[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11482-11483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4658]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


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 
info@bioethics.gov 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: 202-233-3963. E-mail: Hillary.Viers@bioethics.gov. 
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,

[[Page 11483]]

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 info@bioethics.gov, 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.
[FR Doc. 2011-4658 Filed 3-1-11; 8:45 am]
BILLING CODE 4154-06-P