[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Page 33843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13329]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Comments on Issues Related to Incidental Findings 
That Arise in the Clinical, Research, and Direct-To-Consumer Contexts

AGENCY: 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, legal, and social issues 
raised by incidental findings that arise from genetic and genomic 
testing, imaging, and testing of biological specimens conducted in the 
clinical, research, and direct-to-consumer contexts.

DATES: To ensure consideration, comments must be received by July 5, 
2013. 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 
[email protected] 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.

FOR FURTHER INFORMATION CONTACT: Hillary Wicai Viers, Communications 
Director, Presidential Commission for the Study of Bioethical Issues. 
Telephone: 202-233-3960. E-Mail: [email protected]. 
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 (the Bioethics Commission) to advise him on bioethical issues 
generated by novel and emerging research in biomedicine and related 
areas of science and technology. The Bioethics Commission is charged 
with identifying and promoting policies and practices that ensure 
ethically responsible conduct of scientific research and healthcare 
delivery. Undertaking these duties, the Bioethics 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 Bioethics Commission is considering the distinct ethical issues 
raised by incidental findings in the contexts of clinical care, 
research, and direct-to-consumer testing. Emerging medical 
technologies, changing cost structures, and evolving medical practice 
make the likelihood of discovering incidental findings in the clinical, 
research, and direct-to-consumer contexts a growing certainty. At its 
meeting on April 30, 2013, the Bioethics Commission heard from 
ethicists, practitioners, and recipients of incidental findings in each 
of these contexts, and began its consideration of the ethical 
obligations that clinicians, researchers, and providers of direct-to-
consumer testing owe to patients, participants, and consumers.
    The Bioethics Commission is interested in receiving views of 
individuals, groups, and professional communities regarding the ethics 
surrounding incidental findings resulting from large-scale genetic 
testing, imaging, and testing of biological specimens in the clinical, 
research, and/or direct-to-consumer contexts. The Bioethics Commission 
is particularly interested in receiving public commentary regarding:
     Information about the likelihood of incidental findings 
arising in large-scale genetic testing, imaging, and testing of 
biological specimens in the clinic, research, and/or direct-to-consumer 
contexts and any case studies of such;
     What, if anything, patients, participants, and/or 
consumers should be told about incidental findings resulting from 
large-scale genetic testing, imaging, and testing of biological 
specimens before tests are conducted;
     Any duties or ethical obligations that clinicians, 
researchers, and direct-to-consumer companies might have to actively 
look for certain incidental findings;
     Best practices, methods, and mechanisms for determining 
when incidental findings ought to be returned to patients, 
participants, and/or consumers and how the return of these findings 
should occur;
     The acceptability of holding back information--such as 
establishing ``no return'' policies, or stipulations in advance of 
clinical intervention, research, and/or consumer interactions that no 
incidental findings will be returned; and,
     Any best practices or recommendations regarding incidental 
findings that apply no matter the type of test or context.
    To this end, the Commission is inviting interested parties to 
provide input and advice through written comments.
    Comments will be publicly available, including any personally 
identifiable or confidential business information that they contain. 
Trade secrets should not be submitted.

    Dated: May 22, 2013.
Lisa M. Lee,
Executive Director, Presidential Commission for the Study of Bioethical 
Issues.
[FR Doc. 2013-13329 Filed 6-4-13; 8:45 am]
BILLING CODE 4154-06-P