Protection of Human Subjects

Citation
Protection of Human Subjects, 45 C.F.R. Part 46 ("The Common Rule" for Human Subjects Protection).

Overview
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.

Source

 * NISTIR 7497, at 10.