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Federal Regulations and Granting Agency Requirements
The Common Rule is the Federal Policy for the Protection of Human Subjects published in 1991 and codified in separate regulations by 15 federal departments and agencies, as listed below. The U. S. Department of Health and Human Services (DHHS) regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children. Each agency includes in its chapter of the Code of Federal Regulations (CFR) section numbers and language that are identical to those of the DHHS codification at 45 CFR part 46, subpart A. For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and assurances of compliance.
- whether an activity is research that must be reviewed by an IRB
- whether the review may be performed by expedited procedures, and
- whether informed consent or its documentation may be waived.