LARGE-SCALE COLLABORATIVE PROJECT AWARDS

Release Date:  February 28, 2001

RFA:  RFA-GM-01-004

National Institute of General Medical Sciences

Phase I Application Receipt Date:   June 18, 2001
Phase II Application Receipt Date:  January 16, 2002

PURPOSE

The purpose of this RFA is to reannounce the National Institute of General 
Medical Sciences (NIGMS) program of “Large-Scale Collaborative Project 
Awards”, (commonly called large Glue Grants) first issued as GM-99-007 in May 
1999, and subsequently reissued in December 1999 as Notice GM-00-001.  This 
new announcement includes updates and modifications, and should be used in 
lieu of the previous announcements.

The purpose of this program is to enable the solution of major problems in 
biomedical research and to facilitate the next evolutionary stage of 
integrative biomedical science.  The intention is to make resources available 
for independently funded scientists to form research teams to solve a complex 
biological problem that would be beyond the means of any one research group, 
and that is of central importance to biomedical science and to the mission of 
the NIGMS.  It is expected that the participating investigators will already 
hold externally peer reviewed and funded research grants in the area of the 
proposal, and in general, support of new individual research projects will 
not be a part of these large scale project awards.  A high level of resources 
may be requested to allow participating investigators to extend their 
research efforts to form a consortium to approach a research problem of 
overarching importance in a comprehensive and highly integrated fashion.

Grants for this initiative will be awarded in two phases.  The purpose of the 
Phase I award is to provide resources for detailed planning to applicants who 
have demonstrated the selection of an appropriate complex biological problem, 
an innovative plan, and appropriate commitments to its solution from 
participating investigators and institutions.  Phase I applicants will submit 
an overview of the proposed large scale project for peer review.  Successful 
Phase I applicants will receive a $25,000 (direct costs) planning grant, and 
those applicants who receive awards will be eligible to submit a more 
extensively planned and detailed application for a Phase II award to support 
the large scale project itself.

This RFA is one of a pair of initiatives to increase support opportunities 
for collaborative ventures.  A companion program, "Integrative and 
Collaborative Approaches to Research," 
(http://grants.nih.gov/grants/guide/pa-files/PA-00-099.html and 
http://grants.nih.gov/grants/guide/notice-files/NOT-GM-01-001.html)is 
intended to support collaborative activities that are smaller in scale and 
scope than those requested in response to this RFA.  The NIGMS also advises 
that collaborations can be supported by most of the Institute's existing 
support mechanisms and strongly encourages potential applicants to talk with 
program directors in NIGMS to determine the most appropriate support 
mechanism for their collaborative work.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas.  This Request for 
Applications (RFA), Title of RFA, is related to one or more of the priority 
areas.  Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications must fall directly into the areas of research supported by the 
National Institute of General Medical Sciences.  Applicants are advised to 
visit the Institute website at http://www.nigms.nih.gov for information on 
NIGMS areas of interest. The projects must support the NIGMS mission as 
detailed in the publication, "Divisions and Grant Award Mechanisms," 
available from the NIGMS Public Information Office (301/496-7301).  Potential 
applicants may wish to visit the NIGMS website created for this RFA and the 
PA referred to above at http://www.nigms.nih.gov/funding/gluegrants.html. 
Applicants are also strongly advised to contact the NIGMS staff listed below 
to discuss the eligibility of a proposed project.

The major research activity of the principal investigator must be in the 
research area of the collaborative project application, and the principal 
investigator is expected to make a major commitment of effort to directing 
and managing the operation of the project; a substantial level of effort will 
be necessary to manage a project of this magnitude.  NIGMS anticipates that 
each collaborative project will include a substantial number of participating 
investigators.  For example, a modest size large scale collaborative project 
might contain fifteen or more participating investigators, who in the 
aggregate, hold independent peer-reviewed grants in the proposed research 
area in excess of $2.0 million (annual direct costs) at the time of 
application, and who will be actively involved in and committed to the goals 
of the consortium.  However, minimum and maximum numbers of participating 
investigators have not been set.

Applications may be submitted by domestic, non-profit organizations, public 
and private, such as universities, colleges, hospitals, laboratories, units 
of State and local governments, and eligible agencies of the Federal 
government.  Multi-institutional applications are encouraged.  A 
collaborative project may include participating investigators from foreign 
and/or for-profit organizations. Racial/ethnic minority individuals, women, 
and persons with disabilities are encouraged to apply as Principal 
Investigators.

MECHANISM OF SUPPORT

Phase I Applications

For Phase I applications, this RFA will use the National Institutes of Health 
(NIH) R24 grant mechanism.  A Phase I award will be made for three months at 
a level of $25,000 in direct costs to provide for costs associated with 
planning the large scale collaborative project.  Appropriate expenses for a 
planning award include, but are not limited to, salary for release time for 
the principal investigator to commit a significant percentage of effort to 
planning the Phase II application, meetings of the steering committee and 
participating investigators, and consultant costs for initial design and cost 
estimates for proposed core resources.  The anticipated award date for Phase 
I awards is September, 2001.

Phase II Applications

Only applicants who receive a Phase I award will be eligible to submit a 
Phase II application, which will be a new (Type 1) award.  For Phase II 
applications, this RFA will use the NIH Specialized Center (Cooperative 
Agreements) mechanism, U54.  The total project period for an application 
submitted in response to this RFA may not exceed five years. The anticipated 
award date for Phase II awards is September 2002.  Phase II awards will be 
considered for one five-year renewal period following the initial award.

Funding for Phase II applications will be provided by means of cooperative 
agreements.  A cooperative agreement is an "assistance" mechanism in which 
substantial NIH scientific and/or programmatic involvement with the awardee 
is anticipated during the performance of the activities conducted by the 
awardee.  Under a cooperative agreement, the NIH purpose is to support, 
stimulate, and expedite the recipients' activities by jointly being involved 
with them. NIGMS staff will work cooperatively with the award recipients in a 
partner role, but will not assume direction, prime responsibility, or a 
dominant role in the activity.  Details of the responsibilities, 
relationships, and governance of the activities to be funded under the 
cooperative agreements awarded for this Program are discussed later in this 
document under the section "Terms and Conditions."

This RFA is a one-time solicitation, although NIGMS presently anticipates re- 
announcing the solicitation, depending on the availability of funds.  Both 
new and revised Phase I applications, and revised applications for 
unsuccessful Phase II proposals, would be accepted if the solicitation is re-
announced within a two-year period. Only one revision of a Phase I or Phase 
II application will be accepted for consideration.

FUNDS AVAILABLE

NIGMS intends to commit up $10-15 million in total costs in FY2002 to fund 
both Phase I and Phase II awards.  NIGMS anticipates funding up to ten Phase 
I awards; each Phase I award will be for $25,000 in direct costs. Two to 
three Phase II grants will be awarded.  Because the nature and scope of the 
proposed research will vary, it is anticipated that the size of the Phase II 
awards also will vary, and the upper limit for a Phase II award will be $5 
million per year in annual direct costs.  Applications of different scales 
and scope are encouraged. Although the financial plans of NIGMS provide 
support for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications

RESEARCH GOALS, SCOPE, AND ORGANIZATION

Background:

NIGMS' external advisors, who met in May and November 1998, urged the 
Institute to support new mechanisms for collaboration on complex systems in 
biomedical science.  For most of the last thirty years the main approach used 
in biomedical science has been to focus attention on understanding the 
individual steps in biological processes at the subcellular and molecular 
level. Although much still needs to be done in defining and analyzing 
molecular events, it appears that enough of the pieces have been 
characterized to begin to put them together to solve problems of the global 
control and integration of biological processes.  These efforts will require 
the cooperation of many groups of scientists and many types of science.

The mainstay for support of biomedical science has been the traditional 
research project grant, the NIH R01 grant.  While this grant mechanism 
remains the backbone of NIH support for biomedical science, it may not be 
sufficient in and of itself to support the solution of complex problems of 
the type described above.  Many scientists are now expressing a strong need 
for a new type of support that will encourage scientific collaboration and 
provide for a higher level of coordination to solve problems requiring 
multifaceted approaches.  These scientists are able to secure research 
support for their own efforts but seek a means to encourage and facilitate 
the development of an interactive research network around a complex 
biological problem.

The purpose of this request for applications is to address the need to 
coalesce and coordinate efforts on a larger central problem in biomedical 
science and to make collaborations and resources available to a group of 
independently funded investigators.  Biomedical science has entered a new era 
where these collaborations are becoming critical to rapid progress.  This is 
the result of several factors. First, not every laboratory has the breadth to 
pursue problems which increasingly must be solved through the application of 
a multitude of approaches.  These include the involvement of fields, such as 
physics, engineering, mathematics, and computer science, that were previously 
considered peripheral to mainstream biomedical science.  Second, the ability 
to attack large projects that involve considerable data collection and 
technology development require the collaboration of many groups and 
laboratories.  Finally, large-scale, expensive technologies such as 
combinatorial chemistry, DNA chips, high throughput mass spectrometric 
analysis, etc., are not readily available to all laboratories that could 
benefit from their use.  These technologies require specialized expertise, 
but could lend themselves to management by specialists who collaborate or 
offer services to others.

Research Objectives:

The primary research objectives are to solve complex biological problems of 
great significance through large scale collaborative projects that integrate 
broad and diverse areas of science by bringing together independently funded 
investigators who share a connection to a central problem and to facilitate 
the development of integrative biomedical science.  The intention is to 
provide the framework and incentives to foster the development of integrative 
research teams and to provide considerable flexibility for participants to 
request and employ the specific resources necessary to accomplish the job.  
Part of the challenge of each large scale collaborative project will be to 
devise the organizational structure that best facilitates accomplishment of 
the specific scientific goals of that collaborative project.  The main 
outcome expected is the solution of a complex, multifaceted research problem 
of overarching significance, where such a solution could not be achieved in a 
reasonable time frame by separate efforts. An additional expected outcome is 
that collaboration and integration in the biomedical sciences will be 
enhanced.

The research scope for this RFA includes all areas of science that are of 
direct relevance to the National Institute of General Medical Sciences 
(http://www.nigms.nih.gov/about_nigms/overview.html). Participation by 
investigators doing mechanistic clinical science is welcomed as well as by 
investigators doing basic laboratory science.  It is recognized that data 
collection and technology development may be logical and necessary parts for 
some or all large scale collaborative projects.

Possible examples of scientific problems that could be addressed by large-
scale collaborative teams might be:

working out all facets of particular cellular processes, both for the process 
itself and for its integration into and control of cellular function

determining structures and distilling global structure-function principles 
for organelles

quantitatively modeling interacting metabolic pathways in a model organism

determining the multi-level control mechanisms and their integration into the 
biological response to traumatic injury

Whether projects such as these illustrative examples are sufficiently 
important to be funded as large scale collaborative project awards will be 
determined by peer review and relevance to current areas of interest to the 
Institute.  For results of previous competitions, visit the NIGMS glue grant 
website at http://www.nigms.nih.gov/funding/gluegrants.html.

It will not be sufficient to organize a research network simply to promote 
access of individual investigators to research resources.  There must be 
intense and meaningful interaction proposed around a central biological 
problem among the participating scientists, so that progress achieved is 
substantially greater than the sum of the participants' individual 
achievements.  Each large scale collaborative project, as in the examples 
above, could require considerable new resources, but would also require a 
synthesis of information from individual laboratories in order to solve the 
biological problem being addressed.

The Phase I application should provide an overview of the proposed 
collaborative project, including the goals for the project, the reasons for 
using this mechanism, and the approach to the expected elements of a Phase II 
proposal.

The Phase II application should provide a more detailed explanation of the 
proposed project, including specific intermediate goals (milestones) and a 
timeline for their accomplishment.

Elements of a Large-Scale Collaborative Project:

PRINCIPAL INVESTIGATOR:  Each collaborative project will be headed by a 
principal investigator (PI) who will chair and be assisted in governing the 
project by a steering committee. Although a substantial level of effort is 
expected for the PI, minimum levels of effort have not been set for the PI; 
however, the level of effort of the PI will be a factor in the assessment of 
scientific merit and in the Institute's funding selections.

STEERING COMMITTEE:  The steering committee is responsible for governance of 
the large scale collaborative project, and its membership, chosen from 
participating investigators and project staff, should be representative of 
the scope and membership of the proposed collaborative project.  The level of 
effort and commitment to the collaborative project of the members of the 
steering committee will also factor into the assessment of scientific merit 
as well as the Institute's funding selections.  It is expected that the 
principal investigator, the steering committee, and the participating 
investigators will work together to develop reasonable and sound goals and 
operating procedures for the collaborative project.  An NIGMS program 
director will serve as a member of the steering committee and attend its 
meetings.

PARTICIPATING INVESTIGATORS:  In addition to the PI and members of the 
steering committee, each collaborative project will include a team of 
investigators who will contribute to and benefit from participation in the 
project.  The members of the collaborative project will be referred to 
collectively as participating investigators.  It is expected that each of the 
participating investigators will hold an externally peer reviewed and funded 
research grant in the area of the project.  It is expected that the majority 
will be funded through regular research grants supported by NIGMS, other NIH 
institutes and centers, and other governmental and private agencies.  
Exceptions to the rule of external funding may include participating 
investigators from industry, foreign institutions or allied fields not 
traditionally supported by the NIH (e.g., physics and mathematics). However, 
they must provide evidence of their commitment to the project and a listing 
of organizational resources that will be committed to the project.  Principal 
investigators of pilot projects (see below under COLLABORATIVE PROJECT 
RESOURCES) will also be considered participating investigators.  
Participating investigators will work with the other members of the team to 
develop workable guidelines for the collaborative project.  Participating 
investigators must agree to abide by the policies and rules set up for the 
collaborative project and to the terms and conditions herein to be eligible 
to participate.  During the period of the award, a participating investigator 
whose independent research support terminates may continue as a participating 
investigator at the discretion of the steering committee and with the 
approval of the NIGMS program director.  However, funds from this award are 
not to be used to support the independent project of such an investigator.  
It is expected that new participating investigators will be added to the 
collaborative project over the period of the award as deemed appropriate by 
the principal investigator and steering committee and with the approval of 
the NIGMS program director; these additions will be reported in the annual 
progress report.

ADVISORY COMMITTEE:  Each large-scale collaborative project will include an 
external advisory committee whose purpose is to meet annually with the 
principal investigator and the steering committee to assess progress and 
provide feedback on proposed goals for the next year of support.  The members 
will be appointed by the principal investigator in consultation with the 
steering committee and with the approval of the NIGMS program director, after 
the Phase II award has been made, and will be drawn from research scientists 
not involved in the project. The members of the advisory committee should not 
be selected until an award has been made.  The NIGMS program director 
responsible for the award will attend the meeting of the advisory committee 
as a member of the steering committee, but will not be a member of the 
advisory committee.  The advisory committee will meet at least once a year 
immediately prior to the submission of the annual progress report.

COLLABORATIVE PROJECT RESOURCES:  The organizational structure of the 
collaborative project may have a variety of forms depending on the needs of 
the research problem being addressed.  For example, the large scale 
collaborative project could consist entirely of a research and administrative 
structure, including a data coordinating and information dissemination 
center, independent of supporting additional activities in any of the 
laboratories of the participating investigators.  In addition, the large-
scale collaborative project may request the following types of resources:

Bridging projects may be requested for collaboration enhancement activities 
(essentially supplements to the ongoing independent work) in the laboratories 
of the participating investigators. These bridging projects to the 
laboratories of participating investigators are to add to or bridge the 
intellectual and technological approaches of the collaborative project.  They 
are not meant to be stand-alone research efforts but are to be subprojects 
that tie (or enhance the contribution of) the independent work of the 
participating investigator to the large scale collaborative project. A 
bridging project should extend the participating investigator’s independent 
work in a new direction(s).  A bridging project to do more of what the 
investigator is already doing should be considered only if there are 
extraordinary circumstances that make it essential for the effective 
functioning of the large-scale project.  If the participating investigator’s 
work is already closely tied to the large-scale project, a bridging project 
should not be needed.  Substantial new research projects should not be 
submitted for bridging projects; these should be submitted as regular R01 
applications, even if they add value to the large-scale project.

Pilot projects may be requested for investigators without current independent 
support in the area of the collaborative project to add elements where gaps 
exist, or to add investigators with critical knowledge or expertise but 
without a research background in the area of the collaborative project.  
These pilot projects must not exceed $75,000 in annual direct costs and must 
be limited to no more than three pilot projects per large-scale collaborative
project. The pilot project should be of sufficient scope to qualify as a 
stand alone research effort.  It is primarily intended to allow the 
collaborative project to add investigators outside the scientific mainstream 
of the project area in a mode that will allow them to develop independent 
research in the area of the collaborative project. Applicants must explain 
why the principal investigator’s expertise is needed for the large-scale 
project and how the pilot project will contribute directly to the 
accomplishing the aims of the large-scale project.  While funding for a pilot 
project may run for five years, at the discretion of the steering committee, 
it is expected that the principal investigator of a pilot project will seek 
R01 funding during the period of the collaborative project, based on the 
results obtained from the pilot project.

Core resources may be requested to speed progress on the scientific goals of 
the project or add additional capability to the collaborative project by 
adding new or improved technology or by standardizing data among different 
research teams.  An example of new technology might be gene chip microarray 
technology; an example of standardizing results might be establishment of a 
model organism core.  It is expected that each large-scale collaborative 
project will request core resources for information collection, coordination, 
and dissemination.  Other types of resources might be for instrumentation, 
genomics, proteomics, high-throughput assays, or 
computational/bioinformatics/modeling cores.  Requests for core resources 
must be strongly justified in terms of value to achieving the goals of the 
project, value to increasing the synergy of the collaborative project, and 
cost effectiveness.

ADMINISTRATIVE MANAGEMENT PLAN:  Each large-scale collaborative project award 
must include an administrative management plan that outlines the policies and 
procedures for access of participating and non-participating investigators to 
the collaborative project resources.  The application should address the flow 
of information within the project, and plans for how the information will be 
integrated into the solution of the biological problem being addressed. The 
mechanism to add new participating investigators and delete members whose 
association with the project has not been productive should be documented in 
the proposal.  The plan should also include proposed methods for information 
dissemination both within the collaborative project and to the scientific 
community.  Furthermore, each large-scale collaborative project will include 
a mechanism to consider and respond to concerns of the scientific community 
directly affected by the project about the operation and impact of the 
project. A discussion of scientific community views will be part of the 
agenda for annual meetings of the steering committee with the advisory 
committee.

PROJECT MANAGEMENT PLAN:  Each large scale-collaborative project application 
must include a project management plan, including an ongoing evaluation plan, 
to ensure consistent forward progress of the project.  Each collaborative 
project will define, at a minimum, yearly milestones, and those receiving 
awards will have the opportunity to modify these milestones at the time of 
their awards, with the concurrence of NIGMS.  It is expected that the 
milestones will be adjusted annually at the award anniversary dates, both to 
incorporate a team's scientific accomplishments and progress in the field in 
general, as well as to reflect the recommendations of the advisory committee. 
The NIGMS program director responsible for the large-scale collaborative 
project may include outside consultants in the annual progress review and may 
recommend reducing or withholding funds, or termination of the award, for 
failure to meet milestones. A report by the NIGMS program director of each 
collaborative project's progress and any recommendations to modify funding 
will be made annually to the National Advisory General Medical Sciences 
Council.

PLAN FOR DATA SHARING AND INTELLECTUAL PROPERTY:  To address the interests of 
the government in the availability of, and access to, the results of publicly 
funded research, NIH requires applicants who respond to this RFA to develop 
and propose specific plans for sharing the data and materials generated 
through the large-scale collaborative project.  The initial review group will 
comment on the proposed plans. The adequacy of the plans will also be 
considered by NIH staff as one of the criteria for award.  Because 
dissemination is a critical aspect and fundamental purpose of this RFA, the 
proposed sharing and data release plans, after negotiation with the applicant 
when necessary, will be made a condition of the award. Evaluation of renewal 
applications will include assessment of the effectiveness of data and 
material release.  It is further suggested that the members of the large-
scale collaborative project disclose to the steering committee their ties to 
profit-making organizations to aid the project in avoiding conflict of 
interest situations. Applicants are also reminded that the grantee 
institution is required to disclose each subject invention to the Federal 
Agency providing research funds within two months after the inventor 
discloses it in writing to grantee institution personnel responsible for 
patent matters.

SPECIAL REQUIREMENTS FOR COOPERATIVE AGREEMENTS

Terms and Conditions of Award

The following Terms and Conditions will be incorporated into the award 
statement and will be provided to the Principal Investigator as well as to 
the appropriate institutional official, at the time of award.  The following 
special terms of award are in addition to, and not in lieu of, otherwise 
applicable OMB administrative guidelines, HHS grant administration 
regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and 
local Governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies:

The administrative and funding instrument used for this program will be the 
cooperative agreement, an "assistance" mechanism (rather than an 
"acquisition" mechanism), in which substantial NIH programmatic involvement 
with the awardees is anticipated during performance of the activities.  Under 
the cooperative agreement, the NIH purpose is to support and stimulate the 
recipients' activities by involvement in and otherwise working jointly with 
the award recipients in a partnership role; it is not to assume direction, 
prime responsibility, or a dominant role in the activities.  Consistent with 
this concept, the dominant role and prime responsibility resides with the 
awardees for the project as a whole.

Awardees will retain custody of and have primary rights to the data developed 
under these awards, subject to Government rights of access consistent with 
current HHS, PHS, and NIH policies.  Awardees should comply with their 
institutional intellectual property policies and practices as approved in the 
award.  However, awardees will be expected to share (make available) this 
data openly with the scientific community.

Principal Investigator Responsibilities:

The principal investigator is the scientist who assembles the large scale 
collaborative project and is responsible for submitting the application in 
response to this RFA and for performance of the project.  The PI will 
coordinate project activities scientifically and administratively at the 
awardee institution.  The PI will have the overall responsibility for the 
scientific and technical direction and the administration and overall 
operation of the large scale collaborative project.  To assist the PI with 
the governing of the project, a steering committee will be established from 
among the participating investigators and project staff.  The principal 
investigator will chair the steering committee. The membership will be 
representative of the scope of the project. As for all participating 
investigators, the PI must abide by the operating rules and guidelines 
developed by the steering committee.  The Principal Investigator will agree 
to accept participation of NIGMS staff in those aspects of management of the 
project described under "NIGMS Program Director Responsibilities".  He/she 
will also ensure the timely dissemination of information generated by the 
large-scale collaborative project to both the project members and the 
scientific public.

Participating Investigator Responsibilities:

The participating investigators are those scientists holding externally peer 
reviewed grant support in the area of the project and who are involved with 
and committed to the goals of the project. Exceptions to the rule of external 
funding may include participating investigators from industry, foreign 
institutions or allied fields not traditionally supported by the NIH (e.g., 
physics and mathematics); PIs of pilot project are also included.  
Participating investigators will work with the principal investigator, the 
steering committee, and the other members of the large scale collaborative 
project to set goals and develop working procedures; they must agree to 
support the goals of the project and to abide by the operating guidelines and 
procedures established for the project.  Participating investigators will be 
actively involved in the project and interactive with the other members of 
the project.

NIGMS Program Director Responsibilities:

The NIGMS program director will serve as a voting member of the steering 
committee and will attend all meetings.  In addition to having all of the 
duties and responsibilities of a steering committee member, the NIGMS program 
director will facilitate interactions among the steering committee and the 
advisory committee and NIGMS and provide advice and guidance to assure that 
the large scale-collaborative project adheres to the NIH and NIGMS rules and 
regulations.  The NIGMS program director will facilitate communication with 
the scientific community directly affected by the collaborative project and 
will assure that the steering committee and the advisory committee address 
issues and concerns raised by the community.  Additional responsibilities may 
be negotiated at the time of award depending on the individual 
characteristics of the awards to be made.

Steering Committee Responsibilities

A steering committee will serve as the governing board of each large scale 
collaborative project and will participate in setting direction, policies and 
operating procedures.  Membership will include the principal investigator, as 
well as other scientists and administrators drawn from the staff and 
participating investigators of the project, sufficient in breadth and balance 
to be representative of the overall project.  The NIGMS program director will 
serve as a member of the steering committee.  The original members will be 
selected by the principal investigator from among the participating 
investigators and staff to be representative of the scope of the project.  
Additional or replacement members will be selected by the steering committee.  
The steering committee will work with the principal investigator to establish 
the scientific and technical direction of the project, develop common 
guidelines and procedures, establish rules for access to resources of the 
project and for dealing with intellectual property issues, and participate in 
the process of developing a cohesive group.  The steering committee will 
develop a policy regarding disclosure of ties between scientists and profit- 
making organizations to aid the project in avoiding conflict of interest 
situations. The steering committee will monitor bridging projects, core 
resources, and pilot projects for progress and efficiency, and recommend 
modification of support and addition/deletion of these activities as needed 
to facilitate progress on the goals of the large-scale collaborative project.

Advisory Committee Responsibilities:

The advisory committee will be composed of a panel of a minimum of three 
scientists not otherwise associated with the large scale collaborative 
project.  The NIGMS program director will attend the meetings of the advisory 
committee as a member of the steering committee.  The advisory committee will 
meet at least yearly to provide advice to the steering committee of the large 
scale collaborative project about meeting its goals and to comment on plans 
for future directions.  The advisory committee will raise issues for 
consideration by the principal investigator and the steering committee and 
will comment on the appropriateness of the level of NIGMS support to achieve 
the goals of the project. The advisory committee will also comment on the 
impact of the collaborative project on the relevant scientific communities.

Milestones and Evaluations

It is expected that milestones will be adjusted annually at the award 
anniversary dates, both to incorporate a group's scientific accomplishments 
and progress in the field in general, as well as to reflect the 
recommendations of the advisory committee.  In accordance with the procedure 
described above, the NIGMS program director may recommend to the Director, 
NIGMS, augmenting any subproject or core facility, or reducing or withholding 
funds for any subproject or core facility that substantially fails to meet 
its milestones or to remain state-of-the-art.

The Director, NIGMS, retains the right to call a meeting of advisors, most 
likely members of the National Advisory General Medical Sciences Council or 
their designee(s), at any time to provide advice on the scientific progress 
of a large-scale collaborative project.  It is anticipated that such a group 
of advisors may want to attend a meeting of the project advisory committee as
part of its fact-finding mission.

Arbitration Process

Any disagreements that may arise in scientific or programmatic matters 
(within the scope of the award) between award recipients and the NIGMS may be 
brought to arbitration.  An arbitration panel will be convened.  It will be 
composed of three members: a designee of the principal investigator, one 
NIGMS designee, and a third designee with expertise in the relevant area who 
is chosen by the other two; in the case of an individual disagreement, the 
first member may be chosen by the individual awardee.  This special 
arbitration procedure in no way affects the awardee's right to appeal an 
adverse action that is otherwise appealable in accordance with PHS 
regulations 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided indicating that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of  
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43). 

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines are available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the Inclusion of Children as Participants in 
Research Involving Human Subjects that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

PHASE I APPLICATION PROCEDURES

Phase I awards are intended to support planning activities in order to 
structure and organize the large scale collaborative project for submission 
as a Phase II application.  In general, the Phase I application will be used 
to gauge the merit of the basic idea and the conceptual framework for the 
collaborative project; specific review criteria are discussed below.  
Prospective applicants must submit, by June 18, 2001, a Phase I application 
that contains an overview of the proposed large scale collaborative project.  
Phase I applications will be evaluated by an appropriately constituted peer 
review group.  Phase I applicants will be advised by September 2001 whether 
their applications will be funded.  Only Phase I awardees may submit Phase II 
applications for scientific merit review.

Contents of Applications

Phase I and Phase II applications are to be submitted on the standard 
research grant application form PHS 398 (rev. 4/98).  Application kits are 
available at most institutional offices of sponsored research and may be 
obtained from the Division of Extramural Outreach and Information Resources, 
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 
20892-7910, telephone (301) 435-0714, email: grantinfo@nih.gov.

A Phase I response to this RFA should follow the PHS 398 instructions with 
the following modifications:

Application face page. Complete all items.  This is page 1; number succeeding 
pages consecutively. The RFA label found in the PHS-398 (rev. 4/98) 
application form must be affixed to the bottom of the face page of the 
application and must include the RFA number.  Failure to use this label could 
result in delayed processing of the application such that it may not reach 
the review committee in time for review.  On line 2, the number and title of 
this RFA: GM-01-004, "Large-Scale Collaborative Project Awards," must be 
entered, and the YES box must be marked.

The Research Plan should be replaced with the following:

A statement (two page limit) by the principal investigator describing his/her 
commitment, including percent effort, to the large-scale collaborative 
project and identifying the members and percent effort of the steering 
committee.

A project summary (ten page limit) describing the scientific goals and 
operation of the large scale collaborative project.  Explain what complex 
biological problem will be solved. Describe in detail and explain the 
scientific approach to this problem. Explain why a large-scale collaborative 
project is critical to its solution.  Describe the range of scientific 
expertise to be brought to bear on the problem.  It is important to make 
clear the significance of the biological problem chosen and what the value 
added benefit will be from pursuing the problem with a collaborative project, 
rather than individual grants. Approaches envisioned to the key elements of a 
large-scale collaborative project should be described.  The roles that 
bridging projects, pilot projects, and/or core resources will play in the 
collaborative project should be described. The project summary will serve as 
the research plan for the Phase I application.

Biographical sketches and letters of commitment from each of the 
participating investigators that indicate their interest in joining the 
collaborative project.

Other support pages should include only the grants of each participating 
investigator that are in the area of the large-scale collaborative project.

Letters signed by the authorized business official of each of the 
participating investigators' institutions committing support to the 
collaborative project. Arrangements for the participation of investigators 
from industry and foreign sites and resources they may bring to the 
collaborative project should be documented.

A statement of institutional and other resources available to the consortium 
(three pages).

A Literature Cited section is permissible, but appendices will not be allowed 
as part of a Phase I application since a detailed plan is not requested at 
this stage.

A description of the proposed budget allocation (one page, in lieu of the PHS 
398 budget section).  All Phase I awards will be for up to $25,000 for the 
period November 1, 2001 to January 31, 2002.

Review Considerations

Upon receipt, Phase I applications will be reviewed for completeness by CSR 
and responsiveness by the NIGMS.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration.  
Phase I applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer review 
group convened by the NIGMS in accordance with the review criteria stated 
below.

As part of the initial merit review, a process may be used by the initial 
review group in which Phase I applications receive a written critique and 
undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, 
will be discussed and assigned a priority score.

Review Criteria:

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed 
consortium will have a substantial impact on the pursuit of these goals.  
Each of these criteria will be addressed and considered in assigning the 
overall score, weighting them as appropriate for each application. 

Significance.  Does this project address a complex biological problem of 
overarching significance to biomedical science that would be difficult to 
address by separate grants?  If the aims of the application are achieved, how 
will the field of biomedical science be advanced?

Approach.  Is the conceptual framework appropriate to achieve the scientific 
aims of the large scale collaborative project?

Innovation.  Are the project's structure and goals novel? Are the aims 
original and innovative? Will the project attack a problem in a significantly 
new way?  What will be the value added over individual grants?

Investigators.  Is the principal investigator's major research activity 
within the research area of the collaborative project?  Is the principal 
investigator well suited to the scientific and administrative leadership 
required to carry out this work? Are the research grants of the participating 
investigators within the area of the project?  Are the participating 
investigators well chosen for their roles in the project? Do the commitments 
of the principal investigator, steering committee members, and participating 
investigators appear reasonable for the scope of the planned activities?

Environment.  Do the scientific environments in which the work will be done 
contribute to the probability of success? Is the level of institutional 
support adequate?

Additional review criteria for Phase I awards that will also be considered 
include the commitment to the project by the principal investigator, the 
members of the steering committee, and the participating investigators; the 
commitment of the host university to supporting the consortium, reflected, 
for example, in the willingness to work out potential intellectual property 
issues prior to submission of the Phase II application and to remove any 
institutional barriers to the establishment and healthy maintenance of the 
large scale collaborative project.

Award Criteria

Award criteria that will be used to make funding decisions include:

o scientific merit (as determined by peer review)
o program priorities
o program balance
o availability of funds

PHASE II APPLICATION PROCEDURES

Phase I awardees may submit a Phase II application by January 16, 2002 for 
peer review.  Phase II applications are to be submitted on the standard 
research grant application form PHS 398 (rev. 4/98).  Application kits are 
available at most institutional offices of sponsored research and may be 
obtained from the Division of Extramural Outreach and Information Resources, 
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 
20892-7910, telephone (301) 435-0714, email: grantsinfo@nih.gov.

The Phase II application should include detailed plans for the large-scale 
collaborative project.  In addition to an assessment of the merit of the 
basic idea and the conceptual framework, an assessment of the specific plans 
will be conducted.

Contents of Applications

A Phase II response to this RFA should consist of an application that, in 
addition to or in lieu of part of the items requested in the PHS 398, 
includes:

Application face page. Complete all items.  This is page 1; number succeeding 
pages consecutively. The RFA label found in the PHS-398 (rev. 4/98) 
application form must be affixed to the bottom of the face page of the 
application and must include the RFA number.  Failure to use this label could 
result in delayed processing of the application such that it may not reach 
the review committee in time for review. On line 2, the number and title of 
this RFA: GM-01-004, "Large Scale Collaborative Project Awards," must be 
entered and the YES box must be marked.

Abstract of Research Plan.  On page 2, describe briefly the proposed large 
scale-collaborative research project.  List all key personnel involved in the 
collaborative project; use a continuation page if needed.

Table of Contents.  Prepare a Table of Contents that includes the items 
listed below. The major areas to be listed in the Table of Contents appear 
here in capital letters.

BUDGET ESTIMATES: Specific examples of allowable costs that may be requested 
include:

Salaries for the principal investigator, members of the steering committee, 
participating investigators, technical, and support personnel commensurate 
with their level of effort in the large-scale collaborative project. 

Bridging projects to the laboratories of participating investigators.  Pilot 
projects to investigators without current independent research support in the 
area.  These subprojects must not exceed $75,000 in annual direct costs and 
must be limited to no more than three such projects per application. Travel 
of personnel, which may include technicians, predoctoral students, 
postdoctoral trainees, and investigators, to different laboratories to gain 
specialized expertise.

Travel to and conduct of regular meetings of the steering committee and 
regular meetings of the participating investigators.

Core facilities (examples: instrumentation, genomics, proteomics, model 
organism, high-throughput assay, or computational/bioinformatic cores).

Electronic media cores to allow participation of off-site laboratories and/or 
the means necessary to establish collaboratory capabilities and to 
disseminate information.  Travel to and conduct of regular meetings of an 
advisory committee.

In addition to the overall budget, include a separate budget for each 
bridging project and pilot project and each core resource.  Phase II 
applications for large-scale collaborative project awards may not request 
more than $5 million in annual direct costs (exclusive of subcontract 
indirect costs requested as a direct cost by the applicant organization) for 
any year of the award. Salaries for support personnel required for 
coordination and maintenance of the project, such as secretaries, may also be 
included as necessary in an administrative core.

Composite budget.  Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET 
PERIOD," of Form PHS-398 to present the total budget for all requested 
support for the first year.  For each category such as "Personnel," 
Equipment," etc., give the amount requested for each core unit and each 
component project, with subtotals. For consortium arrangements involving 
other institutions or organizations, include total (direct and facilities and 
administration) costs associated with such third-party participation in the 
"Consortium/Contractual Costs" category.  Costs for purchased services should 
be itemized under "Other Expenses."

Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of Form PHS-398 
to prepare a budget, by category, that provides totals for each year of 
requested support.  Requests for any increases in succeeding years must be 
justified in the individual component subprojects (bridging projects and 
pilot projects) and core unit budgets.

Individual component core and research budgets.  For the first year budgets 
of each of the cores and projects, use Form Page 4 of the PHS-398.  Use Form 
Page 5 of the PHS-398 to report the budgets of each of the projects and cores 
for total project period (years 02-05).

Budget justifications and explanations.  Describe the specific functions of 
all key personnel, including consultants, collaborators, and technical staff.  
Provide justifications for requested equipment.  For years 02-05 of the
application, justify any significant increases or decreases in any category
over the first year budget.

BIOGRAPHICAL SKETCHES AND LETTERS OF COMMITMENT: Biographical sketches and 
one page letters of commitment must be included from all participating 
investigators indicating their willingness to follow guidelines and 
procedures established for the large-scale collaborative project.

OTHER SUPPORT: For the principal investigator, steering committee members, 
participating investigators, and heads of core resources, provide a listing 
of all other support for each participant in the usual NIH format for non-
modular applications; support for other investigators such as postdoctoral 
students should not be listed.  For the relevant grant support that allows 
participating investigators to be part of the large scale collaborative 
project, provide the specific aims of the project and describe in sufficient 
detail for evaluation the relationship of the funded grant to the goals of 
the proposed large scale project.

RESOURCES AND ENVIRONMENT:  Complete the "Resources" page of PHS-398 for the 
overall large-scale collaborative project, including both the host 
institution and any participating institutions.  Briefly describe the 
features of the institutional environment(s) that are relevant to the 
effective implementation of the proposed program.  As appropriate, describe 
available resources, such as clinical and laboratory facilities, 
participating and affiliated units, patient populations, geographical 
distribution of space and personnel, and consultative resources.

ANIMAL AND HUMAN SUBJECT ASSURANCES:  Because of the relatively short 
turnaround time for review of Phase II applications, IACUC assurances must be 
completed (and not pending) at the time of submission of the Phase II 
application.  However, IRB approval is no longer required prior to review, 
but only prior to funding 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-031.html).

ADDED REQUIREMENT:  Applications should include a cover sheet that lists 1) 
all participants, including consultants and private sector alliances, 3) all 
the institutional affiliations for each participant, and 3) their roles on 
the project.  This new requirement will facilitate the review of 
applications.

RESEARCH PLAN

Include a detailed Table of Contents with pagination (numeric only) at the 
beginning of the Research Plan.  Identify each component core with a capital 
letter (A,B,C), as well as title, that reflects the order in which the core 
units are presented in the application research plan.  For each core, provide 
the name of the core director.

Page limitations: The program summary, administrative management plan and the 
project management plan sections when combined have an aggregate page limit 
of 30 pages.  Page limitations for other sections are given below.  
Investigators should endeavor to be concise.

PROGRAM SUMMARY: A project summary describing the goals and operation of the 
project. Explain what complex biological problem will be solved and how the 
approach of using a large-scale collaborative agreement is critical to its 
solution.  Discuss the range of scientific expertise to be brought to bear on 
the research problem.  Explain the interactions that will occur between 
investigators at the host site and at the participating sites.  Explain how 
each element of the large-scale collaborative project will contribute to 
successful attainment of its goals. Explain the programmatic value of the 
core resources, bridging projects, and pilot projects. Explain how the 
information coming from the collaborative project and the laboratories of the 
participating investigators will be integrated into comprehensive whole.  
Discuss how information generated by the collaborative project will be 
disseminated to the scientific public.

ADMINISTRATIVE MANAGEMENT PLAN: Describe the structure, organization, and 
operation of the project. Describe the organizational framework and provide 
an organizational chart and the flow of information within the collaborative 
project. Discuss arrangements between the collaborating institutions that are 
important to effective operation of the large-scale collaborative project.  
Detail the usage of the core resources by the participating investigators.  
Include any outreach efforts to provide access to the core resources to 
investigators outside the collaborative project.  Explain how decisions will 
be made to add/delete participating investigators and to respond to changes 
in short term goals that research findings will make necessary.  Discuss how 
the views of the scientific community impacted by the collaborative project 
will be considered. 

PROJECT MANAGEMENT PLAN: Define, at a minimum, yearly milestones. Present a 
project management plan, including milestones, to keep the collaborative 
project moving forward and on track.  Explain how progress in the bridging 
projects and pilot projects and efficiency of the core resources will be 
tracked.  Include an evaluation plan to determine how the collaborative 
project is progressing.  Discuss the plan for evolving milestones. Explain 
how the advisory committee will be used in updating the project management 
plan.

PLAN FOR DATA SHARING AND INTELLECTUAL PROPERTY (two page limit): The 
principal investigator and steering committee should (1) propose a plan for 
providing access to the data and information generated by the large-scale 
collaborative project to the members of the project and the scientific 
public; (2) address if or how intellectual property rights will be exercised; 
(3) discuss guidelines for licensing of joint inventions; (4) discuss 
procedures for settling of intellectual property disputes; (5) discuss the 
existence of any pre-existing intellectual property rights, including options 
to for-profit research sponsors; and (6) propose a plan for disseminating the 
technologies, assays, and associated reagents developed under this RFA.

CORE RESOURCE DESCRIPTIONS

CORE RESOURCE A.  ADMINISTRATIVE CORE (five page limit): This Core must be 
directed by the principal investigator.  Include the objectives of the core, 
a description of its staffing and services to be provided to other core 
resources and to the participating investigators.  Communicating the 
objectives of the collaborative project and fostering opportunities for 
collaboration are encouraged.  Expenses associated with the operation of the 
steering committee, meetings of all or subgroups of the participating 
investigators, and meetings and operation of the advisory committee would 
fall under the administrative core.

CORE RESOURCE B.  INFORMATION DISSEMINATION AND DATA COORDINATING CORE (five 
page limit): Dissemination of information on techniques, scientific findings, 
and methodologies is a vital component of each large-scale collaborative 
project.  Computer technology, print media, and telecommunications are 
relevant.  Describe the staffing (including a Core Director, as well as any 
professional or technical personnel and their duties), facilities, and 
resources that will be devoted to this goal.  Indicate plans to make results 
of research or other unique features of the collaborative project available 
to as wide an audience as possible.  Describe how data generated by the core 
resources and the participating investigators will be processed into the 
information to be disseminated.  Discuss plans for dissemination of published 
and unpublished data.

CORE C (and others).  SCIENTIFIC RESOURCE CORE (S) (ten page limit per core): 
Provide specific titles for any proposed scientific resource cores (e.g., 
instrumentation; genomics; proteomics; model organism; high-throughput assay; 
or computational, modeling, or bioinformatics), along with a designated Core 
Director who possesses expertise in the area of each core.  Describe the 
professional and technical staff to be involved in the core(s), and their 
duties.  Include plans to utilize the core(s), including services that will 
be provided, and to whom, and their bearing on productivity and quality of 
the collaborative research effort.

PROJECTS

BRIDGING PROJECTS (five page limit for each bridging project for the research 
plan: specific aims, background and significance, preliminary studies, and 
research design and methods): Bridging projects will support work in the 
laboratories of the participating investigators; these are essentially 
supplements to their ongoing work. Describe the new research proposed in the 
bridging project and explain how this work more fully integrates the 
participating investigator’s independently supported work into the large 
scale collaborative project.  For all proposed projects, the underlying 
rationale and potential impact of the studies should be specifically 
addressed. Projects must be described in sufficient detail to permit 
evaluation through the competitive peer-review process.  For each bridging 
project undertaken as part of the collaborative project, include a combined 
summary of the specific aims, background and significance, preliminary 
results, and research design and methods.  Also include the following 
sections which do not count against the page limitations: Abstract (one 
paragraph), Children as Research Subjects, Human Subjects including gender 
and minority considerations, Vertebrate Animals, and Literature Cited.

PILOT PROJECTS (ten page limit for each pilot project for the research plan: 
specific aims, background and significance, preliminary studies, and research 
design and methods; maximum of three pilot projects per large scale 
collaborative project): Pilot projects will support the work of investigators 
not already supported in the area of the collaborative project who have 
unique skills or expertise to add to the collaborative project effort.  For 
all proposed projects, the underlying rationale and potential impact of the 
studies should be specifically addressed. How the pilot project will add new 
elements essential to achieving the goals of the collaborative project must 
be described.  Projects must be described in sufficient detail to permit 
evaluation through the competitive peer-review process.  For each pilot 
project undertaken as part of the collaborative project, include the 
following sections: Abstract (one paragraph), Specific Aims, Background and 
Significance, Preliminary Studies, Research Design and Methods, Children as 
Research Subjects, Human Subjects including gender and minority 
considerations, Vertebrate Animals, and Literature Cited.

INSTITUTIONAL COMMITMENTS: Letters signed by authorized business officials of 
each of the participating investigators' institutions committing support to 
the large-scale collaborative project must be included.  Applicants for Phase 
II proposals that include consortium arrangements should refer to the NIH 
Grants Policy Statement appendix on consortium arrangements at 
http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm#Consortium.

APPENDICES: Appendices are allowed for the Phase II applications, but should 
follow the rules for appendices in the PHS-398 instructions.

REVIEW CONSIDERATIONS

Upon receipt, Phase II applications will be reviewed for completeness by CSR 
and responsiveness by the NIGMS.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration.  
Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the NIGMS in accordance with the review criteria stated below.

As part of the initial merit review, a process may be used by the initial 
review group in which applications receive a written critique and undergo a 
process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, 
will be discussed, assigned a priority score, and receive a second level 
review by the National Advisory General Medical Sciences Council.

Review Criteria for the Overall Large Scale Collaborative Project

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed large- 
scale collaborative project will have a substantial impact on the pursuit of 
these goals.  Each of these criteria will be addressed and considered in 
assigning the overall score, weighting them as appropriate for each 
application.

1.  Significance.  Does this large-scale collaborative project address a 
complex biological problem of overarching significance to biomedical science 
that would be difficult to address by separate grants?  If the aims of the 
application are achieved, how will the field of biomedical science be 
advanced?  What will be the effect of these studies on the concepts or 
methods that drive this field? Do the arrangements for data sharing maximize 
the impact of the collaborative project?

2.  Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the scientific aims 
of the collaborative project?  Does the applicant acknowledge potential 
problem areas and consider alternative tactics? Is the project management 
plan adequate?  Is the administrative framework appropriate?  Do milestones 
articulate key indicators set for appropriate times that will demonstrate 
significant forward progress for the collaborative project?  Are the plans to 
monitor and evaluate progress of the collaborative project adequate? Are the 
plans to share the data and findings with the larger community adequate? How 
will the group take the views of the scientific community impacted by the 
large-scale collaborative project into consideration?

3.  Innovation.  Are the large-scale collaborative project's structure and 
goals novel? Are the aims original and innovative? Will the collaborative 
project challenge existing paradigms or develop new methodologies or 
technologies?  Will the collaborative project attack a problem in a 
significantly new way?  What will be the value added over individual grants?

4.  Investigators.  Is the principal investigator's major research activity 
within the research area of the collaborative project?  Is the principal 
investigator well suited to the scientific and administrative leadership 
required to carry out this work?  Is the level of effort proposed for the 
principal investigator and the members of the steering committee appropriate?  
Is the work proposed appropriate to the experience level of the collaborative 
project's research and technical staff?  Are the research grants of the 
participating investigators within the area of the collaborative project?  
Are the participating investigators well chosen for their roles in the 
collaborative project?  Is the plan to add and delete participating 
investigators to and from the collaborative project satisfactory?

Environment.  Do the scientific environments in which the work will be done 
contribute to the probability of success?  Are support personnel and 
resources in place to advance the work?  Will the proposed collaborative 
project take advantage of unique features of the scientific environments of 
the component projects?  Is the level of institutional support adequate?  Are 
the requested core facilities critical to achieving the scientific goals of 
the collaborative project; are they cost effective?  Is access to the core
facilities appropriate?

In addition, the following criteria will be considered for merit review: The 
commitment to the project by the principal investigator and the members of 
the steering committee will be a consideration.  For applications that are 
multi- institutional or that involve industry, the adequacy of plans to 
resolve intellectual property issues will be a consideration.  The commitment 
of the host and participating universities to supporting the large scale 
collaborative project will also be considered: this would be reflected in 
efforts to work out ahead of time potential intellectual property issues and 
to remove any institutional barriers to the establishment and healthy 
maintenance of the collaborative project.

In accordance with NIH policy, all Phase II applications will be reviewed 
with respect to the following:

o The adequacy of plans to include women, minorities and their subgroups, and 
children, as appropriate for the scientific goals of the research.  Plans for 
the recruitment and retention of subjects will also be evaluated.

o The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

? The adequacy of the data and safety monitoring plans (required for clinical 
trials).

Review Criteria for Core Resources.

Consideration of the technical merit of the core units will include:

(1) Facilities within the core compared to the state of the art.  The 
contributions of the cores to fulfilling the goals of collaborative project.

(2) The extent to which core units promote greater collaboration and 
cohesiveness among the participating investigators.

(3) Qualifications, experience, and commitment to the large-scale 
collaborative project mission of the investigators responsible for the core 
resources and their abilities to devote the required time and effort to the 
program.

(4) Appropriateness of the budgetary requests.

Review Criteria for Bridging Projects and Pilot Projects

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of each project in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals. Each 
of the criteria listed below will be addressed and considered in assigning 
the score for a research project, weighting them as appropriate for each 
project.  Note that the project does not need to be strong in all categories 
to be judged likely to have major scientific impact and thus deserve a high 
priority score.  For example, an investigator may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.  In their evaluations, reviewers will comment on:

(1) Significance.  Does this study address an important problem? If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the achieving the goals of the 
collaborative project?  Will the bridging project tie or enhance the 
independent work of the participating investigator to the collaborative 
project, or will the pilot project add an essential missing aspect to the 
collaborative project?

(2) Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

(3) Innovation.  Does the project employ novel concepts, approaches or 
method? Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?

(4) Investigator.  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

(5) Environment.  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

In addition to the above criteria, in accordance with NIH policy, all 
individual scientific projects will be reviewed with respect to the 
following:

o The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

The scientific review group will also examine the provisions for the 
protection of human subjects and the safety of the research environment.

Award Criteria

Award criteria that will be used to make funding decisions include:

o scientific merit (as determined by peer review)
o program priorities
o program balance
o availability of funds

SUBMISSION PROCEDURES FOR PHASE I AND PHASE II APPLICATIONS

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title and number must be typed on 
line 2 of the face page of the application form and the YES box must be 
marked.

The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.

Submit a signed, typewritten original of the application (Phase I or Phase 
II), including the Checklist, and three signed, photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application (Phase I 
or Phase II) and all five sets of any appendix material must be sent to: 
Helen R. Sunshine, Ph.D., Chief
Office of Scientific Review
National Institute of General Medical Sciences
Building 45, Room Number 1As.13
Bethesda, MD  20892

Applications for Phase I must be received by June 18, 2001.  Applications for 
Phase II applications must be received by January 16, 2002.  If an 
application is received after the due date, it will be returned to the 
applicant without review.  The Center for Scientific Review (CSR) will not 
accept any application in response to this RFA that is essentially the same 
as one currently pending initial review, unless the applicant withdraws the 
pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of substantial revisions of applications already reviewed, but 
such applications must include an introduction addressing the previous 
critique.

Schedule:

Phase I Application Receipt Date:          June 18, 2001
Phase I Peer Review Date:                  August 2001
Phase I Award Date:                        September 2001
Phase II Application Receipt Date:         January 16, 2002
Phase II Peer Review Date:                 March/April 2002
Advisory Council Date:                     May 2002
Earliest Anticipated Phase II Award Date:  September 2002

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Michael E. Rogers
Division of Pharmacology, Physiology and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-3827
FAX:  (301) 480-2802
Email:  rogersm@nigms.nih.gov

Dr. James C. Cassatt
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-0828
FAX:  (301) 480-2004
Email:  czj@cu.nih.gov

Dr. Judith H. Greenberg
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-0943
FAX:  (301) 480-2228
Email:  greenbej@nigms.nih.gov

Direct inquiries regarding fiscal matters to:

Mr. Joseph Ellis
Chief, Grants Management Office
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-5510
FAX:  (301) 480-1969
Email: ellisj@nigms.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.821, 93.859, and 93.862.  Awards are made under authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and administered under NIH grants policies and Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


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