Additional protections pertaining to biomedical and behavioral research involving prisoners as subjects.

Office of the Secretary ADDITIONAL PROTECTIONS PERTAINING TO BIOMEDICAL AND BEHAVIORAL RESEARCH INVOLVING PRISONERS AS SUBJECTS

Barred from better medicine? Reexamining regulatory barriers to the inclusion of prisoners in research

In 2015, President Obama announced plans for the Precision Medicine Initiative® (PMI), an ambitious longitudinal project aimed at revolutionizing medicine. Integral to this Initiative is the recruitment of over one million Americans into a volunteer research cohort, the All of UsSM Research Program. The announcement has generated much excitement but absent is a discussion of how the All of Us R...

Ethical Values and Legal Regulation

UNTIL THE EARLY 1970S, R. J. REYNOLDS, DOW Chemical, the US Army, major pharmaceutical companies, and other sponsors conducted a wide variety of research on prisoners—a captive, vulnerable, and easily accessible population. During that time, approximately 90% of all pharmaceutical research was conducted on prisoners, who also were subjected to biochemical research ranging from testing diet drin...

45 CFR 46: Protection of Human Subjects under United States Law (1974)

In the United States, the Code of Federal Regulations Title 45: Public Welfare, part 46 (45 CFR 46) provides protection for human subjects in research carried out or supported by most federal departments and agencies. 45 CFR 46 created a common federal policy for the protection of such human subjects that was accepted by the Office of Science and Technology Policy and issued by each of the depa...

45 CFR 46: Protection of Human Subjects under United States Law (1974)

In the United States, the Code of Federal Regulations Title 45: Public Welfare, part 46 (45 CFR 46) provides protection for human subjects in research carried out or supported by most federal departments and agencies. 45 CFR 46 created a common federal policy for the protection of such human subjects that was accepted by the Office of Science and Technology Policy and issued by each of the depa...