LARGE-SCALE COLLABORATIVE PROJECT AWARDS

RELEASE DATE: July 20, 2004

PA NUMBER:  PAR-04-128 (Reissued as PAR-07-412)

EXPIRATION DATE: June 22, 2007, unless reissued. 

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Institute of General Medical Sciences (NIGMS)
(http://www.nigms.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.859

Application Receipt Dates: Phase I – September 20, 2004-2006
			   Phase II – June 21, 2005-2007

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting a Phase I Application
o Supplementary Instructions 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 Submitting a Phase II Application
o Supplementary Instructions for Phase II Applications
o Peer Review Process for Phase II Applications
o Review Criteria for Overall Phase II Project
o Review Criteria for the Core Resources
o Review Criteria for the Bridging Projects and the Pilot Projects
o Additional Review Considerations for the Overall Project and All Components
o Award Criteria for Phase II Applications
o Required Federal Citations

PURPOSE OF THIS PA  

The purpose of this PA is to re-announce the National Institute of General 
Medical Sciences’ (NIGMS) program of large-scale collaborative project awards 
(also known as glue grants), last issued as RFA GM-02-007 in February 2001.  
Large-scale collaborative project awards are intended to solve critically 
important, complex biological problems within the mission of the NIGMS by 
supporting a team of independently funded investigators to synergize and 
integrate their efforts.  This new announcement includes important updates 
and modifications, and should be used in lieu of any previous announcements.  
This new announcement is being issued as a program announcement (PA).  PAs 
are typically open for three years and are then considered for re-
announcement.  Using a PA with one annual deadline in each of three 
consecutive years allows potential principal investigators to take the time 
needed to develop their ideas and a core network of investigators before 
applying.  It should be noted, however, that NIGMS anticipates making no more 
than one new Phase II (see below) award per year, depending on availability 
of funds.

Another change with this announcement is that Phase I applications, as well 
as Phase II applications, will be reviewed by the National Advisory General 
Medical Sciences Council.  The Institute wishes to involve community 
representatives at an earlier stage in providing advice on whether to 
allocate its resources to support a glue grant approach for a particular 
biomedical problem.  Applicants are also strongly advised to begin consulting 
with NIGMS staff regarding their plans, even in advance of submitting an 
application.  Also new is an added requirement that applicants include a 
diversity plan to increase the number of participating investigators who are 
currently underrepresented in the biomedical, clinical, behavioral, and 
social sciences.  

The maximum amount that a large-scale collaborative project award applicant 
may request is $25 million in direct costs over a five-year period. This high 
level of resources is intended 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.  In 
the past, applications for this program have generally requested the maximum 
amount allowed. One goal of this announcement is to encourage submission of 
applications for lesser amounts as well.  In all cases, the scope of a large-
scale project should be limited to the scale necessary to achieve the desired 
synergistic effect.  

The NIGMS 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.  For example, 
investigators can apply for up to $300,000 in annual direct costs to support 
collaborative and integrative research using the NIGMS collaborative project 
grant mechanism, http://www.nigms.nih.gov/funding/cpg.html.  A good way to 
initiate collaborative interest might be to apply for an NIGMS 
multidisciplinary conference grant, 
http://grants.nih.gov/grants/guide/notice-files/NOT-GM-04-106.html.

RESEARCH OBJECTIVES

The goal of this program remains to enable the solution of complex biological 
problems that are critical to advancing biomedical science and fall within 
the NIGMS mission (http://www.nigms.nih.gov/about/overview.html).  
Solution of the scientific problem selected must be beyond the means of any 
single research group.  The solution will likely involve technology 
development, but the primary focus must be the solution of a biological 
question. Experience has shown that large-scale collaborative project awards 
offer the scientific community a unique funding mechanism that serves the 
needs of interdisciplinary, team science:  It allows independently funded 
investigators to self assemble into teams to provide coordination and 
integration of their work, to add state-of-the-art large-scale technologies, 
and to develop the infrastructure for high volume data collection, 
management, and analysis.  The application of this large-scale mechanism will 
be reserved for the most pressing scientific problems which have reached the 
stage where they require this type of approach for advancement.  The 
paramount considerations for large-scale collaborative project awards are the 
potential impact on biomedical science, the value added over individual grant 
approaches, and the likelihood of success in a ten-year time frame.  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 is imperative that the proposed consortium identify a critical problem in 
biomedical science that is now ready to be solved using a large-scale 
collaborative approach. The importance of the problem, the scope, and 
approaches taken to solve the problem must be very strongly justified.  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.

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 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 the resources for assembling a 
more fully developed proposal.  Successful Phase I applicants will be awarded 
a $50,000 (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.  The Phase II application should provide a 
significantly more detailed explanation of the proposed project, including 
specific intermediate goals (milestones) and a timeline for their 
accomplishment.

MECHANISM(S) OF SUPPORT

PHASE I APPLICATIONS: This PA will use the NIH R24 grant mechanism for Phase 
I applications.  As an applicant, you will be solely responsible for 
planning, directing, and executing the proposed project.  

A Phase I award will be made at a level of $50,000 in direct costs to provide 
for costs associated with planning the large-scale collaborative project. 
This PA uses just-in-time concepts for Phase I applications.  It also uses 
the modular budgeting format. (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  This program does 
not require cost sharing as defined in the current NIH Grants Policy 
Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.  

The anticipated award dates for Phase I awards are February, 2005, February 
2006, and February 2007.  The length of the Phase I awards may be for up to 
one year and does not count against the time limit for Phase II awards.

PHASE II APPLICATIONS: This PA will use the NIH Specialized Centers (U54, 
Cooperative Agreements) awards mechanism for Phase II applications.  

The NIH U54 is a cooperative agreement award mechanism. In the cooperative 
agreement mechanism, the Principal Investigator retains the primary 
responsibility and dominant role for planning, directing, and executing the 
proposed project, with NIH staff being substantially involved as a partner 
with the Principal Investigator, as described under the section "Cooperative 
Agreement Terms and Conditions of Award".    

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.  Phase II 
applications may request up to $25 million dollars in direct costs for a 
five-year period, with no one year exceeding seven million dollars in direct 
costs; this excludes Facilities and Administrative costs 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html.  
Applications asking for shorter time periods are limited to an average of $5 
million in direct costs per year.  Facilities and Administrative costs for 
consortium arrangements are not counted towards the maximum amounts.  
Experience has shown that lower amounts are needed in the first year than in 
subsequent years due to time needed to hire personnel and purchase and 
install equipment.  Applicants should take this into account in planning 
their budgets.  The total project period for an application submitted in 
response to this PA may not exceed five years. The anticipated award date for 
Phase II awards is April 2006, April 2007, and April 2008.  Phase II awards 
will be considered for one and only one five-year renewal period following 
the initial award.

This PA uses just-in-time concepts for Phase II awards.  Follow the 
instructions for non-modular budget research grant applications.  This 
program does not require cost sharing as defined in the current NIH Grants 
Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

This PA will continue for three years.  It may be re-announced at that time.  

All principal investigators (PIs) will be expected to budget for and attend 
and to send additional staff, as appropriate, to scheduled annual meetings of 
the NIGMS large-scale collaborative project awards.

REVISED APPLICATIONS (for applications submitted in response to this PA):  
NIGMS will accept only one revision for a Phase I application. Phase II 
applications that are not funded must submit the Phase I application again 
prior to submitting a revised Phase II application; this requirement for 
resubmission of the Phase I application may be waived in exceptional 
circumstances on the advice of the National Advisory General Medical Sciences 
Council.  Twice-amended applications will not be accepted for either Phase I 
or Phase II applications.  

ELIGIBLE INSTITUTIONS 

You may submit an application 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
o Foreign institutions are not eligible to apply

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

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.  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 
initiative (referred to in the Purpose of this PA 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 the 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.  

SPECIAL REQUIREMENTS 

Large-scale collaborative project awards must include a principal 
investigator, a steering committee, participating investigators, and an 
advisory committee.  See below under terms and conditions of award for the 
roles and requirements for these elements. 

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 an administrative 
structure, including an information dissemination and data coordinating core.  
Alternatively, the large-scale collaborative project may require additional 
components 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 and pilot projects, either as 
separate entities or combined into integrated structures.  

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 may not exceed $100,000 
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 goals and 
delineates the organization of the project to achieve the goals. It also must 
outline 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. In 
addition, timelines for ramping up to a fully operational level should be 
included.  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 PA 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. Computational tools that 
are developed for analysis, visualization, or modeling the data must be 
freely shared with the scientific community as well as the annotated source 
code; others should be free to modify the source code and share the 
modifications with each other; and that the code should be made available to 
be incorporated into commercial products.

The scientific review group will comment on the adequacy and feasibility of 
the plans for sharing research resources and tools.  Data sharing is 
required, and dissemination is a critical aspect and fundamental purpose of 
this PAR.  Therefore, there should be evidence of a genuine commitment of the 
large-scale project leadership to the sharing or research resources.  
Reviewers will consider the data sharing plan, and will factor the plans into 
the determination of the scientific merit or the priority score, because this 
is critical to the purpose of this initiative.  Evaluation of annual progress 
reports and of subsequent renewal applications will also include an 
assessment of the effectiveness of the sharing of research resources.  

The scientific review group will also comment on the adequacy and feasibility 
of the intellectual property plan.  In a Phase I application, the intent is 
to judge the adequacy of the applicant institution's commitment to develop a 
workable intellectual property plan.  In a Phase II application, the 
effectiveness of the management of intellectual property issues will be 
considered as part of the scientific merit review; accordingly, reviewers 
will factor the plan into the determination of the scientific merit and 
priority score.  This will also be an important factor in the institute’s 
decision to make an award, and will become a term and condition of award. 

PLAN FOR DIVERSITY DEVELOPMENT:  Each request for a large-scale collaborative 
project award must include a plan to increase the number of participating 
investigators who are underrepresented in the biomedical, clinical, 
behavioral, and social sciences.

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.

COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD:  

The following section 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 mechanism, the NIH’s 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 primary responsibility 
resides with the awardees for the project as a whole.

1. Principal Investigator Responsibilities:  The PI will have prime 
responsibility and authority for the scientific and technical direction and 
the administration and overall operation of the large-scale collaborative 
project.  The PI will select and chair the steering committee.  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. 
The PI will coordinate project activities scientifically and 
administratively.  

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, and also subject 
to the approved sharing of research resources plan and intellectual property 
plan to 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).

2. 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.  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).  Principal Investigators of pilot projects 
are also included as participating investigators.  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.  They must provide a listing of organizational resources from their 
home institution that will be committed to the project.  Participating 
investigators will be actively involved in the project and interactive with 
the other members of the project.  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 research 
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.

3. NIGMS Program Director Responsibilities:  The NIGMS program director will 
be responsible for the normal stewardship of the award.  In addition, s/he 
will serve as a voting member of the steering committee, attending all 
meetings, and will have substantial programmatic involvement.  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 will 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.

4. Steering Committee Responsibilities:  The steering committee will function 
to provide scientific and administrative advice to the PI and to assist the 
PI by providing oversight and strategic planning for the consortium as a 
whole and for the individual components.  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, deal 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.  Membership will be from a select group from 
those investigators actively involved the functioning of the consortium. It 
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.  Members 
will be selected by the PI in consultation with the steering committee and 
with the approval of the NIGMS program director.  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.  

5. Advisory Committee Responsibilities:  The advisory committee will provide 
scientific and administrative advice to the PI, the steering committee, and 
the members of the consortium only.  It will be composed of a panel of a 
minimum of three scientists not otherwise associated with the large-scale 
collaborative project.  The members will be appointed by the PI in 
consultation with the steering committee, and with the approval of the NIGMS 
program director.  The NIGMS program director will attend the meetings of the 
advisory committee 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 to provide advice to the PI and 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.

6. Milestones and Evaluations:  Milestones upon which progress can be 
evaluated annually must be established for consortium goals.  Progress should 
be assessed and milestones updated 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.

7. 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 by NIH.  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.  
The decision of the arbitration panel, by majority vote, will be binding.  
This special arbitration procedure in no way affects the right of an awardee 
to appeal an adverse action 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 your inquiries concerning this PA 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:  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:  cassattj@nigms.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

o 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:  sunshinh@nigms.nih.gov

o Direct your questions about financial or grants management 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

SUBMITTING A PHASE I APPLICATION

Applicants must submit a Phase I application that contains an overview of the 
proposed large-scale collaborative project.  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 listed below.  Phase I applications will be evaluated by 
an appropriately constituted peer review group.  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). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. 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) 435-0714, Email: GrantsInfo@nih.gov.

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be checked.

SUPPLEMENTARY INSTRUCTIONS FOR PHASE I APPLICATIONS

A Phase I response to this PA should follow the PHS 398 instructions, with 
the following modifications, and the parts should be assembled in the order 
prescribed by the PHS 398:

For listing of personnel on page two, it is important that 1) all 
participants, including consultants and private sector alliances, 2) all the 
institutional and industrial affiliations for each participant, and 3) their 
roles on the project, be included.  

Include a description of the proposed budget allocation.  All Phase I awards 
will be for up to $50,000 for up to a one-year period of support.

Biographical sketches and one-page letters of commitment from each of the 
participating investigators who have already indicated their interest in 
joining the collaborative project should be included.  Biographical sketches 
should include a listing of research 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.  A suggested maximum page length is 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 and to developing a plan for 
increasing diversity of investigators working on the chosen scientific 
problem.

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.

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

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.

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 
must be sent to: 

Dr. Helen R. Sunshine
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, Rm 2An.12F, MSC 6200
Bethesda, MD  20892-6200

APPLICATION PROCESSING: Applications for Phase I must be received by 
September 20, 2004-2006. 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 PA 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.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

RECEIPT AND REVIEW SCHEDULE:

Phase I Application Receipt Date:         September 20, 2004-2006
Phase I Peer Review Date:                 November/December 2004-2006
Phase I Council Review Date:		  January 2005-2007
Phase I Award Date:                       February 2005-2007

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 PAR 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 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
o Receive a written critique
o Receive a second level review by the National Advisory General Medical 
Sciences Council  

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. However, the paramount considerations for large-scale 
collaborative project awards are the potential impact on biomedical science, 
the value added over individual grant approaches, and the likelihood of 
success in a ten-year time frame.

SIGNIFICANCE:  How significant is this research problem to the advancement of 
biomedical science? Has a compelling case been presented for pursuing the 
research problem at this time?  Will there be significant value added over 
individual grants?  

APPROACH:  For the project as a whole, are the conceptual framework, general 
approaches, and proposed analyses reasonable?  Are all of the components 
necessary and sufficient to achieving the scientific aims? Is their planned 
integration appropriate?  Is there a good balance between the application of 
current ideas and approaches, and the development of required new state-of-
the-art ideas and tools? Are potential problems acknowledged and do 
alternatives exist? 

INNOVATION:  Are the proposed aims original and innovative?  Will the 
collaborative project challenge existing paradigms and/or develop new 
methodologies or technologies?  Is the potential impact clearly innovative 
and exciting? 

ENVIRONMENT:  Are the scientific environments where the work will be 
performed optimally selected to enhance the probability of success?  Does 
necessary institutional support appear likely?  Will open and free exchange 
of information be supported by this environment?  Are the bioinformatics 
facilities well-positioned and supported in their planned locations?  

INVESTIGATORS:
Principal Investigator and Steering Committee.  Is there evidence that the PI 
and the central governing body have the vision, scientific expertise, 
administrative capacity and leadership skills to successfully lead the large-
scale project?  Is the level of commitment for the PI and consortium leaders 
adequate?  Is the use of this collaborative team the best way to approach 
this problem?  Is this group well-poised to solve this research problem 
within the next decade?

Participating Investigators.  Are the participating investigators already 
committed to the project among the best in their respective fields? Is the 
skill set for the participating investigators sufficient?  Are there plans to 
apply expertise from diverse disciplines and fields to the scientific 
question, and if not, what specific expertise is lacking?  Is the level of 
commitment for each investigator adequate?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, Phase I 
applications will be reviewed with respect to the following:

o adequacy of commitment to the sharing of research resources with the 
broader scientific community.
o adequacy of commitment to developing a diversity development plan to 
increase the number of participating investigators who are currently 
underrepresented in the biomedical, clinical, behavioral, and social 
sciences.
o adequacy of 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 plans for sharing of research resources 
o plans for handling of intellectual property
o uniqueness as a large-scale effort
o program priorities
o program balance
o availability of funds

SUBMITTING A PHASE II APPLICATION

Phase I awardees may submit a Phase II application for peer review for the 
receipt date immediately following award of the Phase I application or the 
next subsequent receipt date.  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). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. 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) 435-0714, Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS FOR PHASE II APPLICATIONS

Applications in response to this PAR should consist of an application that, 
in addition to or in lieu of part of the items requested in the PHS 398, 
includes:

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 as 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 below 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. Although a 
substantial level of effort is expected for the PI, NIGMS has not set minimum 
levels of effort; 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.  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.  

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 $100,000 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).

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.  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.

Applications for large-scale collaborative project awards may not request 
more than $25 million in direct costs (exclusive of subcontract indirect 
costs requested as a direct cost by the applicant organization, but including 
all equipment) for a five-year award and no more than $7 million in direct 
costs for any one year. Applications must include a rationale for why the 
requested level of resources is critical to success of the project. Also, 
experience has shown that large-scale collaborative project awards require 
considerable time to come up to full speed (including hiring of personnel and 
purchase and installation of equipment).  First year budgets should take that 
into consideration and most likely will require a lower level of resources 
than succeeding years.  Experience has also shown that bioinformatics needs 
are frequently underestimated and these should be planned for appropriately.

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.  Note: each participating 
consortium/contractual organization must submit a separate composite budget 
for both the initial budget period (using Form Page 4) and the entire 
proposed project period (using Form page 5).  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, which 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.  Place the budgets for 
consortium components, cores, bridging projects, and pilot projects 
immediately prior to the description of the relevant individual component.  
For the 01 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 entire project period (years 01-05).

Budget justifications and explanations.  Describe the specific functions, 
including the level of effort, of all key personnel, including consultants, 
collaborators, and technical staff.  Provide detailed justifications for 
requested equipment.  

BIOGRAPHICAL SKETCHES AND LETTERS OF COMMITMENT:  Biographical sketches must 
be included for all participating investigators along with one-page letters 
of commitment indicating their role in the consortium and their willingness 
to follow guidelines and procedures established for the large-scale 
collaborative project.  For all participating investigators, including the 
PI, heads of core resources, and principal investigators of bridging and 
pilot projects, provide a listing of all research support; support for other 
investigators such as postdoctoral students should not be listed.  Highlight 
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.

PARTICIPANT AFFILIATIONS:  Applications should include a separate cover sheet 
that lists 1) all participants, including consultants and private sector 
alliances, 2) all the institutional and industrial affiliations for each 
participant, 3) their roles on the project, and 4) the percent effort listed 
separately for each role.  This added requirement will facilitate the review 
of applications.

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 
strictly using the straightforward format that follows, or may use alternate 
combined formats for some parts of the application, as described below.  
Required components of all applications are the program summary; 
administrative and program management plans; a plan for data sharing and 
intellectual property; Cores A (administrative) and B (information 
dissemination and data coordinating); and responses to the bioinformatics 
questions listed below (see Core Resource C – Bioinformatics Core) if the 
optional bioinformatics core is utilized.  If desired, an optional 
bioinformatics core may be may be combined with Core B.

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, scientific cores and bridging projects may be 
presented in a combined or more integrated fashion.  When this, or a 
different alternate format from that outlined below 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.

Program Summary (Required)

Describe the goals and operation of the large-scale project.  Explain what 
complex biomedical problem is being solved, why it is critical to advancing 
biomedical science, and how the approach of using a large-scale collaborative 
project is necessary.  Also explain why the time is right for its solution 
within a ten-year period.  Provide the background that has dictated your 
choices of approaches selected for the project.  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 a cohesive overall program. 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 a comprehensive whole.  Discuss how and when information and other 
research resources generated by the collaborative projects will be 
disseminated to the participants and to the scientific public.  

Administrative Management Plan (Required)

Describe the structure, organization, and operation of the project and 
explain why this plan has been selected.  Describe the organizational 
framework and provide an organizational chart.  Also describe how information 
will flow within the collaborative project.  Explain the role of the steering 
committee.  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 communities that are impacted by the 
collaborative project will be considered. 

Project Management Plan (Required)

Present a project management plan, including milestones, to keep the 
collaborative project moving forward and on track.  Define yearly milestones 
for the first five-year period of support.  Explain the planned role of the 
steering committee in project management.  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.  The proposed members of the advisory committee 
should not be contacted or selected until an award has been made and the 
names of prospective members should not be included in the application.

The program summary, administrative management plan, and project management 
plan 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 
(Required – three-page limit)

List and comment on how the sharing of research resources and intellectual 
property issues will be handled in the first five-year period of support; 
research resources include, among others, data and information, materials 
such as cell lines and mutant animals, and novel reagents and techniques.  
The PI and steering committee should (1) present their 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; (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; and (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 PA. 

Plan for Diversity Development (Required – two-page limit)

Describe the plan to increase the number of participating investigators who 
are currently underrepresented in the biomedical, clinical, behavioral, and 
social sciences. The adequacy of this plan will serve as an award criterion.

Core Resource A: Administrative Core (Required – 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 and Dissemination and Data Coordinating Core 
(Required – 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 and timing 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 and 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 of each for a maximum of 20 
pages).  

The policies with respect to future dissemination of data and computational 
tools should be explained in the proposal and it is required that they 
conform to the following principles:

Computational tools developed for analysis, visualization, or modeling the 
data must be freely shared with the scientific community as well as the 
annotated source code; others should be free to modify the source code and 
share the modifications with each other; and that the code should be made 
available to be incorporated into commercial products.

The core description must include answers to the following queries, whether a 
separate core or combined with the information dissemination and data 
coordinating core.  

o What are the plans for sharing research data and the timing for release 
policies, and what are the associated intellectual property issues?

o How will the data be made available to the scientific community?  Are there 
browser access, formats for downloading complete data sets, on-line 
computational aids, etc.?  

o What are the nature and structure of the data?  Describe the projected 
plans 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 projected mechanism for communication (both computational and 
human) between the distributed sites and the database managers?  Are there 
data liaisons?

o What are the key interacting databases?  How are the data to be linked?  
What are the plans for modifying or enhancing those linkages?

o How is progress made available to the public, e.g., are lists of the 
systems being analyzed made available?  

o What experience in bioinformatics is available in the group and what 
resources can the consortium draw on?  Discuss the qualifications and 
experience of the bioinformatics team.

o How will the bioinformatics plan evolve over the initial period of support?

Core D:  Scientific Resource Core(s) (Optional - 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 for each who possesses 
expertise in the area of the core.  Describe the planned direction, 
management and use of the core(s), as well as the professional and technical 
staff to be involved in the core(s) and their duties.  Include plans to 
utilize the core(s), such as services that will be provided and to whom and 
their bearing on productivity and quality of the collaborative research 
effort.  

Bridging Projects (Optional – five-page limit for each)

Bridging projects will support work in the laboratories of the participating 
investigators.  Describe the 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.  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 for the specific aims, background and significance, 
preliminary studies, and research design and methods.  Also include, as 
applicable, the following sections, which do not count against the page 
limitations for the section or the overall page limit: Abstract (one 
paragraph), Human Subjects Research (also see special requirements in the 
Federal citations below), Vertebrate Animals, and Literature Cited.

Pilot Projects (Optional – ten-page limit for each)

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.  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 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, which do not count against the page limitations 
for the section or the overall page limit, on Human Subjects Research (also 
see special requirements in the Federal citations below), Vertebrate Animals, 
and Literature Cited.  There is a maximum of three pilot projects allowed per 
large-scale collaborative project.

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 Plan for increasing diversity – 2 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 that 
include consortium arrangements should refer to the NIH Grants Policy 
Statement appendix on consortium arrangements at 
http://grants.nih.gov/archive/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.

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: 

Dr. Helen R. Sunshine
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, Rm 3An.12F, MSC 6200
Bethesda, MD  20892-6200

RECEIPT AND REVIEW SCHEDULE:

Phase II Application Receipt Date:        June 21, 2005-2007
Phase II Peer Review Date:                October/November 2005-2007
Phase II Council Date:                    January 2006-2008
Earliest Anticipated Phase II Award Date: April 2006-2008

APPLICATION PROCESSING: Applications must be mailed on or before the 
prescribed receipt dates above.  Applications for Phase II must be received 
by June 21, 2005-2007. If an application is received after the due date, it 
will be returned to the applicant without review. CSR will not accept any 
application in response to this PA 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 a 
substantial revision of an unfunded version of an application already 
reviewed, but such application must include an Introduction addressing the 
previous critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

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 I applications that are 
complete and responsive to the PA 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 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
o Receive a written critique,
o Receive a second level review by the National Advisory General Medical 
Sciences Council  

REVIEW CRITERIA FOR THE OVERALL PHASE II 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 evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application’s overall score, weighting them as appropriate for each 
application. However, the paramount considerations for glue grants are the 
potential impact on biomedical science, the value added over individual grant 
approaches, and the likelihood of success in a ten-year time frame.

SIGNIFICANCE:  How significant is this research problem to the advancement of 
biomedical science? Has a compelling case been presented for pursuing the 
research problem at this time?  Will there be significant value added over 
individual grants?  

   APPROACH:  For the project as a whole, are the conceptual framework, general 
approaches, and proposed analyses reasonable?  Are all of the components 
necessary and sufficient to achieving the scientific aims? Is their planned 
integration appropriate?  Is there a good balance between the application of 
current ideas and approaches, and the development of required new state-of-
the-art ideas and tools? Are potential problems acknowledged and do 
alternatives exist? 

INNOVATION:  Are the proposed aims original and innovative?  Will the 
collaborative project challenge existing paradigms and/or develop new 
methodologies or technologies?  Is the potential impact clearly innovative 
and exciting? 

ENVIRONMENT:  Are the scientific environments where the work will be 
performed optimally selected to enhance the probability of success?  Does 
necessary institutional support appear likely?  Will open and free exchange 
of information be supported by this environment?  Are the bioinformatics 
facilities well-positioned and supported in their planned locations?  

INVESTIGATORS:
Principal Investigator and Steering Committee.  Is there evidence that the PI 
and the central governing body have the vision, scientific expertise, 
administrative capacity and leadership skills to successfully lead the large-
scale project?  Is the level of commitment for the PI and consortium leaders 
adequate?  Is the use of this collaborative team the best way to approach 
this problem?  Is this group well-poised to solve this research problem 
within the next decade?

Participating Investigators.  Are the participating investigators who have 
committed to the project among the best in their respective fields? Is the 
skill set for the participating investigators sufficient?  Are there plans to 
apply expertise from diverse disciplines and fields to the scientific 
question, and if not, what specific expertise is lacking?  Is the level of 
commitment for each investigator adequate?
 
Others.  Do the professional staff without independent research funding used 
in critical positions have the necessary expertise and experience to 
successfully meet the consortium requirements?  

ADDITIONAL REVIEW CRITERIA FOR THE OVERALL PROJECT: In addition to the above 
criteria, the following items will be considered in the determination of 
scientific merit and the priority score:

o Commitment of the host and participating institutions 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 and record of the leadership to the sharing of research 
resources (including data and information, materials such as cell lines and 
mutant animals, and novel reagents and techniques) generated by the large-
scale project with the broader scientific community.

o Adequacy of the plans to effectively and realistically manage intellectual 
property issues for the collaborative project.

o Adequacy of the diversity development plan to increase the number of 
participating investigators who are currently underrepresented in the 
biomedical, clinical, behavioral, and social sciences.

REVIEW CRITERIA FOR THE 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 availability to devote the required time and effort to 
the program.

REVIEW CRITERIA FOR BRIDGING PROJECTS AND PILOT PROJECTS

Reviewers will be asked to discuss the following aspects of each bridging and 
pilot project. 
  
	SIGNIFICANCE: Does this study address an important problem? 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?  Will this bridging or pilot 
project serve to increase the cohesiveness of the large-scale project?  

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?

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?

INVESTIGATOR(S): 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)?  

ENVIRONMENT: Does the scientific environment in which the work will/has been 
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 CONSIDERATIONS FOR THE OVERALL PROJECT AND ALL COMPONENTS

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed.  (See criteria included in the 
section on Federal Citations, below.)
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  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 in the sections on Federal Citations, 
below.)

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH:  If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

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 award 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 likely impact on the broader scientific community
o uniqueness as a large-scale project
o program priorities
o program balance
o availability of funds

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained. 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.  (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA:  Investigators submitting an NIH application seeking 
$500,000 or more in direct costs in any single year are expected to include a 
plan for data sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing . Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan and will factor the plan into the determination of the 
scientific merit or the priority score, because it is a critical part of the 
fundamental purpose of this initiative.

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).
participating investigators, including the 
PI, heads of core resources, and principal investigators of bridging and 
pilot projects, provide a listing of all research support; support for other 
investigators such as postdoctoral students should not be listed.  Highlight 
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.

PARTICIPANT AFFILIATIONS:  Applications should include a separate cover sheet 
that lists 1) all participants, including consultants and private sector 
alliances, 2) all the institutional and industrial affiliations for each 
participant, 3) their roles on the project, and 4) the percent effort listed 
separately for each role.  This added requirement will facilitate the review 
of applications.

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 
strictly using the straightforward format that follows, or may use alternate 
combined formats for some parts of the application, as described below.  
Required components of all applications are the program summary; 
administrative and program management plans; a plan for data sharing and 
intellectual property; Cores A (administrative) and B (information 
dissemination and data coordinating); and responses to the bioinformatics 
questions listed below (see Core Resource C – Bioinformatics Core) if the 
optional bioinformatics core is utilized.  If desired, an optional 
bioinformatics core may be may be combined with Core B.

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, scientific cores and bridging projects may be 
presented in a combined or more integrated fashion.  When this, or a 
different alternate format from that outlined below 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.

Program Summary (Required)

Describe the goals and operation of the large-scale project.  Explain what 
complex biomedical problem is being solved, why it is critical to advancing 
biomedical science, and how the approach of using a large-scale collaborative 
project is necessary.  Also explain why the time is right for its solution 
within a ten-year period.  Provide the background that has dictated your 
choices of approaches selected for the project.  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 a cohesive overall program. 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 a comprehensive whole.  Discuss how and when information and other 
research resources generated by the collaborative projects will be 
disseminated to the participants and to the scientific public.  

Administrative Management Plan (Required)

Describe the structure, organization, and operation of the project and 
explain why this plan has been selected.  Describe the organizational 
framework and provide an organizational chart.  Also describe how information 
will flow within the collaborative project.  Explain the role of the steering 
committee.  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 communities that are impacted by the 
collaborative project will be considered. 

Project Management Plan (Required)

Present a project management plan, including milestones, to keep the 
collaborative project moving forward and on track.  Define yearly milestones 
for the first five-year period of support.  Explain the planned role of the 
steering committee in project management.  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.  The proposed members of the advisory committee 
should not be contacted or selected until an award has been made and the 
names of prospective members should not be included in the application.

The program summary, administrative management plan, and project management 
plan 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 
(Required – three-page limit)

List and comment on how the sharing of research resources and intellectual 
property issues will be handled in the first five-year period of support; 
research resources include, among others, data and information, materials 
such as cell lines and mutant animals, and novel reagents and techniques.  
The PI and steering committee should (1) present their 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; (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; and (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 PA. 

Plan for Diversity Development (Required – two-page limit)

Describe the plan to increase the number of participating investigators who 
are currently underrepresented in the biomedical, clinical, behavioral, and 
social sciences. The adequacy of this plan will serve as an award criterion.

Core Resource A: Administrative Core (Required – 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 and Dissemination and Data Coordinating Core 
(Required – 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 and timing 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 and 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 of each for a maximum of 20 
pages).  

The policies with respect to future dissemination of data and computational 
tools should be explained in the proposal and it is required that they 
conform to the following principles:

Computational tools developed for analysis, visualization, or modeling the 
data must be freely shared with the scientific community as well as the 
annotated source code; others should be free to modify the source code and 
share the modifications with each other; and that the code should be made 
available to be incorporated into commercial products.

The core description must include answers to the following queries, whether a 
separate core or combined with the information dissemination and data 
coordinating core.  

o What are the plans for sharing research data and the timing for release 
policies, and what are the associated intellectual property issues?

o How will the data be made available to the scientific community?  Are there 
browser access, formats for downloading complete data sets, on-line 
computational aids, etc.?  

o What are the nature and structure of the data?  Describe the projected 
plans 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 projected mechanism for communication (both computational and 
human) between the distributed sites and the database managers?  Are there 
data liaisons?

o What are the key interacting databases?  How are the data to be linked?  
What are the plans for modifying or enhancing those linkages?

o How is progress made available to the public, e.g., are lists of the 
systems being analyzed made available?  

o What experience in bioinformatics is available in the group and what 
resources can the consortium draw on?  Discuss the qualifications and 
experience of the bioinformatics team.

o How will the bioinformatics plan evolve over the initial period of support?

Core D:  Scientific Resource Core(s) (Optional - 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 for each who possesses 
expertise in the area of the core.  Describe the planned direction, 
management and use of the core(s), as well as the professional and technical 
staff to be involved in the core(s) and their duties.  Include plans to 
utilize the core(s), such as services that will be provided and to whom and 
their bearing on productivity and quality of the collaborative research 
effort.  

Bridging Projects (Optional – five-page limit for each)

Bridging projects will support work in the laboratories of the participating 
investigators.  Describe the 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.  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 for the specific aims, background and significance, 
preliminary studies, and research design and methods.  Also include, as 
applicable, the following sections, which do not count against the page 
limitations for the section or the overall page limit: Abstract (one 
paragraph), Human Subjects Research (also see special requirements in the 
Federal citations below), Vertebrate Animals, and Literature Cited.

Pilot Projects (Optional – ten-page limit for each)

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.  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 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, which do not count against the page limitations 
for the section or the overall page limit, on Human Subjects Research (also 
see special requirements in the Federal citations below), Vertebrate Animals, 
and Literature Cited.  There is a maximum of three pilot projects allowed per 
large-scale collaborative project.

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 Plan for increasing diversity – 2 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 that 
include consortium arrangements should refer to the NIH Grants Policy 
Statement appendix on consortium arrangements at 
http://grants.nih.gov/archive/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.

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: 

Dr. Helen R. Sunshine
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, Rm 3An.12F, MSC 6200
Bethesda, MD  20892-6200

RECEIPT AND REVIEW SCHEDULE:

Phase II Application Receipt Date:        June 21, 2005-2007
Phase II Peer Review Date:                October/November 2005-2007
Phase II Council Date:                    January 2006-2008
Earliest Anticipated Phase II Award Date: April 2006-2008

APPLICATION PROCESSING: Applications must be mailed on or before the 
prescribed receipt dates above.  Applications for Phase II must be received 
by June 21, 2005-2007. If an application is received after the due date, it 
will be returned to the applicant without review. CSR will not accept any 
application in response to this PA 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 a 
substantial revision of an unfunded version of an application already 
reviewed, but such application must include an Introduction addressing the 
previous critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

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 I applications that are 
complete and responsive to the PA 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 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
o Receive a written critique,
o Receive a second level review by the National Advisory General Medical 
Sciences Council  

REVIEW CRITERIA FOR THE OVERALL PHASE II 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 evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application’s overall score, weighting them as appropriate for each 
application. However, the paramount considerations for glue grants are the 
potential impact on biomedical science, the value added over individual grant 
approaches, and the likelihood of success in a ten-year time frame.

SIGNIFICANCE:  How significant is this research problem to the advancement of 
biomedical science? Has a compelling case been presented for pursuing the 
research problem at this time?  Will there be significant value added over 
individual grants?  

   APPROACH:  For the project as a whole, are the conceptual framework, general 
approaches, and proposed analyses reasonable?  Are all of the components 
necessary and sufficient to achieving the scientific aims? Is their planned 
integration appropriate?  Is there a good balance between the application of 
current ideas and approaches, and the development of required new state-of-
the-art ideas and tools? Are potential problems acknowledged and do 
alternatives exist? 

INNOVATION:  Are the proposed aims original and innovative?  Will the 
collaborative project challenge existing paradigms and/or develop new 
methodologies or technologies?  Is the potential impact clearly innovative 
and exciting? 

ENVIRONMENT:  Are the scientific environments where the work will be 
performed optimally selected to enhance the probability of success?  Does 
necessary institutional support appear likely?  Will open and free exchange 
of information be supported by this environment?  Are the bioinformatics 
facilities well-positioned and supported in their planned locations?  

INVESTIGATORS:
Principal Investigator and Steering Committee.  Is there evidence that the PI 
and the central governing body have the vision, scientific expertise, 
administrative capacity and leadership skills to successfully lead the large-
scale project?  Is the level of commitment for the PI and consortium leaders 
adequate?  Is the use of this collaborative team the best way to approach 
this problem?  Is this group well-poised to solve this research problem 
within the next decade?

Participating Investigators.  Are the participating investigators who have 
committed to the project among the best in their respective fields? Is the 
skill set for the participating investigators sufficient?  Are there plans to 
apply expertise from diverse disciplines and fields to the scientific 
question, and if not, what specific expertise is lacking?  Is the level of 
commitment for each investigator adequate?
 
Others.  Do the professional staff without independent research funding used 
in critical positions have the necessary expertise and experience to 
successfully meet the consortium requirements?  

ADDITIONAL REVIEW CRITERIA FOR THE OVERALL PROJECT: In addition to the above 
criteria, the following items will be considered in the determination of 
scientific merit and the priority score:

o Commitment of the host and participating institutions 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 and record of the leadership to the sharing of research 
resources (including data and information, materials such as cell lines and 
mutant animals, and novel reagents and techniques) generated by the large-
scale project with the broader scientific community.

o Adequacy of the plans to effectively and realistically manage intellectual 
property issues for the collaborative project.

o Adequacy of the diversity development plan to increase the number of 
participating investigators who are currently underrepresented in the 
biomedical, clinical, behavioral, and social sciences.

REVIEW CRITERIA FOR THE 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 availability to devote the required time and effort to 
the program.

REVIEW CRITERIA FOR BRIDGING PROJECTS AND PILOT PROJECTS

Reviewers will be asked to discuss the following aspects of each bridging and 
pilot project. 
  
	SIGNIFICANCE: Does this study address an important problem? 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?  Will this bridging or pilot 
project serve to increase the cohesiveness of the large-scale project?  

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?

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?

INVESTIGATOR(S): 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)?  

ENVIRONMENT: Does the scientific environment in which the work will/has been 
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 CONSIDERATIONS FOR THE OVERALL PROJECT AND ALL COMPONENTS

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed.  (See criteria included in the 
section on Federal Citations, below.)
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  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 in the sections on Federal Citations, 
below.)

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH:  If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

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 award 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 likely impact on the broader scientific community
o uniqueness as a large-scale project
o program priorities
o program balance
o availability of funds

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained. 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.  (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA:  Investigators submitting an NIH application seeking 
$500,000 or more in direct costs in any single year are expected to include a 
plan for data sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing . Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan and will factor the plan into the determination of the 
scientific merit or the priority score, because it is a critical part of the 
fundamental purpose of this initiative.

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 "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.htm
.  The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. 

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://stemcells.nih.gov/index.asp 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, in the project 
description and elsewhere in the application as appropriate, 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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 PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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.


Law 103-43).

All investigators proposing clinical research should read the "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.htm
.  The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. 

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://stemcells.nih.gov/index.asp 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, in the project 
description and elsewhere in the application as appropriate, 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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 PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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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