March 15, 2013
Washington, D.C. – The Presidential Commission for the Study of Bioethical Issues today publicly released its collection of project-level data about human subjects research supported by the federal government from 2006 to 2010. This dataset, the first ever effort to gather information from across the federal government on human participants in research studies, was a central tool used by the Commission in preparing its December 2011 report on federally supported research involving human volunteers, Moral Science: Protecting Participants in Human Subjects Research.
“There is no other dataset like this in the nation. It represents the kind of collection the Commission has encouraged the federal government to maintain,” said Commission Chair Amy Gutmann, Ph.D. “By releasing these data, we have for the first time provided the public with comprehensive information about more than 55,000 projects supported by the federal government in 2010. The federal government should continue making these data available to promote access to information about federally supported human subjects research.”
In its report, the Commission called on the federal government to improve its tracking of human research projects supported with taxpayer dollars after finding that there was no central repository inside or outside of the government on research involving human subject volunteers. To complete its work, the Commission requested information from the 18 agencies that conduct most federal research with human participants, but found that some federal offices could not readily provide basic data about the research they support.
In its report, the Commission recommended that individual agencies develop or improve internal tracking systems (or use existing systems) to provide basic data about their human research projects to the public. It also recommended that the Office for Human Research Protections or another central office administer a central web-based portal that links all agency systems.
“The database compiled by the President’s Commission offers an unprecedented wide angle view of government supported research” said Dr. Christine Grady, a member of the Commission. “The data also offer an opportunity for further scholarship and analysis because they complement but go far beyond information available in other public registries.”
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 (released December 15, 2011).
To access the data and for more information on the Commission, visit www.bioethics.gov.
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