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NIH: SACGHS PUBLIC COMMENT
SOLICITATION
Dear Colleague:
On behalf of the Secretary's Advisory Committee
on Genetics, Health, and Society (SACGHS), I am
writing to request your input on the Committee's
draft report, Policy Issues Associated with
Undertaking a Large U.S. Population Cohort Project
on Genes, Environment, and Disease. A copy of the
report is available electronically at http://www4.od.nih.gov/oba/SACGHS/public_comments.htm
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
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, M.D., 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. A
central theme of the report is that decisions about
such a project must take account of public views
and attitudes and that public engagement must be
sought in planning for and implementing a large
population project.
SACGHS would welcome your comments on any aspect
of the draft report. In particular, the Committee
would appreciate your 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 by email to mehrotraa@od.nih.gov
by fax to 301-496-9839, or by mail to Secretary's
Advisory Committee on Genetics, Health, and
Society, attn: 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.
In light of the wide range of public policy
issues and questions raised in the draft report,
SACGHS hopes to receive input from the wide range
of individuals, communities and groups who may have
an interest in whether a large population cohort
project is undertaken in the U.S. If you have
colleagues who may wish to comment on the draft
report or know of other individuals, communities,
or groups that might be interested in the issue,
please forward a copy of this letter to them.
Reed V. Tuckson, M.D.
Chair
Secretary's Advisory Committee on Genetics, Health,
and Society (SACGHS)
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