CENTERS OF EXCELLENCE IN COMPLEX BIOMEDICAL SYSTEMS RESEARCH
Release Date: January 26, 2001
RFA: RFA-GM-01-001
National Institute of General Medical Sciences
(http://www.nigms.nih.gov/)
Letter of Intent Receipt Dates For Planning Grants (P20) and Specialized
Center Grants (P50): September 1, 2001
Application Receipt Dates For Planning Grants (P20) and Specialized Center
Grants (P50): October 11, 2001
PURPOSE
The National Institute of General Medical Sciences (NIGMS) will provide
funding for the establishment of new academic Centers of Excellence in
Complex Biomedical Systems Research (CE/CBSR). This program is responsive to
the Biomedical Information Science and Technology Initiative (BISTI) and its
call for National Programs of Excellence in Biomedical Computing (NPEBC). The
CE/CBSR goal is to promote the analysis of the organization and dynamic
behaviors of complex biological systems. The Center Grant mechanism (P50),
together with the Planning Grant mechanism (P20), will support the
development of multi-investigator teams capable of engaging biomedical
complexity with a scope of activities not possible with other funding
mechanisms. Activities will encompass research and training, as well as
workshops, symposia, and other forms of outreach. Centers will support
research activities that may include the development of new instrumentation
and methods, bioinformatics infrastructure, and new theoretical frameworks to
advance knowledge of life processes at the system level. Training activities
may include programs in computational and information sciences. Workshops
and symposia are encouraged, as well as partnering with undergraduate
institutions, especially those with substantial numbers of underrepresented
minority students. Typical areas of NIGMS interest include computationally-
based modeling of processes such as the cell cycle, pattern formation during
embryogenesis, the flux of substrates and intermediates in metabolism, and
the application of network analysis to understanding the integrated systemic
host responses to trauma, burn, or other injury.
NIGMS recognizes that biomedical research is entering an era in which
computational approaches will be used to deepen our understanding of
biological behavior. Building upon mechanistic descriptions of individual
biological constituents there will be an increasing emphasis on concepts and
methods that target systems and their integrated behavior. Multicomponent,
interactive processes at the subcellular, cellular, tissue, and organ levels
will be amenable to modeling and simulation in ways previously limited by the
lack of adequate data. Traditional molecular and genetic approaches will be
augmented with concepts and methods requiring new areas of expertise,
particularly from the computational disciplines of engineering, physics, and
computer science. The need for quantitative data will likely call for the
development of new instrumentation and methods. The organization and
representation of these data streams and their relation to preexisting
knowledge will require bioinformatics advances, and the development of
computer based hypotheses and simulations will require mathematical
expertise, as will the development of new theoretical frameworks.
The organization of projects incorporating these approaches, and the
recruitment of personnel, is not a simple undertaking, and these Centers
grants are designed to support these activities. In addition to research
contributions, successful Centers will provide their home institutions with
the means to implement organizational and professional changes that will make
interdisciplinary research in complex biological systems and bioinformatics
attractive career options for both established and entry level investigators.
The institutions will receive the resources to recruit new investigators who
have the skills needed to develop new methods and tools, and to develop
appropriate training programs in computational and information sciences. In
addition, the Centers will disseminate expertise and knowledge through
workshops and symposia, and, because the Centers will be pioneering a new era
in biological sciences, they will provide outreach activities to
undergraduate institutions, including minority-serving institutions.
Current initiatives related to CE/CBSR can be found in prior NIGMS program
announcements: http://www.nigms.nih.gov/funding/complex_systems.html.
Some groups interested in the scope of this RFA might find the P01 mechanism
more suited to the scale of their efforts, they should consult the prior
announcement at the URL:
http://grants.nih.gov/grants/guide/pa-files/PA-98-077.html.
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, Centers of
Excellence in Complex Biomedical Systems Research, 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.
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
may be included.
MECHANISM OF SUPPORT
Support of this program will be through the National Institutes of Health
(NIH) P50 Specialized Center Grant 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. Most projects that can be initiated now are likely to
have a limited lifetime during which support from the NIGMS will be
appropriate, either because the project goals will have been accomplished or
the Center will have developed to the point that support from other sources
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. The
anticipated award date is July 1, 2002.
Centers will receive an administrative site visit during the third year of
the first grant cycle. The fifth year of funding will depend on the outcome
of that administrative review, and the Principal Investigator (PI) will
receive advice about NIGMS 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 (including F&A costs for subcontracts) 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. It is anticipated that the size of the awards will vary because
the nature and scope of research programs proposed will vary. NIGMS
anticipates establishing two or three such Centers in fiscal year 2002. The
actual number of awards and level of support will depend upon receipt of a
sufficient number of applications of high scientific merit and availability
of funds.
The Principal Investigator of Center Grant must commit a minimum effort of
30%.
NIGMS expects to reannounce this RFA. Revised applications will be accepted
at that time.
At some institutions, the nucleus of a research group that could conduct the
research described in this RFA 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 can be used when the applicant wishes to
request a period of planning and preliminary investigation prior to preparing
a P50 Center application. 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.
While there is no minimum effort requirement for the Principal Investigator
of a Planning Grant, an appropriate commitment must be made. A planning
grant is not required as a precursor to a P50 Center application. Funding of
a planning grant does not obligate NIGMS to fund a subsequent P50 Center
grant.
FUNDS AVAILABLE
For FY 2002, a minimum of $5 million will be committed to fund P50 Center
applications submitted in response to this RFA. It is anticipated that about
2-3 Centers will be funded, however, this funding level is dependent upon the
receipt of a sufficient number of applications of high scientific merit.
Although this program is provided for in the financial plans of NIGMS, the
award of grants pursuant to this RFA is also contingent upon the availability
of funds for this purpose.
RESEARCH OBJECTIVES
Background
The biomedical sciences have undergone a fundamental shift in both the
conceptual and technical approaches that can be brought to bear on certain
problems of profound importance. These problems center on the understanding
of the behavior of biological systems whose function is the product of
spatial and temporal ordering of myriad interacting components. Examples of
first attempts to understand these phenomena can be found at all levels of
biological organization, including the modeling of the circuitry of
bacteriophage lambda regulation, the modeling of the yeast cell division
cycle, and the quantitation of cellular processes such as metabolic flux and
response to stress. At higher levels of organization, modeling approaches
are being used to understand the orderly development of biological pattern in
model organisms such as Drosophila. At the clinical level, new approaches
are being explored to understand the integrated activity of tissues and
organs. Part of the impetus for systems-scale approaches rests on recent
advances in acquiring data of the necessary quality and quantity to permit
computer based modeling. Among the most striking recent examples is the
availability of complete DNA sequences for a number of organisms, including
humans. This advance has made it feasible to generate a truly comprehensive
parts list for any organism. Potentially, the enumeration of all the
informational units of the genomes (protein coding regions, regulatory
elements), their processed forms, and their positional significance, should
be possible and, for some microorganisms, close at hand.
However, the task of assigning functions to all these elements is formidable.
Currently, 30-40% of newly identified coding regions have no known relatives
in existing indices of function, and the identification of regulatory
elements presents a substantial informatics challenge. Much progress is being
made in adapting existing methods (such as gene inactivation) to high-
throughput functional analysis, and developing newer computational approaches
grounded in evolutionary theory. A higher order problem presents itself in
understanding how the genome-encoded components and the stuff of the living
state (metabolites, ions, water) are constituted in networks of interacting
molecules with particular distributions in time and space. Advances in
imaging techniques and analytic methods promise to yield copious quantitative
and spatial data on specific molecules in biological systems. Knowledge of
the network and changes in its components over time, and the local rules by
which the individual components distribute material and information will
substantially advance our knowledge, however, a further hurdle must be
cleared. The medical, biotechnological, and other usefulness of this
information rests on our ability to understand the principles and dynamics
that explain the behavior of the system as a whole. Whether the goal is to
understand the consequences of disease or injury, or to identify particular
molecular targets for drug interventions, or to modify the metabolism of
microorganisms to produce medicines, the challenge is predictability.
Predicting how the system of interest will respond to an intervention is a
computational problem. For biological systems this challenge is daunting.
NIGMS currently is committed to supporting the analysis of complex biological
systems through investigator-initiated research project grants, using the
R01, P01, R21, and other appropriate grant mechanisms. However, the resources
needed to conduct the multi-faceted, multi-disciplinary projects that may be
required to achieve significant advances in these complex areas may be beyond
the scope of the typical R01 or P01 grant. Therefore, this RFA presents an
opportunity for applicants to assemble large teams of investigators from
diverse disciplines that are not possible with other funding mechanisms. High
priority will be given to projects that integrate multi-investigator, multi-
disciplinary approaches with a high degree of interplay between computational
and experimental approaches. A variety of organizational models are possible,
and it is not the purpose of this announcement to prescribe any particular
one.
Scope of Research
The NIGMS intends to support Centers of Excellence in Complex Biomedical
Systems for research areas that 1) are central to its mission, and 2) focus
on developing new computational approaches to biomedical complexity.
Research areas that historically have been computationally based (e.g.,
population genetics, molecular structure) are excluded as a focus of this
Center program. Research projects focusing on disease processes and their
specific organ systems are not eligible. An example of particular interest to
NIGMS has been articulated in the planning document, A Vision for the
Future: A Complete Picture of the Healthy Cell. [URL:
http://www.nigms.nih.gov/news/reports/planning.html] This goal includes all
the aspects of complex systems research previously listed - the catalog of
structure and function, the understanding of intermolecular linkages that
lead to a wiring diagram, and ultimately the understanding of intracellular
behavior and intercellular interactions in time and space.
NIGMS mission areas for which Centers of Excellence in Complex Biomedical
Systems Research would be particularly appropriate include the following:
o Pattern formation and developmental processes in model systems (e.g.,
Drosophila, C. elegans, etc.)
o Metabolic networks and the control of the flux of substrates,
intermediates, and products in cell physiology
o Signaling networks and the regulatory dynamics of cellular processes such
as cell cycle and apoptosis, and response to environmental stress
o Supramolecular machines, such as the replisome, spliceosome, molecular
motor assemblies in cell division and motility
o Organ system networks involved in multi-organ failure in shock, trauma,
and burn injury
NIGMS strongly encourages investigators who propose to develop applications
to discuss their ideas with NIGMS program staff prior to submission, to
ensure that applications will be responsive to the NIGMS mission and intent
for this program.
Center Developmental Activities
Centers will likely support the development of new mathematical tools,
theory, and technologies that foster computational solutions. Examples are
network theoretical structures for understanding genetic and physiological
regulatory circuitry, systems of equations allowing the description of
signaling dynamics, and computer models of morphological changes during
development. The substantial bioinformatics challenge of such work has been
highlighted in the BISTI report
(http://www.nih.gov/about/director/060399.htm): "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." To
this end, Centers may include bioinformatics tool development that could
include DNA sequence feature search programs, specialized databases,
development of data sharing and representation formats, and data mining
algorithms. The plan may also include the design of new instrumentation that
may be required, for example, to obtain time series measurements of multiple
parameters of cell and tissue function, including spatial information by
imaging technologies.
Centers will also be expected to support training in this emerging
discipline. One reason for the current 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 this
program is intended to help to alleviate this shortage by serving as an
academic focus for systems approaches. To maximize their impact, Centers
should integrate the training of young investigators and broaden 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 levels. The NIGMS strongly urges the inclusion of partnering
programs that will help minority-serving institutions to develop capabilities
in these new arenas.
Workshops and courses that may develop from Center activities will serve the
wider community of investigators and their institutions by disseminating
scientific knowledge and organizational information, and are encouraged under
this program.
Center Directors may be asked to join a committee to provide feedback on this
Centers program.
GUIDANCE FOR APPLICANTS FOR P50 CENTER GRANTS
The applicant should identify clearly in the abstract and more fully in the
research plan the new approaches and collaborations, and the specific
biological questions that are to be explored as a result of the establishment
of the Center. The synergies to be achieved through the establishment of
multi-disciplinary teams and novel collaborations should be fully described.
The P50 grant application should specify the administrative and
organizational structure(s) that will be used to support the research. 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 PI 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 NIGMS anticipates will characterize
these Centers require a substantial amount of the PI"s effort to achieve
success. Therefore, the PI 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 are physically separated from each other (i.e., located in
different departments or institutions), the applicant should address how
interactions will be facilitated. NIGMS is not specifying a specific
organizational structure (e.g., specific numbers of projects and cores) in
this RFA, 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 CE/CBSR grant.
The timeline also will assist the investigators, NIGMS, and its advisors in
evaluating progress toward the project"s goals. For those projects for which
the investigator deems it appropriate to do so, NIGMS encourages applicants
to present explicit, quantitative milestones.
NIGMS 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 CE/CBSR will therefore augment programs previously developed by NIGMS
(see http://grants.nih.gov/grants/guide/pa-files/PAR-99-146.html,
http://grants.nih.gov/grants/guide/pa-files/PA-98-082.html) for expanding the
cadre of investigators working in computational biology.
The Center will be expected to have a Board of Advisors, drawn from experts
outside the project. These advisors will meet annually to review and provide
guidance on Center activities. While a description of the Board’s activities
should be included in the application, potential members of the Board should
not be named, contacted, or selected until an award has been made. This
stipulation will allow a wider pool of potential reviewers of the
application.
GUIDANCE FOR APPLICANTS FOR P20 PLANNING GRANTS
Appropriate activities under the P20 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.
DATA AND MATERIALS DISSEMINATION
The NIH is interested in ensuring that the information about new methods,
technologies, computer software, and high-throughput functional data that are
developed through this program become readily available to the research
community for further research and development. Such sharing 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
of data, materials, and software generated through the grant, taking into
consideration the recent Guidance issued by NIH
(http://www.nih.gov/od/ott/RTguide_final.htm). To the extent that established
public databases have the capability for collecting and disseminating the
data that would be collected under the grant, it is NIGMS"s strong preference
that a plan for the rapid deposition of data into such public databases be
described in the application.
The scientific 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.
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 sub-populations 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 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 research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html),
a complete copy of the updated Guidelines are available at:
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to 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) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is 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.
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 access an Internet site.
LETTER OF INTENT
Prospective applicants are encouraged 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 PI, names of other key personnel
and, if applicable, participating institutions, and the number and title of
this RFA. The letter of intent is not binding, and does not enter into the
review of subsequent applications. However, the information that it contains
allows NIGMS staff to estimate the potential review workload and to plan the
review.
The letter of intent is to be sent by September 1, 2001, to:
James J. Anderson, Ph.D.
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
Bldg. 45, Room 2AS-25A
Bethesda, MD 20892-6200
TEL: (301) 594-0943
FAX: (301) 480-2228
Email: andersoj@nigms.nih.gov
APPLICATION PROCEDURES (P50 AND P20)
Applications are to be submitted on the grant application form PHS 398 (for
newly revised version see:
http://grants.nih.gov/grants/funding/phs398/phs398.html)
and must be received by the application deadlines indicated on the first page
of this RFA. Application kits are available at most institutional offices of
sponsored research and may be obtained from:
Division of Extramural Outreach and Information Resources
National Institutes of Health
6701 Rockledge Drive, MSC 7910
Bethesda, MD 20892-7910
TEL: (301) 710-0267
Email: GrantsInfo@nih.gov
The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application. 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
title and number of the RFA must be typed on line 2 of the face page of the
application form and the YES box must be marked.
The sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to
allow for this change. Please note this is in pdf format.
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:
Helen R.Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
Bldg. 45, Room 1AS-13F
Bethesda, MD 20892-6200
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.
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 NIGMS. Incomplete 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 NIGMS in accordance with
the standard NIH peer review procedures. The applications will receive a
second-level review by the National Advisory Council, General Medical
Sciences.
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 CE/CBSR program are evaluated
appropriately, the standard NIH review criteria have been adapted to be more
appropriate for proposals of the scope described in this RFA. In the written
comments reviewers will be asked to discuss the following aspects of the
overall 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. If the Center grant
application includes distinct subprojects, the scientific merit of each
project will be assessed, based on its merit as an independent effort and its
potential importance/contribution to the success of the overall effort. Core
facilities and resources will be assessed for their quality, cost-
effectiveness, and utility to the overall effort.
Overall Review Criteria for P50 Centers
(1) Significance: Importance of the proposed research areas and topics being
explored, and their relevance to the objective of understanding the
organization and dynamics of one or more biomedically important systems.
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 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. Adequacy of plans for a Board of
Advisors to provide scientific and managerial oversight.
(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
complex systems.
(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 PI"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 takes 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, especially for under-represented minorities.
(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 modeling and simulation 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.
Overall Review Criteria for P20 Planning Grants
(1) Significance: Importance of the proposed research areas and topics being
explored, and their relevance to the objective of understanding the
organization and dynamics of one or more biomedical systems. 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 CE/CBSR award.
(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 takes 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
that will include under-represented minorities.
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.
SCHEDULE
Letter of Intent Receipt Dates: September 1, 2001
Application Receipt Dates: October 11, 2001
Peer Review Date: February-March, 2002
Council Review: May, 2002
Earliest Anticipated Start Date: July 1, 2002
AWARD CRITERIA
The following will be considered in making funding decisions:
o Quality of the proposed project as determined by peer review
o Appropriateness of data, materials, and technology sharing plan
o Availability of funds
o Program priority.
INQUIRIES
Inquiries are strongly encouraged. The opportunity to clarify any issues or
questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
James J. Anderson, Ph.D.
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
Bldg. 45, Room 2AS-25A
Bethesda, MD 20892-6200
TEL: (301) 594-0943
FAX: (301) 480-2228
Email: andersoj@nigms.nih.gov
Direct inquiries regarding review issues to:
Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences, NIH
Bldg. 45, Room 1AS-13F
Bethesda, MD 20892-6200
TEL: (301) 594-2881
FAX: (301) 480-8506
Email: sunshinh@nigms.nih.gov
Direct inquiries regarding fiscal matters to:
Joseph Ellis
Grants Administration Branch
National Institute of General Medical Sciences, NIH
Bldg. 45, Room 2AN-32C
Bethesda, MD 20892-6200
TEL: (301) 594-5135
FAX: (301) 480-1969
E-mail: ellisj@nigms.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance Nos.
93.821, 93.859, 93.862. 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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