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Request for Comments on Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues

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AGENCY:

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

ACTION:

Notice.

SUMMARY:

The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the report of the International Research Panel titled, Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues, available for review at http://www.bioethics.gov.

DATES:

To assure consideration, comments must be received by October 11, 2011.

ADDRESSES:

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

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FOR FURTHER INFORMATION CONTACT:

Hillary Wicai Viers, Communications Director, Presidential Commission for the Study of Bioethical Issues, 1425 New York Avenue, NW., Suite C-100, Washington, DC 20005. Telephone: 202-233-3960. E-mail: Hillary.Viers@bioethics.gov. Additional information may be obtained at http://www.bioethics.gov.

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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.

On October 1, 2010, the U.S. Government disclosed that it had supported research on sexually transmitted diseases in Guatemala from 1946 to 1948 involving the intentional infection of vulnerable human populations. In response, President Barack Obama directed the Presidential Commission for the Study of Bioethical Issues (the Commission) to “oversee a thorough fact-finding investigation into the specifics” of the U.S. Public Health Service supported research, and to conduct a review of current 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 asked specifically for assurance “that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally.” President Obama directed the Commission to consult with its counterparts in the global community and to seek the insight of international experts as part of its work on contemporary protections for human subjects of research. The Commission Start Printed Page 55915assembled a subcommittee called the International Research Panel, which met three times in 2011. The proceedings of the International Research Panel are now available for public review and comment at the Commission's Web site, www.bioethics.gov.

Please address comments by e-mail to info@bioethics.gov, or by mail to the following address: Public Commentary, 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.

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Dated: August 30, 2011.

Valerie H. Bonham,

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

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[FR Doc. 2011-23030 Filed 9-8-11; 8:45 am]

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