US Government oversight in clinical research

For over half a century, the FDA and the National Institutes of Health (NIH) have been committed to protecting individuals from possible abuse or harm in clinical trials and to ensuring that prospective and enrolled subjects understand the potential risks and benefits in clinical research. The main mechanism of clinical research oversight is inspection. This commitment to protect subjects was the result of concerns, arising from the abuse of subjects, during the World War II trials at Nuremberg, the promotional distribution of thalidomide resulting in numerous children born with birth defects, the administration of cancer cells to chronically ill and senile patients at a hospital in New York, and others. In 1966, Henry Beecher brought prominent attention to human research abuses in medical schools and hospitals, citing 22 cases involving highly questionable ethics (and Maurice Pappworth did the same in the UK). The response of the US Government to Beecher's stories, led to amendments of the US Food, Drug and Cosmetic Act that required subjects to consent to participating in investigational research. In the 1970s, the National Commission for the Protection of

Human Subjects of Biomedical and Behavioral Research enhanced patient protection with recommendations for IRBs, ethical oversight committees that are responsible for ensuring that subjects who give consent to participate in clinical research fully understand the nature of the research and willingly consent to participate. The FDA revised its regulations in 1981 to require written informed consent in all studies of products that the FDA regulates.

In 1972, the Office for Protection from Research Risks (OPRR) was created as part of the NIH to ensure the safety and welfare of subjects who participate in Health and Human Services (HHS) sponsored research. Institutions engaged in human subject research must provide written assurance of compliance to the Regulations for Protection of Human Subjects (45 CFR Part 46). In 1999, the Advisory Committee to the Director of NIH recommended that the role of OPRR be expanded and that the office be elevated from NIH to HHS. In June 2000, the Office for Human Research Protections (OHRP) was established in the Office of the HHS Secretary to raise its stature and effectiveness.

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