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    FACA FACTS ARCHIVE

    Bioethical Issues Study Commission Seeks Comment on Human Studies Standards
    The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the Federal and international standards for protecting the health and well-being of participants in scientific studies supported by the Federal Government. To assure consideration, comments must be received by the commission by May 2, 2011.

    The Commission was established on November 24, 2009. It advises the President of the United States on bioethical issues generated by novel and emerging research in biomedicine and related areas of science and technology. The Commission is charged to identify and promote policies and practices that assure ethically responsible conduct of scientific research, healthcare delivery, and technological innovation.

    The Commission has begun a review of the current rules and standards for protecting human subjects in scientific studies supported by the Federal Government. The President requested this study on November 24, 2010, following revelations that the U.S. Public Health Service supported research on sexually transmitted diseases in Guatemala from 1946 to 1948 involving the intentional infection of vulnerable populations.

    President Obama asked the Commission Chair ``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 will provide the President with a report of its findings and recommendations in 2011..   The Commission is interested in receiving comments on the existing standards for protecting human subjects, both domestically and internationally; how the current system of global research works in practice; and the ethical and social justice issues that emerge from the current research system. Comments concerning 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; challenges, if any, faced by U.S.-funded researchers working internationally, or international researchers collaborating on U.S.-funded research; and other specific information are requested.

  • Click here to read the Commission's Federal Register notice requesting comments
  • Click here for the Commission's website
 
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