NRPM: Standards for Privacy of Individually Identifiable Health Information. Footnotes


1 The following 17 Departments and Agencies have adopted the Common Rule: (1) Department of Agriculture; (2) Department of Commerce; (3) Department of Defense; (4) Department of Education; (5) Department of Energy; (6) Department of Health and Human Services; (7) Department of Housing and Urban Development; (8) Department of Justice; (9) Department of Transportation; (10) Department of Veterans Affairs; (11) International Development Cooperative Agency: Agency for International Development; (12) Consumer Product Safety Commission; (13) Environmental Protection Agency; (14) National Aeronautics and Space Administration; (15) National Science Foundation; (16) Social Security Administration; (17) Central Intelligence Agency. In addition, the White House Office of Science and Technology Policy is a signatory to the Common Rule, but its policy is not codified in the Code of Federal Regulations.

2 It should be noted that for the Department of Defense, 10 U.S.C. 980 prohibits the waiver of informed consent. Only those studies that qualify for exemption per 45 CFR 46.101(b), or studies that do not meet the 45 CFR 46 definition of human subjects research can be performed in the absence of a process to provide informed consent to prospective subjects. This proposed rule would not affect DOD’s implementation of 10 USC 980.