[ RadSafe ] NIH Funds: Lg-Scale Studies: Genes & Environment in Common Disease

James G. Barnes james.g.barnes at att.net
Sun Mar 12 12:16:12 CST 2006

FYI.  From another listserver.

James Barnes

----- Original Message ----- 
From: "Gary Greenberg, MD" <gngreenberg at GMAIL.COM>
To: <Occ-Env-Med-L at MC.DUKE.EDU>
Sent: Sunday, March 12, 2006 4:37 AM
Subject: [OEM] NIH Funds: Lg-Scale Studies, Genes & Environment in Common

> http://grants1.nih.gov/grants/guide/rfa-files/RFA-HG-06-008.html
> Public Consultation to Inform the Design of Possible Large-Scale
> Studies of Genes and Environment in Common Disease (U01)
> Release Date: February 27, 2006
> Letters of Intent Receipt Date(s): April 10, 2006
> Application Receipt Date(s): May 10, 2006
> Executive Summary
> The purpose of this funding opportunity is to provide support for a
> specialized center to conduct a pilot public consultation study to
> obtain wide societal input to inform the design of a possible large
> U.S.-based longitudinal cohort study of the role of genes and
> environment in health and disease.
>     * Total amount to be awarded:  $1,550,000
>     * Anticipated number of awards:  1
>     * Type of mechanism:  U01 Cooperative Agreement
>     * Eligible organizations include:  For-profit organizations;
> non-profit organizations; public or private institutions, such as
> universities, colleges, hospitals, and laboratories; units of State
> government; units of local government; eligible agencies of the
> Federal government; domestic Institutions; and faith-based or
> community-based organizations.
>     * Eligible principal investigators include:  Any individual with
> the skills, knowledge, and resources necessary to carry out the
> proposed research is invited to work with their institution to develop
> an application for support. Individuals from underrepresented racial
> and ethnic groups as well as individuals with disabilities are always
> encouraged to apply for NIH programs.
>     * Applicants may submit more than one application, provided they
> are scientifically distinct.
>     * See Section IV.1 for application materials.
>     * Telecommunications for the hearing impaired is available at: TTY
> 301-451-0088
> 1. Research Objectives
> Purpose
> The purpose of this funding opportunity is to provide support for a
> specialized center to conduct a pilot public consultation study to
> obtain wide societal input to inform the design and implementation of
> one or more possible large U.S. population-based studies, including a
> longitudinal cohort study, of the role of genes and environment in
> health and disease.
> The goal of the longitudinal cohort study, should it eventually
> materialize, would be to ascertain and quantify the major
> environmental and genetic contributors to common illnesses.  The study
> would analyze environmental exposures, genetic risk factors,
> lifestyle, and medical experiences of a cross-section of America of
> unprecedented size and scope (approximately 500,000 or more
> participants).  Such an initiative, while having great potential for
> developing prevention and intervention efforts that use new,
> genome-based knowledge, would be maximally useful if the research
> participants reflect the diverse makeup of the United States and there
> is general education and engagement of the public in such an
> initiative.  Thus, not only the implementation of such an initiative,
> but its very design, will need to be informed by the active input of a
> broad array of American society.
> The goal of the pilot public consultation study is to obtain
> preliminary vital input relevant to the design and implementation of
> such an initiative, by methodologies such as surveys, focus groups,
> and public meetings with participants who reflect the broad
> demographic makeup of the study cohort envisioned.  The findings from
> these activities will be used to assess public attitudes regarding
> this type of population research: to identify preconceptions and
> concerns; define expectations about privacy protections, return of
> results, and other matters; and inform full-scale efforts for public
> consultation with the specific communities selected for study, should
> such an initiative eventually be launched.  The findings will also be
> used to help develop educational and recruitment materials for
> subjects in such research.
> Background
> Information from the Human Genome Project will be vital for helping to
> define the genetic and environmental factors that contribute to health
> and disease.   In addition to well-designed case-control studies of
> people with and without a particular disease, rigorous and unbiased
> conclusions about the causes of diseases and their population-wide
> impact will require a large representative population to be monitored
> over time. Thus, it has been suggested that the United States should
> consider a large U.S. longitudinal cohort study of genes and
> environment in health and disease.  (See FS Collins, The case for a US
> prospective cohort study of genes and environment, Nature, vol. 429,
> May 27, 2004.)
> The National Human Genome Research Institute (NHGRI), in collaboration
> with several other NIH Institutes, commissioned a group of experts in
> genetics, epidemiology, biostatistics, and ethical, legal, and social
> issues in genetic research to examine the scientific foundations and
> broad logistical outlines of a hypothetical U.S. cohort study of
> genes, environment, and health.  Although funding for such an endeavor
> has not been (and may never be) identified, carefully outlining and
> considering the goals and key design aspects of such a study was
> deemed of high scientific importance.  A summary of the
> recommendations of this expert panel can be found in its report,
> "Design considerations for a potential United States population-based
> cohort to determine the relationships among genes, environment, and
> health:  Recommendations of an expert panel," available at
> http://www.genome.gov/13014436.
> In October 2005 the Secretary's Advisory Committee on Genetics,
> Health, and Society (SACGHS) held a day-long discussion regarding a
> possible large U.S.-based longitudinal cohort study of the role of
> genes and environment in common disease.  A transcript of the SACGHS
> deliberations can be found at
>  The outcome of the SACGHS discussion was that broad-based public
> engagement and input into design and implementation of such an
> initiative would be essential.  SACGHS recommended that a pilot study
> to assess public attitudes about such studies and about certain
> aspects of the proposed study design would be an important first step
> toward engaging the public in this type of research.
> Methodologies to be Used for the Pilot Public Consultation Study
> Based on the recommendations of SACGHS and of the NHGRI expert panel,
> this announcement solicits proposals for a specialized center to
> conduct an effort to obtain preliminary public input into such an
> initiative through several methodologies.  The methods should be
> proposed by the applicant to maximize the validity and usefulness of
> the information obtained, but in general, would be expected to include
> surveys, focus groups, and public meetings designed to explore a wide
> range of relevant issues.  Such issues may include, but are not
> necessarily limited to, the following:
>     * Acceptability of goals of the initiative for U.S. as a whole
>     * Concerns regarding uses of data, for individuals, communities,
> and the public at large
>     * Expectations about privacy protection
>     * Acceptability of open-ended consent
>     * Acceptability of central IRB
>     * Optimal approaches to recruitment, particularly regarding
> identifying and contacting family members
>     * Need for tailoring to individuals or communities with special needs
>     * Expectations about return of information to individuals,
> communities, and the public at large
>     * Need for on-going dialog with participants regarding study goals
> and processes
>     * Advisability of including or excluding children
>     * Intellectual property concerns
> It is anticipated that the pilot public consultation study conducted
> by the specialized center supported by this announcement will not be
> the only effort undertaken to consult the public or engage the
> relevant communities should such population research be undertaken.
> More targeted forms of community engagement, directed at the specific
> communities from which the participants will be recruited, would
> eventually be implemented based on this pilot work if this population
> research were to proceed.  This pilot work is thus intended primarily
> to assess the views of a broad range of the American public regarding
> the relevant issues, and should not be viewed as the sole means by
> which public input will eventually be obtained.
> The surveys and focus groups conducted by the specialized center
> should include a diverse range of geographic locations across the
> U.S., both urban and rural, and should be aimed at both men and women
> of various ages from a range of educational, occupational,
> socioeconomic, racial, and ethnic backgrounds.  Technological
> innovations designed to facilitate the reaching of a wide-ranging
> sample of participants are particularly encouraged.  The public
> meetings should be held in varied locations and should include ones
> sited and arranged specifically to involve underrepresented and
> minority communities.  These meetings should be designed to provide
> opportunities for dialogue, airing of concerns, and the identification
> of research questions of particular interest.
> The findings of each of the elements of the pilot public consultation
> study (surveys, focus groups, and public meetings), should be analyzed
> as they proceed, and an overall analysis of the findings should be
> conducted.  Preliminary analyses of the full data set should be
> completed by September 2008 so that they can be incorporated into the
> design of the longitudinal cohort study, its full-scale public
> consultation component, and other population-based studies should they
> be determined to be feasible and should they be funded within the next
> few years.
> It is anticipated that the specialized center supported by this
> announcement will work closely with representatives of the funding
> agency in designing the survey instruments, the focus group guides,
> the final protocols for the public meetings, and related materials.
> The specialized center will be expected to cooperate closely with the
> funding agency representatives.
> See Section VIII, Other Information - Required Federal Citations, for
> policies related to this announcement.
> ...
> --
> Gary N. Greenberg, MD MPH    Sysop / Moderator Occ-Env-Med-L MailList
> Duke Univ. Med. Ctr.   &   Univ. N. Carolina School Public Health
> GNGreenberg at gmail.com                       http://occhealthnews.net
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