clinical research new zealand

Join our Research Community

Welcome to New Zealand Clinical Research (NZCR), Aotearoa New Zealand’s leading early phase clinical research provider.

Join our research community, help us research new medicines, advance global health and be paid for your involvement. You will be cared for by our expert research team at every step of your clinical trial journey.

NZCR is New Zealand’s leading and most experienced researcher of new medicines.

Our expert research team have conducted over 750 clinical trials involving more than 15,000 New Zealanders.

All our trials are approved by New Zealand regulatory authorities and take place at our state-of-the-art research facilities in Auckland and Christchurch, with satellite sites in Hamilton and Wellington. Our team ensure you are fully informed, and your safety is paramount.

What does a Screening Test involve?

What's it like to Participate in a Study?

Who do we need to join our research community and help us with our research?

We need healthy people who do not take any regular medications and meet BMI (body mass index) and weight criteria. Participants need to be able to stay overnight at our research facility and attend clinic visits.

Sound like you? How to get involved…

First off we need you to register your interest; this will allow us to match you to a trial.

How to Participate in our Clinical Trials

To take part in an NZCR trial, we need you to register your details with us. This will ensure we are providing you with information on a trial that might suit you. All our trials have height, weight, BMI and other criteria in the trial. Once you have registered on our database, we will review your profile and send you information on a suitable trial, why it is being conducted, when it is taking place and the payment you will receive for taking part in the trial.

Clinical Trials going on in your area now

We have trials researching a wide variety of potential new medicines which involve varying overnight stays and follow up visits at our clinics.

Select your prefered location

• Auckland/Hamilton

Christchurch

Requirements:

• Aged 18 – 55 years
• Are in good health
• Weigh between 50-90kg
• Have a BMI between 17.0kg/m2-30.0kg/m2.
• Not taking any regular prescription medications for your health (e.g anti-depressants)
• Non smokers, or smoking less than 10 cigarettes a week

Study Visits: 3 night stay + 25 outpatient appointments

Reimbursement: $7,500 (less tax)

• Be aged 18 – 55 years.
• Are in good health.
• Have a BMI (Body Mass Index) between 18.0 kg/m 2 – 32.0 kg/m 2 
• Not currently taking any regular prescription medications for your health (e.g., anti-depressants)
• Are a non-smoker and/or non-vaper for at least 30 days

Study Participation: 5 night stay + 1 outpatient appointment

Reimbursement: $3,750 (less tax)

AZURE PART F

Why participate in a clinical trial.

Your participation will help us research new medicines which may change the lives of patients in New Zealand and around the world.

Join our research community, get a free health check-up and meet other like-minded people who want to make a difference.

While you are at an NZCR facility, you can enjoy unlimited free WiFi so you can stay in touch with your networks or work if you like. We have areas to work and play with work stations and activities like PS5 and Netflix. Plus a variety of balanced and delicious meals – including vegetarian options.

Take part in our recreational activities and space to socialise and relax. As some participants say – “it’s like a paid holiday”.

Be a part of advancing medicine and improving patient care by participating in our clinical trials today.

Helpful FAQs

A clinical trial is a scientific trial that involves people.  A clinical trial investigates whether a medicine is safe and effective for the treatment of a disease or medical condition. They are conducted by pharmaceutical and biotechnology companies in collaboration with independent investigators (our research doctors).

Results from clinical trials can be used to make new medicines available for patients worldwide.  Clinical trials can involve “healthy participants” and patient populations.

There are several phases in clinical trials.

• Phase 1: Focuses on the safety of the medicine.
• Phase II: Focuses mostly on the effectiveness of the trial medicine in treating the intended disease.
• Phase III: Focuses on safety, effectiveness and determining the right dose to treat the disease.

All NZCR trials are approved by New Zealand regulatory authorities.

• Before agreeing to participate in the trial, participants need to read the participant information sheet and understand what participation in the trial will involve.
• Our staff discuss the trial over the phone to check your eligibility (i.e., if you are suitable for the trial) in a pre- screening phone call.
• If suitable you attend our research facility to meet our medical team who will answer any questions you have, undertake medical tests e.g., blood, urine and other trial specific tests to determine your suitability to take part in the trial.
• If you decide to take part in the trial, you will be asked to sign a consent form.
• This is called Informed Consent. By signing the Consent Form trial participants are agreeing to participate in the trial.
• Participation in clinical trials is voluntary – you can withdraw from the trial at any time. Please note it is important for safety reasons that trial participants attend all the clinic visits as prescribed by the trial staff.

To ensure participant safety, all clinical trials conducted in NZ must be approved by the appropriate regulatory authorities. There is always some risk associated with taking any medicine and there will be an additional risk in taking any new medicines. There is no way to predict how an individual may react to any medication. Health risks and side effects are pre-determined during pre-clinical and early clinical trials, side effects can differ from person to person. There is no way to 100% predict how a treatment will affect an individual, therefore early phase clinical trials involve many rigorous safety assessments.

What our clinical trial participants have to say

As a nursing student, I am interested in medical research. I find doing studies at NZCR is like a paid holiday. I can come in do my trial and not worry about anything else – the cooking, the dishes all get done for me! I feel very safe and well cared for by the medical team at NZCR

"Hi I’m Alex, I have done quite a few studies at NZCR. I have found the nurses and doctors to be professional and caring. The facilities themselves to be comfortable, the lounge area providing a nice place to relax. The food portions have been very large and delicious. It's a great way to support my studying without having to take out a student loan."

This my 2nd trial and it’s a long one (16 days). The hardest part is maybe getting a needle in my arm for a blood test. Otherwise, its like a retreat. I have a lot of time for study, reading & light exercise. I am fed well and enjoy talking and the nurses or other participants.

Jun Jie has completed five clinical trials at NZCR. Here’s what Jun Jie had to say - Read more

Get in touch today

New Zealand Clinical Research (NZCR) provides state of the art research facilities and the expertise to conduct complex early phase clinical research in healthy participant and patient populations.

Volunteer for clinical research

We have a number of open studies for both healthy volunteers and those with existing conditions. Our friendly, expert team ensure that every participant receives outstanding attention and care.

For Volunteers

Help create a healthier community

Join our community of volunteers and help us advance medicine. Our friendly, expert team ensure that every participant receives outstanding attention and care, taking you through the process efficiently with ongoing support and guidance.

For Researchers: Run a trial

Taking medical advancements further

To achieve ground-breaking results and study success, you need a partner with renowned expertise and a proven track record. Find out how Optimal is centred on facilitating the delivery of high-quality data, with rapid enrolment, to accelerate your next clinical development program.

For Researchers: Why NZ?

Get it right the first time

New Zealand boasts one of the fastest regulatory and streamlined online ethics review system, enabling Optimal to provide confidence around start up timelines. This isn’t the only reason why other companies are choosing to do business in New Zealand. Click below to receive a copy of our free guide to find out how you can accelerate your clinical program.

Every day is valuable

Leading today’s research, for a healthier tomorrow.

Optimal was founded with a core focus – to drive the advancement of medicines for improved quality of life for people across the globe. Our combined expertise across a wide range of therapeutic areas, our dedicated research centre and access to a diverse population database, enables us to deliver high-quality data, with rapid enrolment, achieving ground-breaking results and study success.

Rapid enrolment with high-quality data for ground-breaking results

Trials moving health forward

Safe and Secure

Fast and efficient process

It’s about the people.

Rapid, Quality, Trusted

Reach out to new zealand to run your clinical trials.

Optimal is strategically positioned in the world’s most rapidly growing clinical trial region, AsiaPac. On the global stage, New Zealand boasts one of the fastest regulatory and streamlined online ethics review system, enabling us to provide the expertise and service to pharmaceutical companies and CROs wanting to facilitate high-quality and ethically sound studies.

Don’t have time to read the website? Click below to receive a free copy of our guide: "Successful Clinical Trials: How to accelerate your clinical program; get your first patient in quickly and meet your clinical trial milestones”.

Who our clients are

We reach out to both international and national partners, regularly collaborating with global biopharma and start-up biotechs, supporting global programs under FDA and EMA regulations. We foster strong relationships with international and local CROs and vendors.

Logistics providers

Accredited lab providers

“I enjoyed being part of this study, the doctors and nurses were very friendly and gave clear instructions and descriptions of everything that I needed to do. The atmosphere was very friendly, and I was made to feel very welcome. Given the opportunity I would definitely take part in another study.”

“The staff were professional, helpful and I knew I could trust them. They were efficient without being rushed and remained compassionate toward my condition. Optimal Clinical Trials made participating easy -They all treated me with respect, explained things fully and they made sure I knew what was happening before starting and throughout the study. There was ample opportunity to ask questions and help available at all times. I felt totally confident in Dr M. and the nurses. I thoroughly enjoyed being involved in the trial and hope to do others and definitely recommend him and his team to others.”

“Optimal Clinical Trials were a pleasure to be involved with and maintained the utmost professionalism at all times. While undergoing the trial I found I was able to focus entirely on the study at hand because everything else was taken care of and it helped that a member of the team was always on hand to guide me through any difficulties or questions I had. I would not hesitate to undergo another trial with Dr M or his team, or to recommend that others do the same.”

Have a question?

Whether you are a medical researcher or a potential volunteer who wants more information on our current studies, we're here to help.

A Trusted Hand in Research

Seek a partner with a global reputation for stability, quality and diversity.

Consistently achieving first in world patient enrolment, we partner with global biopharma and start-up biotechs, support international programs with the FDA and EMA, and foster strong relationships with CROs, vendors and participants, to ensure the best possible journey for your medicine to market.

People Helping People

Play your part in greater discoveries.

Without volunteers, giving their time, energy and commitment to our medical journey, nothing can be achieved. Our team of experts ensure that participants receive the care, guidance and monitoring they deserve when participating in a trial from beginning to end.

NZACRes was established in 2004 as a professional association for clinical researchers in New Zealand. Membership is open to all those who have an interest in clinical research and as such, we represent a wide range of industry members from the private and public sectors. Our goal is to promote and support clinical research within New Zealand through the provision of networking and educational opportunities, industry resources, and collaborations to address industry issues and create solutions. NZACRes also provides the clinical research community with a unified voice and a means for industry consultation.

Regulations, hdec template updates, hdec piscf templates updated.

Main PISCF, Pregnancy and Reproductive Risks templates have been updated.

Aspiring CRAs

Aspiring cra’s article.

If you are interested in being a CRA and are not sure where to start, read the Aspiring CRA’s article.

HDEC Application Tips

The document provides advice to optimise your chance of gaining Health and Disability Ethics Committee (HDEC) approval.

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Aotearoa Clinical Trials is a network of hospital based clinical trial sites with over 20 years experience in clinical trials in Aotearoa - New Zealand

We achieve fast, high quality outcomes

Investigators

We partner with you in the delivery of outstanding quality research.

Participants

Clinical trials may help you - it will certainly help future generations.

Recruiting trials

A list of all current trials being conducted at Aotearoa Clinical Trials

Trial Sites

ACTT operates at multiple sites based in New Zealand Hospitals

Areas of Interest

A list of therapeutic areas and specialist investigators involved

Reach out to one of our team members

By working closely with partners right across the New Zealand health sector, we create greater insight into improved disease management as well as more equitable access to innovative healthcare.

International Certification

Aoteoroa Clinical Trials is the FIRST clinical trial site network in New Zealand to achieve GCSA Certification - the Global Quality Standard for Clinical Research Sites and IAOCR Workforce  Quality Accreditation (WQA). These awards acknowledge ACTT as a centre of excellence for clinical trials.

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Current Trials

Home / Participants / Current Trials

Select your preferred location

Christchurch.

CURRENTLY RECRUITING

Requirements:

• Aged 18 – 60 years
• BMI 18 - 35 kg/m2
• Smokers allowed
• Any medication will be recorded and reviewed

Study Visits: 2 night stay + 13 follow up visits

Reimbursement:  $4,750 (less tax)

Requirements

• Aged 18 – 70 years
• BMI 30 – 45 kg/m 2
• Meet the diagnostic criteria for modest hypertriglyceridemia 

Study Visits:  One 3-night stay + one 2-night stay + 25 visits

Reimbursement:  $8,500 (less tax)

 Requirements:

• BMI 28 kg/m 2 or more
• Not taking any medications for weight loss
• Type 2 diabetics (not using insulin)
• Have had no changes to your usual medications in the last 90 days

Study Visits:  1 screening visit + 6 follow up visits

( No inpatient stays )

Reimbursement:  $2,100 (less tax)

Groups have flexible start dates!

• Aged 18 – 55 years
• Non-smokers or Ex-smokers
• Not currently taking any medications

Study Visits: 13 follow up visits

Reimbursement:  $4,300 (less tax)

CURRENTLY FULL

• Aged 18 – 50 years
• BMI 18– 35 kg/m2
• Not taking any medications

Study Visits:  4 night stay + 7 follow up visits

Reimbursement:  $4,500 (less tax)

PART F Cohort Requirements:

• Aged 18 - 70 years of age
• BMI of at least 30 kg/m2
• 1 ( or more) unsuccessful weight loss attempt(s)
• Not taking weight loss medications
• No change in weight of more than 5 kg within prior 90 days

Study Visits:  7 follow-up visits

Reimbursement:  $2,500

MAD Cohort Requirements:

• BMI 30 – 40 kg/m 2
• Non-smokers

Study Visits:  13 night stay + 1 follow-up visit

Reimbursement:  $8,000 (less tax)

PART E Cohort Requirements:

• BMI 19 – 35 kg/m 2

Study Visits:  1 x 12-night stay and 1 x 8-night stay + 1 follow-up visit

Reimbursement:  $10,500 (less tax)

ODYSSEY 

• Aged 18 – 45 years
• BMI 18.5 - 30 kg/m2
• Not currently taking regular medications

Study Visits:  2 night stay + 21 follow-up visits

Reimbursement:  $7,000 (less tax)

Get in touch today

New Zealand Clinical Research (NZCR) provides state of the art research facilities and the expertise to conduct complex early phase clinical research in healthy participant and patient populations.

How do clinical trials work in New Zealand?

Information on ethics process, principles of research conduct, regulatory considerations, and research governance.

Researchers initiating clinical trials in New Zealand must take into consideration trial protocol and/or design, resource issues, ethics review, regulatory oversight, institutional policies, research governance and many other issues.

Standardised Indemnity and Compensation Agreements (sICA) have been developed by the New Zealand Association of Clinical Research (NZACRes) and are widely used within the New Zealand clinical trial industry. You can access sICA templates on the NZACRes website .

New Zealand has a world-class record of accomplishment with early phase and proof of concept trials validated by independent, clean and accurate clinical data. Overview of New Zealand Regulatory Enivronment

Medsafe is the Medicines and Medical Devices Regulatory Authority for New Zealand. Medsafe administers the regulatory application for clinical trials under Section 30 of the Medicines Act 1981, involving the use of new medicines, unregistered medicines, scientific assessment of gene technology and medical devices. Approvals are issued by Medsafe under a delegation from the Director-General of Health. Medsafe receives and processes applications, liaises with the relevant Health Research Council committee (Standing Committee on Therapeutic Trials (SCOTT) or Gene Technology Advisory Committee (GTAC)) and the applicant, and issues approval letters as part of the approval scheme for clinical trials. Further information about the scheme can be found in the Guideline on the Regulation of Therapeutic Products in New Zealand – Part 11: Clinical Trials – Regulatory Approval and Good Clinical Practice Requirements. You can find the current regulatory guidance on the Medsafe website. One component of the clinical trials scheme is the self-certification of sites that have study participants in residence while the clinical trial medicines are administered. Further information about the self-certification scheme can be found in Section 4 of the Guideline. A list of sites for which self-certification has been lodged with Medsafe can be reviewed on the Medsafe website.

Section 30 of the Medicines Act 1981 authorises the Director-General of Health to approve a clinical trial involving the use of new and unregistered medicines on the recommendation of the Health Research Council of New Zealand (HRC). The HRC maintains two standing committees to consider clinical trial applications and make recommendations to the Director-General. The Standing Committee on Therapeutic Trials (SCOTT) considers applications for new pharmaceutical-type medicines, and the Gene Technology Advisory Committee (GTAC) considers applications for trials involving new and unregistered gene and other biotechnology therapies. The Terms of Reference for these committees are published on the HRC website . The sponsor of a clinical trial should read these documents before submitting a regulatory approval application, as they provide guidance on the committee processes and the data requirements for applications to be considered by each committee.

Ethics committee approval is a separate process from regulatory approval under Section 30 of the Medicines Act 1981 and is not administered by Medsafe. The New Zealand Health and Disability Ethics Committee (HDEC) administers the ethics approval system, which applies to interventional clinical trials regardless of whether they are trials that require approval under Section 30 of the Medicines Act. Clinical trials that require sample collection and storage, or the use of disclosure of health information are in most cases also subject to ethics approval. In New Zealand only one ethics committee review is required per trial, and this covers all sites. Requirements relating to New Zealand HDEC approval of clinical trials are provided on the New Zealand HDEC website. Locality Authorisation for Ethics The term “Locality Authorisation” refers specifically to the process used by the NZ Health and Disability Ethics Committees (HDECs) for ascertaining that all local governance issues have been addressed at sites participating in a clinical trial. Locality Authorisation approval is required by all sites. To gain full approval for a clinical trial, an application requires approval from HDEC plus a Locality Authorisation. Guides, templates, and forms can be found on the HDEC website.

A national costing tool has been developed by the New Zealand Association of Clinical Research (NZACRes) and is widely used by sites to facilitate accurate and transparent trial costing and to support transparent price discussions. You can access the costing tool on the NZACRes website .

The Medicines Act 1981*, Misuse of Drugs Act 1975, and other legislation control the supply of medicines and medical devices in New Zealand. Ministry of Health approval is required for a trial before medicines can be imported into New Zealand. Detailed information about New Zealand’s medicine control requirements and relevant legislation can be found on the Ministry of Health’s website . Regulatory guidance for importing medical devices into New Zealand can be found on Medsafe’s website. ‍ *Note: The Therapeutic Products Bill passed Parliament in July 2023 and became the Therapeutic Products Act (2023). You can follow updates on regulatory changes here.

In accordance with Section 30 of the Medicines Act 1981, an application for a clinical trial of a new or unregistered medicine for approval for distribution in New Zealand must be lodged by, or in the name of, a person or company residing in New Zealand. Further guidance is also available in Section 3.3 of the Medsafe Guideline on the Regulation of Therapeutic Products in New Zealand .

All imports into New Zealand are subject to the Ministry for Primary Industries (MPI) and New Zealand Customs Import regulations. Detailed information about New Zealand’s importing requirements can be found on the MPI website. You can read more about materials shipping on the NZ Association of Clinical Research (NZACRes) website.

The aim is to provide accurate and balanced information for patients.  The focus of discussions should be to raise awareness of clinical trials and discuss the risks and benefits of participation. This is to ensure that patients can make a fully informed decision on participation in a clinical trial study. A Patient Information Form and Consent Form must be provided to the potential participant and completed. You can access templates on the HEDC website.

From 1 January 2011 all clinical trials conducted in New Zealand are expected to be conducted in accordance with the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95). This applies whether or not approval under the Medicines Act 1981 is required for the trial. In some cases, requirements set out in CPMP/ICH/135/95 do not cover or conflict with provisions in the Medicines Act or in other relevant New Zealand legislation (e.g. legislation relating to reporting requirements or the retention of records). For this reason, some of the requirements specified in CPMP/ICH/135/95 must be modified to achieve compliance with New Zealand law. ‍ Medsafe Guideline on the Regulation of Therapeutic Products in New Zealand.

Medical device developers looking for a rapid, cost effective means of gaining early proof of concept for their products should consider conducting their initial clinical trials in New Zealand. The simple, one ethics committee approval process in New Zealand does not currently require U.S FDA Investigational Device Exemption (IDE) filing prior to the start of the study. More information on Medical Devices – Regulatory Guidance on the Medsafe website.

Standardised Clinical Trial Research Agreements (sCTRA) have been developed by the New Zealand Association of Clinical Research (NZACRes) and are widely used within the New Zealand clinical trial industry. You can access sCTRA templates on the NZACRes website .

In July 2022, New Zealand’s, twenty District Health Boards (DHBs) were disestablished. To begin reforming the health system , the DHBs’ functions were merged into Te Whatu Ora – Health New Zealand, which now leads the day-to-day running of the system for the whole country. Te Whatu Ora also assumed the operational functions of the Ministry of Health, such as managing national contracts. An interim Māori Health Authority was also established in September 2021, ahead of the creation of Te Aka Whai Ora – Māori Health Authority as an autonomous legal entity in July 2022. Te Aka Whai Ora’s role is to provide a more consistent, national leadership of health service delivery with a Te Ao Māori perspective. New Zealanders receive healthcare through a mixture of private and publicly funded services. The public healthcare system is primarily funded through general taxation and is therefore only available to NZ residents.New Zealand’s districts range in population size from approximately 30,000 at the smallest to over 500,000 at the largest. There are currently over 150 hospitals listed as certified providers (private and public) in New Zealand. You can view certified provider maps on the Ministry of Health website . ‍ Te Whatu Ora regions and Public Academic Tertiary Institutions have a research office or similar. The research offices facilitate close working relationships between researchers, clinical staff, ethics committees, funding bodies and commercial sponsors.  These offices act as the central entry point for the approval of research and ensures that governing policies and procedure are adhered to. Contact details for certified clinical trial sites can be found on the Medsafe website.

All research involving Te Whatu Ora – Health New Zealand sites must receive approval from the relevant Research Review Committee before commencing. The relevant Te Whatu Ora site’s Research Office registers the project and organises the review process. ‍ The approval process will involve: • Research Office Application Form • Protocol • Ethics Application • Research Budget • Participant Information Sheets and Consent Forms • Contract or Clinical Trial Agreement • Indemnity and Compensation Agreement • Investigator Brochure • Funding Letter • Evidence of consultation with Māori • Locality Authorisation for Ethics • Scientific peer review • Ethics Approval Letter You can review an example approval process on the Te Whatu Ora – Te Toka Tumai Auckland (previously Auckland DHB) site.

As part of conducting research within Te Whatu Ora – Health New Zealand, an applicant must demonstrate responsiveness to Māori. The Research Application has a section titled Responsiveness to Māori which must be completed for all projects. In most cases, the review is performed either by the Māori Advisor for Research or a similar entity. The Te Whatu Ora Research Office facilitates the review. On completion of the Māori research assessment, a letter of support will be sent to you showing that a process of formal research review has taken place.

NZ Glossary

Use the below to search through some NZ-specific clinical terms. The clinicaltrials.gov site provides a comprehensive glossary of common site terms.

The Accident Compensation Corporation (ACC) provides comprehensive, no-fault personal injury cover for all New Zealand residents and visitors to New Zealand.

Online registry of clinical trials being undertaken in Australia, New Zealand and elsewhere.

ANZCTR website

Any change to the terms of a study, including to the protocol or other supporting documentation, made after a Health and Disability Ethics Committee has approved the study.

A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The group can recommend to the study sponsor that the study be stopped if it is not effective, if it is causing harm to participants, or if it is not likely to serve its scientific purpose. Committee members are chosen based on the scientific skills and knowledge needed to monitor the particular study. Also referred to as a Data Safety and Monitoring Board (DSMB).

The Gene Technology Advisory Committee provides regulatory review of genetically modified products.

The process by which a Health and Disability Ethics Committee (HDEC) checks, in accordance with the Standard Operating Procedures, that a new application (or substantial amendment to a previously approved application) meets or exceeds established ethical standards.

The Health Research Council is the agency responsible for managing the Government’s investment in health research. The HRC’s committees provide advice on gene technology, accredit health and disability ethics committees and institutional ethics committees, monitor the safety of large clinical trials and review applications to use new medicines in trials.

The Health Research Council website

The Health Research Council Ethics Committee ensure that independent ethical assessment of any proposed research submitted for a Health Research Council (HRC) grant has been carried out either by the HRCEC itself, or an ethics committee approved by the HRCEC. The HRCEC approves ethics committees to carry out this function.

An organisation responsible for a hospital, health centre, surgery or other establishment or facility in New Zealand at or from which the procedures outlined in the protocol of a study are to be conducted.

‘Locality review’ is the process by which a locality assesses its suitability for the safe and effective conduct of an intervention study.

New Zealand Medicines and Medical Devices Safety Authority

SCOTT is the Standing Committee on Therapeutic Trials; a standing committee of the Health Research Council (HRC) whose function is to make recommendations to Medsafe regarding the approval of clinical trials of new medicines under section 30 of the Medicines Act 1981.

An administrative check carried out by the  Health and Disability Ethics Committee (HDEC) secretariat to verify that an application or other item of business is complete and may be assigned for review through the full or expedited review pathway.

Case studies

To illustrate some clinical trial journeys with links to supporting material, we've put together two fictional case studies for example health innovations in collaboration with the New Zealand Association of Clinical Research (NZACRes), Te Tītoki Mataora and the National Institute of Health Innovation (NIHI).

Articles, commentary and blogs

Phase I Pharmaceutical: Psoriasis Treatment

Learn more about how a new treatment for psoriasis could navigate the Phase I clinical trial process, with links to further reading on the discussed topics.

Class II Medical Device: Diabetes Monitoring

Learn more about the clinical investigation process for a wearable diabetes monitoring device, with links to further reading on the discussed topics.

Connecting with the clinical trials sector in New Zealand

Search the HealthTech Activator (HTA) directory for listed clinical trials sites and supporting bodies.

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Health research saves lives

Here at the Health Research Council of New Zealand, we support high-quality, high-impact research by investing in People, Ideas and Priorities.

Want to know what the HRC is investing in?

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Cancer Trials New Zealand

Carrying out life changing cancer research.

Cancer Trials New Zealand (CTNZ) was established in 2003 with a vision and commitment to improve cancer control through research.

The primary focus of Cancer Trials New Zealand is to support the development of new research ideas from scientists and clinicians to the point at which they are ready for submission to the relevant project-funding body (Health Research Council, Cancer Society, Cancer Research Trust, Pharmaceutical Industry etc).

Our focus is on those studies with relevance to New Zealanders, from supporting our own researchers through to improving the outcomes of New Zealanders at risk of or already facing the challenges of cancer.

The scope of trials range from, discovering new ways of preventing, diagnosing, treating and monitoring cancer, to the refinement of established treatments and understanding the delivery of care within cancer services.

Building and retaining a high-quality cancer research workforce in New Zealand is one of our great challenges if we are to keep pace with modern strategies in cancer research and care.

Establishment of Cancer Trials New Zealand was made possible by an initial three year foundation seeding grant from Auckland and Northland division of the New Zealand Cancer Society, and we are very grateful that they have been supporting our core activities annually ever since. With their valuable support we continue to work towards achieving our mission.

Our Mission 

To sustain and grow a collaborative clinical research program which is responsive to the principles of equity and the priorities of those affected by cancer in Aotearoa New Zealand

Equitable and improved outcomes for those affected by cancer, emphasizing partnership with Māori and excellence in clinical research

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December 14, 2022

NZ scientists propose system redesign to improve access to clinical trials

by University of Otago

Ensuring that the latest clinical research opportunities, and the health care benefits that flow from them, are available to all New Zealanders is at the heart of a new report.

Enhancing Aotearoa New Zealand Clinical Trials is the result of 18 months of work by the team of researchers.

Professor Frank Bloomfield, director of the University of Auckland's Liggins Institute says there is inequitable access to clinical trials around New Zealand.

"In particular, Māori, Pacific and rural New Zealanders are more frequently missing out both on participating in clinical trials and on their benefits," Professor Bloomfield says.

"Outside of large research groups or large, research-intensive hospitals, of which there are not many, there is limited capacity or resource to support clinical trials taking place or even participation in, for example, a larger national or international trial."

The report proposes establishing a new National Clinical Trials Infrastructure Center that would provide a "front door" for anyone planning a clinical trial, as well as executive leadership, in partnership with Māori and consumers.

New regional Clinical Trials Co-ordinating Centers would support local trial development and conduct to ensure equity of access for researchers and participants.

Professor Lisa Stamp, of the University of Otago, Christchurch, explains that clinical trials are a central element of a modern, high-functioning health system. Clinical trials can provide access to novel treatments for patients and deliver cutting-edge health care.

"Not only would a national clinical trials model give patients access to trials, but international evidence is clear that patients involved in clinical trials do better health wise—their health will benefit," Professor Stamp says.

"The newly emerging structure for the New Zealand health system as a whole represents an opportunity to embed research into the heart of our health services developing a learning health system that works to the highest level for the benefit of people in Aotearoa."

Dr. Matire Harwood, head of the department of General Practice at the University of Auckland, says that a particular issue identified through questionnaires, research and hui leading up to the report is a need to develop the Māori and Pacific research workforce, and support research led by Māori and Pacific providers.

"As well as partnering with Māori and Pacific communities, we need to upskill our tauiwi researchers to conduct culturally responsive and safe trials," Dr. Harwood says.

The report also calls for a national health data system that provides culturally appropriate long-term storage of data and tissue samples , and supports translation of research findings into clinical care.

Professor Stamp says, with the right investment, there is potential to recognize the unique contribution of Māori and Pacific mātauranga to clinical research , while also developing our international reputation for excellence in clinical trials .

Professors Bloomfield and Stamp co-led the report together with Associate Professor Matire Harwood (Ngāpuhi) and Professor Stuart Dalziel, both of the University of Auckland, and Professor Katrina Sharples, of the University of Otago.

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Master of Clinical Research

This course is available

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Master's Degree

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Expected Feb 2025

Victoria University of Wellington

Help improve human health. Study Clinical Research and get the skills you need to carry out evidence-based research that will advance medical knowledge.

You’ll learn to use both qualitative and quantitative research methods, and find out how to critically evaluate current literature. Gain knowledge in good study design and research practice, data analysis and research presentation. You'll find out how to carry out clinical trials and cover ethical and cultural issues in clinical research.

You‘ll be able to expand your current work to include clinical research, or move into a new career as a clinical researcher in a range of areas in the health sector. You might work for a drug company, a hospital clinical trials unit or a research institute.

If you haven’t completed the Diploma but have significant and relevant clinical research experience, you might still be admitted into the Master’s programme.

Programme requirements

For this programme you’ll need to:

Complete the 120 point thesis course Thesis in Clinical Research (CLNR 591)

Entry criteria

To be accepted into this programme you'll need:

• A Postgraduate Diploma in Clinical Research
• To be accepted by the programme director as capable of proceeding with the proposed course of study

Proof of English proficiency

To be accepted into this programme you will need to meet one of the following:

IELTS: minimum overall score of 6.5 with no sub-score below 6.0

TOEFL: minimum score of 90 for the internet-based test with a minimum of 20 in writing

Pearson Test of English: minimum score of 58 (with a ‘Communicative’ score of not less than 50)

EPP: minimum final scores of 4,4,5,5

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New Clinical Research Aims To Reduce Stomach Cancer Rates And Disparities In New Zealand

A new clinical research programme which aims to increase the successful eradication of Helicobacter pylori (H. pylori) , a bacterium that lives in the stomach and is the leading cause of stomach cancer, has been awarded a $150,000 Explorer Grant from the Health Research Council of New Zealand.

H. pylori and stomach cancer disproportionately impact Māori and Pacific peoples in Aotearoa New Zealand. When H. pylori is identified and treated, stomach cancer can be prevented. However, the ability to successfully treat and eradicate H. pylori with commonly used antibiotics is declining due to increasing antibiotic resistance.

Dr Tom Mules and Dr Stephen Inns, gastroenterologists at Te Whatu Ora Hutt Valley and clinical researchers at the Malaghan Institute of Medical Research and the University of Otago, respectively, are developing and validating new methods to test for antibiotic resistance in H. pylori to guide antibiotic prescribing.

H. pylori is responsible for most stomach cancers in New Zealand. Usually contracted in childhood, H. pylori infects the cells of the stomach, causing gastritis, or inflammation of the stomach lining. Left untreated, the inflammation can become chronic leading to tissue damage and ulcers and eventually, cancer.

“The best way to prevent stomach cancer is to eradicate H. pylori ,” says Dr Mules. “However, H. pylori is becoming more resistant to antibiotics, limiting our ability to treat infections.”

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In New Zealand, the current practice is to prescribe everyone the same antibiotics to treat H. pylori, without knowing if it is the right antibiotic regimen for that individual.

“By determining the antibiotic resistance profile of H. pylori, we aim to individualise treatment regimens to increase eradication and decrease inappropriate antibiotic prescribing,” Dr Mules says.

Significant disparities exist in the rates of stomach cancer among Māori and Pacific populations in Aotearoa, who have three to six times higher rates compared to New Zealand Europeans according to a University of Otago study.

“These ethnic inequalities in stomach cancer rates predominantly stem from the higher prevalence of H. pylori infection among Māori and Pasifika,” says Dr Mules. “Māori and Pasifika are also more likely to be infected with a more carcinogenic strain of H. pylori , further contributing to the heightened risk of stomach cancer.”

The research involves extracting H. pylori DNA from patient gastric tissue samples or stool samples taken as part of routine clinical testing for the presence of H. pylori , analysing these samples for the presence of antibiotic resistance genes, and tailoring antibiotic therapy based on this gene profile.

“Being able to individualise treatment so we can prescribe the right antibiotic for the right person is crucial to improve treatment success, while also reducing inappropriate antibiotic prescribing,” says Dr Mules.

Taking place at Hutt Hospital, the first phase of the research programme is already underway.

Dr Mules says the next phase is to perform a clinical trial to determine if routinely testing H. pylori for the presence of antibiotic resistance, and then individualising therapy based on this result, will increase the effectiveness of treatment in the clinical setting.

“This research has the potential to profoundly transform clinical practice, directly addressing and rectifying significant healthcare equity concerns in Aotearoa New Zealand.”

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David Hill: Neurodiversity In Schools; ‘It’s Not New, But Our Understanding Has Increased’

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Ryman Healthcare: Ryman Voted Most Trusted Brand A Milestone Tenth Time

Ryman Healthcare is proud to be named New Zealand’s Most Trusted Brand in 2024 across the aged care and retirement industry. Ryman New Zealand Chief Executive Officer Cheyne Chalmers says winning Most Trusted Brand is the ultimate honour because it is based on votes from the New Zealand public.

Natalie Akoorie - RNZ: University Of Waikato Staff Protest On Open Day Over Stalled Pay Talks

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• Open access
• Published: 01 June 2024

A systematic review of assisted and third-party reproduction guidelines regarding management and care of donors

• Elnaz Iranifard   ORCID: orcid.org/0000-0003-1332-9094 1 ,
• Samira Ebrahimzadeh Zagami   ORCID: orcid.org/0000-0001-6210-8904 2 , 3 ,
• Malihe Amirian   ORCID: orcid.org/0000-0001-6413-3687 4 ,
• Hossein Ebrahimipour   ORCID: orcid.org/0000-0002-1811-372X 5 , 6 &
• Robab Latifnejad Roudsari   ORCID: orcid.org/0000-0002-1438-8822 2 , 3  

Reproductive Health volume  21 , Article number:  75 ( 2024 ) Cite this article

Metrics details

Gamete and embryo donors face complex challenges affecting their health and quality of life. Healthcare providers need access to well-structured, evidence-based, and needs-based guidance to care for gamete and embryo donors. Therefore, this systematic review aimed to synthesize current assisted and third-party reproduction guidelines regarding management and care of donors.

The databases of ISI, PubMed, Scopus, and websites of organizations related to the assisted reproduction were searched using the keywords of “third party reproduction”, “gamete donation”, “embryo donation”, “guidelines”, “committee opinion”, and “best practice”, without time limit up to July 2023. All the clinical or ethical guidelines and best practice statements regarding management and care for gamete and embryo donors written in the English language were included in the study. Quality assessment was carried using AGREE II tool. Included documents were reviewed and extracted data were narratively synthesized.

In this systematic review 14 related documents were reviewed of which eight were guidelines, three were practice codes and three were committee opinions. Five documents were developed in the United States, three in Canada, two in the United Kingdom, one in Australia, and one in Australia and New Zealand. Also, two guidelines developed by the European Society of Human Reproduction and Embryology were found. Management and care provided for donors were classified into four categories including screening, counseling, information provision, and ethical considerations.

While the current guidelines include some recommendations regarding the management and care of gamete/embryo donors in screening, counseling, information provision, and ethical considerations, nevertheless some shortcomings need to be addressed including donors’ psychosocial needs, long-term effects of donation, donors’ follow-up cares, and legal and human rights aspects of donation. Therefore, it is needed to conduct robust and well-designed research studies to fill the knowledge gap about gamete and embryo donors’ needs, to inform current practices by developing evidence-based guidelines.

Plain English summary

Gamete and embryo donors face complex challenges affecting their health and quality of life. To manage these challenges, healthcare providers need guidelines that are based on evidence and donors’ real needs. In order to develop a comprehensive guideline that meets the needs of donors; it is important to review the current guidelines. So, in this study we reviewed the current assisted and third-party reproduction guidelines regarding management and care of donors. We searched databases and relevant websites and found 14 related documents. The main topics recommended for management and care of donors in these guidelines included screening, counseling, information provision, and ethical considerations. We recognized that some of donors’ needs are neglected in these documents including donors’ psychosocial needs, long-term effects of donation on donors, their follow-up cares, and legal and human rights aspects of donation. Therefore, there is need for further research to develop guidelines based on donors’ unmet needs.

Peer Review reports

Introduction

Reproductive donation is defined as using an egg, sperm, or embryo that have been donated by a third person (donor) in order to conceive a child in a person or couple who are not able to reproduce themselves [ 1 , 2 , 3 ]. The use of reproductive donation has led to thousands of birth worldwide [ 4 , 5 ].

Reproductive donation is faced with various challenges in different aspects, such as recruitment and screening of donors, gaining informed consent from involved parties, conflict of interest among involved parties, sociocultural problems as well as religious, ethical, and legal concerns [ 6 , 7 , 8 , 9 , 10 , 11 , 12 ]. Gamete or embryo donation can also have adverse effects on the health and well-being of donors. Physical side effects related to the ovarian stimulation, psychological stress as a result of feeling responsibility and attachment to the donor-convinced child, fear of the revelation of identity, regretting the donation decision, and social burdens like stigma related to the gamete and sperm donation are among some of the psycho-social concerns of third-party reproduction, that could affect the health and well-being of donors [ 6 , 7 , 9 , 13 , 14 , 15 , 16 , 17 ]. Therefore, it is important to understand the needs of gamete and embryo donors to prepare them for the donation process and its possible side effects.

Over the past decades, guidelines have become a valuable tool for the synthesis of health and care-related information [ 18 , 19 ]. Guidelines are a summary of current medical, psychosocial and ethical information as well as knowledge in the form of structured and evidence-based recommendations for care providers and patients/clients about specific circumstances, such as diagnosis, treatment, or care. Guidelines need to be revised regularly to meet the constant development of evidence [ 18 , 19 , 20 , 21 , 22 , 23 ]. Although guidelines are not usually legally binding, deviations from them must be justified [ 20 ]. World Health Organization describes guidelines as recommendations intended to assist recipients and providers of health care and other parties involved to make informed decisions; by providing information about what should be done by each party involved [ 24 ].

Gamete and embryo donors should be considered as patients/clients by the fertility clinics [ 25 ]. Only when the programs see donors as patients/clients the needs and experiences of donors becomes a necessary component of care [ 25 , 26 ]. Gamete and embryo donors go through medical interventions such as physical or psychological screenings or blood tests, that can be challenging for them; also donors may experience adverse effects of donation process on their physical, mental or even social health [ 5 , 25 , 27 , 28 , 29 ]. Based on the challenges of third-party reproduction and the possible adverse effects they can have on the health, well-being, and quality of life of donors [ 5 , 25 , 27 , 28 , 29 ], it is important for healthcare providers to have access to well-structured, evidence-based guidelines to care for gamete and embryo donors’ [ 4 , 26 ].

Although respected organizations in the field of infertility treatment such as American Society for Reproductive Medicine (ASRM), European Society of Human Reproduction and Embryology (ESHRE), and Human Fertilization and Embryology Authority (HFEA) have published guidelines regarding the third party reproduction including care provided for donors [ 30 , 31 , 32 , 33 , 34 ]; various studies from different countries have reported that gamete and embryo donors’ needs and desires have not been met. These studies suggest that at least some donors are receiving insufficient information about practical issues and future consequences of their donation; also, they do not receive proper counseling as needed before, during and/or after donation, or receive no/limited support [ 12 , 25 , 26 , 35 , 36 ].

As mentioned already, evidence suggests that gamete and embryo donors’ needs are not being fully met, and clinical practice regarding donors must be improved. Also the lack of a comprehensive, donor-centered guideline which focuses solely on the gamete and embryo donors’ needs is evident, especially in developing countries, where donors are more likely to be of lower socioeconomic status with limited knowledge and information about the donation process [ 4 , 37 ]. Therefore, to allow a better understanding of current practice, this systematic review was conducted to provide a synthesis of the current assisted and third-party reproduction guidelines regarding management and care of donors.

This systematic review was conducted based on the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) [ 38 ]. The protocol of this systematic review is registered in PROSPERO (international prospective register of systematic reviews) under the code of CRD42023474241.

Search strategy and data sources

The electronic databases of Science Citation Index, PubMed, and Scopus were searched by two researchers (EI, MA), independently, using search strings that included keywords/MESH terms of “third party reproduction”, “gamete donation”, “embryo donation”, “guidelines”, “committee opinion”, and “best practice” as well as Boolean operators of AND/OR, and punctuation tricks (quotation marks), without time limit up to July 2023. Search strategy of electronic databases is available in Additional file 1.

Websites that publish guidelines including Guidelines International Network ( www.g-i-n.net ), National Institute for Health and Clinical Excellence ( www.nice.org.uk ), and National Guidelines Clearinghouse ( www.guideline.gov ); and organizations related to the assisted reproduction techniques including Human Fertilization and Embryology Authority (HFEA), American Society for Reproductive Medicine (ASRM), European Society of Human Reproduction and Embryology (ESHRE), Canadian Fertility and Andrology Society (CFAS), and Fertility society of Australia and New Zealand were manually searched. It should be noted that the organizations related to assisted reproductive techniques were selected based on the appearance of their names in the study selection phase of the initial database search.

After removing the duplicate records, the remaining documents were assessed for inclusion criteria by two authors (EI, MA), independently. All the clinical or ethical guidelines and best practice statements regarding management and care of gamete and embryo donors, written in the English language were included in the study. Guidelines and best practice statements that partly dealt with the subject of management and care of gamete and embryo donors were also included. If there were more than one revision of guidelines, only the latest version was included. Documents other than clinical or ethical guidelines, best practice recommendations and or committee opinions, documents regarding other parties in third-party reproduction (e.g., recipients, healthcare providers, and/or children conceived by third-party reproduction), documents in regards with other aspects of assisted reproduction, documents regarding gamete and embryo donation for purposes other than reproduction (e.g., research) and documents in languages other than English were excluded. A senior researcher (RLR) supervised the data selection process.

Quality assessment

Quality assessment is an important step in writing a systematic review [ 39 , 40 ]. In this systematic review the quality of included documents was assessed by two researchers independently (EI, SEZ), using Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument, which is designed to assess the quality of guidelines, provide direction on guideline development, and guide what specific information ought to be reported in the guidelines [ 40 , 41 ]. AGREE II is a 23-item tool comprising six quality-related domains including scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence; followed by two global rating items. Each item is rated on a 7-point scale. After quality appraisal of each document, based on the 23-item tool, researchers (EI, SEZ, RLR) calculated the quality score for each of the six domains based on the instrument user manual [ 41 ]. Finally, a score (1 to 7, with 1 lowest and 7 highest possible overall score) for overall quality of the guidelines were assigned by the research team based on the scores of all six domains. The overall quality of the documents were also categorized based on the overall score and research team agreement as extremely good (7): if all domains scored ≥ 75%; very good (6): if more than 3 domains scored ≥ 75% and other domains scored ≥ 50%; good (5) if at least one domain scored ≥ 75% and others scored ≥ 25%; moderate (4): if more than 3 domains scored ≥ 50% and others scored ≥ 25%; poor (3): if at least 3 domains socred ≥ 50%; very poor (2): if at least 3 domains scored > 25%, and extremely poor (1): if all domains scored ≤ 25. The quality assessment score of each document and AGREE II Score Sheet can be accessed through Additional file 2 and 3, respectively.

Data extraction and analysis

Full texts of documents that met the inclusion criteria were retrieved and reviewed. Data were extracted and tabulated based on the pre-prepared self-structured checklist, including the name of the guideline, publishing organization, year of publication, country of publication, and clinical and/or ethical recommendations regarding management and care of gamete and embryo donors. The data extraction process was carried on by two researchers (EI, HE) working together. In case of any disagreement between the two researchers, a senior researcher (RLR) commented on the extracted data.

Data analysis

‘ Narrative synthesis’ was used to analyse the data in this study, which refers to an approach to the systematic review and synthesis of findings from multiple studies that primarily use of words and text to summarize the findings of the synthesis. Indeed, its main characteristic is adopting a textual approach to the process of synthesis to ‘tell the story’ of the findings. It can focus on a wide range of questions, and not only those relating to the effectiveness of a particular intervention [ 42 ]. For this purpose, the included guidelines and good practice statements were summarized and synthesized narratively by three researchers working together (EI, SEZ, RLR). As mentioned, data were extracted regarding management/care provided for gamete and embryo donors into spreadsheets. Similar recommendations from different guidelines were put into same columns, and were given a label, then those labels were compared with each other and the labels which point to similar type of management and care were merged into categories. Finaly, recommended clinical and/or ethical management and care of gamete and embryo donors were categorized into four main categories which will be discussed in the ‘result’ section.

Search results

Three hundred seventeen studies were identified through electronic databases (ISI: 104, Scopus: 154, and PubMed: 59). After removing the duplicate studies, the title and abstracts of 177 articles were reviewed, from which 156 articles did not meet the inclusion criteria, and 21 articles were assessed for eligibility. 16 articles were previous versions of included guidelines. Eventually, 5 studies that met the inclusion criteria were retrieved. In addition, 11 guidelines were retrieved through related organizational websites, and after the removal of duplicate guidelines ( n  = 2), the remaining 14 guidelines that met the inclusion criteria, were included in the review (Fig.  1 ).

PRISMA 2020 flowchart of study selection

Guidelines characteristics

Fourteen documents were included in this review of which eight were guidelines [ 30 , 43 , 44 , 45 , 46 , 47 , 48 , 49 ], three were practice codes [ 34 , 50 , 51 ], and three were committee opinions [ 52 , 53 , 54 ]. Five guidelines were developed in the United States [ 30 , 44 , 52 , 53 , 54 ], three Canada [ 45 , 46 , 47 ], two in the United Kingdom [ 34 , 48 ], and one in Australia [ 49 ] and one guideline in Australia and New Zealand [ 50 ] were identified. Also, two guidelines developed by the European Society of Human Reproduction and Embryology (26, 36) were identified. The majority of guidelines (64%) were developed in the last five years ( n  = 9). Guidelines were also categorized by the research team based on their focus on the gamete and embryo donors. If a guideline specifically was developed regarding gamete/embryo donors, it was considered as totally focused; if the document was about third-party reproduction and included some content related to the recipients and/or donation offspring, it was considered partly focused; and if the guidelines were about infertility treatment in general with some content on donors, it was considered slightly focused. The characteristics of the guidelines are available in Table  1 .

Two guidelines were considered of very good quality with overall AGREE II score of 6. Four guidelines were of good quality (overall AGREE II score = 5). While six documents were of poor quality (overall AGREE II score = 3). Also, two guidelines were considered very poor in quality (overall AGREE II score = 2). It must be noted that among the poor-quality documents, there were three committee opinions, which can justify their low score, since some items of the AGREE II tool did not apply to these types of documents. Quality assessment score of each domain and overall score can be found in Additional File 2.

Main findings

Four main categories of management and care provided for gamete and embryo donors were identified including (1) screening (2) counseling (3) information provision and (4) ethical considerations. These categories will be further discussed.

According to the reviewed guidelines gamete and embryo donors must be screened before donation to ensure the safety and well-being of all parties involved in third-party reproduction. Screening guidelines provide evidence-based eligibility and exclusion criteria for potential donors. Although there are variations among guidelines, the screening process mainly consists of taking medical history, physical exams, infectious diseases screening, genetic screening, and psychosocial screening (Table  2 ).

Guidelines recommend taking potential donors’ medical history including surgical history and if relevant, the medical history of their family. In such a way, not only ineligible people are excluded but also health-care providers can assess possible risks due to the donation that can influence potential donors’ health based on their medical history [ 30 , 34 , 46 , 47 , 48 ].

Physical examination of potential donors including pelvic examination of oocyte donors is also recommended by included guidelines [ 30 , 34 , 47 , 48 ].

Based on the reviewed guidelines to minimize the risk of infection transmission among gamete/embryo donors, recipients, and donation offspring; it is important to screen potential donors for infectious diseases [ 30 , 34 , 47 , 48 , 49 , 50 ]. Four guidelines provide detailed recommendations regarding infectious disease, including screening for infectious disease, treatment, re-screening and quarantine period needed for provided gametes and/or embryos before using them in donation [ 30 , 34 , 47 , 48 ]. Tests of HIV-1 and HIV-2 antibody, Hepatitis B antigen and antibody (IgG, IgM), Hepatitis C antibody, and serology for syphilis, except of one guideline that recommends it only in sperm donors [ 46 ] is recommended for all potential gamete/embryo donors [ 30 , 34 , 46 , 47 , 48 ]. While two guidelines recommend routine screening for chlamydia and gonorrhea in all donors [ 30 , 48 ], CEST’s guideline recommends routine chlamydia and gonorrhea screening only in sperm donors [ 46 ], HFEA’s ‘Code of Practice’ advises just routine chlamydia screening only in sperm donors [ 34 ], and CFAS’s ‘Guideline on Third-party Reproduction’ recommends routine gonorrhea screening for only female donors [ 47 ]. Screening for HTLV types I and II, and cytomegalovirus (CMV) (IgG, IgM) are more controversial. CEST’s guidelines recommend routine HTLV and CMV screening only in sperm donors [ 46 ]. CFAS’s ‘Guideline on Third-party Reproduction’ recommends CMV screening in all male donors and HTLV screening in male embryo donors [ 47 ]. ASRM’s Guidance regarding gamete and embryo donation recommends CMV and HTLV screening in all male donors [ 30 ]. HFEA’s ‘Code of Practice’ advises screening for CMV based on the medical history of the donor and HTLV screening based on both medical history and birth or residing country of donors [ 34 ]. Just one guideline recommends routine CMV and HTLV screening in all donors [ 48 ].

Some documents recommended additional testing. Both British guidelines recommend further evaluation for infectious diseases such as HPV and HSV based on medical history, if needed [ 34 , 48 ]. Canadian guidelines recommend ABO and Rh screening in all donors, trachomatis in female donors, and ovarian reserve tests in oocyte donors [ 47 ].

Five guidelines recommend completing a comprehensive genetic/heredity disease questionnaire for potential donors and screening them for genetic diseases to exclude potential donors with genetic/chromosomal defects [ 30 , 34 , 46 , 47 , 48 ].

It is recommended by some of the included guidelines that fertility clinics establish a mechanism to update and monitor the health status of the gamete/embryo donors including medical and genetic disease history [ 30 , 52 ].

According to the included guidelines psychosocial and mental health screening of potential donors is another important part of the donation process, and using validated questionnaires and/or tests and interviewing potential donors in order to identify any absolute or relative exclusion criteria is seen as crucial [ 30 , 34 , 43 , 44 , 45 , 46 , 47 , 48 ].

According to some of the included guidelines the decision to donate gamete/embryo is complicated and donors would benefit from psychological counseling [ 30 , 34 , 51 ]. In earlier guidelines, counseling was carried out to screen potential donors’ mental/psychological health, but the latest guidelines have separated counseling from psychological screening. These guidelines recommend that counseling should be separated from mental screening and/or information provision [ 34 , 48 , 49 , 51 ]. Counseling for donors consists of donation motivation, donation implications on donors’ life, contact with donation offspring, legal issues, time of counseling, providing support, and special concerns (Table  3 ).

Approaches to counseling vary among countries [ 51 ]. As per included guidelines counseling is mandatory for all parties involved in third-party reproduction in Australia, Canada, New Zealand, and the United Kingdom [ 34 , 47 , 49 , 50 ]; although counseling is not mandatory in the United States, ASRM strongly recommends it [ 30 ].

It has been highlighted in the majority of guidelines that during counseling sessions, the counselor must discuss donors’ intentions and motivations to make sure that donors are not coerced or under pressure to donate [ 30 , 43 , 44 , 45 , 47 , 49 ]. Included guidelines emphasis that counselors also should discuss donation implications on donors’ lives, their partners, and their current and/or future children [ 30 , 34 , 43 , 45 , 49 , 51 ]. Also, it has been emphasized in most of the guidelines that it is important to talk through anonymous donation and its consequences. If anonymity is not optional or the donor is open to information sharing, donors’ expectations, needs, and preferences regarding possible future contact with donation offspring must be discussed [ 30 , 34 , 43 , 45 , 49 , 51 , 52 ].

Regarding counseling on legal issues, it has been recommended by included guidelines that counseling on legal issues including donors’ legal rights and responsibilities or donor-conceived child legal parents, must be provided for donors and they must be encouraged to get such counseling [ 30 , 34 , 43 , 44 , 45 , 47 , 49 , 51 ].

Four guidelines emphasized that counseling must be provided before, during, and after donation [ 34 , 43 , 45 , 51 ]. However, HFEA’s code of practice recommends that counseling should be provided at any time on donors’ request [ 34 ]. Good practice recommendations for information provision for those involved in reproductive donation, by ESHRE, recommends counseling should be also provided before, during, and after contact with the donation offspring to donors and their family members [ 51 ]. CFAS recommends follow-up care for oocyte donors, but does not provide more details about it [ 47 ].

Based on the included guidelines among donors, there are groups with special concerns, and their special needs must be met during counseling sessions provided by fertility centers. For instance, known donors must receive counseling both in sessions without the presences of the recipients and joined sessions with the recipients. They must also be counseled about their feelings toward the donation offspring, the effect of treatment failure on the donor, the donors’ role in donation offspring life, family dynamics, and setting boundaries with recipient families [ 30 , 43 , 45 , 51 ]. Embryo donors have also special needs. The donor couple must be counseled in joined and private sessions, with emphasis on the biological relationship between the donor couple and the donation offspring. They should also receive counseling regarding the implications of having a full biological sibling on their own children [ 43 , 45 ]. Based on ESHRE’s ‘good practice recommendations for information provision for those involved in reproductive donation’, Egg-share donors and embryo donors who are under infertility treatment themselves must be counseled about the impact of a possible failed ART while recipients have a successful treatment with the oocyte or embryo they provided [ 51 ].

Two guidelines have pointed out that it is also important to provide support for donors, which could be in the form of support groups and must be culturally and religiously sensitive [ 34 , 49 ]. Regarding donors’ family, two guidelines namely HFEA’s ‘code of practice’ and ESHRE’s ‘good practice recommendations for information provision for those involved in reproductive donation’, have suggested that if requested, donors’ families must be provided with counseling too [ 34 , 51 ].

Information provision

Guidelines have recommended that in order to make an informed decision all donors must access up-to-date, cultural, and religious sensitive information in an appropriate and understandable language [ 34 , 49 , 50 , 51 ]. Donors must also receive information about the donation procedures, side effects, screening results, and responsibilities and rights (Table  4 ).

Also it is emphasized by included guidelines that fertility centers must provide information about donation procedures to donors, including examination and screening tests and the reason those are done, instructions for medication usage and/or necessary lifestyle modifications, and medical procedures that will take place [ 30 , 34 , 43 , 44 , 45 , 46 , 47 , 50 , 51 ]. These guidelines have also highlighted that fertility centers are obligated to inform potential donors of all possible side effects related to gamete/embryo donation on the physical, reproductive, mental, and/or social health of donors including the possibility of ovarian hyper-stimulation syndrome and pregnancy (if donor is sexually active) in oocyte donors; also it must be disclosed to potential donors that due to lack of evidence, long-term side effects of donation are not fully known yet [ 30 , 34 , 43 , 44 , 45 , 46 , 47 , 50 , 51 , 52 ].

As mentioned before potential donors must go through the screening process, including infectious disease, mental health, and genetic screenings; included guidelines recommend fertility centers must inform the potential donors of the results of these screening tests, and if necessary the fertility centers must also provide consulting, treatment, and referrals for potential donors [ 30 , 34 , 47 , 48 , 50 , 51 , 52 ].

Most of the guidelines have pointed out that donors must be given information regarding their responsibilities and rights, including commitment to the process, commitment to update their health status that can affect donor offspring, or provide and update their contact information when donating in a system of identifiable/non-anonymous donation [ 30 , 34 , 45 , 46 , 49 , 50 , 51 , 52 ]. Three guidelines, ‘Guidance regarding gamete and embryo donation’, ‘Guidelines for Third Party Reproduction’, and ‘Good practice recommendations for information provision for those involved in reproductive donation’, have suggested that donors must be informed about the possibility of donor offspring [OR THEIR PARENTS] accessing them [OR THEIR FAMILY MEMBERS, AT ANY TIME] through direct-to-consumer DNA tests; even when the donation has been carried out anonymously [ 30 , 47 , 51 ].

Ethical considerations

The reviewed guidelines offered recommendations on ethical aspects of management and care of gamete and/or embryo donors to ensure respect for the donors’ well-being, dignity, and human rights in third-party reproduction. These ethical aspects include recommendations on obtaining informed consent, donors’ age limit, repetitive donation restriction, donors’ right to know the donation outcome, conditional donation, and compensation (Table  5 ).

The majority of guidelines recommended that fertility centers must obtain informed consent from donors for all the procedures done during gamete/embryo donation including screening tests, egg retrieval, and sharing information with recipients, and they must make sure that decision to donate gamete/embryo was made by free will, and not under coercion or pressure [ 30 , 34 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 ]. Four guidelines addressed donors’ partners consent and pointed out that while there is no need to obtain consent from gamete donors’ partners, donors must be encouraged to talk about their decision to donate with their partners [ 34 , 43 , 45 , 49 ]. Based on guidelines, there should be enough time between each step of information provision, obtaining consent, and initiating donation to ensure donors informed decision-making [ 34 , 44 , 49 ]. Donors must also be informed about how and at which stages of donation they can withdraw their consent [ 34 , 45 , 47 , 49 , 51 , 52 ].

Some guidelines recommend minimum and maximum age limits for donors, the former is set to confirm donors’ ability to give informed consent and the latter is set to ensure the quality of provided gametes [ 30 , 34 , 44 , 46 , 47 , 48 , 49 ]. American guidelines set the lower age limit to 21 years, they also recommend informing the recipient couple if the donor is of older age e.g. oocyte donor older than 34 [ 30 , 44 ]. For British donors, 18 to 35 for egg donors and 18 to 45 for sperm donors is the age limit [ 34 , 48 ]. Canadian guidelines recommend a lower age limit of 18 for all donors; and upper age limit of 35 for egg donors and 40 for sperm donors [ 46 , 47 ]. Australian guidelines set the lower age limit to 18 years, they also recommend informing the recipient couple if the donor is of older age [ 49 ].

Most of the guidelines have emphasized that for the safety of (oocyte) donors and to avoid the risk of inadvertent consanguineous relationships, repetitive gamete/embryo donation must be restricted [ 30 , 34 , 46 , 47 , 48 , 49 , 52 , 53 ]. In Canada and U.S.A oocyte donation is limited to six times during life and sperm donation is limited to 25 children per one million population and 25 pregnancies per 800,000 population, respectively [ 30 , 46 , 47 , 53 ]. In the U.K and Australia, repetitive donation is limited based on the number of recipient families [ 34 , 48 , 49 ]. HFEA set the maximum number of family numbers that can be created using the same donor to 10 families [ 34 ].

Gamete and/or embryo donors might request to know about the outcome of their donations. It is recommended that fertility centers inform potential donors about if and how much information they can access about donation outcomes [ 43 , 52 ]. Two guidelines suggest that donors have the right to know the number, sex, and age of the children resulting from their donation [ 34 , 49 ].

Fertility centers must respect donors’ wishes in regard to set conditions for their donated gametes/embryos as long as these conditions are not against the non-discriminatory treatment guidelines, therefore based on some of the included guidelines donors can limit the number of families that will receive their gamete/embryo or they can donate to the recipient they know but they cannot limit their donation to a specific race, ethnicity or sexual orientation [ 34 , 49 , 51 , 52 ].

Compensation and payment to gamete donors are controversial. While some guidelines prohibit compensation to donors [ 44 , 45 ], the majority of guidelines consider compensation to donors to be fair and ethical [ 30 , 34 , 46 , 47 , 49 , 51 , 52 , 54 ], but there are variations in the amount and mode of payment. HFEA’s ‘code of practice’ suggests a fixed amount of payment per donation for gamete donors, and also recommends that any expense resulting from donation side effects should be covered. Donors may receive payment in the form of benefits in kind, such as accessing treatments in the same fertility clinic [ 34 ]. ASRM guidelines recommend the compensation be a fair and specified amount, which would not interfere with the donor’s informed decision-making process. Three guidelines suggest that any cost related to donation’s side effects must be covered too [ 30 , 52 , 54 ]. Other guidelines suggest reimbursement for time and expenses [ 46 , 47 , 49 , 51 ].

In addition to the ethical recommendations that were discussed, based on two guidelines provided by ASRM including Psychological guidelines for embryo donation and Guidance regarding gamete and embryo donation, staff members of a fertility center are prohibited from donating their gamete/embryo to that center in order to prevent conflict of interests [ 30 , 44 ]. Also, some guidelines recommend if a person is considered ineligible for donation, that person have the right to know the reason, and centers should provide them with an explanation, counseling, and if necessary, referral for treatment [ 34 , 44 ].

In this systematic review, we attempted to provide a summary of recommendations of assisted and third party reproduction guidelines in regards to management and care of gamete and embryo donors. Management and care provided for gamete and embryo donors were classified into four categories including screening, counseling, information provision, and ethical considerations.

It is important to note that relatively limited research has been undertaken to understand the gamete and embryo donors’ needs, expectations and experiences regarding care provided to them [ 26 , 36 , 55 ].

Genetic screening of potential donors is done in order to exclude donors, who are not considered eligible, but it is important to consider donors’ rights and needs. Based on the limited current research on donors’ experience regarding genetic screening, although donors understand and accept the necessity of genetic screening, they have some concerns about different aspects of screening such as its effect on their privacy, implications of the result on their life, ethics of genetic selectivity and ethics and implications of expanded genetic screening. Since genetic screenings do not benefit donors, there should be a balance between the burden of screening on donors, and its benefits for recipients and donor-conceived child [ 56 , 57 , 58 ].

Although guidelines have emphasized on the importance of counseling [ 30 , 34 , 43 , 44 , 45 , 47 , 49 , 51 ], studies on donors’ experiences shows donors’ unmet needs for receiving proper counseling and/or support [ 13 , 59 , 60 ]. Results of the previous studies showed that the psychosocial needs of gamete/embryo donors for counseling and follow-up care are neglected in clinical settings [ 13 , 59 , 60 , 61 ]. This is also the case of post-donation counseling. Although four guidelines recommend post-donation counseling [ 34 , 43 , 45 , 51 ] and one guideline recommends follow-up care for oocyte donors [ 47 ], findings of various studies suggest that donors are not satisfied with the post donation counseling, follow-up, and care provided by the fertility clinics [ 17 , 29 , 36 , 59 , 61 ]. Donors need post-donation counseling regarding their experiences, disclosing donation to family members, receiving information about donor-conceived child, and/or contact with donor-conceived child, but some reports suggest that some donors do not receive the counseling or are not aware that post-donation counseling is available [ 32 , 36 , 62 ].

Also as mentioned before, in contrast to earlier guidelines about counseling of potential donors, which mainly focused on mental health screening for eligible donors, the latest guidelines separate counseling from mental screening and/or information provision [ 34 , 48 , 49 , 51 ]. However, based on donors’ experiences, counseling in clinical settings is still used as a screening tool to determine their eligibility; therefore potential donors may not feel safe to discuss their special worries or problems [ 32 , 63 ]; although it is possible for donors to seek counseling outside fertility clinics in order to manage their concerns or problems regarding donation. Counselors outside fertility clinics may have limited practical knowledge about donation and its implications on parties involved, but they cannot interfere with or stop the donation process even if they consider the potential donor ineligible for donation [ 64 , 65 ]. So, it is important to understand the influence of counseling sessions outside fertility clinics paid by donors, on the donation process.

Also, donors must be counseled regarding the impact of donation and contact with donor-convinced child on their family; even though guidelines mentioned the importance of this topic, there is no specific guidance on how and when donors, and/or their family members should be counseled [ 32 , 35 , 66 ]. There are important topics regarding donation implications that must be discussed with donors prior to donation. Counselors not only should inform donors about possible future contact with the donor-conceived child/children, they should also make sure that donors understand the reasons behind the desire of donation offspring to contact them [ 67 ].

They also should receive counseling about the meaning of family and who is considered family member in the context of reproductive donation, since the understanding of parties involved in reproductive donation about family, and familial relations can be differ [ 68 , 69 , 70 ].

Additionally, donors should be counseled about their desired number of offspring, and for those who have donated multiple times, so there should be counseling on how to manage an overwhelming number of offspring [ 71 , 72 ]. It is also important to notice that the research in this area is limited, therefore there is a need for further research on the meaning of family and its implication on the life of donors, recipients, and donor-conceived children. So, the necessity for developing needs-based guidelines regarding counseling of gamete/embryo donors is felt.

Another neglected but important aspect of both counseling and information provision is the topic of availability of commercial DNA testing, which can jeopardize donors’ anonymity. Donor-conceived children could be linked with donors or other genetically related family members of donors including their children through ancestry/DNA databases or some organizations. This can affect donor, donor’s family, donor-conceived child and the recipient family, significantly. Therefore, it is important to have clear guidelines about informing donors in the initial steps of donation about the unintentional disclosure of donation, and providing them with support about the management of this kind of disclosure within their own family and with the donor-convinced child; if and when it happens [ 32 , 35 , 73 , 74 , 75 ].

According to the reviewed guidelines, fertility centers are obligated to inform potential donors of all possible side effects related to gamete/embryo, however, the fact is that due to the lack of evidence, long-term side effects of donation are not completely identified [ 30 , 34 , 43 , 44 , 45 , 46 , 47 , 50 , 51 , 52 ]. Studies on donors’ experiences and awareness showed that although most donors receive enough information about the short-term side effects of their donation, they still need more information regarding psychosocial side effects and potential physical/psychosocial long-term risks of donation [ 4 , 13 , 15 , 59 , 61 , 76 ]. These studies also pointed to the need for longitudinal studies on donation side effects, in order to improve guidelines, recommendations, and informed consents [ 13 , 15 , 59 , 76 ]. Also, informed consent forms must be transparent regarding the limited knowledge about the long-term side effects of donation especially among oocyte donors [ 77 ].

In relation to the ethico-legal aspects of donation, most of the guidelines have pointed out that donors have the responsibility to update their health status and contact information [ 30 , 34 , 45 , 46 , 49 , 50 , 51 , 52 ], but evidence shows that fertility clinic staffs are not fully aware of how these updating process should be conducted [ 78 ], therefore most gamete donors are rarely contacted to update their medical status. In cases that donors’ medical status is updated, there is also little to no guidance on who and how should inform the recipient parents [ 78 ]. Lack of accurate and comprehensive registry system, which includes and connects data of donors, recipients and all children born from a single donor together with the lack of binding regulations in this context, worsen the situation [ 79 , 80 ].

Regarding donors’ rights, two guidelines recommended that donors must access information about donation offspring [ 34 , 49 ], this is in line with the results of different studies which indicated that donors wish to be informed about the outcome of their donation [ 6 , 59 , 81 ].

One of the most controversial ethical aspects of gamete/embryo donation is compensation or payment to gamete donors. Most current guidelines consider compensation (not payment) to donors to be fair and ethical (28,29,31–33,35,36,38), but in clinical settings for example in the United States the amount of compensation can be negotiated, turning the donation process into a marketing for human gametes [ 82 ]. Those in favor of compensation with no fixated amount argue that it is a necessary step to ensure adequate supply for the growing demand of gamete donation [ 51 , 54 , 82 , 83 ]. However, those against the payment (or compensation without limit), believe that payment in exchange for one’s gamete is a form of objectifying and commodifying humans, and increasing the cost of treatment causes inequality in access to treatment, so that is morally inappropriate [ 51 , 82 , 84 , 85 ].

Another important ethico-legal issues that has been emphasized in the guidelines, is setting a limit on the optimal number of offspring per gamete donor [ 30 , 34 , 46 , 47 , 48 , 49 , 52 , 53 ]. But guidelines, especially in places where there is no registry system and anonymous donation is still an option, like U.S.A, are not clear on how they will keep track of the number of offspring born from a donor [ 79 ]. Also, since there is a possibility of cross-border donation, the limitation of offspring numbers should include overseas born children, also there should be guidance regarding how the number of live births resulted from donations of a single donor will be traced. Donors’ wishes regarding the number of children resulting from their donation should also be considered, since based on previous research most donors rather are keen to limit the number of offspring to a lower number like 10 [ 71 , 72 ]. Also, based on the lack of accurate registry system, it will not be possible for donors to access information about all offspring resulted from their donation. Therefore, painting a realistic picture of donation practices should be at the core of setting guidelines and recommendations so that they are based on reality.

Also, as aforementioned, it should be noted legally that most guidelines are non-bindings [ 20 ]. This raises an issue when fertility centers do not follow the noted guidelines. As pervious research demonstrate, in the cases of non-binding guidelines and/or regulations, some fertility centers may not completely comply with the guidelines [ 3 , 86 , 87 ]. So it seems necessary to launch regulatory bodies to encourage awareness and use of the guidelines and to monitor implementing guidelines into practice to assist practitioners and patients’ decisions regarding appropriate healthcare for specific clinical issues [ 88 ].

The strength of this study is that to the best of our knowledge, this is the first study to review current assisted and third-party reproduction guidelines regarding management and care of donors. A limitation of this study was that only documents written in English were searched and included in the study. Additionally, although it was endeavored to adopt a comprehensive and systematic search strategy to find as many relevant documents as possible, there is still a possibility of missing data due to limited search in gray literature, including materials produced by organizations outside of the traditional commercial or academic publishing such as some of organizations affiliated with the International Federation of Fertility Societies.

This review identified that management and care provided by assisted and third party reproduction guidelines for gamete and embryo donors were classified into four categories including screening, counseling, information provision, and ethical considerations. Nevertheless, there is a gap between guidelines and clinical practice regarding management and care of gamete and embryo donors. In order to inform current practice by developing evidence-based guidelines, well-designed research must be carried out to fill the knowledge gap about gamete and embryo donors’ needs, psychosocial effects of donation, long-term effects of donation on donors, donors' follow-up care, and ethical aspects of donation.

Availability of data and materials

Data is provided within the manuscript or supplementary information files.

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Acknowledgements

The present article was extracted from the Ph.D. thesis of the first author (EI) in Reproductive Health at Mashhad University of Medical Sciences, Mashhad, Iran.

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Elnaz Iranifard

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Samira Ebrahimzadeh Zagami & Robab Latifnejad Roudsari

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Department of Obstetrics and Gynecology, Fellowship of Infertility, School of Medicine, Milad Infertility Treatment Center of Mashhad, University of Medical Sciences, Mashhad, 9137913316, Iran

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EI and RLR contributed substantially in conception of the study. EI and MA performed the database search and study selection and prepared Figure 1 and Additional File 1. EI and SEZ performed the quality assessment and prepared Additional File 2. EI and HE performed the data extraction and prepared Table 1. EI, SEZ, and RLR performed the data synthesis and prepared Tables 2-5. RLR supervised the database search, study selection, quality assessment and data extraction. EI involved in drafting the manuscript. RLR and SEZ critically revised its content. All the authors read and approved the final manuscript and agreed to be accountable for all aspects of the published work ensuring that issues related to the accuracy or completeness of any part of the work are properly investigated and resolved.

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Iranifard, E., Ebrahimzadeh Zagami, S., Amirian, M. et al. A systematic review of assisted and third-party reproduction guidelines regarding management and care of donors. Reprod Health 21 , 75 (2024). https://doi.org/10.1186/s12978-024-01804-2

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DOI : https://doi.org/10.1186/s12978-024-01804-2

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• Peripheral QCT (Quantitative Computed Tomography) scanner which precisely measures cortical bone density, the most accurate index of actual bone density and strength. This tool can be used in infants, children and adults.
• PEA POD (Infant Body Composition) machine which uses whole body densitometry to determine body composition (fat and fat-free mass) in infants weighing between 1 and 8 kg. 
• Equipment to perform sophisticated cardiovascular, exercise and endocrine assessments.
• Portable ultrasound which can be used for a range of functions including carotid intimal thickness assessment and flow mediated vasodilation (an accurate measure of peripheral vascular function).
• Leonardo Jump Plate. This measures jump power as well as balance and is a useful tool in children and adults with impaired gait or motor function.
• Developmental testing suite with video recording.
• Phlebotomy and sample collection rooms.
• Laboratory and sample processing areas.

Clinical research team

The clinic is staffed by a friendly team of paediatric endocrinologists, paediatricians, paediatric and research nurses and administrative staff. Paediatric fellows, PhD and masters students also work in the unit. All staff involved in the set up, conduct and closure of clinical trials maintain current training in ICH-GCP and understand the requirements of The Guideline on the Regulation of Therapeutic Products in New Zealand Part 11: regulatory approval and good clinical practice requirements.

Using the facilities

If you’re interested in using the Clinical Research Unit for research, please contact paykelcru@auckland.ac.nz

Related links

• Why take part in a clinical study?
• Clinical studies in pregnancy