and Human Services (HHS)
EXPIRED
LARGE-SCALE COLLABORATIVE PROJECT AWARDS
RELEASE DATE: March 21, 2002
RFA: GM-02-007
National Institute of General Medical Sciences (NIGMS)
(www.nigms.nih.gov)
APPLICATION RECEIPT DATE: Phase I Applications, June 18, 2002
Phase II Applications, January 15, 2003
THIS APPLICATION 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 Special Requirements for Cooperative Agreements
o Where to Send Inquiries
o Submission Procedures for Phase I Applications
o Peer Review Process for Phase I Applications
o Review Criteria for Phase I Applications
o Award Criteria for Phase I Applications
o Submission Procedures for Phase II Applications
o Peer Review Process for Phase II Applications
o Review Criteria for Phase II Applications
o Award Criteria for Phase II Applications
o Required Federal Citations
PURPOSE OF THIS RFA
The purpose of this RFA is to re-announce the National Institute of General
Medical Sciences (NIGMS) program of "Large-Scale Collaborative Project
Awards," (commonly called Large Glue Grants) last issued as GM-01-004 in
February 2001. This new announcement includes updates and modifications, and
should be used in lieu of any previous announcements.
The goal 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 is of central importance to biomedical science and to
the mission of the NIGMS, and that would be beyond the means of any one
research group. It is expected that the participating investigators will
already hold externally peer-reviewed and funded research grants in the area
of the proposal. 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. Phase I applicants
will submit an overview of the proposed large-scale project for peer review.
The purpose of the Phase I award is to provide resources for assembling a
more fully developed proposal to applicants who have demonstrated the
selection of an appropriate complex biological problem, an innovative
approach to its solution, and appropriate commitments from participating
investigators and institutions. Successful Phase I applicants will receive a
$25,000 (direct costs) planning grant. Those applicants, and only 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), commonly
called Small Glue Grants, is intended to support collaborative activities
that are smaller in scale and scope than those requested in response to this
RFA. Small Glue Grants are for applications requesting up to $300,000 in
direct costs per year. Large Glue Grants are for applications requesting
from $300,000 up to $5,000,000 in direct costs per year.
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.
RESEARCH OBJECTIVES
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. The first Large-Scale Collaborative Award announcement
appeared in May 1999 and has been reissued in each subsequent year. One
award was made in FY 2000 and three awards were made in FY 2001
(http://www.nigms.nih.gov/funding/gluegrants.html).
For most of the last 30 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 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 they also seek a means to encourage and
facilitate the development of an interactive research network around a
complex biological problem.
The purpose of this RFA 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 have become 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 requires the collaboration of many groups and
laboratories. Finally, large-scale, expensive technologies such as
combinatorial chemistry, DNA microarrays, 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, as well as by investigators
doing basic laboratory science, is welcomed. It is also recognized that data
collection and technology development may be logical and necessary parts for
some or all large-scale collaborative projects.
Whether projects 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 examples of successful
applications and 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 would
be substantially greater than the sum of the participants" individual
achievements. Each large-scale collaborative project could require
considerable new resources, such as for a centralized core facility, but
would also require a synthesis of information from participating 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
application.
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 and Organization 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 appropriateness of 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. The members should be chosen from
participating investigators and project staff, and the membership should be
representative of the scope 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 decision. It is expected that the PI, 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 voting
member of the steering committee and attend its meetings. The steering
committee will meet annually with the Advisory Committee, as described below.
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 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 PI 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, of at least three members, whose purpose is to
meet annually with the PI 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 PI 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 and the names of prospective members should not be
included in the application. The NIGMS program director, responsible for the
award, will attend the advisory committee meeting as a member of the steering
committee but will not actually 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 ORGANIZATION AND 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 an information dissemination and data
coordinating core. Alternatively, the large-scale collaborative project may
involve additional activities and may request the following types of
resources, either as distinct entities or in integrated combinations.
Support to Individual Laboratories
Investigators are expected to bring their own support for their individual
laboratories to the collaborative project. The large-scale collaborative
project award mechanism is not meant to support R01-type projects. It is
recognized, however, that in some cases, there may be a need for special
efforts in the individual laboratories of the participating investigators to
enhance the efforts of the consortium or to integrate the individual work of
a participating investigator with the consortium. Two mechanisms have been
designated for this purpose:
Bridging projects may be used to support work in the laboratories of the
individual participating investigators when that work is intended to provide
either a bridging function to more fully integrate the individual work with
the collaborative project or a service function to develop data or resources
or technology to benefit the overall glue project. For example, support to
allow a participating investigator to employ a standardized model system so
that his/her results can be compared with results from other project members
is appropriate. Another example is exchanging personnel among laboratories of
different investigators to transfer technology between glue grant
laboratories or for other purposes that would help in coordinating and
integrating programmatic goals. Another might be to develop an assay to be
used by consortium members. These bridging projects to the laboratories of
individual participating investigators should 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 and expertise
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. Stand-alone new research projects should not be
submitted for bridging projects. If a bridging project could be submitted as
a regular R01 application, it should not be requested as a bridging project,
even if it adds value to the large-scale project. Judgment will be required
on the part of applicants and reviewers alike to distinguish between projects
that are appropriate for support by consortium resources and those that
should be submitted and reviewed as regular research grants (R01s).
Pilot projects may be requested in this application for investigators without
current independent support in the area of the collaborative project in order
to add elements where gaps exist, or to add investigators with critical
knowledge or expertise but who do not have 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 year 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 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
PI of a pilot project will seek R01 funding during the period of the
collaborative project, based on the results obtained from the pilot project.
Cores
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. A bioinformatics core to include assemblage and
organization of data for querying, developing tools for its querying,
computation, and modeling may be requested as a separate core or be combined
with the information dissemination core. Other types of resources might be
for instrumentation, genomics, proteomics, or high-throughput assay cores.
Requests for core resources must be strongly justified in terms of value to
achieve the goals of the project, value to increase 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 describes the
organization of the project and outlines the policies and procedures whereby
participating and non-participating investigators can have access to the
collaborative project resources. The application should address the flow of
information within the project and plans as to how the information will be
integrated into the solution of the biological problem being addressed. The
application should address the mechanism that will be followed to add new
participating investigators and delete members whose association with the
project has not been productive. 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 should discuss the mechanism whereby concerns of the scientific
community directly affected by the project will be considered and responded
to. 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 and 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 the
collaborative project"s progress and any recommendations to modify funding
will be made annually to the National Advisory General Medical Sciences
Council.
PLAN FOR HANDLING INTELLECTUAL PROPERTY AND SHARING OF RESEARCH RESOURCES:
The nature of large-scale collaborative projects is to move entire fields
forward. NIGMS intends that, to the extent possible, all investigators
within a field have equal access to research resources generated by these
collaborative projects. To address this interest in assuring that research
resources are accessible, NIH requires applicants who respond to this RFA to
(1) submit a plan for sharing the research resources generated through the
award, and (2) address how they will exercise intellectual property rights,
should any be generated through this award, while making such research
resources available to the broader scientific community. It is expected that
resources to be shared will include, among others, data and information,
materials such as cell lines and mutant animals, and novel reagents and
techniques.
The sharing of research resources plan and intellectual property plan must
make unique research resources readily available for research purposes to
qualified individuals within the scientific community in accordance with the
NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps/) and
the Principles and Guidelines for Recipients of NIH Research Grants and
Contracts on Obtaining and Disseminating Biomedical Research Resources: Final
Notice, December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html and
http://ott.od.nih.gov/NewPages/64FR72090.pdf). These documents also define
terms, parties, responsibilities, prescribe the order of disposition of
rights, prescribe a chronology of reporting requirements, and delineate the
basis for and extent of government actions to retain rights. Patent rights
clauses may be found at 37 CFR Part 401.14 and are accessible from the
Interagency Edison web page, http://www.iedison.gov.
As noted below (see Peer Review Process and Review Criteria), the scientific
review group will comment, as appropriate, on the adequacy and feasibility of
the sharing of research resources plan and the intellectual property plan.
The review group will describe the adequacy of the plans in an administrative
note and the evaluation of the plans per se will not affect the priority
score. However, because dissemination is a critical aspect and fundamental
purpose of this RFA, evidence of the commitment of the large-scale project
leadership to the sharing or research resources and to effective management
of intellectual property issues will be part of the scientific merit review.
The adequacy of the proposed sharing plans will be an important factor in the
institute"s decision to make an award. Furthermore, the proposed sharing
plans, after negotiation with the applicant when necessary, will be made a
condition of the award. Evaluation of annual progress reports and of
subsequent renewal applications will include an assessment of the
effectiveness of the sharing of research resources.
DISCLOSURES: It is 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.
MECHANISMS 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 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 PI 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, 2002.
The length of the Phase I awards may be for up to one year and do not count
against the time limit for Phase II awards.
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 2003. Phase II awards will be
considered for one five-year renewal period following the initial award.
The NIH U54 is a cooperative agreement award mechanism in which the Principal
Investigator retains the primary responsibility and dominant role for
planning, directing, and executing the proposed project, with the NIH staff
being substantially involved as a partner with the Principal Investigator, as
described under the section "Special Requirements for Cooperative Agreements,
Terms and Conditions of Award."
This RFA is a one-time solicitation. In addition to new applications, both
revised Phase I applications and revised Phase II applications from the
previous two announcements (RFA GM-01-004 and Notice GM-00-001) will be
accepted. However, NIGMS will accept for consideration only one revision of
a previously submitted, unfunded Phase I or Phase II application. Twice-
amended applications will not be accepted. If the solicitation is re-
announced within a two-year period of this announcement, revised Phase I and
Phase II applications from this announcement will again be accepted.
FUNDS AVAILABLE
NIGMS intends to commit approximately $10-15 million in total costs in FY2003
to fund Phase II awards. NIGMS anticipates making up to ten Phase I awards
from FY2002 funds, Phase I awards will be for $25,000 in direct costs.
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 from NIGMS funds will be $5 million in
annual direct costs in any given year. Applications of different scales and
scope are encouraged. Applications requesting direct costs between $300,000
and $5,000,000 per year will be considered responsive to this announcement.
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. NIGMS
anticipates re-announcing the solicitation for the next fiscal year,
depending on the availability of funds.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o Non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
For-profit and foreign institutions are not eligible to submit an application
as the lead institution. However, a collaborative project may include
participating investigators from foreign and/or for-profit organizations.
Multi-institutional applications are encouraged.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Applications must fall directly into the areas of research supported by the
National Institute of General Medical Sciences. Applicants may visit the
Institute website at http://www.nigms.nih.gov for information on NIGMS areas
of interest. Applicants may also wish to visit the NIGMS website created for
this RFA and the PA (referred to in the Purpose of this RFA section) at
http://www.nigms.nih.gov/funding/gluegrants.html. Applicants are strongly
advised to contact the NIGMS staff listed below to discuss NIGMS areas of
interest and the eligibility of a proposed project.
The major research activity of the PI must be in the research area of the
collaborative project application, and the PI is expected to make an
appropriate level of commitment of effort to directing and managing the
operation of the project, a substantial level of effort will be necessary to
manage projects of largest magnitude. While NIGMS expects that the
applications will be multi-institutional with more than one participating
investigator, minimum and maximum numbers of participating investigators or
institutions have not been set. Individuals from underrepresented racial and
ethnic groups, as well as individuals with disabilities, are encouraged to
apply for NIH programs.
SPECIAL REQUIREMENTS FOR COOPERATIVE AGREEMENTS
TERMS AND CONDITIONS OF AWARD: The following section is repetitive of
previous sections but represents Terms and Conditions that will be
incorporated into the award statement and will be provided to the PI, 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.
Principal Investigator Responsibilities:
The PI 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 PI 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 PI 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 projects are also included.
Participating investigators will work with the PI, 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 PI, 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 PI 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 PI 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 for-profit 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 PI 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.
Handling Intellectual Property and Sharing of Research Resources:
Awardees will retain custody of and have primary rights to the research
resources developed under these awards, subject to Government rights of
access consistent with current DHHS, PHS, and NIH policies. Awardees should
comply with their institutional intellectual property policies and practices
as described in the application and approved in this award. Consistent with
the objectives of this award, awardees will be expected to share (make
available) these research resources openly with the scientific community.
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 steering committee without NIH
staff voting, 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.
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:
o Direct your questions about scientific/research 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: [email protected]
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: [email protected]
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: [email protected]
Direct your questions about peer review issues to:
Dr. Helen R. Sunshine
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email: [email protected]
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: [email protected]
SUBMISSION PROCEDURES FOR A PHASE I APPLICATION
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, 2002, 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 2002 whether
their applications will be funded. Only Phase I awardees may submit Phase II
applications for scientific merit review.
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: [email protected].
SUPPLEMENTAL INSTRUCTIONS: A Phase I response to this RFA should follow the
PHS 398 instructions, with the following modifications, and the parts should
be assembled in the order prescribed by the PHS 398:
Application face page. Complete all items. This is page one, number
succeeding pages consecutively.
For listing of personnel on page two, it is important that 1) all
participants, including consultants and private sector alliances, 2) all the
institutional affiliations for each participant, and 3) their roles on the
project, be included.
Include 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 a six-month period of support.
Biographical sketches and letters of commitment from each of the
participating investigators who indicate their interest in joining the
collaborative project should be included. Biographical sketches should
include a listing of other support that includes only the grants of each
participating investigator that are in the area of the large-scale
collaborative project.
The statement of institutional and other resources available to the
consortium should be limited to three pages.
The Research Plan should be replaced with the following:
A statement (two-page limit) by the PI describing his/her commitment to the
large-scale collaborative project and identifying the members and the
commitment of the steering committee. This section should also include a
statement of commitment to developing a plan for handling intellectual
property and the sharing of research resources.
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 adequate 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.
A references 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.
Letters signed by the authorized business official of each of the
participating investigators" institutions committing support to the
collaborative project should be included. Arrangements for the participation
of investigators from industry and foreign sites and resources they may bring
to the collaborative project should be documented.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
http://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 Phase I application
and all five sets of any appendix material must be sent to:
Helen R. Sunshine, Ph.D.
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, 2002. If an application
is received after the due date, it will be returned to the applicant without
review. The 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.
RECEIPT AND REVIEW SCHEDULE:
Phase I Application Receipt Date: June 18, 2002
Phase I Peer Review Date: August 2002
Phase I Award Date: September 2002
Phase II Application Receipt Date: January 15, 2003
Phase II Peer Review Date: March/April 2003
Advisory Council Date: May 2003
Earliest Anticipated Phase II Award Date: September 2003
PEER REVIEW PROCESS FOR PHASE I APPLICATIONS
Upon receipt, Phase I applications will be reviewed for completeness by the
Center for Scientific Review (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 scientific review group convened by the
NIGMS in accordance with the review criteria stated below. As part of the
initial merit review, all applications will:
o Receive a written critique,
and may:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score.
REVIEW CRITERIA FOR PHASE I APPLICATIONS
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.
(1) 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,
will the field of biomedical science be advanced?
(2) APPROACH: Is the conceptual framework appropriate to achieve the
scientific aims of the large-scale collaborative project?
(3) 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?
(4) INVESTIGATORS: Is the PI"s major research activity within the research
area of the collaborative project? Is the PI 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 PI, steering committee members, and
participating investigators appear reasonable for the scope of the planned
activities?
(5) 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: In addition to the above criteria, Phase I
applications will be reviewed with respect to the following:
o commitment to the project by the PI, the members of the steering committee,
and the participating investigators.
o commitment to the sharing of research resources with the broader scientific
community.
o 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 FOR PHASE I APPLICATIONS
Award criteria that will be used to make funding decisions include:
o scientific merit (as determined by peer review)
o adequacy of plans for handling of intellectual property and sharing of
research resources
o program priorities
o program balance
o availability of funds
SUBMISSION PROCEDURES FOR A PHASE II APPLICATION
Phase I awardees may submit a Phase II application by January 15, 2003 for
peer review. 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.
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: [email protected].
SUPPLEMENTAL INSTRUCTIONS: 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.
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 detailed Table of Contents that includes all
elements of the application. Use numeric pagination only. The major areas
to be listed in the Table of Contents appear here in capital letters. Units
should be presented in the order in which they appear in the application.
Under Research Plan, identify each component core with a capital letter (A,
B, C), as well as title, and provide the name of the core director.
BUDGET ESTIMATES: Specific examples of allowable costs that may be requested
include:
Salaries for the PI, members of the steering committee, participating
investigators, and 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 fellows, 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, or high-throughput assay 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, but
including all equipment) 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 01-05).
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 must
be included from all participating investigators along with one page letters
of commitment indicating their willingness to follow guidelines and
procedures established for the large-scale collaborative project. For all
participating investigators, including the PI, and heads of core resources,
provide a listing of all other support, support for other investigators such
as postdoctoral students should not be listed. Include 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 of the relationship of the funded grant
to the goals of the proposed large-scale project.
RESEARCH 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).
PARTICIPANT AFFILIATIONS: Applications should include a separate cover sheet
that lists 1) all participants, including consultants and private sector
alliances, 3) all the institutional affiliations for each participant, 3)
their roles on the project, and 4) the percent effort for each role. This
added requirement will facilitate the review of applications.
Research Plan
Instructions for organization of the large-scale project research plan:
The NIGMS wishes to provide applicants with the flexibility to organize
large-scale collaborative projects in the manner which best facilitates
progress on the project being pursued. Therefore, applicants may organize
and present their large-scale collaborative project applications using the
straightforward format that follows, or alternate formats for some parts of
the application. Required components of all applications are the program
summary, including administrative and program management plans, a plan for
data sharing and intellectual property, and Cores A (administrative) and B
(information dissemination and data coordinating). If desired, Core B may be
may be combined with an optional bioinformatics core (the page limit for the
combined unit will be 20 pages).
The remainder of the Research Plan may be organized as deemed appropriate,
keeping in mind that the major purpose of a large-scale collaborative project
award is to provide resources to enable collaboration rather than primary
research support. For example, the scientific cores and bridging projects
may be presented in a combined or more integrated fashion. When this, or a
different alternate format is used, applicants should explain, in the program
summary, why a different organizational structure is proposed. Any combined
unit may not exceed the sum of the page limits that would have been allowed
for the individual pieces of the unit. For example, if two bridging projects
were submitted as a combined unit, the page limit for the combined unit would
be twice that for one bridging project. In all cases, the Research Plan,
including the required components, may not exceed 160 pages. The Research
Plan includes the program summary, the administrative management plan, the
project management plan, the plan for handling intellectual property and
sharing of research resources, the administrative and information
dissemination cores, as well as any optional cores, bridging projects, and
pilot projects.
PROGRAM SUMMARY: Describe the goals and operation of the large-scale 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 used to address 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. Also describe how information will flow 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 necessitated by research
findings. Discuss how the views of the scientific community that are
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.
PAGE LIMITS: The program summary, administrative management plan and the
project management plan sections when combined have an aggregate page limit
of 30 pages. Page limits for other sections are given within each section
and a summary follows at the end. Investigators should endeavor to be clear
and concise.
PLAN FOR HANDLING INTELLECTUAL PROPERTY AND SHARING OF RESEARCH RESOURCES
(three-page limit): The PI and steering committee should (1) propose a plan
for providing access to the research resources generated by the large-scale
collaborative project to the members of the project and the scientific
public, research resources include, among others, data and information,
materials such as cell lines and mutant animals, and novel reagents and
techniques, (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 research resources developed under this RFA.
Core Resource Descriptions
CORE RESOURCE A. ADMINISTRATIVE CORE (five-page limit): This core must be
directed by the PI. 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 RESOURCE C. BIOINFORMATICS CORE (OPTIONAL AND MAY BE COMBINED WITH CORE
B.) (15 page limit): A bioinformatics core to include assembly and
organization of data for querying, developing tools for its querying,
computation, and modeling may be requested as a separate core or be combined
with the information dissemination core (combining the page limits). The
core description must include answers to the following bioinformatics
queries, whether a separate core or combined with the information
dissemination and data coordinating core. The answers to the questions
should both facilitate the planning for bioinformatics needs as well as
provide important information for the peer review of the application.
o What are the data release policies and what are the associated intellectual
property issues?
o How will the data be available to the scientific community? Will there be
browser access, formats for downloading complete data sets, on-line
computational aids, etc.?
o What is the nature and structure of the data? Present the plans to date
for ontologies, schema, or other data models.
o What is the underlying structure of the database, e.g., relational, object-
oriented, etc.?
o What is the mechanism for communication (both computational and human)
between the distributed sites and the database managers? Will there be data
liaisons?
o What are the key interacting databases? How will the data be linked?
o How will progress be available to the public, e.g., will lists of the
systems being analyzed be available?
o What experience in bioinformatics is available in the group, and what
resources can the consortium draw on?
CORE D. 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, or high-throughput
assay), 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, i.e., specific aims, background and significance, preliminary studies,
and research design and methods): Bridging projects will support work in the
laboratories of the participating investigators. 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 or provides a necessary service
function or technology to the 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, as
applicable, the following sections, which do not count against the page
limitations: Abstract (one paragraph), Human Subjects Research (also see
special requirements in the Federal citations below), Vertebrate Animals, and
Literature Cited.
PILOT PROJECTS (ten page limit for each pilot project for the research plan,
i.e., 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, and Research Design and Methods. As
applicable, include sections on Human Subjects Research (also see special
requirements in the Federal citations below), Vertebrate Animals, and
Literature Cited.
SUMMARY OF PAGE LIMITS:
o Combined length of the project summary, administrative management plan, and
the project management plan 30 pages
o Plan for handling intellectual property and sharing research resources 3
pages
o Administrative core 5 pages
o Information dissemination and data coordinating core 5 pages
o Bioinformatics core (optional) 15 pages
o Scientific cores (optional) 10 pages each
o Bridging projects (optional) 5 pages each
o Pilot projects (optional) 10 pages each
o Combined units (optional) pages equal to combined total for individual
elements
o Overall limit for the Research Plan 160 pages
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 applications 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 they
should follow the rules for appendices in the PHS 398 instructions.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
http://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 Phase II application
and all five sets of any appendix material must be sent to:
Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
Building 45, Room Number 1As.13
Bethesda, MD 20892
Applications for Phase II applications must be received by January 15, 2003.
If an application is received after the due date, it will be returned to the
applicant without review. The 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.
RECEIPT AND REVIEW SCHEDULE:
Phase I Application Receipt Date: June 18, 2002
Phase I Peer Review Date: August 2002
Phase I Award Date: September 2002
Phase II Application Receipt Date: January 15, 2003
Phase II Peer Review Date: March/April 2003
Advisory Council Date: May 2003
Earliest Anticipated Phase II Award Date: September 2003
PEER REVIEW PROCESS FOR PHASE II APPLICATIONS
Upon receipt, Phase II applications will be reviewed for completeness by the
Center for Scientific Review (CSR) and responsiveness by the NIGMS.
Incomplete and/or non-responsive applications will be returned to the
applicant without further consideration. Phase II applications that are
complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate scientific review group convened by the
NIGMS in accordance with the review criteria 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,
and may:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score.
REVIEW CRITERIA FOR PHASE II APPLICATIONS
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 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. Your application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example, you may propose to carry out
important work that by its nature is not innovative but is essential to move
a field forward.
(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, will the field of biomedical science be advanced?
Will these studies affect, in a meaningful and important way, the concepts or
methods that drive this field? Is there a commitment to maximize the impact
of the collaborative project through the sharing of research resources
generated by the large-scale 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? Will the
research resources generated by the large-scale project be shared with the
larger community? 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? Will there be value added over individual grants?
(4) INVESTIGATORS: Is the PI"s major research activity within the research
area of the collaborative project? Is the PI well suited to the scientific
and administrative leadership required to carry out this work? Is the level
of effort proposed for the PI 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?
(5) 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 and are they cost effective? Is access to the core
facilities appropriate?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
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. The adequacy of the data and safety
monitoring plans (required for clinical trials).
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 BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
In addition, the following criteria will be considered:
o Commitment to the project by the PI and the members of the steering
committee.
o Commitment of the host and participating universities to supporting the
large-scale collaborative project, e.g., 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.
o Commitment of the leadership to the sharing of research resources generated
by the large-scale project with the broader scientific community.
In an administrative note, the reviewers will comment on the adequacy of the
proposed plans to deal with intellectual property issues for the
collaborative project and the adequacy of the plans to share research
resources (including data and information, materials such as cell lines and
mutant animals, and novel reagents and techniques).
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 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. Your application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example, you may propose to carry out
important work that by its nature is not innovative but is essential to move
a field forward.
(1) SIGNIFICANCE: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
Will these studies be effective in 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? Is the proposed work appropriate for support by the
large-scale collaborative project or would it be more appropriate for support
by a regular research grant?
(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) INVESTIGATORS: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the PI 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?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
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 BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
AWARD CRITERIA FOR PHASE II APPLICATIONS
Award criteria that will be used to make funding decisions include:
o scientific merit (as determined by peer review)
o adequacy of plans for handling of intellectual property and sharing of
research resources
o program priorities
o program balance
o availability of funds
REQUIRED FEDERAL CITATIONS
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 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are
available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.ht
m. 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
http://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
http://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 http://grants.nih.gov/grants/stem_cells.htm and at
http://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
http://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, 93.859, and 93.862 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
http://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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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