Obtaining Informed Consent from Prisoners
Research involving prisoners requires approval by an IRB whose membership is specifically constituted to address the concerns of this vulnerable population per (45 CFR 46.304). If the research is conducted or supported by HHS, it must also be approved by the Secretary of HHS through the Office for Human Research Protections (OHRP). This approval signifies that “the research represents one of the categories of research permissible under (45 CFR 46.306(a)(2)).”
The HHS regulations (45 CFR 46, Subpart C) require additional protections for prisoners who are involved as participants in research because they may be under constraints as a result of their incarceration that could affect their ability to make a truly voluntary decision about whether or not to participate in research.
The requirements specific to informed consent for prisoners are:
- “Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired.”
- “Adequate assurance exists that parole boards will not take into account a prisoner’s participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole.”