[Federal Register Volume 77, Number 59 (Tuesday, March 27, 2012)]
[Notices]
[Pages 18247-18248]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7329]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Comments on Issues of Privacy and Access With Regard
to Human Genome Sequence Data
AGENCY: The Presidential Commission for the Study of Bioethical Issues,
Office of the Secretary, Department of Health and Human Services.
ACTION: Notice.
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SUMMARY: The Presidential Commission for the Study of Bioethical Issues
is requesting public comment on the ethical issues raised by the ready
availability of large-scale human genome sequence data, with regard to
privacy and data access and the balancing of individual and societal
interests.
DATES: To assure consideration, comments must be received by May 25,
2012. Comments received after this date will be considered only as time
permits.
ADDRESSES: Individuals, groups, and organizations interested in
commenting on this topic may submit comments by email 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: Cary Scheiderer, Senior Policy and
Research Analyst, The Presidential Commission for the Study of
Bioethical Issues, 1425 New York Avenue NW., Suite C-100, Washington,
DC 20005. Telephone: 202-233-3960. Email:
cary.scheiderer@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 and healthcare delivery. 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 is examining issues of privacy and access as
pertains to large-scale human genome sequence data, including whole
exome and whole genome data. As a result of the tremendous
technological advances that have dramatically reduced the cost of
sequencing, the science is at a point where relatively inexpensive,
rapid sequencing of whole human genomes appears not only likely, but
imminent. This prospect raises many questions for the scientific,
medical, ethics, and patient communities related to how this
information can and ought be collected, used, and governed. At the
February 2012 meeting, the Commission decided to focus specifically on
those questions related to privacy and data access and the balancing of
individual and societal interests.
The Commission will spend the next six months soliciting additional
input from the scientific, ethics, and patient communities, as well as
others, to help inform our deliberations of these important topics. The
Commission will provide the President with a report of its findings and
recommendations later this year.
The Commission is particularly interested in policies, practices,
research, and perspectives on issues of privacy and data access as they
relate to the integration of large-scale human genome sequencing into
research and clinical care. 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 implications of large-scale human genome sequencing for
the privacy of individuals, research subjects, patients and their
families; the views of those groups and medical professional
communities about privacy, both as regards genomic information and
evolving notions of privacy, as evidenced and influenced by social
media; and models and mechanisms for protecting privacy, in both
genetic/genomic databases and biobanks, but also in large databases of
sensitive information. The Commission is further interested in
receiving comments on issues related to balancing individual and
societal interests with regard to the sharing of and access to large-
scale human genomic data; the views of patients and other stakeholders
on who should have access to these data and who should control access;
models and mechanisms for governing access to genomic information; the
role of health information technology in providing and governing access
to genomic data; and access to genetic/genomic
[[Page 18248]]
information by law enforcement entities.
Please address comments by email 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 Avenue
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: March 21, 2012.
Wanda K. Jones,
Principal Deputy Secretary for Health, Department of Health and Human
Services.
[FR Doc. 2012-7329 Filed 3-26-12; 8:45 am]
BILLING CODE 4154-06-P