President’s Bioethics Commission Releases Report on Human Subjects Protection

On December 15, 2011, the Presidential Commission for the Study of Bioethical Issues released a report entitled, Moral Science: Protecting Participants in Human Subjects Research. In the wake of the revelations of controversial PHS-supported research in Guatemala from 1946 to 1948, the Commission was charged by President Obama with assessing the current rules for research participants. In general, the Commission concluded that the “US system provides substantial protection for health, rights, and welfare of research subjects” in the US and internationally. Additionally, the Commission made 14 recommendations. The recommendations include improving accountability though enhanced public access to information on research protocols, expanded research into effectiveness of the human research protection system, enhanced treatment and compensation for research-related injury, making the ethical underpinnings of the regulations more explicit, addressing investigator responsibilities, expanding ethics education, respecting equivalent protections, promoting community engagement, ensuring capacity to protect human participants and ensuring ethical study design, among others. The complete report can be found here.