RELEASE DATE:  May 20, 2003

PA NUMBER:  PA-03-127

EXPIRATION DATE:  July 5, 2006, unless reissued. 

National Institute of General Medical Sciences (NIGMS) 
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 

93.847, 93.849


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 an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations


This is a re-announcement of PA-00-099, release date May 23, 2000.  The 
purpose of this initiative is to provide additional support for collaborative 
and integrative activities to groups of currently funded investigators 
working on a common problem of fundamental interest to the National Institute 
of General Medical Sciences (NIGMS) or the National Institute of Diabetes and 
Digestive and Kidney Diseases (NIDDK).  These activities should significantly 
enhance the investigators' existing capabilities and introduce new approaches 
to the research aims of their funded projects.  The new support, using the 
R24 consortium grant mechanism, should allow the participating investigators 
to 1) attract and coordinate expertise in different disciplines and 
approaches and 2) facilitate access to specialized resources and equipment.  
This mechanism must introduce new collaborative activities that will further 
the shared research goals of the consortium members' individual funded 


Biomedical science has entered an era in which collaboration across 
disciplines is essential to tackle many complex biological problems.  This 
increased need for collaborative and integrative approaches stems from the 
rapid progress in understanding biology at the molecular level.  This 
knowledge can now be used to increase our understanding of the global control 
and integration of biological processes.  This effort will require the 
involvement of cross disciplinary groups of scientists and a diversity of 

It is unrealistic to expect that individual laboratories will have the 
breadth of expertise and resources to pursue problems that increasingly 
require multiple approaches. Expertise in disciplines such as chemistry, 
physics, engineering, mathematics, and computer science increasingly will be 
needed to realize the full potential of biomedical research.  Furthermore, 
the ability to attack multifaceted problems will involve sophisticated data 
collection and access to rapidly evolving technologies.  However, 
technologies and approaches, such as combinatorial chemistry, genomic 
analysis, proteomics, and bioinformatics, are not readily available and 
affordable to many laboratories that could benefit from their use.

The purpose of this Program Announcement (PA) is to encourage 
multidisciplinary collaborative and integrative approaches to important 
biological problems.  The goal is to bring together groups of already funded 
investigators and to provide additional resources for new collaborative 
activities via the use of the R24 consortium grant mechanism.  The additional 
funds must support activities that are likely to significantly enhance 
existing capabilities and introduce new approaches to the research aims.  The 
collaborations should be focused on a common problem of fundamental interest 
to NIGMS or NIDDK, the requested resources should be necessary to advance the 
problem being addressed, and the most appropriate collaborators, regardless 
of location, should be involved.  This mechanism is not intended simply to 
support core facilities.  It also is not designed to support groups of 
investigators at the same institution who would normally interact and 
collaborate in the absence of a consortium grant.  The requested resources 
must facilitate a synthesis of information that would not take place if each 
grant was independently supplemented. 

All areas of research traditionally supported by NIGMS will be considered as 
appropriate for the participating components of the R24 grant mechanism.  
Applicants are advised to visit the NIGMS website at 
for detailed information on NIGMS areas of research interest.  Only the 
following areas of research will be considered for NIDDK-funded 
investigators: diabetes and its complications, obesity, kidney and urologic 
diseases, cystic fibrosis, inborn errors of metabolism, endocrinology, and 


This PA will use the NIH R24 grant mechanism.  As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project.  The total project period for an R24 award submitted in response to 
this PA may not exceed four years. 

The R24 grant mechanism will be used to support collaborative activities that 
will substantially enhance the conduct of the already funded research 
projects of two or more consortium members.  A maximum of $300,000 direct 
costs per year will be provided for all or some of the following:

o  Salaries for personnel that bridge or add to the intellectual and 
technological approaches of the individual consortium components

o  Travel expenses for collaborative activities

o  Specialized training of personnel in cross disciplinary concepts, 
approaches and technologies

o  Equipment

o  Access to resources, such as those for genomics, proteomics, high 
throughput technologies, bioinformatics and computational services, 
electronic communication media to facilitate participation of off site 
laboratories and collaborative capabilities

o  Facilities for model systems or organisms

o  Sharing of clinical specimens

NIGMS and NIDDK also encourage consideration of existing and previously 
announced mechanisms whenever appropriate to enhance collaborative and 
integrative approaches to research problems.  These mechanisms include: 
administrative supplements to NIGMS-funded research grants; competing 
supplements to NIGMS-funded research grants; individual R01 grants containing 
a consortium arrangement for a collaborative component; program project (P01) 
and center (P50) grants.  Potential applicants should visit 
or for details of initiatives in specific areas and contact 
NIGMS or NIDDK staff for advice on the most appropriate mechanism to achieve 
their goals.  The R24 consortium grant is not renewable.  Consortia initially 
supported by R24 grants could be continued under other peer-reviewed 
mechanisms, such as an appropriate expansion of participating R01s at the 
time of competing renewal.

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.  This program does not require cost 
sharing as defined in the current NIH Grants Policy Statement at  


You may submit (an) application(s) if your institution has any of the 
following characteristics: 

o For-profit or 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 Domestic or foreign


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. 

Only Principal Investigators (PIs) of NIGMS- or NIDDK-funded R01 or R37 
grants with one or more years of support remaining at the anticipated time of 
award can serve as the PI of the R24 consortium grant.  The PI should be 
prepared to devote at least 10% effort to the R24 consortium grant.  Since 
the PI's NIGMS- or NIDDK-funded grant will not be in phase with the R24 
consortium grant award, the R24 award will continue if the PI's NIGMS- or 
NIDDK- funded grant is renewed.  If the PI's NIGMS- or NIDDK-funded grant 
lapses during the four year term of the R24 consortium grant award, NIGMS or 
NIDDK staff will determine whether to continue the consortium grant, and 
under what conditions. 


CONSORTIUM MEMBERS:  Participating consortium members must have external, 
peer-reviewed grant support from either an NIH Institute or Center, or 
another source.  Participating consortium members may be from the same 
institution or different institutions, including: 

o For-profit or 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 Domestic or foreign

Participating consortium members are expected to devote at least 5% effort to 
the consortium activities.  Their grants do not have to be in phase with the 
grant support of the PI of the R24 grant.  Component projects may end or be 
renewed during the R24 award as long as a minimum of two collaborative 
projects is maintained.  Replacement or addition of participating components 
will be considered for approval by NIGMS or NIDDK staff, as long as the 
overall scientific goals remain the same.

APPLICATION CONTENTS:  The Background section must include a description of 
the already funded component projects in sufficient detail to enable an 
assessment of the degree to which the R24 grant would facilitate 
collaborative and integrative approaches to the shared research problem.  
This section also should contain a rationale for why this group of projects 
and investigators was selected, and why the requested consortium support is 
likely to significantly enhance progress on the shared research problem, 
beyond what could be accomplished with the individual investigators' research 
grant support.  If some of the participating investigators are at the same 
institution, a rationale must be provided explaining how this R24 grant will 
enhance integration and collaboration amongst those participants, beyond what 
would normally be expected of a group of investigators with shared interests 
at the same institution. 

The Experimental Plan should contain a description of the approaches and how 
they will be accomplished to further the shared research goals.  The 
principal investigator should describe how the activities will be coordinated 
and made accessible to all participating consortium members.  Applicants also 
should include specific plans for sharing data and materials that may be 
generated through the consortium grant.  The Resources section should address 
existing intellectual and other resources.


Applicants are strongly advised to contact their program director as well as 
the staff listed below, prior to submission, to discuss the eligibility of a 
proposed application, and also to consult an informational page with 
frequently asked questions and answers at  Applicants also are 
strongly encouraged to submit a letter of intent, at least four weeks prior 
to the submission date, to one of the staff listed below.

We encourage your inquiries to determine the responsiveness of proposed 
applications to this PA and welcome the opportunity to answer questions from 
potential applicants.  Inquiries may fall into two areas: scientific/research 
and financial or grants management issues: 

o Direct your questions about scientific/research issues to one of the 

James Cassatt, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, Room 2AS19, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-0828
FAX:  (301) 480-2004

Marcus Rhoades, Ph.D.
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
45 Center Drive, Room 2AS25, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-0943
FAX:  (301) 480-2228

Michael Rogers, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, Room 2AS49, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-3827
FAX:  (301) 480-2802

Maren R. Laughlin, Ph.D.
Division of Diabetes, Endocrinology and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 6101, MSC 5460
Bethesda, MD  20892-5460
Telephone:  (301) 594-8802
FAX:  (301) 480-3503

o Direct your questions about financial or grants management matters to one 
of the following:

Ms. Marcia Cohn
Grants Administration Branch
Division of Extramural Activities
National Institute of General Medical Sciences
45 Center Drive, Room 2AN44, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-3918
FAX:  (301) 480-2554

Ms. Kathleen Shino
Grants Administration Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 708, MSC 5456
Bethesda, MD  20892-5456
Telephone:  (301) 594-8869
FAX:  (301) 594-9523


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 

APPLICATION RECEIPT DATES:  Applications submitted in response to this 
program announcement will be accepted at the standard application deadlines, 
which are available at  Application 
deadlines are also indicated in the PHS 398 application kit.

requesting up to $250,000 per year in direct costs must be submitted in a 
modular grant format.  The modular grant format simplifies the preparation of 
the budget in these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the 
research grant application instructions for the PHS 398 (rev. 5/2001) at includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types.  Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at 

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the checklist, and five 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)

APPLICATION PROCESSING:  Applications must be mailed on or before the receipt 
dates described at  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 a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 

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.


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
( will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council 
or board.  


The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of the application in order to judge the likelihood that the proposed 
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 the application's overall score, weighting them as appropriate 
for each application.  The application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, an investigator may propose to 
carry out important work that by its nature is not innovative but is 
essential to move a field forward.

SIGNIFICANCE:  Will the integrative and collaborative studies proposed in 
this application further research on an important problem?  If the goals 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or approaches that 
drive this field?

APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated and appropriate to the aims of the 
consortium grant and component projects?  Does the applicant acknowledge 
potential problem areas and consider alternative tactics?

INNOVATION:  Does the project employ novel concepts, approaches or methods?

INVESTIGATORS:  Is the PI of the consortium grant appropriately trained and 
well suited to oversee this work?  Is the work proposed appropriate to the 
experience level of the PI and consortium members?

ENVIRONMENT:  Does the scientific environment in which the work will be done 
contribute to the probability of success?  Do the proposed activities take 
advantage of unique features of the participating members' resources or 
employ useful collaborative arrangements?  Is there evidence of institutional 


In addition to the above criteria, the following items will be considered in 
the determination of scientific merit and the priority score: 
o  Will the proposed collaborative and integrative activities and/or 
resources significantly enhance the ability of the investigators to address 
the research goals of the funded component projects?

o  Do the component projects address a common problem and are they suitable 
for a collaborative and integrative approach?

o  Have the consortium members been assembled with respect to employing the 
talent and expertise that are needed to address the shared research problem, 
regardless of their locations?

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.) 

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 will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below.)

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.  


DATA SHARING: The adequacy of the proposed plan to share data.

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.


Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

For NIGMS and NIDDK, the following also will be considered in making funding 

o Quality of the proposed collaborative activities as determined by peer 
o The degree to which the collaborative components and/or activities will 
significantly enhance the conduct of the research


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. 

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 (
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at  
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 

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

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at and at  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see  
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 

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

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.

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). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
( 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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at 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
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.

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