Final Revisions to the Common Rule

U.S. Department of Health and Human Services

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.

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Regulations Governing (Most) Federally-Funded Human Subjects Research

Department of Health and Human Services

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…

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Notice of Proposed Rulemaking to Amend the Federal Policy for the Protection of Human Subjects


Department of Health and Human Services (and several other federal departments and agencies)

This Federal Register notice from September 2015 outlines proposed changes to the Common Rule. These proposals are not yet final.

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U.S. Food and Drug Administration Regulations Applicable to Human Subjects Research

Food and Drug Administration

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…

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The Future of Human Subjects Research Regulation
2012 Petrie-Flom Center Annual Conference


May 6, 2012

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…

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US Government Clinical Trial Registry
– ClinicalTrials.gov

U.S. National Institutes of Health

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. 

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The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Resear

U.S. Department of Health & Human Services

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.

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Grants and Funding: Research Involving Human Subjects

National Institutes of Health, Office of Extramural Research

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. 

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Bioethics Resources on the Web

National Institutes of Health

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.

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HHS Office of the Inspector General, Office of Evaluations and Inspections

US Department of Health and Human Services

This site includes a variety of government reports related to human subjects research and the agencies responsible for oversight.

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Ethical and Policy Issues in Research Involving Human Participants

National Bioethics Advisory Commission

This 2001 report offers several suggestions for improving the federal oversight system for protecting the rights and welfare of human research participants.

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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs

Institute of Medicine

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.

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Responsible Research: A Systems Approach to Protecting Research Participants

Institute of Medicine

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.

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Moral Science: Protecting Participants in Human Subjects Research

Presidential Commission for the Study of Bioethical Issues

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. 

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Public Responsibility in Medicine & Research

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.

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Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary


Ezekiel Emanuel et al.

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,…

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The Oxford Textbook of Clinical Research Ethics


Ezekiel Emanuel et al.

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.

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‘What Makes Clinical Research Ethical?’

Journal of American Medical Association ,
24/31 (2000): 2701-11

Ezekiel Emanuel, Christine Grady, David Wendler

In this influential article the authors aim to widen the focus of research ethics beyond informed consent, suggesting that there are seven conditions that research with humans must meet to be ethical.

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The Ethical Challenges of Human Research

Oxford University Press,
2012

Franklin G. Miller

This collection of essays covers several key debates in contemporary research ethics, including the ethics of trial design, deception, the placebo effect, and the therapeutic obligations of researchers.

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Evaluating Offers of Payment to Research Participants

Dana Farber Cancer Institute Grand Rounds,
June 15, 2016

Holly Fernandez Lynch (Executive Director) and Emily Largent (Student Fellow alumna)

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

Emily…

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