[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: 
<a href="/cdn-cgi/l/email-protection#aecacfc0c7cbc280cadccbc2c2eec1cbdc80cac1cb80c9c1d8"><span class="__cf_email__" data-cfemail="1c787d7275797032786e7970705c73796e32787379327b736a">[email protected]</span></a>.

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:/<a href="http://www.er.doe.gov/
production/grants/preapp.html">www.er.doe.gov/
production/grants/preapp.html</a>.
    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]
BILLING CODE 6450-01-M


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