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

摘要

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 (DHFW; 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 offense 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 sittiations.