and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
CENTERS FOR EXCELLENCE IN ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS
(ELSI) RESEARCH (CEER)
RELEASE DATE: August 13, 2003
RFA Number: RFA-HG-03-005
Update: The following update relating to this announcement has been issued:
January 8, 2009 - This RFA has been reissued as (RFA-HG-09-003).
(Reissued as RFA-HG-06-025).
(See Clarification NOT-HG-04-001).
National Human Genome Research Institute (NHGRI)
(http://www.genome.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.172
LETTER OF INTENT RECEIPT DATE: October 27, 2003
APPLICATION RECEIPT DATE: November 24, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The Ethical, Legal, and Social Implications (ELSI) Research Program of
the National Human Genome Research Institute (NHGRI) invites center
grant applications (P50 and P20) for the development of Centers of
Excellence in ELSI Research (CEERs). These CEERs will bring
investigators from multiple disciplines together to work in innovative
ways to address important new, or particularly persistent, ethical,
legal, and social issues related to advances in genetics and genomics.
This solicitation is intended to augment NHGRI's ELSI regular research
grants program by supporting research activities that cannot be
effectively supported by R01 and other research grant mechanisms
currently available. NHGRI remains committed to supporting single
investigator-initiated projects that use the R01, R03, and other
appropriate grant mechanisms, and the research consortium strategy for
encouraging interaction among investigators working in an area. The
current list of ELSI funding opportunities can be found online at:
http://www.genome.gov/page.cfm?pageID=10000930.
RESEARCH OBJECTIVES
Background and Significance
In April 2003, the last of the original goals of the Human Genome
Project, the sequencing of the human genome, was finished, marking the
culmination of this historic biomedical research enterprise. The
attention of the biomedical research community is now turning to the
interpretation of this fundamental source of knowledge about human
biology and to the development of approaches for applying genomics to
improving human health and preventing disease. With this changing
focus, new ELSI issues will inevitably arise, with regard to both
accomplishing the necessary research and applying the new knowledge.
Thus, a vigorous program of ELSI research, the results of which will
inform policy development deliberations, will continue to be an
essential component of genomics research.
To date, the NHGRI ELSI Research Program has funded a large number of
research grants from investigators in a wide range of disciplines.
Many of these projects have used interdisciplinary approaches to
investigate important ELSI questions. While considerable progress has
been made on ELSI issues, much remains to be done. In addition, as the
pace of genomic and genetic research increases, the development of
research teams that have the expertise and flexibility to respond
rapidly to the large number of emerging and evolving ELSI issues is
critical. All of these factors contribute to a need for new and more
innovative approaches, including new organizational structures and
funding mechanisms, to carry out ELSI research. The creation of
research centers with the resources and expertise to design and
implement multi-faceted and multi-disciplinary investigations of
particularly complex, persistent or rapidly emerging ELSI issues will
be an important addition to ongoing genetic, genomic and ELSI research
efforts.
Scope of Research
The CEER program is designed to support the development of a research
group that will identify and investigate ELSI research questions that
can best be approached through intensive and extended collaboration
among investigators from multiple disciplines, using diverse
methodologies. The investigators in a CEER will be encouraged to
consider new ways to explore these questions, design innovative and
efficient research projects, propose and disseminate health or social
policy options based on Center research and, when feasible, facilitate
policy development pertinent to a specific issue. Center applicants
are particularly encouraged to identify cutting edge research topics
and approaches that have the possibility of leading to high payoff
solutions to important ELSI problems.
A CEER must identify a theme around which it will be organized. The
research agenda should be focused on a single issue or set of related
issues. CEER themes could be related to one or more of the Grand
Challenges identified in the NHGRI vision document, "A Vision for the
Future of Genomics Research" (Nature (2003) 422: 835-847), also
available at: http://www.genome.gov/11006873. In addition, applicants
can suggest other significant ELSI challenges that extend beyond those
identified in the document above. Following are examples of possible
CEER research topics. They are only examples.
o Genetic Privacy and Discrimination in Medical and Non-medical
settings. (Grand Challenge III-1). Although a substantial amount of
research and policy development has been done on the potential for
insurance or employment discrimination based on genetic information,
this topic remains one of the public's most persistent concerns. A
Center focused on this issue could develop a multi-disciplinary team
to: survey existing research data and relevant policies; examine in
greater depth the ethical, social, cultural and psychological factors
underlying the persistence of these concerns; analyze the legal,
political and economic issues affecting the development and
implementation of relevant state and Federal legislation; examine the
impact of this legislation on the attitudes, behavior and decision
making of individuals and insurance companies or employers; and, based
on these investigations, develop recommendations for the modification
of existing policies or the development of new, more effective
policies.
o Ethical, Legal and Social Factors that Influence the Translation of
Genetic Information to Improved Human Health (Grand Challenges II-5,
II-6 and III-1). Examples of projects in this area would include
analysis of the issues surrounding access to and use of genetic
information and technologies to improve human health. A CEER focused
on this theme could bring its multi-disciplinary research team together
to identify the most likely scenarios for the diffusion of genetic
technologies into health care, including estimation of a timeline;
conduct research to examine factors that will influence utilization,
such as costs, access, and barriers to access; and develop guidance for
the fair use of new genetic technologies in the health care system.
o Issues Surrounding the Conduct of Genetic Research (Grand Challenge
III-1). Much effort has gone into developing guidance for the ethical
conduct of genetic research, including the use of stored tissue
specimens, community consultation when conducting genetic research with
identifiable populations, and obtaining the consent of family members
whose information may be obtained (or even unintentionally discovered)
through the course of research. Studies are needed to examine the
impact of these existing guidelines and practices. Do they adequately
protect research participants? Do they create unnecessary barriers to
the conduct of ethically and scientifically sound research? In
addition, new challenging ethical issues in genomic and genetics
research continue to arise, for which little guidance exists. The
increasing availability and accessibility of large amounts of genetic
information in public databases creates new concerns about protecting
the privacy of individual research participants while at the same time
ensuring access to the data for research purposes. The availability of
this information also raises issues such as how best to ensure that
this data is not used to draw inaccurate or unwarranted conclusions
about individuals or populations. In addition, the continued
development and use of multiplex genetic testing platforms raises
questions about the appropriate handling of findings that are difficult
to interpret or incidental findings that may have unanticipated
implications for research participants. A CEER focused on these themes
could utilize the multi-disciplinary resources of the Center to
identify where the most pressing ethical issues will come from in the
future; explore how best to address these issues; conduct primary data
collection and analysis or secondary analysis of existing data, as
needed; and develop recommendations and a multi-faceted plan for
dissemination which may result in the development of new research
ethics guidance.
o The Impact of Genomics on Concepts of Race, Ethnicity, Kinship and
Individual and Group Identity (Grand Challenge III-2). A Center focused
on this topic could explore how different individuals and cultures
conceive of race, ethnicity, kinship, group identity and self-identity;
how those perceptions may influence the direction and framing of
genetic and genomic research questions; how the findings are
interpreted and presented to the public; and how the public understands
these concepts. The CEER team could then develop guidance for
researchers, media, educators, or policy makers on how to responsibly
and appropriately interpret and use these concepts and the data
generated from this type of research.
Although aspects of each of these issues could be addressed through
regular (R01) or small (R03) research grants, the CEER program will
allow researchers to propose truly interdisciplinary, innovative and
comprehensive approaches to exploring and addressing these issues. To
further clarify the unique nature of the CEER program, the following
list of attributes of a successful CEER application is provided.
A successful CEER will:
o promote intensive and sustainable interactions among basic genomic
and genetic scientists, clinical and social scientists, and researchers
from law, bioethics and the humanities;
o be highly innovative and develop new concepts, methods, analyses,
or ways to consider ELSI issues that will substantially advance the
state of the art in ELSI;
o propose a very substantial advance to addressing a critical issue
in ELSI research. (Achieving a substantial advance can entail
addressing potentially controversial issues or identifying and
exploring issues surrounding emerging technologies that are not yet in
common use. It also can involve the use of new or unproven approaches
or methodologies. These high risk issues and methodologies should be
balanced by the potential for very high payoff and will require a
detailed plan and a very effective management strategy.);
o encompass, as appropriate, the full spectrum of ELSI research from
'basic' analytical investigations that develop conceptual tools and
shared vocabularies to data generating qualitative and quantitative
studies to more 'applied', 'translational' approaches that use these
conceptual tools and data to explore and define appropriate public-
policy options or research or health care guidelines (These policy
options and guidelines must incorporate diverse points of view,
including, as appropriate, communities that may be particularly
vulnerable or disproportionately affected by the issues being
addressed.);
o propose research that cannot be reasonably addressed by a standard
R01 Research Grant (As multidisciplinary collaborations on the core
research continue, additional funding may be sought through the ELSI
regular research and small research grant programs to support other
related research.);
o add value beyond activities in genomics or in ELSI research that
might already be ongoing at the applying institution;
o include a strategy for disseminating the results of the Center's
research;
o increase the pool of ELSI researchers, by offering innovative,
substantive training opportunities across appropriate disciplines. It
will integrate the training of new investigators and broaden the
training of established investigators; and
o help ameliorate the ELSI community's shortage of investigators from
underrepresented minority communities (African Americans, Alaskan
Natives, Hispanic Americans, Native Americans, Pacific Islanders) by
developing effective opportunities to recruit and encourage members of
these communities to develop as independent ELSI investigators.
A CEER will NOT:
o simply continue research already being pursued by the team, or by
others;
o serve as the obvious next step in a project or field, which could
be accomplished by assembling state-of-the-art components and
innovating at the level of a typical R01;
o be a program project; or
o provide infrastructure for an existing program or department.
MECHANISM OF SUPPORT
This RFA will use the Specialized Center (P50) and Exploratory (P20)
grant mechanisms. Responsibility for planning, direction, and
execution of the proposed project will be solely that of the applicant.
This RFA is a one-time solicitation with a receipt date of November 24,
2003. However, NHGRI plans to release this announcement as a Program
Announcement in 2004. The anticipated award date for this RFA is July
2004.
A high priority under this program is the establishment of new academic
Centers in which state-of-the-art ELSI research can be conducted. At
some institutions, the nucleus of a well-functioning collaborative
research group that could conduct the research described in this RFA
may already exist, and such groups will be able to submit suitable P50
applications for this program directly. However, some groups of
investigators may require an opportunity to collect preliminary data,
enhance their collaborative network by strengthening and establishing
new multi-investigator or interdisciplinary relationships, demonstrate
effective collaborations, explore organizational concepts, develop
courses or curricula, or refine and fully develop the vision of the
proposed P50 CEER project. The Exploratory Grant (P20) mechanism
should be used when the applicant wishes to request a period of
planning and preliminary investigation prior to preparing a P50 Center
application.
P50 Specialized Center Grants
A P50 Center grant application may request up to five years of support.
The length of award will be determined through the peer review and
Council advisory processes. Genomics and genetics research is
constantly evolving, and it is anticipated that most Center projects
focusing on related ELSI issues are likely to have a limited lifetime
during which support as a CEER will be appropriate, either because the
project goals will have been accomplished or the Center will have
developed to the point that support from another source will be more
appropriate. Therefore, except in exceptional circumstances, the total
length of support for any P50 Center under this program will not exceed
ten years (the initial grant period of up to five years, plus one
renewal for up to an additional five years).
Each CEER will have annual administrative site (or reverse site)
visits. After the site visit of the third year, a decision will be
made about whether a fifth year of funding will be provided to the
Center. Further, at that review, the Principal Investigator (P.I.)
will receive advice about the NHGRI's interest in accepting a competing
renewal application to extend the initial award. The requested budget
for a CEER may be up to $750,000 in direct costs for the first year for
continuing operations (e.g., personnel, standard office equipment,
supplies, travel and other expenses). Future year budgets may exceed
$750,000 for inflationary adjustments. Under this cap, it is
anticipated that the size of the awards will vary because the nature
and scope of research programs will vary. To accommodate collaborations
that extend beyond single institutions, Facilities & Administrative
(F&A) charges on the subcontracts, which are formally direct costs to
the parent institution, will be excluded in considering the $750,000
operating costs limit.
P20 Exploratory Grants
The planning grant application must explicitly demonstrate how the
planning activities will lead to the P50 application, and describe in
substantial detail a vision of the research to be conducted under the
subsequent P50 grant. The planning grant budget may request funds for
partial salary of key investigators, travel, and some supplies and
equipment. Planning grants will be awarded for up to three years and up
to $150,000 direct cost per year. A planning grant is not required as a
precursor to a P50 Center application. Funding of a planning grant does
not obligate NHGRI to fund a subsequent P50 Center grant.
FUNDS AVAILABLE
NHGRI intends to commit approximately $3,000,000 (total costs) in FY
2004 to fund 2-3 Specialized Centers (P50s) and 2-3 Exploratory Centers
(P20s) in response to this RFA. An applicant may request a project
period of up to 5 years for a P50 and up to 3 years for a P20 and a
budget for direct costs of up to $750,000 per year (excluding F&A costs
on subcontracts) for a P50 and up to $150,000 per year for a P20.
Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of
the NHGRI provide support for this program, awards pursuant to this RFA
are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o Non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic
o Faith-based or community-based organizations
Foreign institutions are not eligible to apply. However, subcontracts
to foreign institutions will be considered.
Investigators from majority institutions are encouraged to consider
partnering with minority-serving institutions.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
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.
SPECIAL REQUIREMENTS
Consortium participation: Annual meetings of investigators from funded
Centers will be held. This will facilitate sharing of information about
current and planned activities as well as communication of research
findings and policy deliberations (and about experience in organizing
and operating a CEER). Such meetings will encourage collaboration among
Centers, reduce duplication of effort, and promote more rapid
dissemination of knowledge and information. The initial meeting will
take place shortly after the Center grants are funded. Funds for travel
to these meetings for up to four investigators (the PI and three
others) per year should be included in the requested budget.
Multidisciplinary and diverse research teams: The CEER program is
intended to facilitate the formation of multidisciplinary teams of
investigators who will develop new ways to frame and investigate ELSI
research questions. These research teams may include basic genomic and
genetic scientists, clinical and social scientists, and researchers
from law, bioethics and the humanities. However, it is essential that
the theme be well anchored in genomic and genetic sciences. NHGRI
particularly encourages the involvement of minority serving
institutions and investigators from minority populations and those with
disabilities.
Management and organization: A CEER will include a well-integrated
project plan. The application should describe the specific
organizational structure that will be used to support the research, and
the synergism that will result because of this arrangement. A well
thought out and carefully described organization is required. The
application should explain how different components of the CEER will
interact and why they are essential to accomplishing the overall goals
of the research. How the combined resources create capabilities that
are more than the sum of the parts should be described. The PI will be
responsible for ensuring that the scientific goals are met and for
developing and managing a decision-making structure and process that
will allow resources to be allocated to meet the Center's goals.
Therefore, the PI will be required to commit at least 30% effort to the
leadership and implementation of the Center. A timeline for the
project should be included in the application that shows how the
Center's goals can be met within the timeframe of the CEER grant. This
timeline will be used to help assess progress toward the Center's
goals.
Training: In addition to a strong research component, a Center is
required to have a highly effective training component that will
leverage the strengths of the multidisciplinary nature of the Center
and its investigators to train the next generation of ELSI scholars,
genome/genetics researchers, clinical and social scientists, and
researchers in law, bioethics and the humanities to be able to develop
independent research programs that address important ELSI problems.
The training component of the Center must include a specific plan for
engaging the talents of individuals from underrepresented minority
groups as outlined in the NHGRI Action Plan
(http://www.genome.gov/10001707). Specific funds may be requested for
training activities to include up to two post-doctoral trainees per
year. The NHGRI has other program announcements that support student
training. Doctoral dissertation research for students from under-
representative minority populations is supported through this program
announcement:
https://grants.nih.gov/grants/guide/pa-files/PA-02-048.html.
Further, it is expected after one year of support on this training
grant, the post-doctoral fellow will have applied for a National
Research Service Award (NRSA-F32). For more information
regarding this program announcement, see:
https://grants.nih.gov/grants/guide/pa-files/PA-99-122.html. For other
ELSI funding opportunities, visit: http://www.genome.gov/10000930.
While exploratory grants are not required to have a training program,
the types of training activities, particularly for training of
investigators from under-represented minority populations that are
appropriate for the subsequent P50 Center should be explored during the
course of the P20 funding.
Site visits: Annual administrative site visits will be scheduled to
assess progress being made in the Centers. Most will likely be held at
the funded institution. Occasionally it may be necessary to hold
reverse site visits, in which investigators travel to Bethesda to
report on progress.
WHERE TO SEND INQUIRIES
Prior to submitting an application, potential applicants are strongly
encouraged to discuss their project with NHGRI program staff. Inquiries
may fall into three areas: programmatic/scientific/research issues;
peer review issues; and financial or grants management issues:
o Programmatic/scientific/research issues should be directed to:
Elizabeth J. Thomson
Program Director, Ethical, Legal, and Social Implications Research
National Human Genome Research Institute
Building 31, Room B2B07
Bethesda, MD 20892-2033
Telephone: (301) 402-4997
FAX: (301) 402-1950
Email: et22s@nih.gov
o Peer review issues should be directed to:
Rudy Pozzatti
Scientific Review Branch
National Human Genome Research Institute, NIH
Building 31, Room B2B37
31 Center Drive
Bethesda, MD 20892-2032
TEL: (301) 402-0838
FAX: (301) 435-1580
o Financial or grants management matters should be directed to:
Jean Cahill
Chief, Grants Management Branch
National Human Genome Research Institute, NIH
Building 31, Room B2B34
31 Center Drive
Bethesda, MD 20892-2032
TEL: (301) 402-0733
FAX: (301) 402-1951
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent by
October 27, 2003 that includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review
workload and plan the review.
The letter of intent should be sent to:
Elizabeth J. Thomson
Program Director, Ethical, Legal, and Social Implications Research
National Human Genome Research Institute
Building 31, Room B2B07
Bethesda, MD 20892-2033
Telephone: (301) 402-4997
FAX: (301) 402-1950
Email: et22s@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at https://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and three signed,
photocopies, in one package to:
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application,
including all appendices, must be sent to:
Scientific Review Branch
National Human Genome Research Institute, NIH
Building 31, Room B2B37
31 Center Drive
Bethesda, MD 20892-2032
TEL: (301) 402-0838
FAX: (301) 435-1580
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes. While the investigator may
still benefit from the previous review, the RFA application is not to
state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NHGRI.
Incomplete and/or non-responsive applications will be returned to the
applicant without further consideration.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NHGRI in accordance with the review
criteria stated below. As part of the initial merit review, all
applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Council for
Human Genome Research.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
To ensure that applications for this CEERs program are evaluated
appropriately, the standard NIH review criteria have been adapted to be
more appropriate for applications of the scope described in this PA. In
the written comments, reviewers will be asked to discuss the following
aspects of the application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of
these goals. The review group will address and consider each of these
criteria in assigning the application's overall score, weighting them
as appropriate for each application. The application does not need to
be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score.
SIGNIFICANCE: Does this study address an important emerging or
particularly persistent ELSI problem related to genomic and genetic
science? If the aims of the application are achieved, will our
understanding or ability to address these issues be advanced? Will
these studies have an effect on the field of ELSI research? Will they
be relevant and useful to the larger scientific and public policy
communities?
INNOVATION: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of
the project? Does the applicant acknowledge potential problem areas and
consider alternative approaches? For proposed multi-component centers,
is there a demonstrated scientific gain from the interrelatedness and
synergy among the components? If any individual component were removed,
would the ability of the CEER to accomplish its overall aims be
impaired?
MANAGEMENT: Is the management plan, including the management structure,
appropriate and adequate to support the CEER? Is there an effective
plan for use of fiscal resources, shared facilities and human resources
to attain the research aims and overall CEER goals? Is there an
adequate plan for the organization and coordination of the CEER
personnel? Is there a high quality plan for making critical decisions
or choices about the overall research direction for the CEER? Where
appropriate, are the approaches used or under development to implement
the research plan cost effective?
PRINCIPAL INVESTIGATOR: Does the PI have the ability, expertise and
experience to lead, coordinate, and manage all of the activities of the
CEER? Does the PI have sufficient leadership qualities and experience
to develop and implement the CEER plans for the entire project?
INVESTIGATORS: Are the additional investigators identified in the
application appropriately trained, from multiple disciplines, and well
suited to carry out this work? To what degree will the individual and
combined expertise of the key personnel contribute to the
accomplishment of the overall goals of the proposed research? Is the
level of effort for the key personnel adequate?
MULTIDISCIPLINARITY OF RESEARCH TEAM: Is the training, background, and
expertise of the multi-disciplinary research team appropriate to
achieve the specific aims and overall goals of the proposed Center?
Does the multi-disciplinary team bring novel capabilities to the
research program? Is there evidence of effective collaboration among
key personnel? Is there evidence that the team has sufficient
expertise in both ELSI and genomic/genetic science? Are investigators
from minority populations and/or those with disabilities included?
TRAINING: What is the quality of the proposed training plan and its
likely effectiveness in producing well-trained researchers who can
develop new approaches to ELSI questions and research? Are there plans
to develop new training opportunities and to integrate them with other
on-going or planned training? Plans to achieve effective training of
underrepresented minorities receive particular attention.
ENVIRONMENT: Does the scientific environment in which the work will be
done contribute to the probability of success? Does the proposed
research plan take advantage of unique features of the scholarly
environment? Is there evidence of adequate institutional support,
including improvement of infrastructure and relief from other academic
duties where necessary? Is the environment adequate for proposed
training activities?
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy
of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the
sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the five items described under Section f
of the PHS 398 research grant application instructions (rev. 5/2001)
will be assessed.
ADDITIONAL CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: October 27, 2003
Application Receipt Date: November 24, 2003
Peer Review Date: March, 2004
Council Review: May, 2004
Earliest Anticipated Start Date: July, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of
the subjects or the purpose of the research. This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition
of clinical research; updated racial and ethnic categories in
compliance with the new OMB standards; clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
https://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom of
Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final
modification to the "Standards for Privacy of Individually Identifiable
Health Information", the "Privacy Rule," on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (classified under the Rule
as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on "Am
I a covered entity?" Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to
the review because reviewers are under no obligation to view the
Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance Nos. 93.172 and is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review. Awards are made under the authorization
of Sections 301 and 405 of the Public Health Service Act as amended (42
USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR
Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants
Policy Statement. The NIH Grants Policy Statement can be found at
https://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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