CENTERS OF EXCELLENCE IN GENOMIC SCIENCE (Modified and reissued, see PAR-05-163)
(superceded by PAR-02-021)
Release Date: May 30, 2000
PA NUMBER: PAR-00-101
National Human Genome Research Institute
Letter of Intent Receipt Dates:
For Exploratory Grants (P20): May 1, September 1, January 1 annually
For Specialized Center (P50): August 1, 2000, April 1 annually thereafter
Application Receipt Dates:
For Exploratory Grants (P20): June 1, October 1, February 1 annually
For Specialized Center (P50): October 1, 2000, June 1 annually thereafter
PURPOSE
The National Human Genome Research Institute (NHGRI) is initiating a program
to establish new academic Centers for advanced genome research. These Centers
of Excellence in Genomic Science (CEGS) grants (P50) will support multi-
investigator, interdisciplinary teams to develop innovative genomic approaches
to address biological problems. The scope of the CEGS program is intended to
be broad with a simple unifying theme that the Centers will address important
biological problems on a genomic scale. A CEGS may focus, for example, on a
particular genome-scale biological problem, on the development of novel
technological and computational methods for the production and analysis of
comprehensive data sets, or on other ways to develop and use genomic
approaches for understanding biological systems. In addition to pursuing
research activities, a Center should help to nurture genomic science at its
institution, for example, by facilitating the interaction of investigators
from different disciplines and by providing training.
The NHGRI particularly encourages the formation of new groups of investigators
to conduct genomic research. As some newly formed groups may require
substantial time and support for development and planning before being in a
position to submit a high quality Center grant application, a CEGS Planning
Grant (P20) is being offered to facilitate this planning. Applicants
intending to focus their Center on bioinformatics approaches may also use the
BISTI planning grant (available at:
http://grants.nih.gov/grants/guide/pa-files/PAR-00-102.html) in preparation
for the CEGS P50 Center grant application.
RESEARCH OBJECTIVES
Background
The NHGRI is currently engaged, along with several other federal, private, and
international organizations, in a multi-year research program called the Human
Genome Project (HGP). Most of the initial goals of the HGP, including genetic
and physical maps of the mouse and human, and the DNA sequences of E. coli, S.
cerevisiae, C. elegans, and D. melanogaster have been realized. Others will
be met imminently, including the complete human sequence. As of April 2000,
more than three-quarters of the human sequence, either in finished or working
draft form, has been deposited in the public sequence databases. After
generation of a working draft version of at least 90% of the genome,
completion of the high quality sequence will follow no later than 2003. Mouse
genome sequencing has also begun, with completion of that sequence anticipated
no later than 2005.
The HGP has been characterized by a focus on large, comprehensive genomic data
sets, such as complete DNA sequences and genomic maps, efficient data
production, and the development of new technologies. Once the DNA sequence of
an organism becomes available, many new avenues to studying its biology are
opened. However, new and improved research tools, approaches, and
capabilities are needed to discover and use the vast amount of biological
information in complete genomic DNA sequences. In 1998, a set of new goals
was adopted for the U.S. Human Genome Program (see Goals at
http://www.nhgri.nih.gov/98plan/). In addition to completing the human and
mouse maps and sequences, the aim of the HGP was extended to developing some
of the new data sets and technological approaches that will be necessary to
understand and use genomic DNA sequence. The purpose of this new solicitation
is to stimulate the development of such new approaches, which are likely to
involve computational, instrumental, biochemical, genetic, and analytical
technologies. These approaches are likely to require the expertise of teams
of investigators from different fields as well as substantial infrastructure.
This Program Announcement (PA) signals an augmentation of the NHGRI Center
grant program. Previous NHGRI solicitations for Center grants have had as
their purpose the production of large data sets, such as genetic maps, physical
maps, or DNA sequences, and were derived from the quantitative resource-
generation goals of the HGP five-year plans. While such programs continue,
this new program is intended to provide support for novel basic genomics
research projects. These new Centers will conduct research into biological
problems at a genomic scale, or develop new methods, approaches, tools, or
technologies to make possible novel analyses of biological questions from a
genomic perspective. Some projects may result in new analyses of existing
data sets. Other projects may result in technologies and methods that provide
the ability to collect, analyze, and present effectively new types of genomic
data sets.
The NHGRI is committed to continuing to support basic genomic research through
investigator-initiated, single-laboratory project grants, using the R01, R21,
and other appropriate grant mechanisms, under existing and future programs.
However, the resources needed to conduct the multi-faceted, multi-disciplinary
projects that may be required to achieve significant advances in these complex
problems are sometimes beyond the scope of the typical R01 grant. Therefore,
this PA presents an opportunity for applicants to assemble the teams of
investigators from diverse disciplines that will be required to approach
biological problems using genomics tools in ways that are not possible today.
High priority will be given to projects that integrate multi-investigator,".,
multi-disciplinary approaches to a scientific problem, especially those that
can meld computational and experimental approaches.
Scope of Research
The U.S. HGP goals for 1998-2003 (Science, Vol. 282, pp. 682 689, 23 Oct.
1998, see http://www.nhgri.nih.gov/98plan/) articulated several areas of
genomics for which substantial research opportunities exist. The more recent
publication of the Biomedical Information Science and Technology Initiative
(BISTI) (http://www.nih.gov/welcome/director/060399.htm) lays out additional
challenges, many of which are complementary to those of the HGP. The
following excerpts from these reports exemplify the challenges and
opportunities that lie ahead:
o Sequencing Technology: In the future, de novo sequencing of additional
genomes, comparative sequencing of closely related genomes, and sequencing to
assess variation within genomes will become increasingly indispensable tools
for biological and medical research....[R]esearch must be supported on new
technologies that will make even higher throughput DNA sequencing efficient,
accurate, and cost-effective, thus providing the foundation for other advanced
genomic analysis tools. (HGP goals)
o Human Genome Sequence Variation: Natural sequence variation is a
fundamental property of all genomes....Basic information about the types,
frequencies, and distribution of polymorphisms in the human genome and in
human populations is critical for progress in human genetics. Better high-
throughput methods for using such information in the study of human disease
are also needed. (HGP goals)
o Technology for Functional Genomics: The availability of entire genome
sequences is enabling a new approach to biology often called functional
genomics the interpretation of the function of DNA sequence on a genomic
scale....Many genes and other functional elements of the genome are discovered
only when the full DNA sequence is known....However, knowing the structure of
a gene or other element is only part of the answer. The next step is to
elucidate function, which results from the interaction of genomes with their
environment....Large-scale characterization of the gene transcripts and their
protein products underpins functional analysis....Improved technologies are
[also] needed for global approaches to the study of non-protein-coding
sequences.... (HGP goals)
o Comparative Genomics: Because all organisms are related through a common
evolutionary tree, the study of one organism can provide valuable information
about others. Much of the power of molecular genetics arises from the ability
to isolate and understand genes from one species based on knowledge about
related genes in another species. Comparisons between genomes....provide insight
into the universality of biologic mechanisms and....into the details of gene
structure and function. (HGP goals)
o Bioinformatics and Computational Biology: Bioinformatics support is
essential to the implementation of genome projects and for public access to
their output....Collection, analysis, annotation, and storage of the ever
increasing amounts of mapping, sequencing, and expression data in publicly
accessible, user-friendly databases is critical to the project"s success. In
addition, the community needs computational methods that will allow scientists
to extract, view, annotate, and analyze genomic information efficiently.
(HGP goals)
o To make optimal use of information technology, biomedical researchers
need, first of all, the expertise to marry information technology to biology
in a productive way. New hardware and software will be needed, together with
deepened support and collaboration from experts in allied fields. Inevitably,
those needs will grow as biology moves increasingly from a bench-based to a
computer-based science, as models replace some experiments and complement
others, as lone researchers are supplemented by interdisciplinary teams. The
overarching need is for an intellectual fusion of biomedicine and information
technology. (BISTI goals)
o The information that biomedical researchers are amassing in profuse
quantities today...creates enormous digital repositories of information. The
scale of those databases swamps all the information collected before....In
order to be useful, the data must be indexed and stored, and the challenges
for data analysis and abstraction are formidable. (BISTI goals)
The passages quoted above from the U.S. HGP five-year plan and the BISTI
report are intended to convey the kinds of subjects and scope of projects that
may be appropriate under this Centers program. This PA does not provide a
list of examples of possible Center themes because of the NHGRI’s desire not
to limit applicants imaginations and to solicit truly new ideas for genomic
approaches to biological problems, related to the goals discussed above. The
NHGRI strongly encourages investigators who propose to develop such novel
approaches to discuss their ideas with NHGRI program staff prior to submitting
an application, to ensure that applications will be responsive to the CEGS
program.
Biomedical research has entered an era in which the solutions to many
important problems will require the collection and analysis of large data
sets, such as an entire genome, an entire set of expressed RNAs or proteins,
an entire gene family from a large number of species, the variation among
individuals for a genomic region of substantial size, or a class of gene
regulatory or chromatin organizational elements. Therefore, the unifying
theme for this program will be that the Centers will address important
biological problems on a genomic scale. Preference will be given to
approaches and technologies that are applicable to a wide variety of cell
types or organisms and that are usable in a high-throughput, cost-effective,
comprehensive manner, i.e., are genomic technologies. Similarly, preference
will be given to approaches designed to be generally applicable at large
scale, for example, not limited to any one genetic locus, specific disease, or
organ system.
Preference will be given to the development of genomic methods for eukaryotes
where genome sequence is available. Methods development or pilot studies
using other systems (e.g., eukaryotes whose genomes have not been sequenced,
or prokaryotes for which the genomic sequence is known) will be considered
with adequate justification, direct applicability to the analysis of
eukaryotic genomes must be evident. Where appropriate, integration with other
NIH genomics initiatives (e.g., NHLBI genomics program
[http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-99-024.html], full-length
cDNA [http://www.ncbi.nlm.nih.gov/MGC/], and
SNPs [http://www.nhgri.nih.gov:80/About_NHGRI/Der/SNPawardees.htm]) will be
considered advantageous.
It is anticipated that these Centers may employ large amounts of data to
accomplish their goals. However, the application of genomic technologies for
data production per se is not the purpose of these Centers. Instead, these
Centers may generate data sets to address a biological problem, or may develop
tools. The generation of test data sets may be appropriate for developing the
methods and technologies, or demonstrating the feasibility of methods under
investigation. The cost-effectiveness of the project plan will be a review
criterion. Decisions by NHGRI to embark on the large-scale implementation of
any new tools developed by these Centers to generate large data sets,
particularly when such projects are expensive, will require careful
consideration, with advice from the scientific community.
Additional Objectives - Training
There is a widely recognized shortage of investigators who have the
interdisciplinary skills needed to conduct most effectively the types of
research described in this PA.
o The HGP has created the need for new kinds of scientific specialists who
can be creative at the interface of biology and other disciplines, such as
computer science, engineering, mathematics, physics, chemistry, and the social
sciences. As the popularity of genomic research increases, the demand for
these specialists greatly exceeds the supply. In the past, the genome project
has benefited immensely from the talents of non-biological scientists, and
their participation in the future is likely to be even more crucial. There is
an urgent need to train more scientists in interdisciplinary areas that can
contribute to genomics. Programs must be developed that will encourage
training of both biological and non-biological scientists for careers in
genomics....[A] stable academic environment for genomic science must be
created so that innovative research can be nurtured and training of new
individuals can be assured. (HGP goals)
o Strong action by the NIH is required because the existing biomedical
research and teaching structures of the universities and research institutions
of this country inadequately value interdisciplinary efforts generally, and
computation in particular. Few grant programs and fewer academic departments
foster the kind of interdisciplinary work required to meet biomedical
challenges, let alone educate students about them. National Programs
specifically would include formal and informal instruction from the
undergraduate through post-graduate levels, and incorporate a range of
opportunities for scholars and researchers to participate. (BISTI goals)
One reason for the lack of adequately qualified personnel is that there are
too few appropriate environments available to support this kind of training.
The establishment of Centers under the CEGS program is intended to help to
alleviate this shortage by serving as an academic focus for genomic research
approaches. To maximize the impact of these Centers, they should integrate
the training of young investigators and broadening the training of established
investigators. Graduate students and postdoctoral fellows should participate
in the research. Additional training activities that leverage strengths of
the institution and the research program of the Center are encouraged. Such
training could be at the undergraduate, graduate, or professional level.
Additional Objectives ELSI
In the case of projects that raise ethical, legal, or social concerns (e.g.,
the study of sequence variation), a component of the Center focusing on
analysis of such concerns as they relate to the particular research proposed
is encouraged.
MECHANISM OF SUPPORT
Support of this program will be through the National Institutes of Health
(NIH) P50 Specialized Center and P20 Exploratory Grant mechanisms.
Responsibility for the planning, direction, and execution of the proposed
project will be solely that of the applicant.
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 is a rapidly changing field, and it is
anticipated that most projects that can be initiated now are likely to have a
limited lifetime during which support from the NHGRI 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, the total length of support for any P50 Center under
this program will be limited to no more than ten years.
In general, Centers will receive an administrative site visit during the third
year of each competing cycle. The fifth year of funding will depend on the
outcome of that administrative review, and 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 Center may be up to $2 million direct costs per
year for continuing operations (e.g., personnel, supplies, travel and other
expenses), funds for initial large equipment may be requested in excess of
this $2 million limit if well justified. Under this cap, it is anticipated
that the size of the awards will vary because the nature and scope of research
programs proposed will vary. The NHGRI anticipates establishing ten or more
such Centers over the next few years, and therefore expects that two to four
P50 awards will be made per year. The actual number of awards and level of
support will depend on receipt of a sufficient number of applications of high
scientific merit and availability of funds.
A high priority under this program is the establishment of new academic
Centers in which state-of-the-art genomics research can be conducted. At some
institutions, the nucleus of a research group that could conduct the research
described in this PA may already exist, and such groups will be able to submit
suitable applications for this program directly. However, some groups of
investigators may need an opportunity to establish themselves and formulate
plans in preparation for submitting a Center application. The Exploratory
Grant (P20) mechanism will be used when the applicant wishes to request a
period of planning and preliminary investigation prior to preparing a P50
Center application. Appropriate activities under the CEGS Planning Grant
include the establishment of new multi-investigator or interdisciplinary
relationships, exploration of organizational concepts, development of the
rationale and research design for the subsequent Center, and the collection of
preliminary data. 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 at a direct cost not to
exceed $150,000 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.
Applicants anticipating the submission of projects that are largely or
exclusively computational should be aware that an additional planning grant
opportunity for entry into the CEGS P50 program described here is available.
Information on the Planning Grants: National Program for Excellence in
Biomedical Computing (Pre-NPEBC) program is available at
http://grants.nih.gov/grants/guide/pa-files/PAR-00-102.html.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic non-profit organizations, public and
private, such as universities, colleges, hospitals, laboratories, units of
State and local governments, and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with disabilities are
encouraged to apply as Principal Investigators. Applications from foreign
institutions and for-profit organizations will not be accepted, however,
subcontracts to foreign institutions and for-profit organizations will be
considered.
GUIDANCE FOR APPLICANTS FOR P50 CENTER GRANTS
The applicant should identify clearly in the abstract and more fully in the
research plan the new capabilities that are proposed to be developed, or what
specific biological question is to be studied, as a result of the
establishment of the Center. The synergies achieved through the establishment
of multi-disciplinary teams and novel collaborations should be fully
described.
The P50 grant application should specify the specific administrative and
organizational structure(s) that will be used to support the research, and the
synergies enabled by those structures. It is anticipated that these projects
will be multi-disciplinary and will draw on a variety of resources. Thus, a
well thought-out and carefully described organization will be required. The
P.I. is responsible for ensuring that scientific goals are met, and for
developing and managing a decision-making structure and process that will
allow resources to be allocated (and reallocated, if necessary) to meet those
goals. Projects of the complexity, both scientific and managerial, that NHGRI
anticipates will characterize these Centers require a substantial amount of
the P.I.’s effort to achieve success. Therefore, the P.I. will be required to
devote at least 30% effort to the leadership and implementation of the Center.
If core facilities or shared resources are required, these should be
described, as should their management and service to the research projects.
The proposal should explain how different components of the organization,
including key personnel, will interact, why they are essential to
accomplishing the research, and how the combined resources create capabilities
that are more than the sum of the parts. "Centers-without-walls" are welcome
under this solicitation. If any of the components is physically separated
from each other (i.e., different departments or institutions), the proposal
should address how that separation will be managed. The NHGRI is not
specifying a specific organizational structure (e.g., specific numbers of
projects and cores) in this PA, preferring that applicants develop the
structure that would best promote the research. However, applicants should
note that the effectiveness of the proposed structure will be a criterion of
the evaluation prior to an award and will be monitored after an award is made.
A timeline for the project should be presented. This timeline should outline
how the project"s goals can be met within the time frame of a CEGS grant. The
timeline will also assist the investigators, NHGRI, and its advisors in
evaluating progress toward the project"s goals. For those projects for which
the investigator deems it appropriate to do so, NHGRI encourages applicants to
present explicit, quantitative milestones.
The NHGRI encourages applicants to devise a strategy for the Center"s training
component that best takes advantage of the research program, the
investigators talents, and other institutional resources, to offer unique and
substantial training opportunities for students and other investigators. The
CEGS will therefore become an additional mechanism, to those previously
developed by NHGRI (see
http://www.nhgri.nih.gov/Grant_info/Funding/Training/), for expanding the
cadre of investigators working in the field of genomics. Training of
racial/ethnic minority individuals, women, and persons with disabilities is a
particularly high priority.
Data and Materials Dissemination
The sharing of materials, data, and software in a timely manner has been an
essential element in the rapid progress that has been made in genome research.
While Public Health Service (PHS) policy requires that investigators make
unique research resources, including DNA sequences and mapping information,
readily available when they have been published (NIH Grants Policy Statement,
October 1, 1998, p. II-62), the advisors to the NIH and the Department of
Energy (DOE) genome programs have encouraged more rapid sharing
(http://www.nhgri.nih.gov:80/Grant_info/Funding/Statements/data_release.html).
This has become the norm in the genome community.
The NIH is interested in ensuring that the information about new methods,
technologies, computer software, and genomic biology data that is developed
through this program becomes readily available to the research community for
further research and development, with the expectation that this will
eventually lead to information and products that improve the health of the
public. For this reason, applicants should develop and propose specific plans
for sharing the data, materials, and software generated through the grant,
taking into consideration the recent Guidance issued by NIH
(http://www.ott.nih.gov/policy/rt_guide_final.html). To the extent that established
public databases (e.g., GenBank or dbSNP) have the capability for collecting
and disseminating the data that would be collected under the grant, it is the
NHGRI’s strong preference that a plan for the rapid deposition of data into
such public databases be described in the application.
The initial review group will comment on the proposed plan for sharing and
data release. The adequacy of the plan will also be considered by NIH staff
as one of the criteria for award. The proposed sharing plan, after
negotiation with the applicant when necessary, will be made a condition of the
award. Evaluation of renewal applications will include assessment of the
effectiveness of data, materials, and software release.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, telephone
number, and e-mail address of the P.I., names of other key personnel and, if
applicable, participating institutions, and the number and title of this PA.
Although a letter of intent is not required, is not binding, and does not
enter into the review of subsequent applications, the information that it
contains allows NHGRI staff to estimate the potential review workload and to
avoid possible conflict of interest in the review. Please note that
applicants planning to request $500,000 or more in direct costs for any year
must contact NHGRI program staff before submitting the application (see
ADDITIONAL APPLICATION PROCEDURES FOR P50 CENTER GRANTS, below).
The letter of intent is to be sent to:
Jeffery A. Schloss, Ph.D.
Division of Extramural Research
National Human Genome Research Institute, NIH
Bldg. 31, Room B2-B07
Bethesda, MD 20892-2033
TEL: (301) 496-7531
FAX: (301) 480-2770
Email: jeff_schloss@nih.gov
APPLICATION PROCEDURES (P50 AND P20)
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the application deadlines indicated on the first
page of this PA. Application kits are available at most institutional offices
of sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714,
email: GrantsInfo@nih.gov.
The title and number of the PA must be typed on line 2 of the face page of the
application form and the YES box must be marked.
Submit a signed 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
Bldg. 31, Room B2-B37
Bethesda, MD 20892-2032
TEL: (301) 402-0838
FAX: (301) 435-1580
ADDITIONAL APPLICATION PROCEDURES FOR P50 CENTER GRANTS
If the Center is to be organized into projects, then the page limits specified
in the PHS 398 form for sections a-d of the Research Plan will apply for each
project. If, however, the Center is to integrate its activities in such a way
that describing individual projects would not be helpful, then the limit for
the narrative section (a-d) is 40 pages. Please note that there is no
requirement to submit this maximum number of pages, instead, concise,
articulate applications are desired.
In accordance with NIH policy (NIH Guide for Grants and Contracts, March 20,
1998, available at http://grants.nih.gov/grants/guide/notice-files/not98-030.html),
an applicant planning to submit an application requesting $500,000
or more in direct costs for any year MUST contact NHGRI program staff before
submitting the application, as plans for the study are being developed, to
obtain agreement that NHGRI will accept the application for review. The
applicant must identify, in a cover letter sent with the application, the
NHGRI staff member who agreed to accept assignment of the application. The
NHGRI is not obligated to accept applications requesting more than $500,000 in
the absence of such staff agreement. This policy requires an applicant to
obtain agreement for acceptance of both any such application and any
subsequent amendment.
ADDITIONAL APPLICATION PROCEDURES FOR P20 PLANNING GRANTS
The planning activities to be carried out, and the justification for their
necessity, should be described in the context of the anticipated P50 Center
grant application.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by CSR and for
responsiveness by the NHGRI. Incomplete applications will be returned to the
applicant without further consideration. Applications that are complete and
responsive to the PA will be evaluated for scientific and technical merit by
an appropriate peer review group, convened by the NHGRI in accordance with the
standard NIH peer review procedures. The applications will 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 CEGS program are evaluated appropriately,
the standard NIH review criteria have been adapted to be more appropriate for
proposals 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. Each of these criteria will
be considered in assigning the overall score, weighting them as appropriate
for each application. Note that 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. For example, an investigator may propose to
carry out important work that is not innovative but is essential to move a
field forward.
Review Criteria for P50 Centers
(1) Significance: Importance of the proposed research areas and topics being
explored, and their relevance to investigation of a biological problem,
particularly one that is amenable to genomic approaches. Utility to
researchers of any technology, research tools, software, scientific
approaches, etc. that are proposed to be developed. Likely effect of the
proposed research on the field, and likely impact on the larger biological
community.
(2) Approach: Quality of the scientific research plan. Likelihood that the
proposed research plan will achieve the aims of the proposed research.
Appropriateness of the proposed experimental approach, conceptual framework,
design, methods, analyses, techniques, and technologies to the proposed
research. Acknowledgement of potential problems and consideration of
alternative approaches. For proposed multi-component centers, the scientific
gain from combining the research components in a center, i.e., the degree of
interrelatedness and synergy among the components.
(3) Management: Appropriateness and quality of the management plan, including
the effectiveness of the management structure. Quality of the plan for
deployment of equipment and human resources to attain the research aims and
overall Center goals. Organization and coordination of the personnel.
Quality of the plans for making critical decisions or choices about overall
research direction during the project. Where appropriate, the cost-
effectiveness of approaches used or under development.
(4) Innovation: Novelty or originality of approach, method, technology,
experimental design (including presentation, organization, analysis or
application of data), conceptual framework, or the insight provided into a
genomic or biological problem.
(5) Investigators: Appropriateness of the scientific training, background,
and expertise of the Principal Investigator and key personnel to achieving the
specific aims and overall goals of the proposed research. Contribution that
the individual and combined scientific expertise of the key personnel will
make to the achievement of the overall goals of the proposed research.
Adequacy of the P.I.’s ability to lead and coordinate the activities, and
develop and implement the management plan, as required for the project’s
success. Adequacy of the level of effort of key personnel.
(6) Environment: Adequacy of the scientific environment and resources
available, including space, equipment, services, infrastructure, and
facilities. Degree to which the proposed research plan, experiments, or
organization take advantage of unique features of the scientific environment.
Degree of institutional commitment, including any needed expansion of
facilities, improvement of infrastructure, and relief from other academic
duties where necessary. Environment for training or educational activities.
(7) Data release and distribution of research tools: Adequacy of plans for
dissemination to the scientific community of research tools or research
resources (e.g., data sets, computer software, mutant stocks, DNA libraries)
that are proposed to be developed.
(8) Training: Quality of the proposed training plan and its likely
effectiveness in meeting community needs. Plans to integrate the training
components of the Center with other on-going or planned training.
Review Criteria for P20 Planning Grants
(1) Significance: Importance of the proposed research areas and topics being
explored, and their relevance to elucidating a biological problem,
particularly one that is amenable to genomic approaches. Effect of the
proposed areas of research on the field, and the likely impact on the larger
biological community.
(2) Approach: Quality of the scientific research plan. Likelihood that the
proposed planning grant will culminate in the ability of the participants to
form an on-going collaboration, generate relevant preliminary data, if
appropriate, and submit a competitive application for a CEGS.
(3) Management: Quality of the plan for acquisition, organization, and
deployment of equipment and human resources to attain the goals of the
exploratory research. Potential success of the proposed exploratory
components. Adequacy of the level of effort of key personnel.
(4) Innovation: Novelty or originality of the research area being
investigated or the methods to be developed.
(5) Investigators: Appropriateness of the training, background, and expertise
of the P.I. and key personnel to achieving the specific aims and overall goals
of the proposed research.
(6) Environment: Adequacy of the scientific environment and resources
available, including space, equipment, services, infrastructure, and
facilities. Degree to which the proposed research plan, experiments, or
organization take advantage of unique features of the scientific environment.
Degree of institutional commitment, including any needed expansion of
facilities, improvement of infrastructure, and relief from other academic
duties where necessary. The environment for training and educational
activities.
(7) Data release and distribution of research tools: Adequacy of plan to
develop a responsive data and tools distribution plan.
(8) Training: Adequacy of plan to develop an effective training component.
Additional Review Criteria for P50 and P20 Applications
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o If the application proposes to involve human subjects, then the adequacy of
plans to include both genders, minorities and their subgroups, and children as
appropriate for the scientific goals of the research will be evaluated. Plans
for the recruitment and retention of subjects will also be evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research.
o The adequacy of the proposed protection for humans, animals, or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
AWARD CRITERIA
Applications will compete for available funds with all other recommended
applications received through this and other NHGRI programs. The following
will be considered in making funding decisions: Quality of the proposed
project as determined by peer review, appropriateness of data, materials, and
technology sharing plan, availability of funds, and program priority.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are provided 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 research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research" that were published in the Federal Register of March 28, 1994 (FR 59
14508-14513), and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11,
March 18, 1994, and are available on the web at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH 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 were published in the NIH Guide for
Grants and Contracts, March 6, 1998, and are available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
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 PA, Centers of Excellence in
Genomic Science, 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.
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. Reviewers are cautioned that their anonymity may
be compromised when they directly connect to an Internet site.
INQUIRIES
Inquiries are strongly encouraged. The opportunity to clarify any issues or
questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Jeffery A. Schloss, Ph.D.
Division of Extramural Research
National Human Genome Research Institute, NIH
Bldg. 31, Room B2-B07
Bethesda, MD 20892-2033
TEL: (301) 496-7531
FAX: (301) 480-2770
Email: jeff_schloss@nih.gov
Direct inquiries regarding review issues to:
Scientific Review Branch
National Human Genome Research Institute, NIH
Bldg. 31, Room B2-B37
Bethesda, MD 20892-2032
TEL: (301) 402-0838
FAX: (301) 435-1580
Direct inquiries regarding fiscal matters to:
Jean Cahill
Grants Administration Branch
National Human Genome Research Institute, NIH
Bldg. 31, Room B2-B34
Bethesda, MD 20892-2031
TEL: (301) 402-0733
FAX: (301) 402-1951
E-mail: jc166o@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.172. Awards are made under authorization of sections 301 and 405 of the
Public Health Service Act as amended (42 USC 241 and 284) and administered
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts
74 and 92. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-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, and 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.
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NIH Funding Opportunities and Notices
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