2011-4658. Request for Comments on Human Subjects Protections in Scientific Studies

AGENCY:

The Presidential Commission for the Study of Bioethical Issues, Office of the Secretary, Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

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.

DATES:

To assure consideration, comments must be received by May 2, 2011.

ADDRESSES:

Individuals, groups, and organizations interested in commenting on this topic may submit comments by e-mail to [e-mail] or by mail to the following address: Public Commentary, The Presidential Commission for the Study of Bioethical Issues, 1425 New York Ave. NW., Suite C-100, Washington, DC 20005.

FOR FURTHER INFORMATION CONTACT:

Hillary Wicai Viers, Communications Director, The Presidential Commission for the Study of Bioethical Issues, 1425 New York Avenue, NW., Suite C-100, Washington, DC 20005. Telephone: [phone]. E-mail: [e-mail]. Additional information may be obtained at http://www.bioethics.gov.

SUPPLEMENTARY INFORMATION:

On November 24, 2009, the President established the Presidential Commission for the Study of Bioethical Issues (Commission) to advise him 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. In undertaking these duties, the Commission seeks to identify and examine specific bioethical, legal, and social issues related to potential scientific and technological advances; examine diverse perspectives and possibilities for international collaboration on these issues; and recommend legal, regulatory, or policy actions as appropriate.

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 President charged the Commission to seek the insights and perspective of international experts and consult with counterparts in the global community. The Commission will provide the President with a report of its findings and recommendations later this year.

To implement this mission, the Commission wishes to develop a thorough understanding of the current U.S. and international standards for protecting the health and well-being of participants in scientific studies supported by the Federal Government. To this end, the Commission is inviting interested parties to provide input and advice through written comments. Among other issues, 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 all especially welcome. The Commission is under a very tight deadline and would appreciate comments within 60 days.

Please address comments by e-mail to [e-mail], or by mail to the following address: Public Commentary, The Presidential Commission for the Study of Bioethical Issues, 1425 New York Ave. NW., Suite C-100, Washington, DC 20005. Comments will be publicly available, including any personally identifiable or confidential business information that they contain. Trade secrets should not be submitted.

Dated: February 17, 2011.

Valerie H. Bonham,

Executive Director, The Presidential Commission for the Study of Bioethical Issues.