Human subjects in U.S. government-funded research

Although human subjects in U.S. government-funded research are generally protected by existing rules and regulations, their safety and well-being could be enhanced with stronger measures, a presidential commission on bioethical matters said Thursday.

In a 208-page report, the Presidential Commission for the Study of Bioethical Issues said it “cannot say that all federally funded research provides optimal protections against avoidable harms and unethical treatment.”

The commission 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.

The assessment of research standards was initiated at the request of U.S. President Barack Obama following an 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.

Obama gave the commission two assignments: to oversee a thorough fact-finding investigation into the specifics of the studies and to assure that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally.

“The Commission is confident that what happened in Guatemala in the 1940s could not happen today,” commission chairwoman Amy Gutmann, who is also president of the University of Pennsylvania in Philadelphia, said in a news briefing.

“However, it is also clear that improvements can be made to protect human subjects going forward,” she added.

The commission proposed that all U.S. agencies funding human research make the basic data about their studies publicly available by, for example, establishing a central web-based portal linking to each agency’s data or creating a unified federal database.

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