[Federal Register Volume 62, Number 41 (Monday, March 3, 1997)]
[Notices]
[Pages 9419-9420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5131]
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DEPARTMENT OF ENERGY
Office of Energy Research
Energy Research Financial Assistance Program Notice 97-11: Human
Genome Program--Ethical, Legal, and Social Implications
AGENCY: U.S. Department of Energy.
ACTION: Notice inviting grant applications.
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SUMMARY: The Office of Health and Environmental Research (OHER) of the
Office of Energy Research (ER), U.S. Department of Energy (DOE), hereby
announces its interest in receiving applications in support of the
Ethical, Legal, and Social Implications (ELSI) subprogram of the Human
Genome Program (HGP). The HGP is a coordinated, multi disciplinary,
directed research effort aimed at obtaining a detailed understanding of
the human genome at the molecular level. This particular research
notice invites research grants that address ethical, legal, and social
implications from the use of information and knowledge resulting from
the HGP.
DATES: Preapplications referencing Program Notice 97-11 should be
received by April 17, 1997. Formal applications submitted in response
to this notice must be received by 4:30 p.m., E.D.T., July 10, 1997, to
permit timely consideration for awards in Fiscal Year 1998.
ADDRESSES: Preapplications referencing Program Notice 97-11 should be
sent to Dr. Daniel W. Drell, Health Effects and Life Sciences Research
Division, ER-72, Office of Health and Environmental Research, Office of
Energy Research, U.S. Department of Energy, 19901 Germantown Road,
Germantown, MD 20874-1290. Formal applications referencing Program
Notice 97-11 should be forwarded to: U.S. Department of Energy, Office
of Energy Research, Grants and Contracts Division, ER-64, 19901
Germantown Road, Germantown, MD, 20874-1290. ATTN: Program Notice 97-
11. This address also must be used when submitting applications by U.S.
Postal Service Express Mail or any commercial mail delivery service, or
when hand carried by the applicant.
FOR FURTHER INFORMATION CONTACT:
Dr. Daniel W. Drell, Health Effects and Life Sciences Research
Division, ER-72, Office of Health and Environmental Research, Office of
Energy Research, U.S. Department of Energy, 19901 Germantown Road,
Germantown, MD 20874-1290, phone: (301) 903-6488 or E-mail:
[email protected].
SUPPLEMENTARY INFORMATION: The DOE encourages the submission of
applications that will address, analyze, or anticipate ELSI issues
arising from advances in the scientific understanding of genetically
influenced susceptibilities/sensitivities, complex or multi-genic
characteristics and conditions, and human polymorphisms. This may
include research on privacy and confidentiality issues (as well as
ownership and commercialization issues) arising from the creation, use,
maintenance, and disclosure of genetic information relevant to such
complex or multi-genic conditions. This may also include research on
the privacy implications of the development of HGP materials,
resources, databases and technologies, as well as the privacy
implications of the use of genetic information obtained in the
workplace. Issues to be examined may also include (but are not limited
to) implications of advances in the genetic characterization of complex
traits and susceptibility/sensitivity genes and the impacts of advances
in knowledge about polygenic conditions for individuals and communities
potentially faced with these impacts (e.g. courts, schools, etc).
Applications should demonstrate knowledge of the relevant
literature, and should include detailed plans for the gathering and
analysis of factual information and the associated ethical, legal, and
social implications. All applications should include, where
appropriate, detailed discussion of human subjects protection issues;
e.g., storage of, manipulation of, and access to data. Provisions to
ensure the inclusion of women, minorities, and potentially disabled
individuals must be described, unless specific exclusions are
scientifically necessary and justified in detail. All proposed research
applications should address the issue of efficient dissemination of
results to the widest appropriate audience. All applications should
include letters of agreement to collaborate from potential
collaborators; these letters should specify the contributions the
collaborators intend to make if the application is accepted and funded.
The DOE also solicits applications for the preparation and
dissemination of educational materials in any appropriate medium that
will enhance understanding of the ethical, legal, and social aspects of
the HGP among the public or specified groups; a particular interest of
this notice is Institutional Review Boards (IRBs) and genome
investigators who work with patients. This may include (but is not
limited to) implications of disease predispositions, susceptibility
genes, increased knowledge of polygenic conditions, informed consent
issues or Human Genome Project materals- and resources-development and
dissemination projects (e.g. the creation of a human DNA library,
etc.). If an educational effort for a specific group is proposed, the
value to the Human Genome Program of that group or community should be
explained in detail. In addition, the DOE encourages applications for
the support of novel and innovative conferences focusing on the
concerns addressed in this notice (e.g. susceptibility/sensitivity
genes, polymorphisms, and education of IRBs and investigators).
Educational and conference applications should demonstrate
awareness of the relevant literature, and include detailed plans for
the accomplishment of project goals. In applications that propose the
production of series for broadcast, audio-visuals or other educational
materials, the DOE requests that samples of previous similar work by
the producers and writers be submitted along with the application. In
applications for the support of educational activities, the DOE
requests inclusion of a plan for assessment of the effectiveness of the
proposed activities. For conference applications, a detailed and
largely complete roster of speakers is necessary. At the completion of
the conference, a summary or report is required. Educational and
conference applications must also demonstrate awareness of the need to
reach the widest appropriate audience, and not be focused exclusively
on a local community or group.
Possible outcomes of these research and/or educational efforts may
include (but are not limited to): model guidelines for research
practices for studies of polygenic conditions and susceptibility genes;
consensus documents on implications or significance of the genetic
bases for
[[Page 9420]]
complex conditions; privacy and confidentiality studies of genetic
information pertinent to complex conditions; model policies for genetic
information about polygenic conditions for various settings (e.g. the
workplace); exploration of worker/workplace issues; and materials for
IRBs.
In all applications, a clear description of expected products or
``deliverables'' should be included, as well as a time line for their
production and dissemination. In the absence of tangible products,
rigorous assessments must be included to facilitate evaluation of
progress.
DOE does not encourage applications dealing with issues consequent
to the initiation or implementation of genetic testing protocols. Also,
DOE does not encourage survey-based research, unless a compelling case
is made that this methodology is critical to address an issue of
uncommon significance. For applications which propose the development
of college-level curricula, DOE requests both detailed justification of
the need for external support, beyond normal departmental and college
resources, evidence of commitment from the parent department or
college, and a dissemination plan. Applications for the writing of
scholarly publications or books should include justifications for the
relevance of the publications or book to the goals of the Human Genome
Project as well as discussion of the estimated readership and impact.
DOE ordinarily will not provide unlimited support for a funded program
and thus strongly encourages the inclusion of plans for transition to
self-sustaining status.
The dissemination of materials and research data in a timely manner
is essential for progress towards the goals of the DOE Human Genome
Program. The OHER requires the timely sharing of resources and data.
Applicants should, in their applications, discuss their plans for
disseminating research results and materials that may include, where
appropriate, publication in the open literature, wide-scale mailings,
etc. Once OHER and the applicant have agreed upon a distribution plan,
it will become part of the award conditions. Funds to defray the costs
of disseminating results and materials are allowable; however, such
requests must be sufficiently detailed and adequately justified.
Applicants should also provide timelines projecting progress toward
achieving proposed goals.
Potential applicants are strongly encouraged to submit a brief
preapplication that consists of two to three pages of narrative
describing the research project objectives and methods of
accomplishment. These will be reviewed relative to the scope and
research needs of the DOE's Human Genome Program. Principal
investigator address, telephone number, FAX number and E-mail address
are required parts of the preapplication. A response to each
preapplication discussing the potential program relevance of a formal
application generally will be communicated within 20 days of receipt.
ER's preapplication policy for submitting preapplications can be found
on ER's Grants and Contracts Web Site at: http:/www.er.doe.gov/
production/grants/preapp.html.
It is anticipated that approximately $1,500,000 will be available
for grant awards in this area during FY 1998, contingent upon
availability of appropriated funds. Multiple year funding of grant
awards is expected, and is also contingent upon availability of funds.
Previous awards have ranged from $50,000 per year up to $500,000 per
year with terms from one to three years; most awards average about
$200,000 per year for two or three years. Similar award sizes are
anticipated for new grants. Applications will be subjected to formal
merit review (peer review) and will be evaluated against the following
evaluation criteria which are listed in descending order of importance
codified at 10 CFR 605.10(d):
1. Scientific and/or Technical Merit of the Project.
2. Appropriateness of the Proposed Method or Approach;
3. Competency of Applicant's personnel and Adequacy of Proposed
Resources;
4. Reasonableness and Appropriateness of the Proposed Budget.
The evaluation will include program policy factors such as the
relevance of the proposed research to the terms of the announcement and
an agency's programmatic needs. Note, external peer reviewers are
selected with regard to both their scientific expertise and the absence
of conflict-of-interest issues. Non-federal reviewers will often be
used, and submission of an application constitutes agreement that this
is acceptable to the investigator(s) and the submitting institution.
To provide a consistent format for the submission, review and
solicitation of grant applications submitted under this notice, the
preparation and submission of grant applications must follow the
guidelines given in the Application Guide for the Office of Energy
Research Financial Assistance Program 10 CFR Part 605. Access to ER's
Financial Assistance Application Guide is possible via the World Wide
Web at: http:/www.er.doe.gov/production/grants/grants.html.
DOE policy requires that potential applicants adhere to 10 CFR 745
``Protection of Human Subjects'', or such later revision of those
guidelines as may be published in the Federal Register.
The Catalog of Federal Domestic Assistance Number for this program
is 81.049, and the solicitation control number is ERFAP 10 CFR Part
605.
Issued in Washington, DC, on February 25, 1997.
John Rodney Clark,
Associate Director, for Resource Management, Office of Energy Research.
[FR Doc. 97-5131 Filed 2-28-97; 8:45 am]
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