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 behavioural 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, foetuses, 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)?
General
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