Human Research Protections- Standards & Regulations - page 7

5
Subpart D of 45 CFR 46:
Additional DHHS Protections for Children Involved as Subjects in Research
Subpart E of 45 CFR 46: Registration of Institutional Review Boards
 Privacy Act of 1974, 5 U.S.C. § 552a
This Act establishes a code for how identifying information that is in U.S. federal records systems
should be collected, used and disseminated, and thereby provides protections against potential
misuse of records. It applies to U.S. federal records systems, such as the Department of Justice,
the Bureau of Prisons, and the Tax Division.
 U.S. Food and Drug Administration Human Subjects Protections Regulations (21 CFR part 50)
These U.S. Food and Drug Administration (FDA) human subjects protections regulations apply to
all clinical investigations regulated by the FDA as well as projects that support applications for
research or marketing permits for products regulated by the FDA. Examples of such products are:
 Foods
 Dietary supplements
 Infant formulas
 Food and color additives
 Drugs for human use
 Medical devices for human use
 Biological products for human use
 Electronic products