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President's Bioethics Commmission Released Its Report on Human Subjects Protection

December 21, 2011
In its report concerning federally-sponsored research involving human volunteers, the Commission concluded that current rules and regulations provide adequate safeguards to mitigate risk.

In its report concerning federally-sponsored research involving human volunteers, the Presidential Commission for the Study of Bioethical Issues concluded that current rules and regulations provide adequate safeguards to mitigate risk. In its report, “Moral 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.

In the report’s central finding, the Commission found that the “U.S. system provides substantial protections for the health, rights, and welfare of research subjects.” The Commission recommended several areas where improvements could be made to current rules and procedure including that each federal department or agency supporting research with human subjects maintain a core set of data for their research programs that includes the title and lead investigator of each project, the location of each study, and the amount appropriated for the research. Among the recommendations, the Commission included a recommendation to promote community engagement based on the Good Participatory Practice (GPP) Guidelines for biomedical HIV prevention trials, a resource developed by AVAC and UNAIDS.

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. MHRP Director, COL Nelson Michael is one of 13 members appointed to the Commission by President Obama.

MHRP is dedicated to conducting its HIV research in the most ethical manner. Our program’s philosophy is firmly anchored on the premise that HIV prevention, care and treatment must be available to the entire community in which MHRP conducts research, not just potential research volunteers and their families. This ensures an ethical, sustainable and non-coercive HIV vaccine research program in resource-limited environments.

For more information on the report, visit www.bioethics.gov.