Lori Williamson, MS, CGC


FYI  (from Lori Williamson)



Secretary's Advisory Committee on Genetics, Health, and Society

REQUEST FOR PUBLIC COMMENT
Draft Report on Policy Issues Associated with Undertaking a
Large U.S. Population Cohort Project on Genes, Environment, and Disease

**************************

The Secretary's Advisory Committee on Genetics, Health, and Society
(SACGHS)
is seeking public input on a draft report, Policy Issues Associated with
Undertaking a Large U.S. Population Cohort Project on Genes,
Environment,
and Disease.

The draft report is available electronically at
<http://www4.od.nih.gov/oba/sacghs/public_comments.htm>.
In a 2004 priority-setting process, SACGHS determined that opportunities
and
challenges associated with conducting large population cohort studies
aimed
at understanding the relationships of genes, the environment, and
common,
complex diseases warranted in-depth study.  The Director of the National
Institutes of Health (NIH), Elias A. Zerhouni, specifically requested
SACGHS's advice on the scientific, public, and ethical processes and
pathways that might help NIH or HHS make decisions about undertaking
such an
effort.  Dr. Zerhouni specified that the Committee could be most helpful
to
the Secretary by conducting an inquiry that includes the following
steps:
	*	Step 1:  Delineate the questions that need to be
addressed
in order for policymakers to determine whether the U.S. Government
should
undertake, in any form, a large population project to elucidate the
influence of genetic variation and environmental factors on common,
complex
disease.
	*	Step 2:  Explore the ways in which, or processes by
which,
the questions that are identified in Step 1 can be addressed, including
the
need for any intermediate research studies, pilot projects, or policy
analysis efforts. 
	*	Step 3:  Taking into account the possible ways in which
the
questions could be addressed, determine which approaches are optimal and
feasible and recommends a specific course of action for moving forward.
SACGHS's draft report focuses on preliminary and intermediate questions,
steps, and strategies in five areas that should be addressed before an
informed decision can be made about whether the United States should
undertake a large population cohort project on the interaction of genes,
environment and disease.  These five areas are research policy, research
logistics, regulatory and ethical issues, public health implications of
research results, and social implications of research results.  The
report
also identifies options for how these issues might be addressed.
Comments on any aspect of the draft report are welcome.  In particular,
the
Committee would appreciate the public's assessment of whether:  
	1)	The policy issues identified in the draft report are
appropriately focused; 
	2)	Any policy issues have been overlooked; and, 
	3)	The issues are organized in appropriate categories and
addressed in such a way as to give policymakers sufficient understanding
of
why the issue is important.  
In addition, the Committee would value feedback on the sections of the
draft
report that discuss the importance of public engagement and the
mechanisms
that could be employed to achieve such engagement.   
Please address comments to Reed V. Tuckson, M.D., SACGHS Chair, and send
them to Ms. Amita Mehrotra at [log in to unmask]
<mailto:[log in to unmask]>.  Comments may also be sent by fax to
301-496-9839 or by mail to:
Secretary's Advisory Committee on Genetics, Health, and Society
ATTENTION:  Ms. Amita Mehrotra
NIH Office of Biotechnology Activities
6705 Rockledge Drive, Suite 750
Bethesda, MD 20892 (20817 for non-US Postal Service mail)

In order to be considered in the development of the final report,
comments
should be submitted by close of business Monday, July 31, 2006.
SACGHS was established by the Department of Health and Human Services
(HHS)
to serve as a public forum for deliberations on the broad range of human
health and societal issues raised by the development and use of genetic
and
genomic technologies and, as warranted, to provide advice on these
issues.
For more information about the Committee, please visit
<http://www4.od.nih.gov/oba/sacghs.htm>.

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