The Common Rule (45 CFR 46)
The US rules that require an ethics committee to approve research on people and require informed consent, written in 1991 and rewritten in 2018 so that a single committee can oversee a multi-site cancer trial and patients can give broad consent for future use of their samples.
Overview
United States, federal regulation. The Federal Policy for the Protection of Human Subjects, the Common Rule, was adopted in 1991 by fifteen federal departments and agencies and is codified for the Department of Health and Human Services at Title 45 of the Code of Federal Regulations, part 46, subpart A. A revised rule was published on 19 January 2017 and took effect on 21 January 2019. Trials conducted under an FDA investigational new drug application also follow the FDA's parallel rules at 21 CFR parts 50 and 56. Primary text: the Office for Human Research Protections page and the eCFR.
What it requires: review by an institutional review board (IRB), informed consent with specified elements, extra protections for prisoners, children and pregnant women, and continuing review. The 2018 revision added a concise 'key information' section at the start of consent forms, allowed broad consent for storage and future research on identifiable biospecimens, exempted some low-risk research, and (from January 2020) required a single IRB for cooperative research at multiple US sites, which National Institutes of Health policy had demanded since 2018. Both descend from the National Research Act of 1974 and the Belmont Report of 1979, written after the Tuskegee syphilis study.
Why it matters in oncology: multi-site cancer trials and tumour biobanks are exactly the research that single IRB review and broad consent were designed for, and the Common Rule is what turns the Declaration of Helsinki's principles into enforceable US law. Debates continue over whether de-identified biospecimens should need consent at all, a proposal the 2017 rule considered and dropped.
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