§ 50.44 - Restrictions on clinical investigations involving prisoners.

(a) Except as provided in § 50.44(b), clinical investigations regulated by the Food and Drug Administration under sections 505(i), 507(d), and 505(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration may not involve prisoners as subjects.

(b) Clinical investigations that are regulated by the Food and Drug Administration under sections 505(i), 507(d), or 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, may involve prisoners as subjects only if the institution responsible for the conduct of the clinical investigation has certified to the Food and Drug Administration that the institutional review board has approved the clinical investigation under § 50.48; and

(1)(i) In the judgment of the Food and Drug Administration, the proposed clinical investigation involves solely research on practices both innovative and accepted, which have the intent and reasonable probability of improving, the health and well-being of the subjects;

(ii) In cases in which these studies require the assignment of prisoners in a manner consistent with protocols approved by the institutional review board to control groups that may not benefit from the research, the study may proceed only after the Food and Drug Administration has consulted with appropriate experts, including experts in penology, medicine, and ethics, and has published notice in the Federal Register of its intent to approve such research; or

(2) Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis, which is much more prevalent in prisons than elsewhere) provided that the Food and Drug Administration has consulted with appropriate experts, including experts in penology, medicine, and ethics, and has published notice in the Federal Register of its intent to approve such research; subject to the approval of the Food and Drug Administration, prisoners may participate in the research even though they are assigned, in a manner consistent with protocols approved by the institutional review board, to control groups that may not benefit from the research.