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Protection of Human Subjects.
There are two sets of regulations under the same name.
- Department of Health and Human Services, 45 C.F.R. Part 46 ("The Common Rule" for Human Subjects Protection) (Eff. July 14, 2009) (full-text).
- These regulations require consent of research subjects, subject to some exemptions, including research on records where if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Consent forms must include notice of adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- Food and Drug Administration, 21 C.F.R. Part 50 ("The FDA Rule" for Human Subjects Protection) (Rev. Apr. 1, 2012) (full-text).
- NISTIR 7497, at 10.