Commission Begins Work on Human Subjects Report
The panel is writing a report after last year's shocking disclosure of a sexually transmitted disease study conducted in 1946-48. It plans to submit its report before the end of this year.
Sparked by the discovery last October that the U.S. Public Health Service had supported research in 1946-48 that involved infecting soldiers, prisoners, and mental hospital patients in Guatemala with syphilis and gonorrhea without their consent, a presidential commission is now working quickly to conduct its research.
The Presidential Commission for the Study of Bioethical Issues published a notice on March 2 seeking comments by May 2, saying it needs them by that date because it is working under a very tight deadline. It seeks comments about federal and international standards for protecting the health and well-being of people participating in scientific studies supported by the U.S. government. Comments should be e-mailed to [email protected] or mailed to: Public Commentary, The Presidential Commission for the Study of Bioethical Issues, 1425 New York Ave. NW, Suite C-100, Washington, DC 20005.
President Obama created the commission in November 2009 to advise him on bioethical issues generated by novel and emerging research. He asked it to conduct this study on Nov. 24, 2010, after the discovery of unpublished papers of a U.S. Public Health Service medical officer that described the 1946-48 study, which was supported by USPHS. The commission was asked "to convene a panel to conduct . . . a thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government."
The commission seeks comments about existing standards for protecting human subjects, both domestically and internationally; how the current system of global research works in practice; the ethical and social justice issues that emerge from the current research system; the benefits of medical research; differences across global norms and standards; standards for ancillary care and post-trial access to treatment; trial design; duties to participants; and challenges, if any, faced by U.S.-funded researchers working internationally or international researchers collaborating on U.S.-funded research.