What conditions must be met for an IRB to approve research involving prisoners?
Along with the requirements of subpart A, an IRB must make the following seven additional findings required by the regulations in order to review and approve research involving prisoners: • The research under review represents one of the categories of research permissible under 45 CFR 46.306(a)(2); • 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 receiving such advantages in the limited-choice prison environment is impaired; • The risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers; • Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. U
Related Questions
- When should an Institutional Review Board (IRB) or institution request a "407" review for research involving children as subjects?
- What happens if an IRB chooses the wrong category of research involving prisoners in its certification to OHRP?
- What conditions must be met for an IRB to approve research involving prisoners?
