LARGE-SCALE COLLABORATIVE PROJECT AWARDS
Release Date: February 28, 2001
RFA: RFA-GM-01-004
National Institute of General Medical Sciences
Phase I Application Receipt Date: June 18, 2001
Phase II Application Receipt Date: January 16, 2002
PURPOSE
The purpose of this RFA is to reannounce the National Institute of General
Medical Sciences (NIGMS) program of Large-Scale Collaborative Project
Awards , (commonly called large Glue Grants) first issued as GM-99-007 in May
1999, and subsequently reissued in December 1999 as Notice GM-00-001. This
new announcement includes updates and modifications, and should be used in
lieu of the previous announcements.
The purpose of this program is to enable the solution of major problems in
biomedical research and to facilitate the next evolutionary stage of
integrative biomedical science. The intention is to make resources available
for independently funded scientists to form research teams to solve a complex
biological problem that would be beyond the means of any one research group,
and that is of central importance to biomedical science and to the mission of
the NIGMS. It is expected that the participating investigators will already
hold externally peer reviewed and funded research grants in the area of the
proposal, and in general, support of new individual research projects will
not be a part of these large scale project awards. A high level of resources
may be requested to allow participating investigators to extend their
research efforts to form a consortium to approach a research problem of
overarching importance in a comprehensive and highly integrated fashion.
Grants for this initiative will be awarded in two phases. The purpose of the
Phase I award is to provide resources for detailed planning to applicants who
have demonstrated the selection of an appropriate complex biological problem,
an innovative plan, and appropriate commitments to its solution from
participating investigators and institutions. Phase I applicants will submit
an overview of the proposed large scale project for peer review. Successful
Phase I applicants will receive a $25,000 (direct costs) planning grant, and
those applicants who receive awards will be eligible to submit a more
extensively planned and detailed application for a Phase II award to support
the large scale project itself.
This RFA is one of a pair of initiatives to increase support opportunities
for collaborative ventures. A companion program, "Integrative and
Collaborative Approaches to Research,"
(http://grants.nih.gov/grants/guide/pa-files/PA-00-099.html and
http://grants.nih.gov/grants/guide/notice-files/NOT-GM-01-001.html)is
intended to support collaborative activities that are smaller in scale and
scope than those requested in response to this RFA. The NIGMS also advises
that collaborations can be supported by most of the Institute"s existing
support mechanisms and strongly encourages potential applicants to talk with
program directors in NIGMS to determine the most appropriate support
mechanism for their collaborative work.
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 Request for
Applications (RFA), Title of 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/.
ELIGIBILITY REQUIREMENTS
Applications must fall directly into the areas of research supported by the
National Institute of General Medical Sciences. Applicants are advised to
visit the Institute website at http://www.nigms.nih.gov for information on
NIGMS areas of interest. The projects must support the NIGMS mission as
detailed in the publication, "Divisions and Grant Award Mechanisms,"
available from the NIGMS Public Information Office (301/496-7301). Potential
applicants may wish to visit the NIGMS website created for this RFA and the
PA referred to above at http://www.nigms.nih.gov/funding/gluegrants.html.
Applicants are also strongly advised to contact the NIGMS staff listed below
to discuss the eligibility of a proposed project.
The major research activity of the principal investigator must be in the
research area of the collaborative project application, and the principal
investigator is expected to make a major commitment of effort to directing
and managing the operation of the project, a substantial level of effort will
be necessary to manage a project of this magnitude. NIGMS anticipates that
each collaborative project will include a substantial number of participating
investigators. For example, a modest size large scale collaborative project
might contain fifteen or more participating investigators, who in the
aggregate, hold independent peer-reviewed grants in the proposed research
area in excess of $2.0 million (annual direct costs) at the time of
application, and who will be actively involved in and committed to the goals
of the consortium. However, minimum and maximum numbers of participating
investigators have not been set.
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. Multi-institutional applications are encouraged. A
collaborative project may include participating investigators from foreign
and/or for-profit organizations. Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as Principal
Investigators.
MECHANISM OF SUPPORT
Phase I Applications
For Phase I applications, this RFA will use the National Institutes of Health
(NIH) R24 grant mechanism. A Phase I award will be made for three months at
a level of $25,000 in direct costs to provide for costs associated with
planning the large scale collaborative project. Appropriate expenses for a
planning award include, but are not limited to, salary for release time for
the principal investigator to commit a significant percentage of effort to
planning the Phase II application, meetings of the steering committee and
participating investigators, and consultant costs for initial design and cost
estimates for proposed core resources. The anticipated award date for Phase
I awards is September, 2001.
Phase II Applications
Only applicants who receive a Phase I award will be eligible to submit a
Phase II application, which will be a new (Type 1) award. For Phase II
applications, this RFA will use the NIH Specialized Center (Cooperative
Agreements) mechanism, U54. The total project period for an application
submitted in response to this RFA may not exceed five years. The anticipated
award date for Phase II awards is September 2002. Phase II awards will be
considered for one five-year renewal period following the initial award.
Funding for Phase II applications will be provided by means of cooperative
agreements. A cooperative agreement is an "assistance" mechanism in which
substantial NIH scientific and/or programmatic involvement with the awardee
is anticipated during the performance of the activities conducted by the
awardee. Under a cooperative agreement, the NIH purpose is to support,
stimulate, and expedite the recipients" activities by jointly being involved
with them. NIGMS staff will work cooperatively with the award recipients in a
partner role, but will not assume direction, prime responsibility, or a
dominant role in the activity. Details of the responsibilities,
relationships, and governance of the activities to be funded under the
cooperative agreements awarded for this Program are discussed later in this
document under the section "Terms and Conditions."
This RFA is a one-time solicitation, although NIGMS presently anticipates re-
announcing the solicitation, depending on the availability of funds. Both
new and revised Phase I applications, and revised applications for
unsuccessful Phase II proposals, would be accepted if the solicitation is re-
announced within a two-year period. Only one revision of a Phase I or Phase
II application will be accepted for consideration.
FUNDS AVAILABLE
NIGMS intends to commit up $10-15 million in total costs in FY2002 to fund
both Phase I and Phase II awards. NIGMS anticipates funding up to ten Phase
I awards, each Phase I award will be for $25,000 in direct costs. Two to
three Phase II grants will be awarded. Because the nature and scope of the
proposed research will vary, it is anticipated that the size of the Phase II
awards also will vary, and the upper limit for a Phase II award will be $5
million per year in annual direct costs. Applications of different scales
and scope are encouraged. Although the financial plans of NIGMS provide
support for this program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications
RESEARCH GOALS, SCOPE, AND ORGANIZATION
Background:
NIGMS" external advisors, who met in May and November 1998, urged the
Institute to support new mechanisms for collaboration on complex systems in
biomedical science. For most of the last thirty years the main approach used
in biomedical science has been to focus attention on understanding the
individual steps in biological processes at the subcellular and molecular
level. Although much still needs to be done in defining and analyzing
molecular events, it appears that enough of the pieces have been
characterized to begin to put them together to solve problems of the global
control and integration of biological processes. These efforts will require
the cooperation of many groups of scientists and many types of science.
The mainstay for support of biomedical science has been the traditional
research project grant, the NIH R01 grant. While this grant mechanism
remains the backbone of NIH support for biomedical science, it may not be
sufficient in and of itself to support the solution of complex problems of
the type described above. Many scientists are now expressing a strong need
for a new type of support that will encourage scientific collaboration and
provide for a higher level of coordination to solve problems requiring
multifaceted approaches. These scientists are able to secure research
support for their own efforts but seek a means to encourage and facilitate
the development of an interactive research network around a complex
biological problem.
The purpose of this request for applications is to address the need to
coalesce and coordinate efforts on a larger central problem in biomedical
science and to make collaborations and resources available to a group of
independently funded investigators. Biomedical science has entered a new era
where these collaborations are becoming critical to rapid progress. This is
the result of several factors. First, not every laboratory has the breadth to
pursue problems which increasingly must be solved through the application of
a multitude of approaches. These include the involvement of fields, such as
physics, engineering, mathematics, and computer science, that were previously
considered peripheral to mainstream biomedical science. Second, the ability
to attack large projects that involve considerable data collection and
technology development require the collaboration of many groups and
laboratories. Finally, large-scale, expensive technologies such as
combinatorial chemistry, DNA chips, high throughput mass spectrometric
analysis, etc., are not readily available to all laboratories that could
benefit from their use. These technologies require specialized expertise,
but could lend themselves to management by specialists who collaborate or
offer services to others.
Research Objectives:
The primary research objectives are to solve complex biological problems of
great significance through large scale collaborative projects that integrate
broad and diverse areas of science by bringing together independently funded
investigators who share a connection to a central problem and to facilitate
the development of integrative biomedical science. The intention is to
provide the framework and incentives to foster the development of integrative
research teams and to provide considerable flexibility for participants to
request and employ the specific resources necessary to accomplish the job.
Part of the challenge of each large scale collaborative project will be to
devise the organizational structure that best facilitates accomplishment of
the specific scientific goals of that collaborative project. The main
outcome expected is the solution of a complex, multifaceted research problem
of overarching significance, where such a solution could not be achieved in a
reasonable time frame by separate efforts. An additional expected outcome is
that collaboration and integration in the biomedical sciences will be
enhanced.
The research scope for this RFA includes all areas of science that are of
direct relevance to the National Institute of General Medical Sciences
(http://www.nigms.nih.gov/about_nigms/overview.html). Participation by
investigators doing mechanistic clinical science is welcomed as well as by
investigators doing basic laboratory science. It is recognized that data
collection and technology development may be logical and necessary parts for
some or all large scale collaborative projects.
Possible examples of scientific problems that could be addressed by large-
scale collaborative teams might be:
working out all facets of particular cellular processes, both for the process
itself and for its integration into and control of cellular function
determining structures and distilling global structure-function principles
for organelles
quantitatively modeling interacting metabolic pathways in a model organism
determining the multi-level control mechanisms and their integration into the
biological response to traumatic injury
Whether projects such as these illustrative examples are sufficiently
important to be funded as large scale collaborative project awards will be
determined by peer review and relevance to current areas of interest to the
Institute. For results of previous competitions, visit the NIGMS glue grant
website at http://www.nigms.nih.gov/funding/gluegrants.html.
It will not be sufficient to organize a research network simply to promote
access of individual investigators to research resources. There must be
intense and meaningful interaction proposed around a central biological
problem among the participating scientists, so that progress achieved is
substantially greater than the sum of the participants" individual
achievements. Each large scale collaborative project, as in the examples
above, could require considerable new resources, but would also require a
synthesis of information from individual laboratories in order to solve the
biological problem being addressed.
The Phase I application should provide an overview of the proposed
collaborative project, including the goals for the project, the reasons for
using this mechanism, and the approach to the expected elements of a Phase II
proposal.
The Phase II application should provide a more detailed explanation of the
proposed project, including specific intermediate goals (milestones) and a
timeline for their accomplishment.
Elements of a Large-Scale Collaborative Project:
PRINCIPAL INVESTIGATOR: Each collaborative project will be headed by a
principal investigator (PI) who will chair and be assisted in governing the
project by a steering committee. Although a substantial level of effort is
expected for the PI, minimum levels of effort have not been set for the PI,
however, the level of effort of the PI will be a factor in the assessment of
scientific merit and in the Institute"s funding selections.
STEERING COMMITTEE: The steering committee is responsible for governance of
the large scale collaborative project, and its membership, chosen from
participating investigators and project staff, should be representative of
the scope and membership of the proposed collaborative project. The level of
effort and commitment to the collaborative project of the members of the
steering committee will also factor into the assessment of scientific merit
as well as the Institute"s funding selections. It is expected that the
principal investigator, the steering committee, and the participating
investigators will work together to develop reasonable and sound goals and
operating procedures for the collaborative project. An NIGMS program
director will serve as a member of the steering committee and attend its
meetings.
PARTICIPATING INVESTIGATORS: In addition to the PI and members of the
steering committee, each collaborative project will include a team of
investigators who will contribute to and benefit from participation in the
project. The members of the collaborative project will be referred to
collectively as participating investigators. It is expected that each of the
participating investigators will hold an externally peer reviewed and funded
research grant in the area of the project. It is expected that the majority
will be funded through regular research grants supported by NIGMS, other NIH
institutes and centers, and other governmental and private agencies.
Exceptions to the rule of external funding may include participating
investigators from industry, foreign institutions or allied fields not
traditionally supported by the NIH (e.g., physics and mathematics). However,
they must provide evidence of their commitment to the project and a listing
of organizational resources that will be committed to the project. Principal
investigators of pilot projects (see below under COLLABORATIVE PROJECT
RESOURCES) will also be considered participating investigators.
Participating investigators will work with the other members of the team to
develop workable guidelines for the collaborative project. Participating
investigators must agree to abide by the policies and rules set up for the
collaborative project and to the terms and conditions herein to be eligible
to participate. During the period of the award, a participating investigator
whose independent research support terminates may continue as a participating
investigator at the discretion of the steering committee and with the
approval of the NIGMS program director. However, funds from this award are
not to be used to support the independent project of such an investigator.
It is expected that new participating investigators will be added to the
collaborative project over the period of the award as deemed appropriate by
the principal investigator and steering committee and with the approval of
the NIGMS program director, these additions will be reported in the annual
progress report.
ADVISORY COMMITTEE: Each large-scale collaborative project will include an
external advisory committee whose purpose is to meet annually with the
principal investigator and the steering committee to assess progress and
provide feedback on proposed goals for the next year of support. The members
will be appointed by the principal investigator in consultation with the
steering committee and with the approval of the NIGMS program director, after
the Phase II award has been made, and will be drawn from research scientists
not involved in the project. The members of the advisory committee should not
be selected until an award has been made. The NIGMS program director
responsible for the award will attend the meeting of the advisory committee
as a member of the steering committee, but will not be a member of the
advisory committee. The advisory committee will meet at least once a year
immediately prior to the submission of the annual progress report.
COLLABORATIVE PROJECT RESOURCES: The organizational structure of the
collaborative project may have a variety of forms depending on the needs of
the research problem being addressed. For example, the large scale
collaborative project could consist entirely of a research and administrative
structure, including a data coordinating and information dissemination
center, independent of supporting additional activities in any of the
laboratories of the participating investigators. In addition, the large-
scale collaborative project may request the following types of resources:
Bridging projects may be requested for collaboration enhancement activities
(essentially supplements to the ongoing independent work) in the laboratories
of the participating investigators. These bridging projects to the
laboratories of participating investigators are to add to or bridge the
intellectual and technological approaches of the collaborative project. They
are not meant to be stand-alone research efforts but are to be subprojects
that tie (or enhance the contribution of) the independent work of the
participating investigator to the large scale collaborative project. A
bridging project should extend the participating investigator’s independent
work in a new direction(s). A bridging project to do more of what the
investigator is already doing should be considered only if there are
extraordinary circumstances that make it essential for the effective
functioning of the large-scale project. If the participating investigator’s
work is already closely tied to the large-scale project, a bridging project
should not be needed. Substantial new research projects should not be
submitted for bridging projects, these should be submitted as regular R01
applications, even if they add value to the large-scale project.
Pilot projects may be requested for investigators without current independent
support in the area of the collaborative project to add elements where gaps
exist, or to add investigators with critical knowledge or expertise but
without a research background in the area of the collaborative project.
These pilot projects must not exceed $75,000 in annual direct costs and must
be limited to no more than three pilot projects per large-scale collaborative
project. The pilot project should be of sufficient scope to qualify as a
stand alone research effort. It is primarily intended to allow the
collaborative project to add investigators outside the scientific mainstream
of the project area in a mode that will allow them to develop independent
research in the area of the collaborative project. Applicants must explain
why the principal investigator’s expertise is needed for the large-scale
project and how the pilot project will contribute directly to the
accomplishing the aims of the large-scale project. While funding for a pilot
project may run for five years, at the discretion of the steering committee,
it is expected that the principal investigator of a pilot project will seek
R01 funding during the period of the collaborative project, based on the
results obtained from the pilot project.
Core resources may be requested to speed progress on the scientific goals of
the project or add additional capability to the collaborative project by
adding new or improved technology or by standardizing data among different
research teams. An example of new technology might be gene chip microarray
technology, an example of standardizing results might be establishment of a
model organism core. It is expected that each large-scale collaborative
project will request core resources for information collection, coordination,
and dissemination. Other types of resources might be for instrumentation,
genomics, proteomics, high-throughput assays, or
computational/bioinformatics/modeling cores. Requests for core resources
must be strongly justified in terms of value to achieving the goals of the
project, value to increasing the synergy of the collaborative project, and
cost effectiveness.
ADMINISTRATIVE MANAGEMENT PLAN: Each large-scale collaborative project award
must include an administrative management plan that outlines the policies and
procedures for access of participating and non-participating investigators to
the collaborative project resources. The application should address the flow
of information within the project, and plans for how the information will be
integrated into the solution of the biological problem being addressed. The
mechanism to add new participating investigators and delete members whose
association with the project has not been productive should be documented in
the proposal. The plan should also include proposed methods for information
dissemination both within the collaborative project and to the scientific
community. Furthermore, each large-scale collaborative project will include
a mechanism to consider and respond to concerns of the scientific community
directly affected by the project about the operation and impact of the
project. A discussion of scientific community views will be part of the
agenda for annual meetings of the steering committee with the advisory
committee.
PROJECT MANAGEMENT PLAN: Each large scale-collaborative project application
must include a project management plan, including an ongoing evaluation plan,
to ensure consistent forward progress of the project. Each collaborative
project will define, at a minimum, yearly milestones, and those receiving
awards will have the opportunity to modify these milestones at the time of
their awards, with the concurrence of NIGMS. It is expected that the
milestones will be adjusted annually at the award anniversary dates, both to
incorporate a team"s scientific accomplishments and progress in the field in
general, as well as to reflect the recommendations of the advisory committee.
The NIGMS program director responsible for the large-scale collaborative
project may include outside consultants in the annual progress review and may
recommend reducing or withholding funds, or termination of the award, for
failure to meet milestones. A report by the NIGMS program director of each
collaborative project"s progress and any recommendations to modify funding
will be made annually to the National Advisory General Medical Sciences
Council.
PLAN FOR DATA SHARING AND INTELLECTUAL PROPERTY: To address the interests of
the government in the availability of, and access to, the results of publicly
funded research, NIH requires applicants who respond to this RFA to develop
and propose specific plans for sharing the data and materials generated
through the large-scale collaborative project. The initial review group will
comment on the proposed plans. The adequacy of the plans will also be
considered by NIH staff as one of the criteria for award. Because
dissemination is a critical aspect and fundamental purpose of this RFA, the
proposed sharing and data release plans, 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 and
material release. It is further suggested that the members of the large-
scale collaborative project disclose to the steering committee their ties to
profit-making organizations to aid the project in avoiding conflict of
interest situations. Applicants are also reminded that the grantee
institution is required to disclose each subject invention to the Federal
Agency providing research funds within two months after the inventor
discloses it in writing to grantee institution personnel responsible for
patent matters.
SPECIAL REQUIREMENTS FOR COOPERATIVE AGREEMENTS
Terms and Conditions of Award
The following Terms and Conditions will be incorporated into the award
statement and will be provided to the Principal Investigator as well as to
the appropriate institutional official, at the time of award. The following
special terms of award are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines, HHS grant administration
regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and
local Governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies:
The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic involvement
with the awardees is anticipated during performance of the activities. Under
the cooperative agreement, the NIH purpose is to support and stimulate the
recipients" activities by involvement in and otherwise working jointly with
the award recipients in a partnership role, it is not to assume direction,
prime responsibility, or a dominant role in the activities. Consistent with
this concept, the dominant role and prime responsibility resides with the
awardees for the project as a whole.
Awardees will retain custody of and have primary rights to the data developed
under these awards, subject to Government rights of access consistent with
current HHS, PHS, and NIH policies. Awardees should comply with their
institutional intellectual property policies and practices as approved in the
award. However, awardees will be expected to share (make available) this
data openly with the scientific community.
Principal Investigator Responsibilities:
The principal investigator is the scientist who assembles the large scale
collaborative project and is responsible for submitting the application in
response to this RFA and for performance of the project. The PI will
coordinate project activities scientifically and administratively at the
awardee institution. The PI will have the overall responsibility for the
scientific and technical direction and the administration and overall
operation of the large scale collaborative project. To assist the PI with
the governing of the project, a steering committee will be established from
among the participating investigators and project staff. The principal
investigator will chair the steering committee. The membership will be
representative of the scope of the project. As for all participating
investigators, the PI must abide by the operating rules and guidelines
developed by the steering committee. The Principal Investigator will agree
to accept participation of NIGMS staff in those aspects of management of the
project described under "NIGMS Program Director Responsibilities". He/she
will also ensure the timely dissemination of information generated by the
large-scale collaborative project to both the project members and the
scientific public.
Participating Investigator Responsibilities:
The participating investigators are those scientists holding externally peer
reviewed grant support in the area of the project and who are involved with
and committed to the goals of the project. Exceptions to the rule of external
funding may include participating investigators from industry, foreign
institutions or allied fields not traditionally supported by the NIH (e.g.,
physics and mathematics), PIs of pilot project are also included.
Participating investigators will work with the principal investigator, the
steering committee, and the other members of the large scale collaborative
project to set goals and develop working procedures, they must agree to
support the goals of the project and to abide by the operating guidelines and
procedures established for the project. Participating investigators will be
actively involved in the project and interactive with the other members of
the project.
NIGMS Program Director Responsibilities:
The NIGMS program director will serve as a voting member of the steering
committee and will attend all meetings. In addition to having all of the
duties and responsibilities of a steering committee member, the NIGMS program
director will facilitate interactions among the steering committee and the
advisory committee and NIGMS and provide advice and guidance to assure that
the large scale-collaborative project adheres to the NIH and NIGMS rules and
regulations. The NIGMS program director will facilitate communication with
the scientific community directly affected by the collaborative project and
will assure that the steering committee and the advisory committee address
issues and concerns raised by the community. Additional responsibilities may
be negotiated at the time of award depending on the individual
characteristics of the awards to be made.
Steering Committee Responsibilities
A steering committee will serve as the governing board of each large scale
collaborative project and will participate in setting direction, policies and
operating procedures. Membership will include the principal investigator, as
well as other scientists and administrators drawn from the staff and
participating investigators of the project, sufficient in breadth and balance
to be representative of the overall project. The NIGMS program director will
serve as a member of the steering committee. The original members will be
selected by the principal investigator from among the participating
investigators and staff to be representative of the scope of the project.
Additional or replacement members will be selected by the steering committee.
The steering committee will work with the principal investigator to establish
the scientific and technical direction of the project, develop common
guidelines and procedures, establish rules for access to resources of the
project and for dealing with intellectual property issues, and participate in
the process of developing a cohesive group. The steering committee will
develop a policy regarding disclosure of ties between scientists and profit-
making organizations to aid the project in avoiding conflict of interest
situations. The steering committee will monitor bridging projects, core
resources, and pilot projects for progress and efficiency, and recommend
modification of support and addition/deletion of these activities as needed
to facilitate progress on the goals of the large-scale collaborative project.
Advisory Committee Responsibilities:
The advisory committee will be composed of a panel of a minimum of three
scientists not otherwise associated with the large scale collaborative
project. The NIGMS program director will attend the meetings of the advisory
committee as a member of the steering committee. The advisory committee will
meet at least yearly to provide advice to the steering committee of the large
scale collaborative project about meeting its goals and to comment on plans
for future directions. The advisory committee will raise issues for
consideration by the principal investigator and the steering committee and
will comment on the appropriateness of the level of NIGMS support to achieve
the goals of the project. The advisory committee will also comment on the
impact of the collaborative project on the relevant scientific communities.
Milestones and Evaluations
It is expected that milestones will be adjusted annually at the award
anniversary dates, both to incorporate a group"s scientific accomplishments
and progress in the field in general, as well as to reflect the
recommendations of the advisory committee. In accordance with the procedure
described above, the NIGMS program director may recommend to the Director,
NIGMS, augmenting any subproject or core facility, or reducing or withholding
funds for any subproject or core facility that substantially fails to meet
its milestones or to remain state-of-the-art.
The Director, NIGMS, retains the right to call a meeting of advisors, most
likely members of the National Advisory General Medical Sciences Council or
their designee(s), at any time to provide advice on the scientific progress
of a large-scale collaborative project. It is anticipated that such a group
of advisors may want to attend a meeting of the project advisory committee as
part of its fact-finding mission.
Arbitration Process
Any disagreements that may arise in scientific or programmatic matters
(within the scope of the award) between award recipients and the NIGMS may be
brought to arbitration. An arbitration panel will be convened. It will be
composed of three members: a designee of the principal investigator, one
NIGMS designee, and a third designee with expertise in the relevant area who
is chosen by the other two, in the case of an individual disagreement, the
first member may be chosen by the individual awardee. This special
arbitration procedure in no way affects the awardee"s right to appeal an
adverse action that is otherwise appealable in accordance with PHS
regulations 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16.
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.
PHASE I APPLICATION PROCEDURES
Phase I awards are intended to support planning activities in order to
structure and organize the large scale collaborative project for submission
as a Phase II application. In general, the Phase I application will be used
to gauge the merit of the basic idea and the conceptual framework for the
collaborative project, specific review criteria are discussed below.
Prospective applicants must submit, by June 18, 2001, a Phase I application
that contains an overview of the proposed large scale collaborative project.
Phase I applications will be evaluated by an appropriately constituted peer
review group. Phase I applicants will be advised by September 2001 whether
their applications will be funded. Only Phase I awardees may submit Phase II
applications for scientific merit review.
Contents of Applications
Phase I and Phase II applications are to be submitted on the standard
research grant application form PHS 398 (rev. 4/98). 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) 710-0267, email: grantinfo@nih.gov.
A Phase I response to this RFA should follow the PHS 398 instructions with
the following modifications:
Application face page. Complete all items. This is page 1, number succeeding
pages consecutively. The RFA label found in the PHS-398 (rev. 4/98)
application form must be affixed to the bottom of the face page of the
application and must include the RFA number. 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. On line 2, the number and title of
this RFA: GM-01-004, "Large-Scale Collaborative Project Awards," must be
entered, and the YES box must be marked.
The Research Plan should be replaced with the following:
A statement (two page limit) by the principal investigator describing his/her
commitment, including percent effort, to the large-scale collaborative
project and identifying the members and percent effort of the steering
committee.
A project summary (ten page limit) describing the scientific goals and
operation of the large scale collaborative project. Explain what complex
biological problem will be solved. Describe in detail and explain the
scientific approach to this problem. Explain why a large-scale collaborative
project is critical to its solution. Describe the range of scientific
expertise to be brought to bear on the problem. It is important to make
clear the significance of the biological problem chosen and what the value
added benefit will be from pursuing the problem with a collaborative project,
rather than individual grants. Approaches envisioned to the key elements of a
large-scale collaborative project should be described. The roles that
bridging projects, pilot projects, and/or core resources will play in the
collaborative project should be described. The project summary will serve as
the research plan for the Phase I application.
Biographical sketches and letters of commitment from each of the
participating investigators that indicate their interest in joining the
collaborative project.
Other support pages should include only the grants of each participating
investigator that are in the area of the large-scale collaborative project.
Letters signed by the authorized business official of each of the
participating investigators" institutions committing support to the
collaborative project. Arrangements for the participation of investigators
from industry and foreign sites and resources they may bring to the
collaborative project should be documented.
A statement of institutional and other resources available to the consortium
(three pages).
A Literature Cited section is permissible, but appendices will not be allowed
as part of a Phase I application since a detailed plan is not requested at
this stage.
A description of the proposed budget allocation (one page, in lieu of the PHS
398 budget section). All Phase I awards will be for up to $25,000 for the
period November 1, 2001 to January 31, 2002.
Review Considerations
Upon receipt, Phase I applications will be reviewed for completeness by CSR
and responsiveness by the NIGMS. Incomplete and/or non-responsive
applications will be returned to the applicant without further consideration.
Phase I 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 criteria stated
below.
As part of the initial merit review, a process may be used by the initial
review group in which Phase I applications receive a written critique and
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 the application in order to judge the likelihood that the proposed
consortium will have a substantial impact on the pursuit of these goals.
Each of these criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application.
Significance. Does this project address a complex biological problem of
overarching significance to biomedical science that would be difficult to
address by separate grants? If the aims of the application are achieved, how
will the field of biomedical science be advanced?
Approach. Is the conceptual framework appropriate to achieve the scientific
aims of the large scale collaborative project?
Innovation. Are the project"s structure and goals novel? Are the aims
original and innovative? Will the project attack a problem in a significantly
new way? What will be the value added over individual grants?
Investigators. Is the principal investigator"s major research activity
within the research area of the collaborative project? Is the principal
investigator well suited to the scientific and administrative leadership
required to carry out this work? Are the research grants of the participating
investigators within the area of the project? Are the participating
investigators well chosen for their roles in the project? Do the commitments
of the principal investigator, steering committee members, and participating
investigators appear reasonable for the scope of the planned activities?
Environment. Do the scientific environments in which the work will be done
contribute to the probability of success? Is the level of institutional
support adequate?
Additional review criteria for Phase I awards that will also be considered
include the commitment to the project by the principal investigator, the
members of the steering committee, and the participating investigators, the
commitment of the host university to supporting the consortium, reflected,
for example, in the willingness to work out potential intellectual property
issues prior to submission of the Phase II application and to remove any
institutional barriers to the establishment and healthy maintenance of the
large scale collaborative project.
Award Criteria
Award criteria that will be used to make funding decisions include:
o scientific merit (as determined by peer review)
o program priorities
o program balance
o availability of funds
PHASE II APPLICATION PROCEDURES
Phase I awardees may submit a Phase II application by January 16, 2002 for
peer review. Phase II applications are to be submitted on the standard
research grant application form PHS 398 (rev. 4/98). 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) 710-0267, email: grantsinfo@nih.gov.
The Phase II application should include detailed plans for the large-scale
collaborative project. In addition to an assessment of the merit of the
basic idea and the conceptual framework, an assessment of the specific plans
will be conducted.
Contents of Applications
A Phase II response to this RFA should consist of an application that, in
addition to or in lieu of part of the items requested in the PHS 398,
includes:
Application face page. Complete all items. This is page 1, number succeeding
pages consecutively. The RFA label found in the PHS-398 (rev. 4/98)
application form must be affixed to the bottom of the face page of the
application and must include the RFA number. 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. On line 2, the number and title of
this RFA: GM-01-004, "Large Scale Collaborative Project Awards," must be
entered and the YES box must be marked.
Abstract of Research Plan. On page 2, describe briefly the proposed large
scale-collaborative research project. List all key personnel involved in the
collaborative project, use a continuation page if needed.
Table of Contents. Prepare a Table of Contents that includes the items
listed below. The major areas to be listed in the Table of Contents appear
here in capital letters.
BUDGET ESTIMATES: Specific examples of allowable costs that may be requested
include:
Salaries for the principal investigator, members of the steering committee,
participating investigators, technical, and support personnel commensurate
with their level of effort in the large-scale collaborative project.
Bridging projects to the laboratories of participating investigators. Pilot
projects to investigators without current independent research support in the
area. These subprojects must not exceed $75,000 in annual direct costs and
must be limited to no more than three such projects per application. Travel
of personnel, which may include technicians, predoctoral students,
postdoctoral trainees, and investigators, to different laboratories to gain
specialized expertise.
Travel to and conduct of regular meetings of the steering committee and
regular meetings of the participating investigators.
Core facilities (examples: instrumentation, genomics, proteomics, model
organism, high-throughput assay, or computational/bioinformatic cores).
Electronic media cores to allow participation of off-site laboratories and/or
the means necessary to establish collaboratory capabilities and to
disseminate information. Travel to and conduct of regular meetings of an
advisory committee.
In addition to the overall budget, include a separate budget for each
bridging project and pilot project and each core resource. Phase II
applications for large-scale collaborative project awards may not request
more than $5 million in annual direct costs (exclusive of subcontract
indirect costs requested as a direct cost by the applicant organization) for
any year of the award. Salaries for support personnel required for
coordination and maintenance of the project, such as secretaries, may also be
included as necessary in an administrative core.
Composite budget. Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET
PERIOD," of Form PHS-398 to present the total budget for all requested
support for the first year. For each category such as "Personnel,"
Equipment," etc., give the amount requested for each core unit and each
component project, with subtotals. For consortium arrangements involving
other institutions or organizations, include total (direct and facilities and
administration) costs associated with such third-party participation in the
"Consortium/Contractual Costs" category. Costs for purchased services should
be itemized under "Other Expenses."
Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of Form PHS-398
to prepare a budget, by category, that provides totals for each year of
requested support. Requests for any increases in succeeding years must be
justified in the individual component subprojects (bridging projects and
pilot projects) and core unit budgets.
Individual component core and research budgets. For the first year budgets
of each of the cores and projects, use Form Page 4 of the PHS-398. Use Form
Page 5 of the PHS-398 to report the budgets of each of the projects and cores
for total project period (years 02-05).
Budget justifications and explanations. Describe the specific functions of
all key personnel, including consultants, collaborators, and technical staff.
Provide justifications for requested equipment. For years 02-05 of the
application, justify any significant increases or decreases in any category
over the first year budget.
BIOGRAPHICAL SKETCHES AND LETTERS OF COMMITMENT: Biographical sketches and
one page letters of commitment must be included from all participating
investigators indicating their willingness to follow guidelines and
procedures established for the large-scale collaborative project.
OTHER SUPPORT: For the principal investigator, steering committee members,
participating investigators, and heads of core resources, provide a listing
of all other support for each participant in the usual NIH format for non-
modular applications, support for other investigators such as postdoctoral
students should not be listed. For the relevant grant support that allows
participating investigators to be part of the large scale collaborative
project, provide the specific aims of the project and describe in sufficient
detail for evaluation the relationship of the funded grant to the goals of
the proposed large scale project.
RESOURCES AND ENVIRONMENT: Complete the "Resources" page of PHS-398 for the
overall large-scale collaborative project, including both the host
institution and any participating institutions. Briefly describe the
features of the institutional environment(s) that are relevant to the
effective implementation of the proposed program. As appropriate, describe
available resources, such as clinical and laboratory facilities,
participating and affiliated units, patient populations, geographical
distribution of space and personnel, and consultative resources.
ANIMAL AND HUMAN SUBJECT ASSURANCES: Because of the relatively short
turnaround time for review of Phase II applications, IACUC assurances must be
completed (and not pending) at the time of submission of the Phase II
application. However, IRB approval is no longer required prior to review,
but only prior to funding
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-031.html).
ADDED REQUIREMENT: Applications should include a cover sheet that lists 1)
all participants, including consultants and private sector alliances, 3) all
the institutional affiliations for each participant, and 3) their roles on
the project. This new requirement will facilitate the review of
applications.
RESEARCH PLAN
Include a detailed Table of Contents with pagination (numeric only) at the
beginning of the Research Plan. Identify each component core with a capital
letter (A,B,C), as well as title, that reflects the order in which the core
units are presented in the application research plan. For each core, provide
the name of the core director.
Page limitations: The program summary, administrative management plan and the
project management plan sections when combined have an aggregate page limit
of 30 pages. Page limitations for other sections are given below.
Investigators should endeavor to be concise.
PROGRAM SUMMARY: A project summary describing the goals and operation of the
project. Explain what complex biological problem will be solved and how the
approach of using a large-scale collaborative agreement is critical to its
solution. Discuss the range of scientific expertise to be brought to bear on
the research problem. Explain the interactions that will occur between
investigators at the host site and at the participating sites. Explain how
each element of the large-scale collaborative project will contribute to
successful attainment of its goals. Explain the programmatic value of the
core resources, bridging projects, and pilot projects. Explain how the
information coming from the collaborative project and the laboratories of the
participating investigators will be integrated into comprehensive whole.
Discuss how information generated by the collaborative project will be
disseminated to the scientific public.
ADMINISTRATIVE MANAGEMENT PLAN: Describe the structure, organization, and
operation of the project. Describe the organizational framework and provide
an organizational chart and the flow of information within the collaborative
project. Discuss arrangements between the collaborating institutions that are
important to effective operation of the large-scale collaborative project.
Detail the usage of the core resources by the participating investigators.
Include any outreach efforts to provide access to the core resources to
investigators outside the collaborative project. Explain how decisions will
be made to add/delete participating investigators and to respond to changes
in short term goals that research findings will make necessary. Discuss how
the views of the scientific community impacted by the collaborative project
will be considered.
PROJECT MANAGEMENT PLAN: Define, at a minimum, yearly milestones. Present a
project management plan, including milestones, to keep the collaborative
project moving forward and on track. Explain how progress in the bridging
projects and pilot projects and efficiency of the core resources will be
tracked. Include an evaluation plan to determine how the collaborative
project is progressing. Discuss the plan for evolving milestones. Explain
how the advisory committee will be used in updating the project management
plan.
PLAN FOR DATA SHARING AND INTELLECTUAL PROPERTY (two page limit): The
principal investigator and steering committee should (1) propose a plan for
providing access to the data and information generated by the large-scale
collaborative project to the members of the project and the scientific
public, (2) address if or how intellectual property rights will be exercised,
(3) discuss guidelines for licensing of joint inventions, (4) discuss
procedures for settling of intellectual property disputes, (5) discuss the
existence of any pre-existing intellectual property rights, including options
to for-profit research sponsors, and (6) propose a plan for disseminating the
technologies, assays, and associated reagents developed under this RFA.
CORE RESOURCE DESCRIPTIONS
CORE RESOURCE A. ADMINISTRATIVE CORE (five page limit): This Core must be
directed by the principal investigator. Include the objectives of the core,
a description of its staffing and services to be provided to other core
resources and to the participating investigators. Communicating the
objectives of the collaborative project and fostering opportunities for
collaboration are encouraged. Expenses associated with the operation of the
steering committee, meetings of all or subgroups of the participating
investigators, and meetings and operation of the advisory committee would
fall under the administrative core.
CORE RESOURCE B. INFORMATION DISSEMINATION AND DATA COORDINATING CORE (five
page limit): Dissemination of information on techniques, scientific findings,
and methodologies is a vital component of each large-scale collaborative
project. Computer technology, print media, and telecommunications are
relevant. Describe the staffing (including a Core Director, as well as any
professional or technical personnel and their duties), facilities, and
resources that will be devoted to this goal. Indicate plans to make results
of research or other unique features of the collaborative project available
to as wide an audience as possible. Describe how data generated by the core
resources and the participating investigators will be processed into the
information to be disseminated. Discuss plans for dissemination of published
and unpublished data.
CORE C (and others). SCIENTIFIC RESOURCE CORE (S) (ten page limit per core):
Provide specific titles for any proposed scientific resource cores (e.g.,
instrumentation, genomics, proteomics, model organism, high-throughput assay,
or computational, modeling, or bioinformatics), along with a designated Core
Director who possesses expertise in the area of each core. Describe the
professional and technical staff to be involved in the core(s), and their
duties. Include plans to utilize the core(s), including services that will
be provided, and to whom, and their bearing on productivity and quality of
the collaborative research effort.
PROJECTS
BRIDGING PROJECTS (five page limit for each bridging project for the research
plan: specific aims, background and significance, preliminary studies, and
research design and methods): Bridging projects will support work in the
laboratories of the participating investigators, these are essentially
supplements to their ongoing work. Describe the new research proposed in the
bridging project and explain how this work more fully integrates the
participating investigator’s independently supported work into the large
scale collaborative project. For all proposed projects, the underlying
rationale and potential impact of the studies should be specifically
addressed. Projects must be described in sufficient detail to permit
evaluation through the competitive peer-review process. For each bridging
project undertaken as part of the collaborative project, include a combined
summary of the specific aims, background and significance, preliminary
results, and research design and methods. Also include the following
sections which do not count against the page limitations: Abstract (one
paragraph), Children as Research Subjects, Human Subjects including gender
and minority considerations, Vertebrate Animals, and Literature Cited.
PILOT PROJECTS (ten page limit for each pilot project for the research plan:
specific aims, background and significance, preliminary studies, and research
design and methods, maximum of three pilot projects per large scale
collaborative project): Pilot projects will support the work of investigators
not already supported in the area of the collaborative project who have
unique skills or expertise to add to the collaborative project effort. For
all proposed projects, the underlying rationale and potential impact of the
studies should be specifically addressed. How the pilot project will add new
elements essential to achieving the goals of the collaborative project must
be described. Projects must be described in sufficient detail to permit
evaluation through the competitive peer-review process. For each pilot
project undertaken as part of the collaborative project, include the
following sections: Abstract (one paragraph), Specific Aims, Background and
Significance, Preliminary Studies, Research Design and Methods, Children as
Research Subjects, Human Subjects including gender and minority
considerations, Vertebrate Animals, and Literature Cited.
INSTITUTIONAL COMMITMENTS: Letters signed by authorized business officials of
each of the participating investigators" institutions committing support to
the large-scale collaborative project must be included. Applicants for Phase
II proposals that include consortium arrangements should refer to the NIH
Grants Policy Statement appendix on consortium arrangements at
http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm#Consortium.
APPENDICES: Appendices are allowed for the Phase II applications, but should
follow the rules for appendices in the PHS-398 instructions.
REVIEW CONSIDERATIONS
Upon receipt, Phase II applications will be reviewed for completeness by CSR
and responsiveness by the NIGMS. Incomplete and/or non-responsive
applications will be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the NIGMS in accordance with the review criteria stated below.
As part of the initial merit review, a process may be used by the initial
review group in which applications receive a written critique and 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, assigned a priority score, and receive a second level
review by the National Advisory General Medical Sciences Council.
Review Criteria for the Overall Large Scale Collaborative Project
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 the application in order to judge the likelihood that the proposed large-
scale collaborative project will have a substantial impact on the pursuit of
these goals. Each of these criteria will be addressed and considered in
assigning the overall score, weighting them as appropriate for each
application.
1. Significance. Does this large-scale collaborative project address a
complex biological problem of overarching significance to biomedical science
that would be difficult to address by separate grants? If the aims of the
application are achieved, how will the field of biomedical science be
advanced? What will be the effect of these studies on the concepts or
methods that drive this field? Do the arrangements for data sharing maximize
the impact of the collaborative project?
2. Approach. Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the scientific aims
of the collaborative project? Does the applicant acknowledge potential
problem areas and consider alternative tactics? Is the project management
plan adequate? Is the administrative framework appropriate? Do milestones
articulate key indicators set for appropriate times that will demonstrate
significant forward progress for the collaborative project? Are the plans to
monitor and evaluate progress of the collaborative project adequate? Are the
plans to share the data and findings with the larger community adequate? How
will the group take the views of the scientific community impacted by the
large-scale collaborative project into consideration?
3. Innovation. Are the large-scale collaborative project"s structure and
goals novel? Are the aims original and innovative? Will the collaborative
project challenge existing paradigms or develop new methodologies or
technologies? Will the collaborative project attack a problem in a
significantly new way? What will be the value added over individual grants?
4. Investigators. Is the principal investigator"s major research activity
within the research area of the collaborative project? Is the principal
investigator well suited to the scientific and administrative leadership
required to carry out this work? Is the level of effort proposed for the
principal investigator and the members of the steering committee appropriate?
Is the work proposed appropriate to the experience level of the collaborative
project"s research and technical staff? Are the research grants of the
participating investigators within the area of the collaborative project?
Are the participating investigators well chosen for their roles in the
collaborative project? Is the plan to add and delete participating
investigators to and from the collaborative project satisfactory?
Environment. Do the scientific environments in which the work will be done
contribute to the probability of success? Are support personnel and
resources in place to advance the work? Will the proposed collaborative
project take advantage of unique features of the scientific environments of
the component projects? Is the level of institutional support adequate? Are
the requested core facilities critical to achieving the scientific goals of
the collaborative project, are they cost effective? Is access to the core
facilities appropriate?
In addition, the following criteria will be considered for merit review: The
commitment to the project by the principal investigator and the members of
the steering committee will be a consideration. For applications that are
multi- institutional or that involve industry, the adequacy of plans to
resolve intellectual property issues will be a consideration. The commitment
of the host and participating universities to supporting the large scale
collaborative project will also be considered: this would be reflected in
efforts to work out ahead of time potential intellectual property issues and
to remove any institutional barriers to the establishment and healthy
maintenance of the collaborative project.
In accordance with NIH policy, all Phase II applications will be reviewed
with respect to the following:
o The adequacy of plans to include women, minorities and their subgroups, and
children, as appropriate for the scientific goals of the research. 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.
? The adequacy of the data and safety monitoring plans (required for clinical
trials).
Review Criteria for Core Resources.
Consideration of the technical merit of the core units will include:
(1) Facilities within the core compared to the state of the art. The
contributions of the cores to fulfilling the goals of collaborative project.
(2) The extent to which core units promote greater collaboration and
cohesiveness among the participating investigators.
(3) Qualifications, experience, and commitment to the large-scale
collaborative project mission of the investigators responsible for the core
resources and their abilities to devote the required time and effort to the
program.
(4) Appropriateness of the budgetary requests.
Review Criteria for Bridging Projects and Pilot Projects
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 each project in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals. Each
of the criteria listed below will be addressed and considered in assigning
the score for a research project, weighting them as appropriate for each
project. Note that the project 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 by its nature is not innovative but is essential to move
a field forward. In their evaluations, reviewers will comment on:
(1) Significance. Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the achieving the goals of the
collaborative project? Will the bridging project tie or enhance the
independent work of the participating investigator to the collaborative
project, or will the pilot project add an essential missing aspect to the
collaborative project?
(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?
(3) Innovation. Does the project employ novel concepts, approaches or
method? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
(4) Investigator. Is the 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 other researchers (if any)?
(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?
In addition to the above criteria, in accordance with NIH policy, all
individual scientific projects will be reviewed with respect to the
following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. 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.
The scientific review group will also examine the provisions for the
protection of human subjects and the safety of the research environment.
Award Criteria
Award criteria that will be used to make funding decisions include:
o scientific merit (as determined by peer review)
o program priorities
o program balance
o availability of funds
SUBMISSION PROCEDURES FOR PHASE I AND PHASE II APPLICATIONS
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. Type the RFA
number on the label. Failure to use this label could result in delayed
processing of the application such that it may not reach the review committee
in time for review. In addition, the RFA title and number must be typed on
line 2 of the face page of the application form and the YES box must be
marked.
The 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, typewritten original of the application (Phase I or Phase
II), 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 (Phase I
or Phase II) and all five sets of any appendix material must be sent to:
Helen R. Sunshine, Ph.D., Chief
Office of Scientific Review
National Institute of General Medical Sciences
Building 45, Room Number 1As.13
Bethesda, MD 20892
Applications for Phase I must be received by June 18, 2001. Applications for
Phase II applications must be received by January 16, 2002. If an
application is received after the due 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.
Schedule:
Phase I Application Receipt Date: June 18, 2001
Phase I Peer Review Date: August 2001
Phase I Award Date: September 2001
Phase II Application Receipt Date: January 16, 2002
Phase II Peer Review Date: March/April 2002
Advisory Council Date: May 2002
Earliest Anticipated Phase II Award Date: September 2002
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Dr. Michael E. Rogers
Division of Pharmacology, Physiology and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3827
FAX: (301) 480-2802
Email: rogersm@nigms.nih.gov
Dr. James C. Cassatt
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0828
FAX: (301) 480-2004
Email: czj@cu.nih.gov
Dr. Judith H. Greenberg
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
FAX: (301) 480-2228
Email: greenbej@nigms.nih.gov
Direct inquiries regarding fiscal matters to:
Mr. Joseph Ellis
Chief, Grants Management Office
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5510
FAX: (301) 480-1969
Email: ellisj@nigms.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.821, 93.859, and 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 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, 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.
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