Surrogate Consent for Research
Below are selected links to federal resources that pertain to or that include specific reference to legally authorized representatives and surrogate consent for research, including reports, statutes, policies and related regulatory or policy materials.
- The Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979) (refer to section C-1 under "Comprehension," discussing use of surrogates when subjects’ comprehension may be severely limited)
- Title 45 Code of Federal Regulations Part 46 (Subpart A, also called the "Common Rule") (U.S. Department of Health and Human Services, 2008) (refer to sections 46.111(a)(4) and 46.116, which permit investigators to obtain consent from legally authorized represententatives, or surrogates, in lieu of subjects)
- Title 21 Code of Federal Regulations Part 50 (U.S. Food and Drug Administration, 2008) (refer to sections 50.20, 50.27(a), and 56.111(a)(4), which permit investigators to obtain consent from legally authorized representatives)
- HHS Office for Human Research Protections (refer to informed consent FAQs pertaining to consent from subjects’ legally authorized representatives or surrogates)
- National Institutes of Health Office of Extramural Research Policy on research involving persons with questionable capacity to consent (1999)
- National Human Research Protections Advisory Committee (NHRPAC) Final Report on informed consent and the decisionally impaired (1998)
- Report and Recommendations of the National Bioethics Advisory Commission, "Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity" (1998) (see Chapter 3 beginning at page 27, Advance Planning, Surrogate Decision Making, and Assent or Objection)
- HHS Request for Information and Comments on Research That Involves Adult Individuals with Impaired Decision-making Capacity (72 Federal Register 50966, September 5, 2007)
- Strauss, D.H., and Flynn, L, Secretary’s Advisory Committee on Human Research Protections, HHS. Report of Subcommittee on the Inclusion of Individuals with Impaired Decision-Making in Research (July 15-16, 2008).
New resources related to surrogate consent for research will be added as they become available. Please feel free to suggest additional federal resources not listed here.