• Home

  |

• About HHS

  |

• Newsroom

  |

• FAQs

  |

• Regulations

  |

• A-Z Index

Yes, in addition to the requirements of subpart A, subpart C of the HHS regulations at 45 CFR part 46 identifies more requirements for research involving prisoners. In summary, the major additional considerations are:

• the exemptions that generally apply to certain types of research involving human subjects do not apply to research involving prisoners (45 CFR 46.101, footnote 1);
• in order to approve research involving prisoners, the IRB must find that the proposed research falls into one of the permissible categories of research, and make six other findings;
• the institution must certify to OHRP that an IRB has reviewed the proposal and made seven required findings, and receive OHRP authorization prior to initiating any research involving prisoners; (45 CFR 46.305(c))
• the IRB must include a prisoner or prisoner representative, (45 CFR 46.304(b)) and meet a membership requirement concerning the number of IRB members not associated with a prison involved in the research; (45 CFR 46.304(a))and
• Secretarial waiver of informed consent in certain emergency research is not applicable to research involving prisoners (61 FR 51531, October 2, 1996)

Last Reviewed: 01/20/2011

• How do the regulations define “prisoner”?
• When is an institution “engaged” in research involving prisoners?
• Do the exemptions apply to research involving prisoners?
• What are the categories for permissible research involving prisoners?
• Does research involving prisoners not conducted or supported by HHS require Secretarial consultation?

• Prisoner Research