04/08/2025
In December 2024, following the release of the 2024 revision of the Declaration of Helsinki (DoH), US Food and Drug Administration (FDA) staff shared the FDA’s perspective on what their role was in the development of the 2024 DoH and how it may impact FDA procedures in an interview with the Office of Global Policy and Strategy (OGSP). The FDA was brought in early on in the revision process to provide their regulatory perspective on changes to the ethical principles within the DoH. The DoH is intended to guide clinical research involving human participants that is often used as the foundation for other guidelines such as the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).
The revision addresses modern issues concerning trial data integrity and participant’s rights, safety, and welfare. Topics that were discussed include:
Protection and inclusion of vulnerable populations:
In previous revisions, the DoH used wording that may have made researchers hesitant to enroll vulnerable populations, the DoH still does not define exactly what a vulnerable population is which may lead to further confusion and hesitancy.
Improvement on Study Design:
An emphasis was put on how it is ultimately the sponsor’s responsibility to ensure the study design is rigorous to avoid research waste while remaining scientifically sound.
Updates to Ethical Principles during Public Health Emergency:
This of course addresses COVID and the ethical challenges that arise in clinical trials when disaster or emergencies strike.
Importance of Biobanks:
The 2024 DoH revision included additions to this section to address personal data stored after trials. The Declaration of Teipei was referenced here as it pertains directly to research on health databases, big data, and biobanks.
Changes to FDA GCP requirements and policies:
While the DoH is a valuable resource to reference when it comes to ethical principles, the FDA has their own regulatory framework and guidance (multiple FDA draft and final guidance are referenced throughout the conversation). Therefore, no direct changes will be made due to the DoH revision.
Dr. Hilary Marston and Ann Meeker-O’Connell are the FDA staff members who shared these perspectives, both of whom we have followed in recent blogs 10/1/2024 and 02/26/2025. The full transcript of the interview is available online here, and the latest version of the DoH here. For updates to the FDA’s guidance as well as other FDA activity relative to clinical trials, please visit our website and subscribe to our blog and sign up for our newsletter, both free of charge.
-The Clinical Pathways Team
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