CENTERS OF EXCELLENCE IN COMPLEX BIOMEDICAL SYSTEMS RESEARCH
Release Date: June 25, 2002
RFA: GM-03-002
National Institute of General Medical Sciences (NIGMS)
http://www.nigms.nih.gov/
LETTER OF INTENT RECEIPT DATES: September 11, 2002
APPLICATION RECEIPT DATES: October 11, 2002
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanisms of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Reviews Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
This RFA re-announces the National Institute of General Medical Sciences
(NIGMS) RFA for the establishment of new academic Centers of Excellence in
Complex Biomedical Systems Research (CE/CBSR) that was published in the NIH
Guide on January 26, 2001. The goal of the CE/CBSR program is to promote
institutional development of pioneering research and training programs
focused on quantitative, systems level analysis of biological phenomena of
biomedical importance within the NIGMS mission. NIGMS supports fundamental
inquiries focused on cell biology and biophysics, genetics and developmental
biology, human physiology in the areas of trauma, burn, inflammation, and
multiorgan failure, and pharmacology and anesthesiology. NIGMS does not
support research focused on diseases that are the domain of other Institutes
and Centers within the NIH. The CE/CBSR program also is responsive to the
Biomedical Information Science and Technology Initiative (BISTI) and its call
for National Programs of Excellence in Biomedical Computing (NPEBC).
Non-exclusive examples of appropriate research foci of CE/CBSR Centers are
the organization and dynamic behaviors of subcellular, cellular, and
developing systems, the relationship of genetic and environmental variation
to the expression of phenotype, and the understanding of organ system
responses to injury and stress. Approaches might include computationally-
based modeling, e.g., of processes such as the cell cycle, pattern formation
during embryogenesis, the flux of substrates and intermediates in metabolism,
system wide responses to pharmaceuticals, and cellular stress responses.
Statistical and other mathematical tools may be used to analyze the genetic
architecture of complex traits, and network analysis may be applied to
understanding the integrated systemic host responses to trauma, burn, or
other injury.
The P50 Center Grant mechanism 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. Training activities may
include programs in computational and information sciences. Partnering with
undergraduate institutions, especially those with substantial numbers of
underrepresented minority students, is encouraged.
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 genetic 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 and to track changes over time. 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.
The challenges are substantial. A significant fraction of newly identified
coding regions have no known relatives in existing indices of function, and
the identification of regulatory elements presents a significant 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.
At the organismal level, phenotype must take into account the relationships
and interactions of biological and environmental variables. Basic biological
systems, including gene sequences, structures, and pathways that direct
metabolism and development vary within individuals, among individuals, among
populations, and among species. Advances in complex systems level
understanding must ultimately include models that account for this variation.
Medical, biotechnological, and other uses of biological information
increasingly depends 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.
The effort to get a quantitative "handle" on biological systems and their
integrated behavior requires diverse expertise. In particular, contributions
from the computational disciplines of engineering, physics, and computer
science are needed. The development of new theoretical frameworks will in
large part be a mathematical endeavor. As modeling and simulation studies
advance in sophistication, there will be a demand for better quality and
increased quantities of data, and therefore the development of new
instrumentation and methods. The organization and representation of these
new data streams, and their integration with preexisting knowledge, will
challenge current capabilities in bioinformatics.
The organization of projects incorporating multidisciplinary approaches and
the recruitment and training of skilled personnel are not simple
undertakings, and these CE/CBSR 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.
NIGMS currently supports 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 may not be 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. Innovation is critical. A variety
of organizational models are possible, and it is not the purpose of this
announcement to prescribe any particular one.
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:
https://grants.nih.gov/grants/guide/pa-files/PA-98-077.html.
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.,
molecular structure and modeling) are excluded as a focus of this Center
program. Research projects focusing on disease processes and their specific
organ systems are not eligible. 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, and molecular
motor assemblies in cell division and motility
o Organ system networks involved in multi-organ failure in shock, trauma,
and burn injury
o Genetic architecture of biological complexity related to inherited
variation and environmental fluctuations.
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, analytical tools to discover the relationship of
genotypic variation to phenotype, and computer models of morphological
changes during development.
The substantial bioinformatics challenge of engaging large data streams and
developing models 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 be expected to provide national leadership in complex systems
research. To do so, they will be expected to support training and outreach
activities that will insure the flow of information and expertise both into
and out of the Center. One reason for the current lack of adequately
qualified personnel is that there are too few appropriate environments
available to support 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, visiting investigatorships, 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.
Center Directors may be asked to join a committee to provide feedback on the
success of the CE/CBSR program.
MECHANISM OF SUPPORT
This RFA will use NIH P50 Specialized Center Grant mechanism. As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation, but may
be reannounced. Future unsolicited, competing-continuation applications
based on this project will compete with all investigator-initiated
applications and will be reviewed according to the customary peer review
procedures. The anticipated award date is July 1, 2003.
This RFA uses just-in-time concepts.
FUNDS AVAILABLE
The NIGMS intends to commit approximately $6 million in FY03 to fund 2-3 new
P50 Center grants in response to this RFA. An applicant may request a
project period of up to 5 years and a budget for direct costs of up to $2M
per year, exclusive of facilities and administrative costs for collaborating
institutions. Funds for initial large equipment may be requested in excess of
this $2M limit if prior approval is obtained from staff, listed below, prior
to application. 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
NIGMS provide support for this program, awards pursuant to the RFA are
contingent upon the availability of funds and the receipt of a sufficient
number of meritorious applications. At this time, it is not known if this
RFA will be reissued. The total length of support for any P50 Center under
this program will be limited to no more than ten years.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution is a domestic organization
and 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
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
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 Principal Investigator of Center Grant must commit a minimum effort of
30%.
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.
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 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.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: Scientific/research, peer review, and financial or grants management
issues:
Direct your questions about scientific/research issues to:
James J. Anderson, Ph.D.
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences, NIH
Bldg. 45, Room 2AS-25A
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
FAX: (301) 480-2228
Email: andersoj@nigms.nih.gov
Direct your questions about peer 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
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email: sunshinh@nigms.nih.gov
Direct your questions about financial or grants management matters to:
Joseph Ellis
Grants Administration Branch
National Institute of General Medical Sciences, NIH
Bldg. 45, Room 2AN-32C
Bethesda, MD 20892-6200
Telephone: (301) 594-5135
FAX: (301) 480-1969
E-mail: ellisj@nigms.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent 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 the 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 NIGMS staff to estimate the potential review workload and
plan the review.
The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:
James J. Anderson, Ph.D.
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences
Bldg. 45, Room 2AS-25A
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
FAX: (301) 480-2228
Email: andersoj@nigms.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@nig.gov.
SUPPLEMENTAL INSTRUCTIONS: The applicant should identify clearly in the
description 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 the Center 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 will 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 applicant 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.
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.
NIGMS encourages applicants to devise a strategy for the Center"s training
and outreach components that best take 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 https://grants.nih.gov/grants/guide/pa-files/PAR-99-146.html,
https://grants.nih.gov/grants/guide/pa-files/PA-98-082.html) for expanding the
cadre of investigators working in computational biology.
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 applications 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:
Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
Bldg. 45, Room 1AS-13F
Bethesda, MD 20892-6200
APPLICATION PROCESSING: Applications must be received by 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.
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. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an Introduction addressing the previous critique.
PEER REVIEW PROCESS
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 review procedures stated below.
As part of the initial merit review, all applications will:
o Receive a written critique
o Receive a second level review by the National Advisory General Medical
Sciences Council
o And may 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.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments reviewers will be asked to discuss the following aspects
of your application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application"s overall score, weighting them as appropriate
for each application. If the P50 Center Grant application includes distinct
subprojects, the scientific merit of each will be assessed, based on its
merit as an independent effort and its potential importance/contribution to
the success of the overall effort (the projects will not receive separate
scores, however).
REVIEW CRITERIA FOR P50 CENTER GRANT APPLICATIONS:
(1) SIGNIFICANCE: Does the study address an important problem? If the aims
of the application are achieved, how do they advance scientific knowledge?
What will be the effect of these studies on the concepts or methods that
drive this field? Will this center serve as a model for cross-disciplinary
interactions?
(2) 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 tactics? For proposed multi-component centers, do the individual
components exhibit a high degree of interrelatedness and synergy? Are the
proposed core facilities essential to the success of the center?
(3) 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?
(4) INVESTIGATOR: Is the principal investigator appropriately trained and
well suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and the other researchers?
Has the principal investigator demonstrated the ability to manage large
projects?
(5) ENVIRONMENT: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support, including any needed expansion of facilities, improvement of
infrastructure, and relief from other academic duties where necessary?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
application will also be reviewed with respect to the following:
o PROTECTIONS: 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.
o INCLUSION: 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
included in the section on Federal Citations, below.)
o DATA SHARING: The adequacy of the proposed plan to share data.
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
OTHER REVIEW CRITERIA:
o Quality and appropriateness of the management plan, including the
effectiveness of the management structure and the PI"s ability to lead and
coordinate the activities.
o Adequacy of plans for a Board of Advisors to provide scientific and
managerial oversight.
o Quality of the proposed training plan and outreach activities and their
likely effectiveness in meeting community needs, including provisions for
engaging under-represented minorities.
RECEIPT AND REVIEW SCHEDULE:
Letter of Intent Receipt Date: September 11, 2002
Application Receipt Date: October 11, 2002
Peer Review Date: February – March 2003
Council Review: May, 2003
Earliest Anticipated Start Date: July 1, 2003
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
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 AMENDMENT "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.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s) for the hESC line(s) to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
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.
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 No. 93.821, and is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.
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 described at https://grants.nih.gov/grants/policy/policy.htm and under
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
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.