TABLE 3-3Summary of Regulations Applicable to Research Even If It Is Not Federally Funded by Any Agency

VariableFederal State
AdultJuvenileAdultJuvenile
Medical treatment Nontherapeutic/CosmeticNot permittedNot permittedFDA Subpart AFDA Subpart A, FDA Subpart D, state policy
Pharmaceutical/medical device—therapeutic (for specific inmate’s condition)DOJ Subpart A [Applicable DHHS regulations incorporated by reference in BOP policy]FDA Subpart ADOJ Subpart A [Applicable DHHS regulations incorporated by reference in BOP policy]FDA Subpart AFDA Subpart DFDA Subpart A, state policyFDA Subpart A, FDA Subpart D, state policy
Non-FDA-regulated medical treatment—therapeuticDOJ Subpart A [Applicable DHHS regulations incorporated by reference in BOP policy]DOJ Subpart A [Applicable DHHS regulations incorporated by reference in BOP policy]Varies by stateVaries by state
Nonmedical ResearchDOJ Subpart ABOP research policyDOJ Subpart ABOP research policyVaries by stateVaries by state

NOTE: FDA, Food and Drug Administration; DOJ, Department of Justice; DHHS, Department of Health and Human Services; BOP, Bureau of Prisons.

SOURCES: 28 C.F.R. Part 46, Subpart A; BOP, 1999; 21 C.F.R. Part 50, Subparts A, D; 45 C.F.R. Part 46, Subparts A, C.

From: 3, Federal Regulatory Landscape

Cover of Ethical Considerations for Research Involving Prisoners
Ethical Considerations for Research Involving Prisoners.
Institute of Medicine (US) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research; Gostin LO, Vanchieri C, Pope A, editors.
Washington (DC): National Academies Press (US); 2007.
Copyright © 2007, National Academy of Sciences.

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