Resources: Human Subjects Research
On January 19, 2017, federal regulators published the Final Rule to amend and update the Federal Policy for the Protection of Human Subjects (“the Common Rule”). Key provisions govern research with identifiable private information, identifiable biospecimens, broad consent, new exemption categories, and single IRB review of multi-site research.
This set of regulations governs the protection of human subjects in research supported or conducted by HHS, as well as several other federal agencies. It covers basic protections for all subjects (known as the “Common Rule”), as well as specific protections for certain subpopulations, including pregnant women, children, and prisoners.Additional…
This Federal Register notice from September 2015 outlines proposed changes to the Common Rule. These proposals are not yet final.
FDA’s regulations governing clinical trials are found at different parts of Title 21 of the Code of Federal Regulations. Use the link to search for 21 CFR Part 50 (Informed Consent) and 21 CFR Part 56 (Institutional Review Boards).Additional information can be found in 21 CFR Part 312 (Investigational New…
This conference brought together a variety of experts on human subjects research to discuss the 2011 Advanced Notice of Proposed Rulemaking and offer suggestions for how to best regulate human subjects research going forward. Video is available here, and the conference papers will be available as an…
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Resear
The Belmont Report is the foundational document on which current human subjects research regulations are based. It set forth the principles of respect for persons, beneficence, and justice to make recommendations regarding informed consent, assessment of risks and benefits, and subject selection.
This site provides HHS and NIH requirements and resources for the extramural community involved in human subjects research in their roles as Applicants/Grantees, Offerors/Contractors, Peer Reviewers, and Institutional Officials. It includes regulations, policies, guidance, training materials, and FAQs.
This excellent website provides links to a variety of resources related to human subjects research, including major ethics codes and standards (such as the Declaration of Helsinki, Nuremberg Code, Belmont Report, and CIOMS International Ethical Guidelines); regulations, policies, and guidance; and resources for institutional review boards.
This site includes a variety of government reports related to human subjects research and the agencies responsible for oversight.
This 2001 report offers several suggestions for improving the federal oversight system for protecting the rights and welfare of human research participants.
This report examines the possible roles of accreditation in strengthening accountability and oversight of programs responsible for protecting human subjects. One such accrediting organization now in existence is the Association for the Accreditation of Human Research Protection Programs.
This 2002 report was commissioned by HHS following the death of Jesse Gelsinger in a gene therapy experiment at the University of Pennsylvania. It covers ethics review of research protocols, informed consent, safety monitoring, and compensation for research-related injury.
This 2011 report is the result of a thorough review of current regulations and international standards to assess whether they adequately protect human participants in federally funded research, and offers several recommendations for improvement.
This organization aims to advance the highest ethical standards in the conduct of biomedical and social science/behavioral research through education, membership services, professional certification, and public policy initiatives.Their website has a variety of useful resources.
This book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest,…
This book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings, including scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research.
DFCI Ethics Grand Rounds
Evaluating Offers of Payment to Research Participants
Holly Fernandez Lynch, JD, MBioethics
Executive Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School
Faculty, Harvard Medical School Center for Bioethics