[Federal Register Volume 65, Number 10 (Friday, January 14, 2000)]
[Notices]
[Pages 2384-2386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-957]
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DEPARTMENT OF ENERGY
Office of Science Financial Assistance Program Notice 00-10;
Human Genome Program--Ethical, Legal, and Social Implications
AGENCY: Department of Energy.
ACTION: Notice inviting grant applications.
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SUMMARY: The Office of Biological and Environmental Research (OBER) of
the Office of Science (SC), 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). Applications should focus on issues of (1)
genetics and the workplace, (2) storage of genetic information and
tissue samples, (3) education, or (4) complex or multigenic traits. The
HGP is a coordinated, multidisciplinary, 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: Potential applicants are strongly encouraged to submit a brief
preapplication. All preapplications, referencing Program Notice 00-10,
should be received by 4:30 p.m., E.S.T., February 17, 2000. Early
submissions are encouraged. A response discussing the potential program
relevance and encouraging or discouraging a formal application
generally will be communicated within 20 days of receipt.
Formal applications submitted in response to this notice must be
received by 4:30 p.m., E.D.T., April 6, 2000, to be accepted for merit
review and to permit timely consideration for award in Fiscal Year
2000.
ADDRESSES: Preapplications, referencing Program Notice 00-10, should be
sent to: Dr. Daniel W. Drell, Office of Biological and Environmental
Research, SC-72, 19901 Germantown Road, Germantown, MD 20874-1290.
Formal applications, referencing Program Notice 00-10, should be
forwarded to: U.S. Department of Energy, Office of Science, Grants and
Contracts Division, SC-64, 19901 Germantown Road, Germantown, MD 20874-
1290, ATTN: Program Notice 00-10. 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. An original and seven copies of the application must be
submitted.
FOR FURTHER INFORMATION CONTACT: Dr. Daniel W. Drell, Office of
Biological and Environmental Research, SC-72, Office of Science, U.S.
Department of Energy, 19901 Germantown Road, Germantown, MD 20874-1290,
telephone: (301) 903-6488 or E-mail: daniel.drell@science.doe.gov. The
full text of Program Notice 00-10 is available via the Internet using
the following web site address: http://www.sc.doe.gov/production/
grants/grants.html.
SUPPLEMENTARY INFORMATION: The DOE encourages the submission of
applications that will address, analyze, or anticipate ELSI issues
associated with human genome research in four broad areas:
I. Genetics and the Workplace
Research is encouraged on the uses, impacts, implications of, and
privacy of genetic information in the workplace. A particular emphasis
of this solicitation is screening and monitoring programs that involve
the collection and evaluation of genetic information. Research is also
encouraged on the use of the workplace as a research venue. Research
could explore historical experiences, current practices,
[[Page 2385]]
international practices, the economics of, and lessons learned as they
pertain to the collection and use of worker genetic information.
Research can include issues arising from the creation, use,
maintenance, privacy and disclosure of genetic information obtained in
workplace settings that can include, but is not limited to, workplaces
at which DOE activities are taking place or have in the past.
II. Storage of Information and Samples
Research is encouraged on access to, and protection of genetic
information stored in databases (especially computerized databases), or
obtained from stored human tissue or sample archives. Research can
explore threats to, issues surrounding, and protection of the
confidentiality of genetic data in databanks and databases, ways to
anonymize existing or new genetic records and samples, to assess the
economics of genetic data collection, and to explore the intellectual
property protection of genetic information and genome research tools,
technologies, and resources.
III. Education
Research is encouraged to disseminate relevant 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 solicitation is the
provision of innovative and novel materials to Institutional Review
Boards (IRB) and Ethics Boards that review protocols involving the
gathering of genetic information or from genome investigators who work
with human subjects or materials from which human genetic information
can be obtained. Educational efforts should not target specific groups
that have already been the subject of past ELSI awards (for further
information about past awards under previous ELSI solicitations, see
http://www.ornl.gov/hgmis/resource/elsi.html#doe.)
IV. Complex or Multigenic Traits
Research is encouraged that addresses the ethical, legal, and
societal implications of advances in the scientific understanding of
complex or multi-genic characteristics and conditions, gene-environment
interactions that result in diseases or disease susceptibilities, and
human polymorphisms. In particular, the DOE is interested in studies
that explore the novel issues raised by research on complex conditions.
Such conditions may include, but are not limited to, behavioral
conditions, diseases of aging, vulnerability to substance abuse,
susceptibility to workplace exposure hazards, or other common
conditions with a partial genetic basis. In addition, research is
encouraged on the responses of institutions (e.g., courts, employers,
companies or company health officers, schools, etc., including Federal
Agencies) that must deal with ``genetic uncertainty,'' e.g.,
uncertainty about the significance of results of screening for
susceptibility genes, uncertainty about the role of yet-undefined
environmental influences, and uncertainty about the implications of
different alleles at highly polymorphic genes when those alleles are
not fully characterized.
All applications should demonstrate knowledge of the relevant
literature, any related completed activities, 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 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. 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.
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., privacy and access to research
materials, workplace uses of genetic information, education of targeted
groups such as IRBs and investigators, and susceptibility/sensitivity
genes, and polymorphisms. Educational and conference applications
should demonstrate awareness of the relevant literature, include
detailed plans for the accomplishment of project goals, and clearly
describe the outcome or ``deliverables'' from the activity. For
conference applications, a detailed and largely complete roster of
speakers is necessary. 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.
For all conferences supported under this notice, a summary report is
required following the conference. In applications that propose the
production of 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 requires inclusion of a plan for assessment of the
effectiveness of the proposed activities.
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. DOE generally discourages applications for local
efforts (e.g., college or school curricula that will not be widely
disseminated) and requests 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 toward the goals of the DOE Human Genome
Program. The OBER 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 OBER 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 time lines projecting progress toward
achieving proposed goals.
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Additional Request for Small Grants
The DOE also encourages small grant applications, to a maximum of
$33,000 total costs, for innovative and exploratory activities within
the previously described areas. Such exploratory grants could be used
to carry out pilot or investigative research on an issue consistent
with any of the above areas of ELSI research, support a sabbatical
leave to organize and hold a conference, or to initiate start-up
studies that could generate preliminary data for a subsequent grant
application. This program could be appropriate for a research scientist
interested in exploring a related area of ELSI research, or a scholar
conducting ELSI research of one type to explore an ELSI research topic
of a different type. Such applications must use the standard DOE
application forms which can be found on the Internet at: http://
www.sc.doe.gov/production/grants/grants.html, but the description of
research activities should not be more than five pages and curriculum
vitae should not exceed two pages. These small grants, which will be
peer reviewed, will not extend beyond one year from the award date. It
is expected that up to nine of these awards might be made in FY 2000.
As with larger applications to this notice, applications should be sent
to the address given above.
Program Funding
It is anticipated that approximately $1,200,000 will be available
for multiple grant awards including any small grants to be made during
Fiscal Year 2000, contingent upon the availability of appropriated
funds. Multiple year funding of grant awards is expected, and is also
contingent upon the 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 not applicable for any small grants as stated above.
Similar award sizes are anticipated for new grants. Generally,
conference awards do not exceed $25,000 and indirect costs are not
allowed as part of conference grant awards.
Collaboration
Applicants are encouraged to collaborate with researchers in other
institutions, such as: universities, industry, non-profit
organizations, federal laboratories and federally funded research and
development centers (FFRDCs), including the DOE National Laboratories,
where appropriate, and to incorporate cost sharing and/or consortia
wherever feasible. Additional information on collaboration is available
in the Application Guide for the Office of Science Financial Assistance
Program that is available via the Internet at: http://www.sc.doe.gov/
production/grants/Colab.html.
Preapplications
A brief preapplication should be submitted. The preapplication
should identify, on the cover sheet, the institution, Principal
Investigator name, address, telephone, fax and E-mail address, title of
the project, and the field of scientific research. The preapplication
should consist of a two to three page 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. Preapplications are strongly encouraged but not
required prior to submission of a full application. Please note that
notification of a successful preapplication is not an indication that
an award will be made in response to the formal application.
Applications will be subjected to a scientific merit review (peer
review) and will be evaluated against the following evaluation criteria
listed in descending order of importance as 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 may be used, and
submission of an application constitutes agreement that this is
acceptable to the investigator(s) and the submitting institution.
Information about development and submission of applications,
eligibility, limitations, evaluation, selection process, and other
policies and procedures may be found in 10 CFR part 605 and in the
Application Guide for the Office of Science Financial Assistance
Program. Electronic access to the Guide and required forms is made
available via the World Wide Web at: http://www.sc.doe.gov/production/
grants/grants.html. DOE is under no obligation to pay for any costs
associated with the preparation or submission of applications if an
award is not made. DOE policy requires that potential applicants adhere
to 10 CFR part 745 ``Protection of Human Subjects'', or such later
revision of those guidelines as may be published in the Federal
Register.
The Office of Science, as part of its grant regulations, requires
at 10 CFR 605.11(b) that a recipient receiving a grant and performing
research involving recombinant DNA molecules and/or organisms and
viruses containing recombinant DNA molecules shall comply with the
National Institutes of Health ``Guidelines for Research Involving
Recombinant DNA Molecules,'' which is available via the World Wide Web
at: http://www.niehs.nih.gov/odhsb/biosafe/nih/rdna-apr98.pdf, (59 FR
34496, July 5, 1994), 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 January 7, 2000.
John Rodney Clark,
Associate Director of Science for Resource Management.
[FR Doc. 00-957 Filed 1-13-00; 8:45 am]
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