Federal Protection for Human Research Subjects: An Analysis of the Common Rule and Its Interactions with FDA Regulations and the HIPAA Privacy Rule

Publication Date: June 2005

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Health

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Abstract:

The Common Rule (45 CFR 46, Subpart A) governs research that is conducted on human beings if it is funded by one of 18 federal agencies. It requires a review of proposed research by an Institutional Review Board (IRB), the informed consent of research subjects, and institutional assurances of compliance with the regulations.

In 1974, 45 CFR 46 was published following some cases of harm to human subjects, such as those caused by thalidomide drug trials and the United States Public Health Service syphilis study in Tuskeegee, Alabama. The regulations had their roots in numerous international agreements, such as the Nuremberg Code and the Declaration of Helsinki, and domestic policies, such as those put forth by the Department of Health, Education and Welfare (DHEW; now the Department of Health and Human Services, HHS). In 1991, 16 federal agencies adopted 45 CFR 46, Subpart A, which then became known as the Common Rule.

Since the Common Rule took effect, events like the death of Jesse Gelsinger in 1999 due to his participation a clinical trial have prompted scrutiny of the Rule and its ability to protect research subjects. In order to help enhance research subject protections, in 2000 HHS removed the Office for Protection from Research Risks (OPRR) from the National Institutes of Health (NIH), and created a new office -- the Office for Human Research Protections (OHRP) -- in an elevated position in HHS. In addition, groups like the National Bioethics Advisory Commission and the National Academies raised the following policy questions: (1) Should the Common Rule be applied to non-federally funded research, social and behavioral research, international clinical trials, and research with human biological materials? (2) Do existing provisions ensure the participation and protection of children, prisoners, minorities, those with diminished capacity, pregnant women, fetuses, neonates, and people in emergency situations? (3) What should be the requirements regarding IRBs' membership, responsibilities, training, and registration? (4) How should conflicts of interest, accreditation, ongoing research, and adverse event reporting be handled? (5) How should basic and research-related medical care's cost, and IRB liability for harm be handled? (6) How should the human subjects protection system be reassessed, adequate resources ensured, and the burdens and benefits of amending regulations appropriately weighed? (7) How does 45 CFR 46 interact with the Food and Drug Administration (FDA) regulations for the protection of human subjects (21 CFR 50 and 56), and the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (45 CFR 146)?

Legislation to revise the Common Rule has been introduced in every Congress since 1997. In the 109th, the PhRMA Act of 2005 (H.R. 870) was introduced, to provide criminal penalties for concealing evidence of serious drug adverse events. Bills introduced in former Congresses include the Protection for Participants in Research Act of 2003 (H.R. 3594, 108th Congress), the Research Revitalization Act of 2002 (S. 3060, 107th Congress), and the Human Research Subject Protections Act of 2002 (H.R. 4697, 107th Congress). This report will be updated as needed.