means?

The word "euthanasia" draws its roots from Greek meaning "good death." As it is used in this discussion, it means "the act of ending the life of a person suffering from either a terminal illness, or an incurable disease." The AMA is against physicians assisting in euthanasia. There is currently only one state in the US that allows for euthanasia, and that is Oregon, where in 1997, the "Death With Dignity Act" went into effect. Euthanasia advocates stress that it should be allowed as an extension of a person's autonomy. Those who are against euthanasia often say that it can lead to the devaluation of human life, and to a slippery slope in which the old and disabled will be killed on the whims of healthy people. We examined one case and the Oregon law to view the ethics of euthanasia.

Case One: A woman was diagnosed with motor neurone disease (the same disease that Stephen Hawking has) 5 years ago. This is a condition that destroys motor nerves, making control of movement impossible, while the mind is virtually unaffected. People with motor neurone disease normally die within 4 years of diagnosis from suffocation due to the inability of the inspiratory muscles to contract. The woman's condition has steadily declined. She is not expected to live through the month, and is worried about the pain that she will face in her final hours. She asks her doctor to give her diamorphine for pain if she begins to suffocate or choke. This will lessen her pain, but it will also hasten her death. About a week later, she falls very ill, and is having trouble breathing.

Questions for Case 1:

Does she have a right to make this choice, especially in view of the fact that she will be dead in a short while (say six hours)? Is this choice an extension of her autonomy?

Is the short amount of time she has to live ethically relevant? Is there an ethical difference between her dying in 6 hours and dying in a week? What about a year, and how do you draw this distinction?

Is the right for a patient's self-determination powerful enough to create obligations on the part of others to aid her so that she can exercise her rights? She clearly cannot kill herself. She can't move, but should someone be FORCED to help her, or to find someone to help her?

Should the money used to care for this woman be taken into account when she is being helped? Do you think that legalizing euthanasia could create conflicts of interest for the patient/ or the doctor? Will people feel that they need to end their lives earlier to save money?

Ask each student: If you were the physician, what would you do? Note: if you would pass her off to another doctor knowing he or she would do it, does this free you from you ethical obligations?

Oregon's Death With Dignity Act: We discussed the following questions pertaining to the Death With Diginity Act.

Death With Dignity Questions:

Look at the requirements for the request. Do you see any problems with them? (The woman from case 1 would not qualify.)

Why would they put in these guidelines? Should they be there, if they keep a competent person like the woman above from living her autonomy? (Is it to protect the doctors so they will not have to GIVE the medication?)

Is there a moral difference between prescribing the drug and actually giving it to the patient? If not, why put in the rules?

Why do you think they wouldn't let a person who is terminally ill and in pain with possibly more than 6 months receive assistance in dying? Say someone is diagnosed with HIV?

Does the justification of euthanasia necessarily justify the assisted suicide of a healthy person?

Do you think a weakness of this law is the probability of patients being influenced by family members? (For example, for financial or other reasons?) Note: Approximately 60% of Oregonians in 2000 said (before they died) that they used the prescription at least in some part due to fear of being a burden on their family.

The AMA says that euthanasia is fundamentally incompatible with the physician's role as healer. What do you think about this statement? Why should a physician have to be the one who does this?

Assisted Reproduction:

This is a difficult subject because it involves reproductive issues. In our culture, reproductive liberty, the freedom to decide when and where to conceive a child is highly protected, and this can make these cases much more difficult.

Case 1: There are two types of surrogacy. One type involves a surrogate mother who uses her own egg and carries the baby for someone else. The other type is a "gestational surrogacy" in which the mother has no genetic tie to the child she carries. In the case presented, a gestational surrogate is used.

A woman, after a bout with uterine cancer had a hysterectomy (surgical removal of the uterus). Before, its removal, however, she had several eggs removed for possible fertilization in the future. Now married, the woman wishes to have a child with her husband. Obviously she cannot bear the child herself, so the couple utilizes a company to find a surrogate mother for them. The husband's sperm is used to fertilize one of the wife's eggs, and is implanted in the surrogate mother. The couple pays all of the woman's pregnancy-related expenses and an extra $18,000 as compensation for her surrogacy. After all expenses are taken into account the couple pays the woman approximately $31,000 and the agency approximately $5,000. Though the surrogate passed stringent mental testing to ensure she was competent to carry another couple's child, after carrying the pregnancy to term, the surrogate says that she has become too attached to "her" child to give it up to the couple. A legal battle ensues.

In the United States it is illegal to pay a person for non-replenishable organs. The fear is that money will influence the poor to harm their bodies for the benefit of the rich. Do you see a parallel between this case and this law? Can allowing surrogate mothers to be paid for their troubles allow poorer women to be oppressed?

Does paying the surrogate harm her and/or the child's dignity?

Is it selfish/conceited for this couple to want children of their own genetic make-up? If yes, does this change if you can "easily" have a child? (Note: Over 100,000 children in the U.S. are waiting to be adopted. However, most are older, have several siblings, or have special needs.)

On their website, the AMA says "that surrogacy contracts [when the surrogate uses her own egg], while permissible, should grant the birth mother the right to void the contract within a reasonable period of time after the birth of the child. If the contract is voided, custody of the child should be determined according to the child's best interests." Do you see any problems with this? (What's a reasonable time? In a way can you steal the surrogate's child?)

One of the main arguments against the use of surrogate mothers is that carrying and giving birth to a child is such an emotional event that it is impossible to determine if the surrogate will be able to give up the child. Though adults enter into the contract, the child could ultimately suffer if a long custody battle ensues (as it could in states where surrogacy contracts hold no legal value, such as Virginia). With the possibility of such battles, do you think it is acceptable for parents to use a surrogate mother?

Do you think that if the surrogate is awarded the baby, this could cause emotional harm to the child?

Who do you think should receive the child, and why?

A married couple wishes to have a child; however, the 32 year old mother knows that she is a carrier for Huntington's disease (HD). HD is a genetic disorder that begins showing signs at anywhere from 35-45 years of age. Its symptoms begin with slow loss of muscle control and end in loss of speech, large muscle spasms, disorientation and emotional outbursts. After 15-20 years of symptoms HD ends in death. HD is a dominant disorder which means that her child will have a 50% chance of contracting the disorder. Feeling that risking their baby's health would be irresponsible, the couple decides to use in vitro fertilization to fertilize several of the wife's eggs. Several eggs are harvested, and using special technology, only eggs that do not have the defective gene are kept to be fertilized. The physician then fertilizes a single egg, and transfers the embryo to the mother. Approximately 9 months later, the couple gives birth to a boy who does not carry the gene for the disorder.

Is this a case of eugenics? "Eugenics" is defined as "the hereditary improvement of the human race controlled by selective breeding" (dictionary.com)

Would it be acceptable for the parents to select for sex as well, or should they only select an embryo that does not have HD? How would this be different?

Is it ethical for this couple to have a baby when the mother could begin showings signs of HD when the baby is just a few years old?

With this technology possible, would it be ethical for this couple to have a child without genetically ensuring it would not have the disease? What if we did not have this technology, would it be ethical for a known carrier to have a child? (If not, how far should this carry? a carrier for cystic fibrosis ( which is recessive)? )

Weighing everything we have discussed, do you believe the couple acted ethically?

Response To Bio-Terrorism

The possibility of terrorists using biological weapons on the citizens of the United States has been a major topic in the press for the last several years. Smallpox has been speculated to be the perfect biological terror agent because of the potency of the virus, and because of the lack of herd immunity present in the US population. The following case presents a possible way in which the virus could be released in the population and a possible response. The questions following the case involve the ethics surrounding the government's response.

Smallpox Facts:

Smallpox initially has flu-like symptoms, which are recognizable 7-19 days after exposure. After 2-4 days of flu-like symptoms, the fever begins to decrease, and pox will form.

An infected person is contagious one day before the characteristic pox appear.

Approximately 30-50% of unvaccinated people exposed to smallpox will contract the disease.

The mortality rate for smallpox was approximately 20-40%.

The vaccine that was used was approximately 90% effective.

It is possible that if terrorists were to use the smallpox virus, that they would genetically modify it. If this were the case, then the vaccine may not prevent all of the disease symptoms for those vaccinated.

Facts gathered from: http://www.vbs.admin.ch/ls/e/current/fact_sheet/pocken/

Date: June 22, 2005. A 27-year-old man is brought into a New York City emergency room with a 101-degree fever, and what he believes is chickenpox (Varicella). After a brief examination, the 35-year-old physician is puzzled because the pox do not appear to be typical of the varicella-zoster virus. Worried, he calls in another physician for her opinion. She takes one look at the patient, determines he has small pox, and immediately orders him to be quarantined. She notifies the Centers for Disease Control and Prevention (CDC) and asks them what should be done. While doing background on the patient, he tells the physicians that he is a flight attendant and that he has flown to Orlando, FL, Los Angeles, CA, Chicago, IL, and Seattle, WA in the past few weeks while working. Though he is given excellent treatment, and had been in perfect health a few days earlier, the patient dies 7 hours after admittance to the hospital.

The CDC decides that mandatory small pox vaccines will be administered to all workers in the NYC hospital, and to all patients who were in the ER. His co-workers are all given mandatory vaccines as well, as are all people living in his apartment complex. They also ship stored quantities of the vaccine to all of the cities where the man had flown to for work. The vaccines are offered to citizens of these cities. Finally, all people, along with their families who had been on the man's flights in the weeks preceding the appearance of the disease are forced to receive the vaccine.

Questions: Note: The flight attendant was most likely given small pox by a bio terrorist who flew on his plane sometime during the past week/week and a half. The terrorist would have been contagious but would not have shown symptoms. Virtually every person the man came into contact with would have gotten the virus.

Is it ethical for the CDC to force people to get the vaccine?

An LA woman on the flight is religiously opposed to vaccines. Under California law she can normally refuse vaccines on religious or personal grounds. However, the government says she must receive the vaccine or face mandatory quarantine. What do you think of this?

Do you think that for more common diseases, for example measles, that it is ethical for the state to allow people to refuse vaccines (even for religious grounds)? What if their refusal can harm others who cannot have the vaccine, such as people who are immunocompromised like AIDS patients?

Is it ethical for someone to refuse the vaccine?

You had driven down to Los Angeles 5 days ago to visit a friend for the weekend. While in town, you visited many tourist attractions. You are worried and you try to get the vaccine, but are denied it because of limited resources. What do you think of this?

Citizens begin calling for the mandatory quarantining of people directly exposed to the victim, i.e those living in his apartment complex, those working in the ER, those who flew on the plane in the prior week. What do you think of this?

The smallpox vaccine, like many other vaccines (example: oral polio vaccine) can actually transmit the virus to others. In light of this, is it ethical for people to get the vaccine? (Note: they are vaccinating those who may not want to be vaccinated)

Today, should health care workers be allowed/forced to get the smallpox vaccine? What about non-health care worker citizens?

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The Cambridge medical ethics workbook: case studies, commentaries and activities

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Medicine, health care, and philosophy

Donna Dickenson

The European Biomedical Ethics Practitioner Education Project (EBEPE), funded by the BIOMED programme of the European Commission, is a five-nation partnership to produce open learning materials for healthcare ethics education. Papers and case studies from a series of twelve conferences throughout the European Union, reflecting the 'burning issues' in the participants' healthcare systems, have been collected by a team based at Imperial College, London, where they are now being edited into a series of seven activity-based workbooks for individual or group study. These draft workbooks are now being read by a network of critical readers across Europe, whose comments will be incorporated into the final versions of the workbooks. The result will be the first European-wide and Europe-centred resource for teaching students, practitioners, and members of ethics committees. Topics covered include: Resource allocation and rationing The rights of children and young people Long-term ...

medical research ethics case studies

Journal of Medical Ethics

Paquita de Zulueta

The Journal of Healthcare Ethics & Administration

The 2017 story of Charlie Gard is revisited. Upon the British High Court's ruling in favor of the physicians that the infant should be allowed to die without the experimental treatment, the view of the public as well as the opinions of bioethicists and Catholic bishops are divided, interestingly along with a cultural line. American bioethicists and Catholic bishops tend to believe that the parents should have the final say while British/European bioethicists and Catholic bishops in general side with the court's decision. The paper explores the place of culture in bioethical reasoning between the UK/Europe and the US while claiming that cultural differences are more important than geopolitical or religious differences to understand the bioethical positions of a group. In addition, the authors introduce a decision-making program for handicapped neonates which is developed by the American Jesuit Bioethicist, Richard McCormick, and modified further by the contemporary American Jesuit Bioethicist, Peter A. Clark, in an attempt to see if the program's normatizing categories can contribute to the culture-laden ethical discussions on Charlie's case. However, it is admitted that the McCormick-Clark device is borne out of the American and Catholic theological context.

Paul Brodwin

Chikezie Onuoha

Avicenna Journal of Medicine

Hassan Chamsi-Pasha

Eric Vogelstein

It is nearly universally thought that the kind of decision-making competence that gives one a strong prima facie right to make one’s own medical decisions essentially involves having an ability (or abilities) of some sort, or having a certain level or degree of ability (or abilities). When put under philosophical scrutiny, however, this kind of theory does not hold up. I will argue that being competent does not essentially involve abilities, and I will propose and defend a theory of decision-making competence according to which one is competent only if one possesses a certain kind of rationality in making treatment decisions.

leonardo de castro

Copyright ©2001 Eubios Ethics Institute (All rights reserved, for commercial reproductions). 31 Colwyn Street, Christchurch 8005, New Zealand ... PO Box 125, Tsukuba Science City, Ibaraki 305-8691, Japan ... Eubios Ethics Institute World Wide Web: http://www.biol.tsukuba.ac.jp ...

Journal of medical ethics

Rosamond Rhodes

In this paper, I provide a brief sketch of the purposes that medical ethics serves and what makes for good medical ethics. Medical ethics can guide clinical practice and biomedical research, contribute to the education of clinicians, advance thinking in the field, and direct healthcare policy. Although these are distinct activities, they are alike in several critical respects. Good medical ethics is coherent, illuminating, accurate, reasonable, consistent, informed, and measured. After this overview, I provide specific examples to illustrate some of the ways in which medical ethics could go wrong as a caution and a reminder that taking on the role of an ethicist involves serious responsibilities that must be exercised with care.

Shamima Lasker

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  • Published: 03 August 2023

Raising concerns on questionable ethics approvals – a case study of 456 trials from the Institut Hospitalo-Universitaire Méditerranée Infection

  • Fabrice Frank   ORCID: orcid.org/0000-0002-6524-4570 1 ,
  • Nans Florens   ORCID: orcid.org/0000-0002-0960-6055 2 ,
  • Gideon Meyerowitz-katz   ORCID: orcid.org/0000-0002-1156-9345 3 ,
  • Jérôme Barriere   ORCID: orcid.org/0000-0003-1113-8948 4 ,
  • Éric Billy   ORCID: orcid.org/0000-0002-8859-0089 5 ,
  • Véronique Saada   ORCID: orcid.org/0000-0001-8021-9050 6 ,
  • Alexander Samuel   ORCID: orcid.org/0000-0003-4547-5280 7 ,
  • Jacques Robert   ORCID: orcid.org/0000-0003-4380-1476 8 &
  • Lonni Besançon   ORCID: orcid.org/0000-0002-7207-1276 9  

Research Integrity and Peer Review volume  8 , Article number:  9 ( 2023 ) Cite this article

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The practice of clinical research is strictly regulated by law. During submission and review processes, compliance of such research with the laws enforced in the country where it was conducted is not always correctly filled in by the authors or verified by the editors. Here, we report a case of a single institution for which one may find hundreds of publications with seemingly relevant ethical concerns, along with 10 months of follow-up through contacts with the editors of these articles. We thus argue for a stricter control of ethical authorization by scientific editors and we call on publishers to cooperate to this end.

We present an investigation of the ethics and legal aspects of 456 studies published by the IHU-MI (Institut Hospitalo-Universitaire Méditerranée Infection) in Marseille, France.

We identified a wide range of issues with the stated research authorization and ethics of the published studies with respect to the Institutional Review Board and the approval presented. Among the studies investigated, 248 were conducted with the same ethics approval number, even though the subjects, samples, and countries of investigation were different. Thirty-nine (39) did not even contain a reference to the ethics approval number while they present research on human beings. We thus contacted the journals that published these articles and provide their responses to our concerns. It should be noted that, since our investigation and reporting to journals, PLOS has issued expressions of concerns for several publications we analyze here.

This case presents an investigation of the veracity of ethical approval, and more than 10 months of follow-up by independent researchers. We call for stricter control and cooperation in handling of these cases, including editorial requirement to upload ethical approval documents, guidelines from COPE to address such ethical concerns, and transparent editorial policies and timelines to answer such concerns. All supplementary materials are available.

Peer Review reports

There are over 27 million scientific articles listed on the National Health Institute Platform PubMed. Previous investigations have shown that about 2% of scientists admitted to have fabricated, falsified or modified data or results at least once [ 1 ]. The business of scientific publication has surged during the last decade, including a staggering growth in the number of articles submitted and finally accepted for publication [ 2 ]. The peer review process is crucial for assessing the quality of hypotheses, methods, reliability of the data, and identifying any obvious ethical shortcomings. The Covid-19 pandemic was a stress test for the academic publishing system and unveiled several failures in processes evaluating quality of scientific publications [ 3 , 4 , 5 , 6 , 7 ]. Neglected or non-existent review procedures [ 3 , 6 ], editorial conflicts of interests combined with expeditive peer review [ 3 ], inconsistent publications with, e.g., missing data [ 8 ], failure to retract or delayed retractions [ 6 , 7 ], and irregularities in legal permissions are among the most common concerns seen in biomedical publications relating to the COVID-19 pandemic. The latter is particularly critical as it can directly put study participants at risk.

Regulation of clinical research became gradually an issue after the crimes perpetrated by the Nazis during World War II [ 9 ]. Later, these issues were reinforced by notoriously unethical studies conducted in the following decades, such as the Tuskegee Syphilis Study [ 10 ]. In the 1950 and 1960 s, the thalidomide adverse effects scandal reinforced this tendency by defining vulnerable groups such as, pregnant women [ 11 ]. More recently, ethics has evolved with new concerns for the protection of healthy volunteers following the TGN1412 disaster [ 12 ].

To prevent these ethical quandaries, countries have different governance system for ensuring appropriate moral conduct in clinical research. This commonly includes both legal requirements for conducting research, as well as guidelines for the oversight into and approval of ethical research. In France, this is done through the legislative framework. In this context, the French legislation was updated in 2016 with the Jardé Law on good practices in clinical research [ 13 ]. It should be noted that the legislative framework encountered in France is not the same as in other countries which may have other governance instead. French regulation requires that any experimentation on human beings must be approved by an independent ethics committee and depending on the complexity of the protocol, additional authorizations are required, especially regarding the collection of body fluids such as stool, vaginal secretions or urine.

In this paper, we present an investigation into papers published by the Institut Hospitalo-Universitaire Méditerranée Infection (IHU-MI ), a large clinical and research center in the city of Marseilles in the south of France. The IHU-MI employs over 700 people, covering a range of research topics related to infectious disease including basic biomedical research, epidemiological work, clinical trials,

This center has been the subject of research controversy since the advent of the COVID-19 pandemic, largely due to the actions of Professor Didier Raoult, former head of the institute. The original notoriety of the IHU-MI came from the now-infamous promotion of hydroxychloroquine, an anti-malarial medication, in combination with azithromycin for the treatment of COVID-19 [ 14 ]. This regimen was promoted as the most effective treatment for COVID-19 based on the results of a small, poorly-controlled observational study that has been described as having “major methodological shortcomings which make it nearly if not completely uninformative” and “fully irresponsible” in an independent review commissioned by the parent publishing company Elsevier [ 15 , 16 , 17 , 18 ]. This study also elicited negative peer-review comments on PubPeer, an independent review site that collates commentary on scientific studies, and from the French authorities [ 19 ]. The hydroxychloroquine/azithromycin regimen has remained popular in some minds despite increasingly robust evidence that it is ineffective in the treatment of COVID-19 and furthermore may increase the risk of death [ 18 ], demonstrating once more the danger of problematic and potentially unethical research [ 20 ]. Of note, IHU-MI has had previous retractions for alleged data fabrication, but thus far not due to ethical concerns [ 20 ].

Concerns on ethical approvals from IHU-MI have been raised outside scientific journals [ 21 ]. In August 2021, Elisabeth Bik pointed out issues about ethical approvals including research on vulnerable populations like homeless study participants [ 22 ]. These initial reports prompted us to further investigate potential concerns about ethics in the published literature from the institute. We have found and report below about highly worrying data in IHU-MI publications.

For post-publication critiques, the Committee on Publication Ethics (COPE) recommends referring to the journal or publisher policy [ 23 ], depending on the availability of an editorial policy for the reported issue. In case editorial policy does not take post-publication critiques into account, this policy should be amended. We can thus hope that the critiques formulated here might be helpful for journals to improve their peer reviewing policies. This is the whole meaning of our approach.

Investigation

Due to a great deal of national interest following publicization of poor research practices at IHU-MI, the French government investigated the unit and then launched legal actions in early September 2022. This followed a damning report from IGAS (Inspection Générale des Affaires Sociales) on the ethics and conduct of research taking place at IHU-MI during the period of investigation [ 24 ]. The seriousness of the accusations reported, combined with previous reports of questionable conduct and publication ban [ 20 ], made us question whether current academic editorial processes could have caught such concerns regarding the legal framework implemented at IHU-MI when conducting clinical trials. This paper provides the results of a detailed review covering the work of researchers at IHU-MI, analyzing published ethical statements.

After noticing that some Institutional Review Board (IRB) identification numbers were identical in several publications from the IHU-MI, we started by screening studies on IRB numbers on “Google Scholar”. We found several repetitions, and we finally noticed that one of the IRB approval numbers (09–022) appeared in hundreds of publications while the publications’ topics and the patients involved in studies were significantly different. We then used “Google Scholar” to identify all occurrences of this approval number.

We then decided to further investigate the bibliography of this institute by screening PubPeer reports and analyzing them. We did not contact directly IHU-MI since their answer to the PubPeer posts showed they were already aware of the concerns reported here. Furthermore, cyber and legal harassment made any direct contact with this institute more difficult than it should have been [ 21 , 25 , 26 ]. We only recently contacted Prof. Didier Raoult, former head of IHU-MI, since he was listed as editor-in-chief of the journals where some of the articles we report here were published but received no answer to this day. This list has also been reported to French Health Authority, namely the “Agence Nationale de Sécurité du Médicament” (ANSM), in charge of the evaluation of the legality of clinical studies, in July 2022. These publications were only evaluated regarding ethics criteria and our findings have no significance regarding the validity of their content.

We attempted to conduct a relatively systematic review of all recent biomedical research published by key authors at the IHU-MI, using “Google Scholar” profiles and PubPeer. This involved searching the bibliographies of senior scholars (i.e., Professors) at the institute, however given the sheer number of studies, we limited the search parameters to those published in the last 25 years. Screening on PubPeer was conducted by searching author names, and reviewing the resulting comments on papers. The results from PubPeer were then used to complete the data obtained from analysis of “Google Scholar” results. Frequently-repeating IRB-approval numbers were entered into “Google Scholar” to list of all their occurrences.

Request for the official IRB approval

We qualitatively determined whether IRB approval was likely to have been granted for different studies. This was done by discussion among the authors, and we present the tabulated findings in the results of the number of separate published works that use the same IRB approval number.

Contact of editors

While papers have been retracted in the past for issues concerning ethical approval [ 27 ], most of the Retraction Watch database entries seem to contain only Expressions of Concern (EOCs) or retractions relating to “ethical violations by author” or “lack of IRB/IACUC approval.” As such, it is not surprising that COPE did not provide guidelines on reporting and investigating IRB approval duplications such as what we have found. Indeed, current COPE guidelines on issues on ethics approval only focus on handling concerns at the time of submission of a manuscript [ 28 ] and not after publication or for cases of potentially fraudulent duplication of IRB approval numbers. As a result, we have further analysed the dataset to append the journal Editor-in-Chief’s name and email after screening the journals websites for information. In some cases, such as discontinued journals, the last known editor-in-chief was contacted. When no contact form or mail was available on the journal’s page, we contacted the editor-in-chief directly through academic mail found on the university affiliation’s website.

We thus contacted all editors of journals that published papers for which our analysis could raise concerns. The number of editors we contacted may seem very low compared to the number of publications we report, but many of them have been published in the same journal: for example “New Microbes and New Infections” published 135 of the studies we report. The low number of answers (despite reminder emails) led us to contact some publishers including Elsevier, for “New Microbes and New Infections”, without any satisfactory answer to this day. It should be noted that some of the authors of the papers we investigated are in many cases on the editorial team of the journals which have published the papers. Such concerns had already been highlighted with respect to this institute and some of their COVID-19 papers which had been peer-reviewed under 24 h in journals in which the authors presented with editorial conflicts of interest [ 3 ]. Related to our concerns, the journal “New Microbes and New Infections” is famous for being closely related to the team whose work we investigated [ 29 ] and had many members of the IHU-MI on the editorial board [ 30 ]. As such, editorial contact to report on the issues we have identified was indeed difficult.

At the time of writing, we have not approached the STM integrity hub. We have only contacted the ethics officer at Elsevier, since this publisher counts for most of the articles we report; from some answers of the editor-in-chief, we have no doubt that they did not intend to take any action.

After cleaning, we noticed that the IRB approval number 09–022 had been used 248 times over 12 years (between 2009 and 2021). Reusing approvals is allowed if results are from samples originally approved by the committee and in compliance with local laws related to clinical research. However, we found that those 248 publications covered a large variety of samples (stool, vaginal secretions, urine, samples taken during surgical procedures), a wide array of populations (adults, children, healthy volunteers, obese patients, etc.) and countries (France, Senegal, Niger, Gabon, Saudi Arabia, etc.) as depicted in Fig.  1 (see the Additional file 2 “Table S1 – Studies_with_09–022_IRB.csv”). Among the 248 studies identified, we have found at least one that was conducted after the Jardé Law was implemented, as well as many more published after 2016 with no dates of patient enrollment identifiable.

figure 1

Various subjects, samples, and countries for the 248 studies with the IRB number 09–022

Further investigation in the bibliography from IHU-MI showed a total of 456 studies that could have ethical and legal concerns of the same type: multiple and different studies with the same IRB, absence of legal authorization, recruitment starting before authorization was obtained, etc. (see Additional file 2 Table S2 “Table S2-Clinical_Research_Papers_With_Ethical_Concerns.csv”).

In biomedical research, researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Most, if not all, scientific publishing companies have subscribed to the declaration of Helsinki [ 31 , 32 , 33 , 34 ], which is also recommended by COPE [ 35 ].

We could not access the original file with the IRB number 09–022, even after requesting this document from French authorities. However, we obtained a copy of the outline of the document (see Additional file 3 ). Based on our analysis, this form does not allow such a wide variety of samples, clinical conditions, and geographical origin to be documented. We could not find any reasonable explanation for such a multiplicity of identical occurrences in the literature. The original document should mention all those samples, conditions, and countries. If amendments have been made, they have not been explicitly mentioned in the articles from IHU-MI cited herein.

Contact of the editors

An overview of the journals that have published most of these articles is available in Fig.  2 .

figure 2

Journals involved in the 456 studies with legal authorization concerns

Out of the 85 journals that we contacted, 19 editorial teams have responded to our email while 66 have not replied to us yet. A complete list of the journals, dates at which they have been contacted, as well as date and summary of the response is available in Additional file 2 (“Table S3 – Editors contact.csv”).

In summary, among the studies we have investigated, 248 were conducted with the same ethics approval number, even though the subjects, samples, and countries of investigation were different. Thirty-nine (39) of the manuscripts we considered did not even contain a reference to the ethics approval number although they contained research on human beings. We have contacted the 85 journals that published these articles and only 19 of them have replied to our queries so far. However, a publisher, PLOS [ 36 ], has issued expressions of concerns for several publications we have analyzed over ethical concerns.

Taking French legal framework into account, we made a rapid analysis and this showed these studies could include different categories of research involving human beings (RIPH) i.e. 6 RIPH 1, 67 RIPH 2 and 202 RIPH 3 for which no legally-required authorization has been reported by the authors.

Since we have reached out to editors, PLOS Biology has issued a wide expression of concern for 49 articles published by this institute, including 12 for which we have reported concerns on ethics approval. Out of these 12 articles, ten use the same ethics approval number, namely 09–022. Given that we have not raised concerns about the remaining 37 articles, there appears to be some concern at the editorial level of the work done by IHU-MI more broadly than this investigation identified. Thus, our figures should serve as a baseline estimate of the total number of papers which may have issues that are associated with IHU-MI. To our best knowledge, no other public editorial decision has been made from other publishing venues yet, although we hope that the concerns from PLOS Biology will help either obtaining clarifications from the authors on such concerns, or drive other journals to publicly respond too.

Editorial practices in verifying ethics and lawfulness of clinical research are still very heterogeneous and all journal are not members of COPE. We wish to initiate a conversation to improve the ethical controls at the editorial level across published academic research, and for changes to facilitate post-hoc investigations in future work, despite not suggesting any mean of enforcing these controls.

While some publishers already require the upload of ethics approval, this is not a largely adopted requirement. We thus argue that the practice should become more widely and rigorously adopted, or that, at the very least, ethics approval numbers are provided as metadata along a submission such that post-hoc analysis could be done in a more systematically fashion through mining of submission’s metadata. This metadata could be made available through PubMed along with a basic description of the study and its targeted population, intervention(s), and country of study.

We argue that submission processes should be amended to require the potentially confidential upload of ethical documents linked to clinical research, and that editorial procedures should pay attention to the international (and potentially local) ethical framework for research by including, for instance, basic verification steps. This responsibility should absolutely not be placed on reviewers whose primary mission is to ensure the scientific robustness of the research as well as its relevance for publication. Indeed, much of this process could be easily automated by publishing companies such as Elsevier to avoid precisely the issues identified in this review. Placing the weight on an editorial responsibility would also facilitate further verification. Indeed, as we have ourselves experienced, independent researchers investigating the adequacy of ethical documents are not likely to obtain an answer from IRBs or ethical committees, while editors and publishers would have an easier and more legally anchored claim to request those documents. In conclusion, there is an urgent need for publishers to require clinical research approvals. This could be done by requesting validation from the sponsoring organization or from the authority that issued the IRB number. There is also a critical need for COPE to provide clear guidelines on how to report (for researchers) and how to handle (for editors and journals) issues with ethics approval in published manuscript. While we are aware that further editorial verifications could create additional and potentially difficult to navigate publication steps, we however believe that the recommendations we put forward here could easily be put in place without an increased bureaucratic cost. Indeed, our most drastic recommendation would be to normalize the upload of IRB documents for which IRB and publishers could easily implement regulations based on existing policies from journals which already implement such requirements.

We finally argue that editorial responses within a strict timeline should be put in place, such that journals and editorial teams have a responsibility to respond to ethical queries from researchers within a reasonable time [ 7 ] as well as disclose reasonable concerns that have been publicly raised on articles, and this even before reaching out to authors.

Since we cannot ask every editor to know every framework of every country for every type of clinical research, this would of course not solve all the problems, but we think that this might be a step forward to a better respect of ethics and thus of patient rights. While additional editorial constraints are unlikely to eliminate fraud or questionable practices altogether, they can help limit them, raise awareness about them, and facilitate their detection. We believe that the new editorial policies on ethics and IRB approval that we suggest would advance scientific processes in the same way that requiring the publication of clinical trials registration has facilitated research on the spin of medical research [ 37 , 38 ], the prevalence of outcome switching, and other questionable reporting practices and likely help reduce these practices and adopt new standards to produce more robust and ethical research.

We have presented a case study of 456 trials from the Institut Hospitalo-Universitaire Méditerranée Infection. Our investigation has revealed serious concerns on the ethics approvals of these trials ranging from the re-use of the same ethics approval number 248 times on trials with significantly different subjects, samples, and countries of investigation, to potential lack of local ethics approval for studies conducted abroad. To the best of our knowledge, our investigation is the first to reveal concerns over the potentially inappropriate reuse of ethics approval numbers on such a massive scale. While our concerns have been acted on by one publisher (PLoS), most publishers are either still investigating the issue or have not yet responded to us. This investigation thus highlights the needs for guidelines and processes for readers, reviewers, and editorial teams, to report and respond to ethics approval misuse and concerns.

Availability of data and materials

The datasets supporting this article are available.

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Conceptualization: FF, NF, LB. Methodology: FF, NF, LB. Investigation: FF. Writing – original draft: FF, NF, EB. Writing – review & editing: FF, NF, GMK, JB, EB, VS, AS, LB, JR. The author(s) read and approved the final manuscript.

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Supplementary Information

Additional file 1: figure 1..

Various subjects, samples, and countries for the 248 studieswith the IRB number 09-022.  Figure 2. Journals involved in the 444 studies with legal authorization concerns.

Additional file 2: Table S1.

 Studies_with_09–022_IRB.  Table S2. Clinical_Research_Papers_With_Ethical_Concerns.  Table S3.  Editors contact.

Additional file 3:

 Outline of IRB approval.

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Frank, F., Florens, N., Meyerowitz-katz, G. et al. Raising concerns on questionable ethics approvals – a case study of 456 trials from the Institut Hospitalo-Universitaire Méditerranée Infection. Res Integr Peer Rev 8 , 9 (2023). https://doi.org/10.1186/s41073-023-00134-4

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Case Study: Research Ethics

Short-course Zidovudine Compared to What? A Trial to Prevent Mother-to-Infant HIV Transmission is a classroom-based interactive case study that addresses ethical and scientific issues in research. The research example used in this case study is a randomized controlled trial of zidovudine to prevent mother-to-child transmission of HIV in developing countries after its effectiveness had been established in developed countries. The case study focuses on ethical issues, particularly the appropriateness and selection of a comparison (placebo) group, the review process, and informed consent.

Learning Objectives

After completing this case study, the participant should be able to:

  • Discuss the principle of equipoise and its relevance in designating an appropriate comparison group in a randomized controlled trial (RCT)
  • Describe the role of an Institutional Review Board
  • List the required elements of informed consent and discuss key considerations in using informed consent in developing countries
  • Describe the ethical rationale for conducting an interim analysis of a clinical trial

The case study is intended to be used in the classroom, with students reading text and responding to questions under the facilitation of an instructor. The instructor should provoke discussion and exchange of ideas among participants.

Instructor and participant versions are available. The participant’s version includes all text and questions and space for answers. The instructor’s version includes all of the text and questions, plus teaching points and responses for each question.

FETP Case Study ZVD Instructor Guide [435K, 24 pages]

FETP Case Study ZVD Participant Guide [342K, 22 pages]

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  • Alumni Colloquium Series 2022-23

Research Ethics and Policy Series (REPS): "Regulatory and Ethical Perspectives on Pragmatic Trials: Lessons from Three Cases"- Mark Neuman, MD, MSc

12:00pm - 1:00pm • Hybrid: RCH B102AB, Richards Bldg., 3700 Hamilton Walk (and virtual via Zoom)

Regulatory and Ethical Perspectives on Pragmatic Trials: Lessons from Three Cases

Mark neuman, md, msc.

Director, Research Partnerships , Leonard Davis Institute of Health Economics Associate Professor, Anesthesiology and Critical Care , Perelman School of Medicine Director, Penn Center for Perioperative Outcomes Research and Transformation (CPORT) , Perelman School of Medicine | University of Pennsylvania

Mark Neuman, MD, MSc, Professor of Anesthesiology at Penn, will discuss regulatory and ethical issues raised in the process of designing, implementing, and reporting multi-center pragmatic trials, with a focus on 3 recently completed or planned studies focusing on aspects of anesthesia care for older surgical patients:

REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture; NCT02507505), DROP-Benzo (De-adopting Routine Preoperative Benzodiazepines for Older Surgical Patients; NCT05436392); and My Anesthesia Choice-Hip Fracture ( www.myanesthesiachoice.org ; registration pending).

Key areas of discussion will include:

  • Navigating clinician attitudes towards comparators and questions around equipoise
  • Implementing single IRB processes
  • Designing an approach to human subjects research review for a study conducted in partnership with a national private medical group working at hundreds of hospitals, surgery centers, and physician offices across multiple states

Lunch provided. Streaming available via Zoom.

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  • Epistemic injustice, healthcare disparities and the missing pipeline: reflections on the exclusion of disabled scholars from health research
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  • http://orcid.org/0000-0003-3868-5765 Joanne Hunt 1 ,
  • http://orcid.org/0000-0002-0205-1165 Charlotte Blease 1 , 2
  • 1 Department of Women's and Children's Health , Uppsala University , Uppsala , Sweden
  • 2 Digital Psychiatry, Department of Psychiatry, Beth Israel Deaconess Medical Center , Harvard Medical School , Boston , Massachusetts , USA
  • Correspondence to Joanne Hunt, Department of Women's and Children's Health, Uppsala University, Uppsala 751 05, Sweden; joanne.hunt{at}uu.se

People with disabilities are subject to multiple forms of health-related and wider social disparities; carefully focused research is required to inform more inclusive, safe and effective healthcare practice and policy. Through lived experience, disabled people are well positioned to identify and persistently pursue problems and opportunities within existing health provisions that may be overlooked by a largely non-disabled research community. Thus, the academy can play an important role in shining a light on the perspectives and insights from within the disability community, and combined with policy decisions, these perspectives and insights have a better opportunity to become integrated into the fabric of public life, within healthcare and beyond. However, despite the potential benefits that could be yielded by greater inclusivity, in this paper we describe barriers within the UK academy confronting disabled people who wish to embark on health research. We do this by drawing on published findings, and via the lived experience of the first author, who has struggled for over 3 years to find an accessible PhD programme as a person with energy limiting conditions who is largely confined to the home in the UK. First, we situate the discussion in the wider perspective of epistemic injustice in health research. Second, we consider evidence of epistemic injustice among disabled researchers, focusing primarily on what philosophers Kidd and Carel (2017, p 184) describe as ‘strategies of exclusion’. Third, we offer recommendations for overcoming these barriers to improve the pipeline of researchers with disabilities in the academy.

  • Disabled Persons
  • Quality of Health Care

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Data sharing not applicable as no datasets generated and/or analysed for this study.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ .

https://doi.org/10.1136/jme-2023-109837

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Introduction

People with disabilities have been described as an ‘unrecognized health disparity population’. 1 Health disparity (or health inequity) is understood as an avoidable and unjust difference in health or healthcare outcomes experienced by social, geographical or demographic groups with a history of socioeconomic, political or cultural discrimination and exclusion. 1 2 Despite the passage of landmark disability legislation, including the UK Equality Act 2010, the US Americans with Disabilities Act 1990 and the United Nations Convention on the Rights of Persons with Disabilities (adopted in 2006), disability-related health and healthcare disparities persist. Disabled people report lower levels of well-being on average compared with non-disabled people, are at increased risk of physical and mental comorbidity and are more likely to die younger. 1–3 There are multiple reasons as to why health disparities persist along the lines of disability; however, prejudicial biases, engendering structural barriers to care, play a critical part. For example, recently, the WHO 2 reported that people with disabilities are significantly more likely to perceive discrimination and stigma in healthcare contexts compared with non-disabled people. This is supported by a wealth of literature from across the world revealing institutional, physical and attitudinal healthcare barriers for disabled people, including medical professionals’ ambivalence or lack of understanding towards disability, lack of confidence vis-à-vis providing quality care and physically inaccessible clinics and clinical equipment. 4–7

Health and healthcare-related disparities also intersect with broader social disparities. For example, people with disabilities are less likely to be employed and earn less when they are in work, despite the fact that disability incurs higher living costs. 2 In the UK, government data from 2021 reveal a disability employment gap of 28%, 8 with a disability pay gap of 14%. 9 Recent figures from the US Bureau of Labor Statistics 10 indicate that the unemployment rate among disabled people is over twice the rate for non-disabled people, with similar trends across other countries. 2 Perhaps unsurprisingly, disabled people are also more likely to live in poverty than their non-disabled counterparts. 2 11 Compounding matters is structural disablism: discrimination and stigma (woven into collective attitudes, organisational policies, legislation and infrastructure) that often go unnoticed by non-disabled people but can take a serious toll on individuals living with disabilities. In 2023, the UK’s Office for National Statistics reported that the suicide rate was higher among people with disabilities than any other demographic group. 12

To better understand and address such disparities, carefully focused research is needed. 2 In this regard, people with lived experience of chronic illness and disability can offer unique insights that can strengthen and help drive richer research, where disabled people are positioned equally as co-researchers, as opposed to the traditional dynamic of disabled ‘research subject’ to be passively studied. Through first-hand experience, via experiential or standpoint epistemology, 13 disabled researchers are often well positioned to understand how health-related policies and practices (informed through largely non-disabled research communities) may unwittingly harm or otherwise disadvantage disabled persons. 14 Researchers with disabilities may also be more motivated and well placed to perceive knowledge gaps, and to pose penetrating and uncomfortable questions necessary to galvanise change. Embracing viewpoint diversity, and the input of disabled researchers, could therefore represent a powerful pathway to improve understanding and to develop more inclusive health and healthcare policy and practice.

The history of the disabled people’s movement within the UK, 15–17 whereby disabled scholar-activists entered the academy and contributed to profound changes in social practice and policy, constitutes an exemplar of the potential value of viewpoint diversity and disability standpoint, the legacy of which continues today, most notably within disability studies, but also more widely within critical social sciences and humanities. 18–20 However, within health sciences—particularly those tightly tied to science, technology, engineering and mathematics (STEM)—there appear to be greater barriers to including disabled scholars and integrating disabled knowledges. 21–23 For example, research shows that the percentage of people with a declared disability is lower in STEM subjects relative to non-STEM subjects at first degree, postgraduate level and within the academic workforce. 22 Moreover, a 2020 data analysis brief from the UK All-Party Parliamentary Group on Diversity and Inclusion in STEM 23 reported that the UK STEM workforce had a lower representation of disabled people relative to the rest of the UK workforce (11% vs 14%). Here, it is noteworthy that the analysis used the wider definition of STEM, that of ‘STEM(H)’ which specifically includes health and related fields. 23 Such exclusions are further compounded by intersectionality, the intersection and co-constitution of multiple forms of social (dis)advantage. 24 Indeed, the intersection of disability with other minoritised identities 19 21 23 is yet another reason to promote disability inclusion within the academy and beyond.

Despite the potential benefits that could be yielded by greater inclusivity, in this paper we describe barriers within the UK academy confronting disabled people who wish to embark on health research. We do this by drawing on published findings, and via the lived experience of the first author (hereafter, ‘JH’) who has struggled for over 3 years to find an accessible PhD programme in the UK as a person with ‘energy limiting conditions’ (ELC) 25 26 who is largely confined to the home. First, we situate the discussion in the wider perspective of epistemic injustice in health research. Second, we consider evidence of epistemic injustice among disabled researchers, in particular those with ELC, by situating this in the legal context in the UK, and by detailing the nature of barriers experienced. Third, we offer recommendations for overcoming these barriers in the academy.

A note on nomenclature: we recognise that person-first language (‘people with disabilities’) is the globally prevalent form. 18 As a self-identifying disabled person broadly ascribing to the British social model of disability, 16 17 JH tends towards identity-first language (‘disabled people’). Therefore, while recognising the semantic and ideological divergences embedded within different forms of disability-related language, 18 we have chosen to adopt both forms in this paper to reflect our case for viewpoint diversity.

Additionally, while recognising the heterogeneity of disability and disability-related exclusions, 19 we focus on ELC: health conditions that share energy impairment as a key experience and substrate of disability discrimination or disablism.

ELC include but are not limited to ‘medically unexplained’ or contested conditions such as myalgic encephalomyelitis/chronic fatigue syndrome, alongside ‘rare’ conditions such as Ehlers-Danlos syndromes. 25 26 Since ELC do not conform to socially prevalent (fixed, non-fluctuating, easily identifiable) stereotypes of disability, disablism largely manifests as clinical and social disbelief, resulting in ELC being poorly recognised and poorly researched through the lens of disability rights and diversity, equity and inclusion (DEI). 25 26 Equally, while we focus on exclusions within the academic space, it is important to note that people with ELC (and wider disabled communities) are subject to marginalisation and exclusion in all social arenas, including education, employment and the healthcare system itself. 25–28 Moreover, measures to improve physical inclusion (such as wheelchair-accessible environments) are oftentimes ineffective or insufficient among people with ELC who are confined to the home, thus furthering marginalisation of this group. In this respect, we recognise that people diagnosed with mental health conditions (notably but not limited to agoraphobia or social anxiety) may be confined to the home and are subject to similar dynamics of disability-related disbelief and associated exclusions as evidenced in the ELC arena. 29–31 Therefore, while we focus on ELC, the following discussion and recommendations for academic inclusion may benefit others with ‘hidden’ or poorly recognised health conditions.

The importance of ELC-specific research is arguably amplified by the emergence of long COVID, another condition that sits well within the ELC umbrella. 26 The concept of ELC arose from research led by disabled people within and outside of the UK academy 25 26 and thus represents an example of the potential value of ‘disability standpoint’ in contributing to health and healthcare-related research gaps. Nevertheless, there is very little peer-reviewed academic literature explicitly focusing on ELC (for recent exceptions see ref 32–34 ). To our knowledge, and motivating this paper, there is no research exploring academic exclusions in the ELC arena through a lens of epistemic injustice.

Epistemic injustice

Epistemic injustice refers to a variety of wrongs perpetrated against individuals in their capacity as a knower or contributor to knowledge. According to philosopher Miranda Fricker, 35 it takes two forms: testimonial injustice and hermeneutic injustice. The former arises when an individual is unfairly discriminated against with respect to their capacity to know or contribute to knowledge. This form of injustice often arises because of negative stereotypes about a demographic group. For example, in the case of disability, testimonial injustice may take the form of global, unjustified prejudices about the intellectual or bodily capacity of disabled individuals to contribute to knowledge. Disabled people may, for example, be seen as lacking the stamina, strength, reliability or acuity to offer useful insights. Philosophers of medicine Ian Kidd and Havi Carel 36 sum it up as a ‘pre-emptive derogation of the epistemic credibility and capacities of ill persons’ that involves ‘a prior view, for instance, of ill persons being confused, incapable or incompetent, that distorts an evaluation of their actual epistemic performance’. Testimonial injustice can take the form of implicit or explicit discrimination on the part of the hearer, leading to an outright dismissal or discrediting of the contribution of individuals to discussions in which they might otherwise offer valuable insights.

As others have argued, many people with disabilities may have acquired valuable knowledge about their condition through lived experience that renders them experts on aspects of their illness, the nature of health services and the quality of provider care. 27 37 38 Notwithstanding, it is also important to clarify that living with an illness need not automatically afford epistemic privilege. Rather, the point is that a finer awareness is needed to move past unhelpful stereotyping, to appreciate the contributions to knowledge that individuals may make. This, with a view to avoiding global or unwarranted assumptions about the credibility of individuals’ contributions to knowledge formation activities.

Hermeneutic injustice represents a wrong which Fricker describes as the set of structural and social problems that arise because ‘both speaker and hearer are labouring with the same inadequate tools’. 35 This form of injustice arises when individuals are precluded from accessing, or can only partially access, resources that could improve understanding about their experiences. Because of this asymmetry, those with unequal access to resources can suffer additional disadvantages that serve to further undermine their status and impede understanding about their condition. Kidd and Carel describe two kinds of means—which they dub ‘strategies’—by which hermeneutic injustice can be explicitly or implicitly perpetuated. 39 The first includes a range of structural barriers to participation in practices whereby knowledge is formed. Kidd and Carel argue that these can encompass physical barriers and subtler exclusions such as employing specific terminologies and conventions that serve to exclude the participation of disadvantaged people who might otherwise usefully contribute to knowledge. 39 A related, second strategy of exclusion, they argue, is the downgrading of certain forms of expression (such as first-person experiences, affective styles of presentation or vernacular) as evidence of the diminished credibility of the marginalised group. This demotion, Kidd and Carel contend, serves to further frustrate the efforts of the disadvantaged individual to participate, compounding ‘epistemic disenfranchisement’. 39 In this way, hermeneutic injustice can lead to a vicious, self-perpetuating cycle of testimonial injustice.

In what follows, we focus primarily on evidence of hermeneutic injustice, including strategies of exclusion among disabled researchers with ELC, who are largely or completely confined to the home and who seek to contribute to knowledge formation activities within the UK academy. Before we delve into the evidence, however, we offer some contextual caveats. First, it is important to offer some legal context with respect to disability rights. On the most charitable analysis, we acknowledge that not every individual who is disabled can expect to participate in every research context. For example, some barriers—such as the design or location of laboratories—might preclude full participation among some disabled researchers even with significant adaptations. Our aim then is to examine forms of epistemic injustice that pertain to ‘reasonable adjustments’, a legal term that we will unpack. Since our focus is on barriers to people with disabilities in British universities, we focus on UK legislation; however, what we have to say doubtlessly applies to other countries and regions.

Evidence of epistemic injustice among disabled researchers

Background on uk disability legislation.

Under Section 20 of the UK Equality Act 2010, higher education providers in England, Scotland and Wales are legally bound to provide ‘reasonable adjustments’ for people with disabilities who require them. 40 Section 6 of the Act defines disability as the experience of an impairment that has a ‘substantial’, long-term adverse impact on a person’s ability to engage in daily activities. Section 20 clarifies that the duty to make reasonable adjustments exists where any provisions or criteria offered or required by education providers place disabled people at a ‘substantial’ disadvantage relative to non-disabled people. 40

Health scholars have identified vagueness and therefore ambiguities in how qualifiers such as ‘substantial’ and ‘reasonable’ are interpreted. 41 Moreover, it has been contended that ‘reasonable adjustments’ rely on a non-disabled and potentially ableist perspective of what is reasonable, while also placing the burden to prove eligibility for adjustments onto disabled people, thus individualising the structural problem of normalised discrimination. 42 As previously outlined, ELC are poorly recognised as forms of disability, and research demonstrates that people living with diagnoses that can be positioned as ELC struggle to gain the recognition necessary to obtain reasonable adjustments. 32–34 43 Section 19 of the Equality Act 2010 explains that indirect discrimination occurs when one party applies a provision, criterion or practice that puts a person with a protected characteristic (such as disability) at a substantial disadvantage when compared with people without that protected characteristic. 40 44

The Equality Act allows for scenarios where discrimination may be justified (known as ‘objective justification’) in cases where providers can demonstrate that their policies or provisions constitute ‘a proportionate means of achieving a legitimate aim’. 40 Among the considerations about what might constitute a proportionate means are the size of the organisation, the practicalities and costs involved. 44 However, these are seldom explicitly articulated as a justification for the status quo, and the resulting ambiguities (which ultimately can only be resolved by tribunal or court) mean—as we will next find out—that disability discrimination may inadvertently become normalised.

Evidence of strategies of exclusion

Despite an ostensible increase in DEI policies within the academy, 45 46 there exists considerable literature demonstrating experiences of physical and attitudinal barriers to participation in academic research among disabled students and academics, including those with diagnoses that sit within the ELC umbrella. 29 31–34 43 46 There is also evidence that disability-related inequities in higher education persist in terms of degree completion, degree attainment and progression onto skilled employment or postgraduate study, within and beyond STEM. 21 22 47 48 The experience of JH is that such disparities are deeply entwined with physical and attitudinal barriers to full epistemic participation within the academy. Drawing on research findings and situating these against the lived experience of JH, we now explore evidence of strategies of exclusion for disabled researchers that, we argue, could contribute to epistemic injustice.

Studies that reveal barriers to academic participation, among people with ELC and disabled people more broadly, focus on two principal scenarios: (1) experiences of higher education students who can attend ‘on campus’ but require accommodations, 29 33 43 and (2) experiences of academics (from PhD study level upwards) navigating workplace barriers pertaining to reasonable adjustments, employment and career progression opportunities. 31 34 46 49 Where these barriers occur, we suggest they point to evidence of hermeneutical injustice that may also be underpinned by testimonial injustice. Indeed, chief among themes across such literature is that of ableism, understood as ‘a cultural imaginary and social order centred around the idealised able-bodied and -minded citizen who is self-sufficient, self-governing and autonomous’ 50 ; this ‘social order’ is founded on global prejudices about disabled bodies and minds. 50 Reports of academic ableism are evidenced as manifesting through, inter alia, a lack of accessible buildings and equipment, institutional inability or unwillingness to facilitate disability-related accommodations, and lack of familiarity (or consensus) among faculty and non-academic staff as to what constitutes disability-specific DEI practice and policy. 31 43 45 46 Additionally, increasing literature probes the creeping neoliberalisation of academia, which is contended to intersect with and perpetuate ableism, most notably though institutional normalisation of competition and hyperproductivity as a reflection of ‘excellence’. 31 46 Relatedly, and notably among students or academics with health conditions that can be positioned as ELC, the question of whether or how to disclose disability and implications of (non)disclosure is receiving critical attention. 21 29 31 33 34 43

Furthermore, as previously outlined, scarce attention has been paid to ELC explicitly, especially among people with ELC who are largely or completely confined to the home, yet may wish to continue within or enter academic spaces and thus require remote access. JH’s experience is that some of these people are not only marginalised within the academy but may be excluded from accessing it altogether. This, it would appear, is owing to a failure of institutions to facilitate remote access programmes. Here again, to understand how strategies of exclusion operate, we must turn to legal considerations. In terms of what might be considered ‘reasonable’, the willingness of research institutes to extend remote access to students and faculty during successive lockdowns owing to the SARS-CoV-2 pandemic 31 51 52 suggests that failure to extend such accommodations to disabled people who depend on them, and especially where research can be conducted from home, would be difficult to justify.

Yet, such remote access tends to be considered at best an ‘adjustment’ to preferred or ‘normal’ (non-disabled) practice, and provision appears to be patchy and poorly signposted; lack of clarity over which research institutes offer remote delivery programmes may thus constitute the initial hurdle. Some universities appear to offer remote PhDs within some disciplines but not within others, and the exclusions do not appear to be related to pragmatics such as requiring laboratory access. For example, according to JH’s enquiries, and information received, one UK research institute and member of the Russell Group (representing UK leading research-intensive institutions) offered distance learning PhD programmes in 2021 and 2022 within psychology, but not within sociology. For added context, JH’s research interests are interdisciplinary but primarily straddle disability studies (typically sited within academic schools of sociology and faculties of social sciences) and psychology. This is with a view to researching disability-affirmative, socioculturally and politically cognisant approaches to psychotherapy practice and policy. However, in academic fora, psychology and psychotherapy (often aligned with health sciences faculties) foreground heavily medicalised understandings of disability, and JH’s experience has been that psychology departments have not been open minded or welcoming vis-à-vis the prospect of integrating sociocultural and political perspectives, as per disability studies. In practice, this has meant that JH’s endeavours to find an accessible PhD have been limited to the purview of sociology. These disciplinary exclusions arguably represent the legacy of the reluctance of psychology, wider health sciences and life sciences to embrace disability in all its diversity. 21–23 50

In response to an enquiry as to why the above institution did not offer remote access PhDs in disability studies/sociology, the postgraduate admissions team informed JH: ‘All our PhD students undertake mandatory units which are only delivered in person’ (email, 10 February 2022). It is unclear how these mandatory units differ from units offered on remote access programmes. Indeed, a recurring motif throughout JH’s enquiries across various UK institutions is that further probing about potentially exclusionary policies results in ambiguous responses, or no response at all. Reasons for lack of remote access offered by other institutions included a mandatory requirement for direct (on-campus) contact with the PhD supervisor or the need to participate in onboarding sessions face to face on campus. However, lack of justification about why this was necessary was not offered.

Again, it might be expected that institutional willingness to provide remote access during lockdowns would serve as a precedent for remote access to become the norm rather than the exception. 46 However, in response to JH challenging lack of remote access provision on these grounds, the reply from the admissions team at another Russell Group university was as follows:

While during the last year some teaching and supervision has taken place online this is a temporary measure and not part of a formal distance learning course. Some supervision and teaching is also now taking place back on campus in person again. All ‘on campus’ programmes are subject to government mandated attendance requirements. (email, 28 January 2022)

When JH requested more details regarding these government-mandated attendance requirements, the admissions team declared that the enquiry would be passed onto another point of contact. Over 2 years later, no further details have been forthcoming. Ad hoc adjustments pertaining to remote delivery might be possible at some institutions, but it seems conceivable that these may be dependent on the supervisor’s individual preferences rather than policy, perhaps permitting prejudicial judgements about disability to interfere with decision-making.

Furthermore, for those fortunate enough to find a supervisor willing to ‘accommodate’ them, additional strategies of exclusion arise pertaining to funding via doctoral training programme (DTP) and research council consortiums. For example, a representative of the UK White Rose social sciences DTP 53 (covering seven UK higher education institutions in Northern England) informed JH that, in accordance with Economic and Social Research Council (ESRC) policy, disabled students confined to the home are not eligible to be considered for funding. Further digging revealed that this policy is not limited to the White Rose DTP; for example, the UK Midlands Graduate School DTP, 54 covering a further eight UK higher education institutions, lists the same exclusion criteria on its website at time of writing. When JH challenged the White Rose DTP’s policy on grounds of (dis)ableism, a representative forwarded the following response from the ESRC:

UKRI [UK Research and Innovation, non-departmental body of the UK government responsible for funding research] terms and conditions confirm that UKRI funded students must live within a reasonable travel time of their Research Organisation (RO) or collaborative organisation to ensure that they are able to maintain regular contact with their department and their supervisor. This should also ensure that the student receives the full support, mentoring, access to a broad range of training and skill development activities available at their RO, as well as access to the resources and facilities required to complete their research successfully and to a high standard. Our expectation also reflects that we want to avoid students studying in isolation […] (email, 15 December 2022)

In light of the considerable evidence that scholars across many disciplines can work remotely, the assumption that disabled people cannot research to a ‘high standard’ while confined to the home is problematic. Additionally, the reasoning around avoiding isolation, while likely well intended, does not hold much weight from JH’s standpoint. Many disabled people frequently experience significant physical and emotional isolation through navigating a (dis)ableist society and develop numerous strategies (including use of remote access technology) to mitigate this; in this respect, they may even be considered ‘experts by experience’ in resiliently striving to manage isolation. 51 55 56 Social media, for example, is used by many disabled people to connect with others, share ideas on managing health conditions and disability discrimination and develop collective advocacy and activism initiatives. 55 Refusing to offer remote access on (partial) grounds that disabled people may not be able to cope with the ensuing isolation risks infantilising people with disabilities, and withholds one of the very tools that can facilitate inclusion and thus counter isolation.

Moreover, literature suggests that being on campus does not necessarily prevent disabled people from experiencing or overcoming isolation, notably emotional isolation or alienation arising from lack of accommodations and thus feeling ‘unwelcome’ or ‘less than’. 33 46 The ESRC’s reasoning would therefore appear to arise from a non-disabled perspective (or at least, a perspective not attuned to certain facets of disability culture). Funding-related barriers are aggravated by the general lack of other funding opportunities for disabled students. For example, while scholarships for other under-represented groups are justly offered across many institutions, 57–59 often with emphasis on recruiting traditionally marginalised candidates, similar much-needed initiatives for people disadvantaged through disability are conspicuously absent. This is particularly important to address since disability and economic disadvantage are entwined in a complex manner, 2 11 and because, as previously noted, disability is intersected with other forms of social (dis)advantage. 19 21 24 28

It is worth emphasising that the exclusionary practices pertaining to health-related research, as discussed here, may be more pervasive and entrenched than we have presented. Discussing the impact of academic ableism, Brown 46 notes that disability disclosure rates, though on the increase in undergraduate admissions, drop between undergraduate and academic employment level. Brown identifies two factors that might explain this: (a) disabled academics may avoid disclosure for fear that declaring disability would impede their career, and (b) disabled students may simply drop out of the academy. As the foregoing demonstrates, JH’s experience suggests that the second factor may be entwined with disabled students being excluded from the academy because they cannot meet ‘on campus’ attendance requirements. It is currently unknown how many fledgling academics with disabilities have been excluded from the academy owing to discriminatory policies and academic culture, but it seems likely that JH’s case is not exceptional. Recent research recounts that some disabled faculty are being refused remote working arrangements as lockdown accommodations begin to revert to ‘normal’ practice. 60 For disabled researchers in perpetual lockdown, such refusals might result in experiences such as those detailed here remaining unknown and thus unaddressed.

In summary, where a ‘leaky pipeline’ exists vis-à-vis academic representation of some historically oppressed groups, 61 62 it appears that there exists no pipeline at all for a subgroup of disabled people who cannot leave their homes due to a combination of body/mind restrictions and lack of social provisions such as healthcare. Yet, disadvantages created by refusing remote access accommodations to scholars with disabilities who are confined to the home are certainly substantial. Beyond the potential loss to collective wisdom, the hermeneutical injustice perpetuated by barriers to education and employment among disabled people results in what Kidd and Carel describe as a ‘double injury’, 39 since it leads to significant ramifications for the psychosocial well-being and financial security of those excluded.

Conclusions and recommendations

Despite an ostensible increase in commitment to DEI policy and practice, the academy is far from an inclusive space for disabled people. In the case of disabled people who are unable to leave the home, we might better speak of outright exclusions as opposed to marginalisation. The above discussion has demonstrated that various strategies of exclusion operate within the academy that serve to exclude some people with disabilities ‘from the practices and places where social meanings are made and legitimated’. 39 Such exclusions risk further marginalising an already hermeneutically marginalised group, with concomitant psychosocial, occupational and financial harms. Additionally, these exclusions incur a loss of collective wisdom that adversely impacts the development of inclusive, safe and effective healthcare practice and policy.

Although we urge the importance of universities facilitating remote access to disabled scholars, we add a note of caution. First, a remote access academy should be offered in complementarity with, as opposed to an alternative to, ensuring accessibility of academic buildings and equipment, or to otherwise supporting disabled people to attend on campus. This is especially important since we also acknowledge that remote access is not a solution for all disabled people. 52 63 Of note, while remote access can be understood as an assistive technology that helps support the health, well-being and social inclusion of people with disabilities, 2 the digital divide means that disabled people are also less likely to be able to access this technology compared with their non-disabled counterparts. Such marginalisation is owing to lack of devices, broadband connectivity or reduced digital literacy, underpinned by financial, social and educational disparities as already discussed. 1 2 63 Our promotion of remote access as an inclusivity tool does not negate the need to address this divide. Nevertheless, recent research has shown that a leading UK online education provider (University of Derby) has three times as many disabled students as the national average, 30 suggesting that remote delivery of academic programmes can be a significant facilitator of DEI. We therefore conclude by offering recommendations with a view to building on such strategies of inclusion.

Given the lack of familiarity vis-à-vis disability-specific DEI practice and policy, as reported in literature 31 45 46 and as experienced by JH, our first recommendation is for formalised disability equality training and education initiatives that specifically take account of people with ELC and those confined to the home. Since report of such training reinforcing disability-related stereotyping exists, 31 there should be greater emphasis on co-producing such resources with people with disabilities, including those confined to the home who are often excluded from public policy-making. Such initiatives, which could also beneficially target personnel involved in research councils and DTPs, should address implicit personal and organisational biases, facilitate understanding of how current policy and practices perpetuate (dis)ableism and promote a proactive approach to equity and inclusion, specifically in the case of people confined to the home. Disabled researchers and disability studies scholars have argued that an institutional culture change is necessary to move beyond a perfunctory engagement in, or basic legal compliance with, DEI initiatives; a foregrounding of the social model of disability and universal design principles has thus been proposed in developing DEI policy and practice. 29 31 46 The social model upends academically prevalent (individualistic) representations of disability and reasonable adjustments, by placing the onus for change on social structures and institutions as opposed to the people who are discriminated against. 16 17 In the case of ELC, we suggest that the social structures requiring greatest change to facilitate inclusion are attitudinal contexts, most notably disbelief. 24 25 In complement to the social model, application of universal design tenets to academic contexts, which involve building ‘accommodations’ into academic standard and managing disability-related diversity proactively as opposed to reactively, 29 31 46 should be extended to remote access. In practice, this means reducing the likelihood that disabled people have to ask and prove eligibility for reasonable adjustments. 42

Second, we recommend greater institutional transparency, including clear guidance for researchers with disabilities, vis-à-vis remote working policies. For many research and study programmes, online library access, supervision and other meetings represent acceptable accommodations, if not candidates for integration into academic standard as a complement to on-campus delivery. Such accommodations should be clearly signposted and, where remote working is not possible or government mandates apply, both transparency and strong justifications are required. In this regard, an institution outside of the UK has set a precedent. Uppsala University in Sweden has welcomed JH as research affiliate in the Department of Women’s and Children’s Health, operating entirely via remote access. This approach, which embraces remote working as if it were standard practice (as per universal design principles), is invaluable in challenging the prevalent yet exclusionary academic notion of dominant (on-campus) practice and policy as ‘normal’ and ‘ability neutral’. It thus serves as an exemplar for disability-related best practice for UK institutions.

Third, the current funding system requires considerable revision to better include people with disabilities who are confined to the home. In cases where research projects can be conducted remotely, there is surely no justification for exempting this group of disabled people from being eligible to apply for grants and PhD stipends. As per our above recommendations for remote accommodations, information on funding eligibility should be easily accessible, with strong and transparent rationale for any exclusions. Additionally, existing initiatives to ring-fence funding for researchers from minoritised groups to study health-related inequities 64 should be extended to include disabled people. Without such measures, much-needed research might never be conducted. This article, which has arisen from disability standpoint, and both disability and academic allyship, has indicated a considerable research gap pertaining to how disabled students or academics confined to the home experience barriers to health-related research. With a view to addressing this research gap with the added value of disability standpoint, funding opportunities must facilitate the inclusion of disabled researchers. Yet, while some under-represented groups are supported through funding-related DEI schemes, 64 disability is often overlooked.

Finally, we recommend a more formalised and universally applied academic DEI monitoring and ombudsman scheme, both to assess DEI-related shortcomings and to support minoritised researchers in raising concerns. Disabled scholars have suggested using Disability Standard (a form of benchmarking used in business to assess inclusivity and accessibility) to analyse gaps in disability-related DEI practice and policy 31 ; practical application across UK universities appears very limited. Existing schemes to promote DEI within the education sector should ensure that disability, including disabled people confined to the home, is represented and consider how institutional compliance can be secured. ‘Advance HE’ is a UK non-governmental body that promotes excellence in higher education, an objective the body acknowledges as entwined with DEI. 65 While DEI ‘international charters’ pertaining to gender and race exist with a view to encouraging providers to commit to inclusion of under-represented groups, 65 an equivalent charter specifically for disability does not exist. Here again, we recognise that different forms of discrimination intersect and that race and gender shape disability. 2 21 28 Moreover, while we do not mean to overlook recent efforts among Advance HE and other bodies to include disability in DEI initiatives, 66 the voluntary nature of many of these initiatives (which ‘encourage’ higher education institutions to address more fully disability-related DEI) will likely allow the inequitable status quo to persist. Seeking to ground a collective institutional commitment to disability inclusion within legislation, or at the very least within a transparent ‘award’ system as with DEI initiatives pertaining to other under-represented groups, 65 would likely lend more gravitas to such schemes and ‘nudge’ research institutes towards greater accountability.

In summary, insights from scholars with disabilities can help to inform more inclusive, safe and effective health-related interventions, with further benefits for social inclusion. Current academic structures deny opportunities to the very people who are well placed to identify and research the most overlooked problems in our health systems. If we truly prize DEI, the academy must become more accessible to disabled people.

Ethics statements

Patient consent for publication.

Not applicable.

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X @JoElizaHunt, @crblease

JH and CB contributed equally.

Contributors Both authors contributed equally to all aspects of the paper. As corresponding author, JH acts as guarantor.

Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests None declared.

Provenance and peer review Not commissioned; externally peer reviewed.

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Infected blood scandal – what you need to know

  • Thought Leadership

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The findings of the UK’s Infected Blood Inquiry have been reported. Over 3,000 people have died after receiving contaminated blood products in the 1970s, 80s and 90s. Professor Emma Cave, of Durham Law School, and Professor Bobbie Farsides, of Brighton and Sussex Medical School, Co-Chairs of the Medical Ethics group for the Infected Blood Inquiry, set out the background to this scandal.

The infected blood scandal has been hailed the  worst treatment disaster  in the history of the NHS. Over  3,000 people have died  as a result of receiving contaminated blood products in the 1970s, 80s and 90s, and it is estimated that an infected person still dies  every four days .

As the scandal unfolded, repeated calls for  justice and recognition  were ignored. An independent public inquiry was finally announced in  2017 . The delay is itself a  source of harm .

Too many have died without redress or adequate support. The  infected blood inquiry , chaired by Sir Brian Langstaff, is the  largest public inquiry  ever carried out in the UK. The inquiry is due to issue its final report on May 20 2024.

Public inquiries  are major investigations set up by government to respond to catastrophic events. The  infected blood inquiry  has investigated the causes and effects of the infected blood scandal to get to the truth of what happened.

The inquiry team has reviewed  extensive evidence , including many thousands of pages of public records, and evidence from the government, the NHS, the national blood services and pharmaceutical companies.

Thousands of  oral and written submissions  from those infected and affected were considered.

In oral hearings across the UK, people gave powerful accounts of their experiences and heard, in turn, from people who had been involved in offering treatment, determining policy and responding to the emerging disaster.

Some 2,007 of the infected and affected were appointed as “core participants”, and they worked with the inquiry team to formulate questions put to ten  expert groups .

Nowadays, the infections with which the inquiry has been particularly concerned – hepatitis B, hepatitis C and HIV – are better understood and effective treatments are available. However, although doctors were aware of the risks of hepatitis B in the 1970s, hepatitis C and HIV took much longer to identify and understand.

Unexplained hepatitis  was discussed from 1969, and the infectious agent hepatitis C, which can lead to chronic infection, serious liver damage and death, was identified in 1989.

The first UK case of  Aids was in 1981 . HIV was identified as the cause in 1983, but there was no treatment for Aids and the  stigma was considerable .

Of the thousands of men, women and children infected with hepatitis C or HIV, the route of infection was most commonly a direct result of a contaminated blood transfusion, or through the use of medical treatment derived from contaminated human blood products.

People were put at risk by blood transfusions required to save their lives or aid their recovery, and by treatments aimed at managing blood clotting conditions such as haemophilia.

In the 1960s, patients with haemophilia were generally treated with a frozen blood product called cryoprecipitate, or cryo for short. Cryo posed a relatively low risk of passing on infection because a single dose was derived from a single blood donation. But it was difficult to store and administer and made life difficult for patients.

In the early 1970s, a revolutionary new treatment, factor VIII, resolved many of these problems and was seen as a major advance. However, factor VIII was made by concentrating pooled plasma collected from tens of thousands of donors. This increased the risk of passing on blood-borne infections, as just one donor carrying a virus could contaminate an entire batch that would then be used to treat many patients.

As doctors switched to offering factor VIII, the NHS struggled to meet demand and began to import supplies from the US.

These products were especially hazardous because in the US, people with a high risk of infection, including prisoners, were paid to provide blood. This was in contrast to the UK blood donation system which has always relied on altruistic donation.

Against this backdrop, the inquiry considered whether patients were treated appropriately in terms of issues such as informed consent, information sharing around risk, openness and transparency, and involvement and  subsequent infection  in research.

Compensation

In 2022, an  independent report , chaired by Sir Robert Francis, recommended compensation irrespective of any issue of legal liability or of the findings of the inquiry.

The  UK government accepted  the moral case for compensation and made initial  payments of £100,000  to 4,000 of the infected and bereaved partners in 2022.

Though welcomed, this was far from the compensation package recommended by Francis. In an  interim report , Langstaff concluded that “wrongs were done at an individual, collective and systemic level”.

He was also clear that there was a strong moral case for compensation for the wrongs and the harms people had suffered. He  recommended  that a full compensation scheme should not wait until the final report was published on May 20.

The  government resisted , citing the need to base compensation considerations on the final report, and has set up a new  expert group  to advise.

Find out more

This article is republished from  The Conversation under a Creative Commons license. Read the  original article .

Learn more about Professor Emma Cave , Durham Law School, and Professor Bobbie Farsides , of Brighton and Sussex Medical School.

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  • v.55(1); Jan-Mar 2013

Ethics in medical research: General principles with special reference to psychiatry research

Ajit avasthi.

Department of Psychiatry, Postgraduate Institute of Medical Education and Research, Chandigarh, India

Abhishek Ghosh

Sidharth sarkar, sandeep grover.

Ethics is an understanding of the nature of conflicts arising from moral imperatives and how best we may deal with them. Ethics in medical research deals with the conflicts of interest across various levels. Guidelines have been proposed for standardized ethical practice throughout the globe. The four fundamental principles of ethics which are being underscored are autonomy, non-maleficence, beneficence, and justice. Some special ethical issues have particular relevance to psychiatric research arising primarily from the specific vulnerabilities of those with mental illness and the risks posed by some research methodologies. Accordingly, sensitivity is required in the design of psychiatric research. It is suggested that though the value of published guidelines and the help that may be available from research ethics committees is quite great, the primary responsibility for maintaining high standards of practice in research rests with research workers themselves.

INTRODUCTION

The word “ethics” is derived from the Greek word, ethos, which means custom or character. Ethics is an understanding of the nature of conflicts arising from moral imperatives and how best we may deal with them.[ 1 ] It deals with the choices we make and our actions in relation to those choices. It deals with the choices made by both clinicians and patients and the duties and obligations of clinicians to their patients. Medical ethics also deals with the choices made by society, the distribution of resources, and access to health care, and the dilemmas arising from them.[ 2 ] An issue, mainly for the developing countries, has been the extent to which ethical principles are considered universal or as culturally relative – the universalist versus the pluralist view. The challenge to international research ethics is to apply universal ethical principles to biomedical research in a multicultural world with a multiplicity of health-care systems and considerable variation in standards of health care.[ 3 ]

History is unfortunately peppered with stories of abuse carried out in the name of medical research. The most dreadful of all atrocities was possibly conducted by Nazi doctors who used convicts for human experimentation. The discovery of these experiments stunned the whole world which led to the formulation of Nuremberg code[ 4 ] to prevent recurrence of such episodes. It was the first international code for ethics in clinical research laying down the guidelines for research on human subjects. It laid down 10 clear principles to be followed by researchers and made voluntary consent essential, allowed subjects to withdraw from the experimentation at any time, banned experiments that could result in major injury or death of the subjects, and made mandatory to have preclinical data before experimenting on humans. Even Nuremberg code failed to terminate unethical research practices. Eventually a set of guidelines was adopted by the 18 th World Medical Association (WMA)[ 5 ] General Assembly, which was called the Declaration of Helsinki. It contained 32 principles, which stress on informed consent, confidentiality of data, vulnerable population, and requirement of a protocol, including the scientific reasons of the study, to be reviewed by the ethics committee. Though Declaration of Helsinki had created a stir in the medical community, medical atrocities continued. The malpractice in the Tuskegee Syphilis Study in the US was possibly the next eye opener which ushered the Belmont Report[ 6 ] in 1979 and laid the foundation for regulations regarding ethics and human subjects’ research in the US. With the increasing interest of pharmaceutical industries in carrying out research experiments in the developing and the underdeveloped countries, the Council for International Organizations of Medical Sciences (CIOMS)[ 3 ] in association with World Health Organization (WHO) developed “International Ethical Guidelines for Biomedical Research Involving Human Subjects” in 1982.

CARDINAL PRINCIPLES OF ETHICS IN RESEARCH

The four principles of Beauchamp and Childress – autonomy, non-maleficence, beneficence, and justice – have been extremely influential in the field of medical ethics, and are fundamental for understanding the current approach to ethical assessment in health care. Respect for autonomy stands for acting intentionally after being given sufficient information and time to understand the information. Beneficence is directed to promote the well-being of patients and society. On the other hand, non-maleficence implies first do no harm which can be achieved by careful decision making and having adequate training. Justice deals with the equitable distribution of social benefits.[ 7 , 8 ]

MEDICAL RESEARCH – DEFINITION, TYPES, AND ISSUES

The term “research” refers to a class of activity designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles, or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. In the present context, “research” includes both medical and behavioral studies pertaining to human health. Usually “research” is modified by the adjective “biomedical” to indicate its relation to health. Those who support the need for research argue that no new treatment should be offered outside the context of a controlled trial, so that treatments’ effectiveness and efficacy can be measured ab initio , not only for the sake of the patients currently receiving it but also for all future patients. Research involving human subjects includes:[ 1 , 9 ]

  • Studies of a physiological, biochemical, or pathological process, or of the response to a specific intervention – whether physical, chemical, or psychological – in healthy subjects or patients;
  • Controlled trials of diagnostic, preventive, or therapeutic measures in larger groups of persons, designed to demonstrate a specific generalizable response to these measures against a background of individual biological variation;
  • Studies designed to determine the consequences for individuals and communities of specific preventive or therapeutic measures; and
  • Studies concerning human health-related behavior in a variety of circumstances and environments.

Conflicts of interest are inherent to the majority of relationships among individuals and of those with companies and institutions and, certainly, research involving human beings is no exception. In relation to clinical research, conflicts of interest occur at different levels and usually permeate through various lines (e.g., in the pharmaceutical industry, about their decisions to invest and develop new products, especially vaccines and drugs, and also in relation to marketing of these products). Among the investigators, the conflicts may be related to the financial gains to participate in pharmacy sponsored trials, or to the expected academic career boost attained with the publication of the results of the trials and also to personal interests such as the financial support for trips to international conferences.[ 10 ]

Therefore, medical research which is absolutely necessary and fundamental for acquiring and propagating worthwhile novel knowledge is equally controversial because of the conflicts of interest of the researchers or the sponsors. Both universal and regional guidelines have been proposed to strike a balance between these two opposing interests and to ensure standardized ethical research.

PRINCIPLES OF ETHICS IN MEDICAL RESEARCH

Principles of essentiality.

Refers to whether the research is considered to be absolutely essential after a due consideration of the existing scientific knowledge in the proposed area of research. This should be scrutinized by an independent and responsible body of persons who, after careful consideration, come to the conclusion that the research is likely to benefit the humanity or environment.[ 11 ]

Principles of voluntariness, informed consent, and community agreement

Research participants should be fully apprised of the research and the associated risks and benefits. The participants should be informed of the right to abstain from the research or withdraw consent at any time. Where research entails treating any community, the principles of voluntariness and informed consent apply to the community as a whole and to each individual member. In case a person is incapable of giving consent, a legally acceptable guardian should give the informed consent.

Principles of non-exploitation

The participants should be fully apprised of all the possible dangers that may arise during the research so that they can appreciate all the physical and psychological risks. Each research should include an in-built mechanism for compensation for the human participants either through insurance cover or by any other appropriate means to cover foreseeable and unforeseeable risks, and provide remedial action and comprehensive aftercare.

Principles of privacy and confidentiality

The identity and records of the participants are as far as possible kept confidential (except when required for legal reasons). This is to avoid any form of hardship, discrimination or stigmatization as a consequence of having participated in the research.

Principles of precaution and risk minimization

Due care and caution should be taken at all stages of the research and experiment to ensure that the research participant and those affected by it including the community are put to the minimum risk, suffer from no known irreversible adverse effects, and generally, benefit from the research or experiment. There should be a plan for interim reviews to detect whether any intervention arm (active or control) is associated with increased risks, so that undue harms are avoided by stopping the research.

Principles of professional competence

Research should be conducted by competent and qualified persons who act with total integrity and impartiality and who have been made aware of the ethical considerations to be borne in mind in respect of such research or experiment.

Principles of accountability and transparency

The research or experiment should be conducted in a fair, honest, impartial, and transparent manner after full disclosure is made by those associated with the research or experiment of each aspect of their interest in the research, and any conflict of interest that may exist. Full and complete records of the research should be retained for such reasonable period as may be prescribed or considered necessary for the purposes of post-research monitoring, evaluation of the research, conducting further research, and scrutiny by the appropriate legal and administrative authority, if necessary.

Principles of the maximization of the public interest and of distributive justice

The research or experiment and its subsequent application should be conducted and used to benefit all human kind (and not just those who are socially better off), in particular, the research participants themselves and or the community from which they are drawn.

Principles of public domain

The research findings should be brought into the public domain so that its results are generally made known through scientific and other publications. This would help in consolidating the scientific knowledge base of the field being studied and would prevent the undue replication of studies which pose risks to some subjects.

Principles of totality of responsibility

Professional and moral responsibility should be observed, for the due observance of all the principles, guidelines, or prescriptions of those directly or indirectly connected with the medical research. This extends to the institutes where this research is carried out, as well as the sponsors of the research. The research should be duly monitored and constantly subject to review and remedial action at all stages.[ 11 ]

SPECIAL REFERENCE TO PSYCHIATRY RESEARCH

Neuropsychiatric disorders are highly prevalent conditions with significant morbidity, yet only modestly effective treatments are available. The suffering and loss caused by these diseases call for the development of truly innovative interventions. Testing such innovative approaches can carry risks of significant harm[ 12 ] even while raising hopes for future benefits.[ 13 ] Furthermore, the very nature of many neuropsychiatric disorders creates ethical complexity because many persons with such disorders have impaired cognition or emotion. If a patient's impairment is severe enough, he or she will be incompetent to give informed consent for research.[ 14 ] In our society, surrogate or proxy consent-based research remains an area of unsettled policy. Finally, at a more speculative level, interventions that alter behavior, or even knowledge that can predict or explain behaviors, can challenge traditional norms of social regulation and interaction.[ 15 ]

Methods for solving these dilemmas have included the development of more objective rules to guide the practitioner, such as utilitarianism and deontology. Deontological approaches possibly cannot resolve moral conflicts, and so the psychiatrist is “denied an available remedy.” Utilitarianism is seen by the authors as too difficult to calculate benefits and risks, and demands an impartiality that clinicians would find difficult to achieve. Both deontology and utilitarianism, a respect for patient autonomy, and utility, a measurement of consequences, are seen as theories that do not help clinicians in practice. This is particularly the case in conflict situations as in psychiatric research.[ 16 ] Therefore, research in psychiatry demands a special attention.

Issues in relation to competence and consent

Participation in research usually involves some degree of risk, discomfort, or sacrifice of the personal care that patients enjoy when they receive ordinary treatment.[ 17 ] Ordinarily, we allow research subjects to incur these discomforts or sacrifice personal care because we believe that people have the right to run certain risks for rewards that seem to them worthwhile. These rewards may include the pride that comes from altruistic behavior, the hope that they themselves might benefit from the results of the study at some point in the future, and the more immediate possibility that they may have access through the study to assessment techniques or therapeutic approaches that would not otherwise be available to them. But when subjects’ capacities to make decisions are impaired, they may materially misconstrue the situation into which they are entering.[ 18 ]

To resolve these conflicts, proposals have been made that range from banning certain types of research with psychiatric patients to requiring independent evaluation of the capacities of potential subjects, to appointing representatives to remove subjects from studies when the risk–benefit ratio appears to be swinging against them.[ 19 , 20 ]

As per WMA guidelines for ethical research, “In research involving subjects who are mentally incapable of giving consent, the physician should seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for their inability to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research should be obtained as soon as possible from the subject or a legally authorized representative” (WMA 2008; clause 29). An additional caveat in clause 28 reads, “When a potential research subject who is deemed incompetent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorized representative. The potential subject's dissent should be respected.”[ 21 ] It should always be remembered that impairments exist on a spectrum, and some degree of dysfunction is not incompatible with competent decision making. Thus, although the presence of cognitive and related impairments in schizophrenia, for example, warrants concern about subjects’ abilities to decide whether to enter a research project, by no means does it call for the exclusion of all persons with schizophrenia from investigational studies. Individuals who have severe mental disorder and lack adequate decision-making capacity may improve significantly with educational remediation.[ 22 , 23 ] Patients can be given information through conversation, lectures, pamphlets, articles, medication groups, instruction sheets, books and videotapes, consent forms, and interactive videodiscs. Repeated disclosure of information is another technique which can be followed.[ 24 ]

However, systematic evaluation, even in non-psychiatric populations and in high-income countries, has shown that participants in randomized trials recall information poorly, are not often aware that placebos form one arm of treatment, demonstrate inadequate comprehension of the process of chance in treatment allocation, understand and use only a proportion of what is presented in consent forms, do not really understand the issue of equipoise, and participate not for altruistic reasons but because they expect some improvement by participation.[ 25 ] Cognitive dysfunction and the symptoms shown to be associated with impaired decisional capacity are not unique to schizophrenia and may occur with many other forms of illness.[ 26 ] Furthermore, studies have also shown that many people with schizophrenia are able to give informed consent and retain related information across time. So, diagnosis of mental illness itself does not disqualify a person to enter into a research as competence of decision making is case specific and variable across the time.

Issues in relation to confidentiality

Patients, health-care providers, and patient advocacy organizations have expressed increasing concern about the confidentiality of clinical information stored in large computerized databases.[ 27 – 30 ] The accumulation of ever-larger stockpiles of sensitive information raises reasonable concerns about inappropriate access and unauthorized disclosure. Given the stigma often attached to psychiatric disorders and psychiatric treatment, confidentiality of information on mental health and substance abuse treatment is especially critical. A few occurrences of inappropriate use or disclosure of clinical information have been well publicized.[ 28 , 30 ]

Firstly, continued research access to population-based records data is essential to protecting the rights and interests of people with psychiatric illness. Investigators conducting any such research should take all possible steps to limit access to confidential information, minimize risks of disclosure, and (when possible) obtain informed consent for research use of clinical data. The most effective strategy for preventing disclosure of confidential information is to remove all identifying information from medical records data before any research use.[ 31 ] Secondly, when potential research uses are anticipated at the time of data collection, those collecting clinical information should be obligated to advise patients regarding possible research use. However, obtaining individual informed consent for each specific research use is impossible or extremely impractical.[ 32 ] Lastly, research intended to increase public domain medical knowledge should be clearly differentiated from proprietary activities. If legitimate public domain research activities were clearly distinguished from other uses of large clinical databases, efforts to regulate storage and disclosure of clinical data could concentrate on the activities that are now largely unregulated.[ 33 ]

However, advances in mental health science promise great benefits for those who suffer, or will come to suffer, from mental illness and, in some cases, for research subjects themselves. While persons with mental illness may be vulnerable in several ways, research regulations that focus primarily on their vulnerabilities and deficits could encourage and possibly exacerbate the stigmatization already felt by this population.[ 34 , 35 ] Further, it may be unjust to exclude, by overly restrictive regulation, those people with mental illness who could benefit from research participation. An ethically appropriate framework for psychiatric research ethics balances rigorous protections for human subjects with recognition of the enormous social and individual benefits arising from well-designed and ethically conducted scientific research.[ 36 – 38 ] How this balance is struck has important implications for research ethics generally, particularly for research involving vulnerable persons.

Though a number of ethical guidelines have been formulated for clinical research, malpractice is still widely acknowledged. It could be understood by the fact that ethical guidelines in many countries like India are just the recommendations and not a law. For proper enforcement, guidelines should be made a part of the law as has been done in the US and some other countries of the world.[ 39 ] We need better research, and research done for the right reasons. The second intriguing issue is the cross-cultural applicability of ethical guidelines.[ 40 ] In this era of advanced globalization, the problems of medical ethics can no longer be viewed only from the perspective of wealthy countries. Global bioethics seeks to identify key ethical problems faced by the world's 6 billion inhabitants and envisages solutions that transcend national borders and cultures. The relevance of global bioethics is obvious with respect to international research ethics (as evidenced by the controversy over changes to the Declaration of Helsinki), global vaccine initiatives, or global health equity.[ 41 ] Last but not the least; doctors are specially trained to be good clinicians but are seldom taught even the fundamentals of ethical clinical research. The post-graduate dissertation or the PhD thesis is a precious opportunity to train tomorrow's investigators in the elements of ethical clinical research.[ 42 ] The attributes of a clinical researcher like truthfulness and accountability toward integrity are expected to propagate standardized ethical practice.

Source of Support: Nil

Conflict of Interest: None declared

medRxiv

Understanding Diagnostic Error Patterns and Contributing Factors: A Descriptive Analysis of Medical Error Reports at a Tertiary Hospital in Kenya 2019-2021

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Background Diagnostic errors in healthcare pose substantial risks, leading to increased costs, patient anxiety, and delayed diagnoses. Despite its prevalence, diagnostic errors have historically received less attention compared to other medical errors, necessitating urgent action to address these critical issues. This is more so in the low- and middle-income countries. (LMICs). This study aimed to analyze patterns and associated factors of diagnostic error reported to the Patient Safety Unit of Kenyatta National Hospital (KNH), a tertiary teaching hospital in Nairobi, Kenya. Methods This was a descriptive retrospective study of medical error reports(MER) forms submitted to KNH from 2019-2021.Type of medical errors, contributing factors, site, timing of error, and outcome were recorded. Descriptive statistics, chi-square tests, and logistic regression were employed to assess error types, contributing factors, and associated likelihoods. Results Among 640 MER forms analysed, diagnostic errors were reported in 40 percent of cases, predominantly associated with delayed diagnosis, wrong diagnosis, and failure to test. Contributing factors to MER included communication issues (36.1%), staff-related factors (48.9%), and equipment issues (15.6%). Diagnostic errors were more likely during non-working hours (OR 1.969, p < 0.047) and in Accident and Emergency department (OR 2.36, p < 0.022) within KNH. Conclusion Diagnostic errors represent a significant proportion of medical errors at KNH, particularly in Accident and Emergency settings. Strategies to involve more physicians in error reporting and enhance communication practices are recommended.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study was funded by the Kenyatta National Hospital for the purpose of quality improvement in diagnostic safety.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study received ethics approval from the Kenyatta National Hospital-University of Nairobi Ethics Review Committee (Approval No. P847/10/2021) and obtained a research permit from the National Commission for Science Technology and Innovation (Permit Ref. 517313).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Data Availability

Data is available is needed. This does not have patient identifiers and is available for sharing.

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