President’s Bioethics Commission Releases Report on Human Subjects Protection

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Media Contact:Laura Cavender | cavender@upenn.edu | 215-746-6411December 15, 2011

WASHINGTON, D.C. ‚Äď The Presidential Commission for the Study of Bioethical Issues today issued its report concerning federally sponsored research involving human volunteers, concluding that current rules and regulations provide adequate safeguards to mitigate risk.  In its report, ‚ÄúMoral Science: Protecting Participants in Human Subjects Research," the Commission also recommended 14 changes to current practices to better protect research subjects, and called on the federal government to improve its tracking of research programs supported with taxpayer dollars.

University of Pennsylvania President Amy Gutmann is Chair of the Commission and Penn Law Professor Anita Allen also serves as a member.

President Obama requested that the Commission undertake an assessment of research standards following the October 2010 revelation that the U.S. Public Health Service supported unethical research in Guatemala from 1946 to 1948 that involved intentionally exposing thousands of Guatemalans to sexually transmitted diseases without their consent.  The President gave the Bioethics Commission two assignments: to oversee a thorough fact-finding investigation into the specifics of the studies (released September 13, 2011); and to assure that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally.

‚ÄúThe Commission is confident that what happened in Guatemala in the 1940s could not happen today,‚ÄĚ Gutmann said.  ‚ÄúHowever, it is also clear that improvements can be made to protect human subjects going forward.  With the Commission‚Äôs recommendations, society will continue to benefit from advances in quality of life made possible by human subjects research and ensure respect for the inherent dignity of individual research volunteers.‚ÄĚ

More information is available at http://www.bioethics.gov

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