INVESTIGATOR-INITIATED INTERACTIVE RESEARCH PROJECT GRANTS

NIH GUIDE, Volume 23, Number 28, July 29, 1994



PA NUMBER:  PA-94-086



P.T. 34



Keywords:

  Biomedical Research, Multidiscipl 

  Grants Administration/Policy+ 



National Institute on Alcohol Abuse and Alcoholism

National Institute on Aging

National Institute of Allergy and Infectious Diseases

National Institute of Arthritis and Musculoskeletal and Skin Diseases

National Cancer Institute

National Institute of Child Health and Human Development

National Institute of Dental Research

National Institute of Diabetes and Digestive and Kidney Diseases

National Institute on Drug Abuse

National Institute of Environmental Health Sciences

National Library of Medicine

National Institute of Mental Health

National Institute of Nursing Research

National Center for Research Resources



Application Receipt Dates:  February 15, June 15, October 15



Introduction:  This is to rescind NIH PA-93-078, on Investigator-

Initiated Interactive Research Project Grants (Volume 22, Number 16,

April 23, 1993), and replace it with the following Program

Announcement.



The purpose of this revised Program Announcement is to clarify several

important aspects of the Interactive Research Project Grant (IRPG)

program, as originally announced in the NIH Guide for Grants and

Contracts, Vol. 22, No. 16, April 23, 1993.  The full text of the

revised Program Announcement, which replaces and supersedes the

original text, is available electronically, as well as from the

Institute or Center contacts listed under INQUIRIES.  In addition, a

new brochure, "Special Instructions for Preparing Applications for

Investigator-Initiated Interactive Research Project Grants," is

available from the Office of Grants Information, Division of Research

Grants, NIH, 301/435-0714, and from the Institute or Center contacts.



The key clarifications in this revised Program Announcement are as

follows:



1.  The important characteristics of IRPG applications and their

differences from Program Projects are explained more clearly.



2.  The section on STUDY POPULATIONS has been updated to reflect the

latest NIH policy required under the NIH Revitalization Act of 1993 and

announced in the Federal Register of March 28, 1994 (FR 59 14508-

14513), and printed in the NIH Guide for Grants and Contracts, Vol. 23,

No. 23, March 18, 1994.  All applications received on or after June 1,

1994 must conform to this new policy.



3.  The requirements for format and layout of each application in the

IRPG group have been stated more clearly.



4.  The procedures for submission of applications and the receipt dates

for applications, including AIDS and AIDS-related applications, have

been clarified.



5.  The guidelines for requesting limited shared resources for projects

in the IRPG group have been clarified.



6.  The special instructions for preparation of Section 7, Consultants/

Collaborators, of the Research Plan have been clarified.



7.  Table II, Distribution of Effort of All Personnel in the IRPG, is

no longer required.



8.  The process for referral of the applications and the review

criteria for the collaborative arrangements have been clarified.



PURPOSE



Certain questions in biomedical and behavioral research require

research efforts that extend beyond the level practicable in a single

project or require a variety of technical approaches beyond the means

of a single investigator.  There may be areas of investigation that are

under-represented in individual research project grant (R01) and First

Independent Research Support and Transition (FIRST) (R29) award

applications because of the lack of available collaborative effort on

a local level.  Further, the perceived merit of individual projects may

be diminished by the lack of a comprehensive, interdisciplinary

approach or by limitations in resident technical expertise.



The National Institutes of Health (NIH) has used many ways to encourage

strong collaboration among research scientists.  These have ranged from

specific interaction of the Federal government with academia/industry

through contract or cooperative agreement solicitations to Requests for

Applications (RFAs) that solicit research applications involving

various forms of cooperation among applicants.  This Program

Announcement provides for a new kind of formal interaction, based on

the initiative of applicants, to enhance existing interactions with

colleagues or to develop new collaborative relationships.



The Interactive Research Project Grant (IRPG) program encourages the

coordinated submission of related research project grant (R01) and, to

a limited extent, FIRST award (R29) applications from investigators who

wish to collaborate on research, but do not require extensive shared

physical resources.  These applications must be scientifically

interrelated in some manner and must describe the objectives and

scientific importance of the interchange of, e.g., ideas, data, and

materials, among the collaborating investigators.  A minimum of two

independent investigators with related research objectives are

encouraged to submit concurrent, collaborative, cross-referenced

individual R01 and/or R29 applications.  The proposed projects must not

be dependent upon each other to the extent that one could not be

accomplished in the absence of the other.  Applicants may be from one

or several institutions.  Applications will be reviewed independently

for scientific merit.  Applications judged to have significant and

substantial merit will be considered for funding both as independent

awards and in the context of the proposed IRPG collaboration.



ELIGIBILITY REQUIREMENTS



Applications may be submitted by foreign and domestic, for-profit and

non-profit organizations, public and private, such as universities,

colleges, hospitals, laboratories, units of State and local

governments, and eligible agencies of the Federal government.  Foreign

institutions, however, are not eligible for the R29 award.

Applications may be submitted from one or more institutions.

Applications from or involving minority institutions, minority

individuals, and women are encouraged.



Applicants for IRPG awards may not concurrently submit additional R01

or R29 applications (either investigator-initiated or in response to an

RFA) that represent significant duplication of the efforts described in

the IRPG.  Concurrent submission of program project (P01) or

cooperative agreement (U01, U10, U19, etc.) applications requesting

support for essentially similar work also is prohibited.



MECHANISM OF SUPPORT



Support of this program will be by the traditional research project

(R01) grant and the FIRST (R29) award.  The IRPG group must consist of

a minimum of two independent applications.  An IRPG package may consist

of a combination of R01 and R29 applications, or R01 applications only,

but may not consist solely of R29 applications.  Applications for both

new (Type 1) and competing renewal (Type 2) awards may be submitted as

IRPGs.



Occasionally, Institutes and Centers of the NIH may issue additional

Program Announcements that include IRPGs.  The RFA also may be used, in

limited circumstances, to solicit applications for IRPG awards in a

discrete scientific area.  Although the level of interaction for IRPGs

between or among applicants in these solicitations will conform to

those outlined here for the investigator-initiated IRPG, there may be

minor differences outlined in the RFA.  For example, all RFA

solicitations will specify a single receipt date that will be different

from those listed in this program announcement.



All Public Health Service (PHS) and NIH grants policies will apply to

applications received in response to this program announcement.



This revised program announcement supersedes any previous program

announcements regarding IRPG awards.  Future IRPG applications must

follow the instructions presented in this program announcement.



RESEARCH OBJECTIVES



The NIH encourages qualified independent investigators to develop and

submit coordinated R01 and R29 applications that address any research

area supported by the Institutes or Centers listed above.  The IRPG

program could be used constructively to support collaborative efforts

designed to accelerate the development of fundamental knowledge and/or

enhance the clinical application of that knowledge.  The IRPG award may

fit well with clinical applications that propose limited, testable

research questions or focused therapeutic and related correlative

laboratory studies.  However, the IRPG program is not appropriate for

large epidemiologic studies or multi-institutional clinical trials

using common protocols.



If there is a question about the appropriateness of a set of

applications for the IRPG program, applicants are encouraged to discuss

the issues with NIH staff contacts listed under INQUIRIES.



IRPG Characteristics



The IRPG application consists of a number of investigator-initiated

projects that share an aspect of relationship of objectives.  The

projects may involve several institutions and may be interdisciplinary.

The IRPG program is intended to promote collaborative efforts between

or among projects, while providing a record of independently acquired

awards credited to each individually funded investigator and allowing

retention of research autonomy by the named Principal Investigator (PI)

of each project. Each grantee will have the ability to submit on

his/her behalf competing supplements as appropriate to incorporate

promising new directions of research as they evolve.  The freedom to

establish collaborations on an equal footing at separate sites

(including foreign locations, with the exception that only domestic

organizations and institutions are eligible to receive FIRST (R29)

awards), and the transferability of awards made to individual

investigators, are other benefits.  Nevertheless, each investigator may

benefit, because the IRPG award establishes a larger framework of

reference for the proposed work and facilitates formal collaborations

tailored to achieving investigator-initiated research objectives.



Thus, the IRPG application must demonstrate a sense of collaboration

toward related goals.  It must describe how the participants intend to

take the opportunity to participate in mutually-beneficial

interactions, while maintaining the independence of their projects.

The IRPG application may involve utilization of shared resources in

advancing effective collaborations.  It is important for each

individual application comprising a portion of the overall IRPG to

describe the proportion of the shared resources needed for that

individual project.



Since each component R01 and R29 is an independent application, it

should be prepared in the same level of detail and with the same care

as a traditional R01 or R29 application.  Each project also should be

able to stand on its own scientifically; the projects proposed must not

be dependent on each other, but should be designed so that they could

be accomplished independently.  For example, one project should not be

completely dependent on another project for provision of a critical

chemical or reagent, testing or processing of key samples, or

interpretation of data.



Comparison with Program Projects



Historically, the NIH has relied on multi-component awards, such as

program projects (P01), center grants (P30, P50), and cooperative

agreements (U01) to encourage multi-disciplinary collaboration in areas

requiring integration and coordinated direction of basic and clinical

research components.  In general, such awards include the provision of

extensive core facilities/resources and appointment of a program

director to manage the overall effort.



However, for many research areas it may be appropriate to consider an

intermediate level of collaboration that is beyond that practicable for

single projects.  For such scientifically originated collaborative

efforts, the exchanges of data, materials, and ideas, rather than

shared extensive physical resources or central oversight, are the

primary requirement.  The concept of the IRPG put forth in this program

announcement is meant to address and facilitate this class of research

activity.



The IRPG allows interaction to be initiated among applicants, as is the

case with a program project grant (P01) application, but the IRPG

differs from the P01 in important ways.  The IRPG group consists of

investigator-initiated applications on related but independent topics,

with a formalized agreement to collaborate in specific ways.  The

collaboration may include limited shared scientific resources.  The

IRPG program can be useful where interdependency among efforts is not

a requirement, but where the intended collaboration would enhance goal

achievement.  The IRPG application must provide for interaction between

or among the investigators arising from their desire to collaborate as

independent investigators.  The scope of research in each component of

a successful IRPG group should be greater than could be achieved

without the collaboration.  The proposed collaborations should have a

demonstrable impact on ability of the investigators to achieve the

projects' goals.



In contrast, the P01 has a well-defined major objective or central

theme, most commonly incorporates collaborative efforts among

investigators from the same institution, may involve significant core

resources, and is under the direct control of a central principal

individual with authority over research direction and budget.  If

significant core resources beyond a limited amount are needed,

applicants should consider applying for a P01.



STUDY POPULATIONS



If human subjects are involved, each component application must address

these issues.



INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS



It is the policy of the NIH that women and members of minority groups

and their subpopulations must be included in all NIH supported

biomedical and behavioral research projects involving human subjects,

unless a clear and compelling rationale and justification is provided

that inclusion is inappropriate with respect to the health of the

subjects or the purpose of the research.  This new policy results from

the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43)

ad supersedes and strengthens the previous policies (Concerning the

Inclusion of Women in Study Populations, and Concerning the Inclusion

of Minority in Study Populations) which have been in effect since 1990.

The new policy contains some new provisions that are substantially

different from the 1990.  The new policy contains some new provisions

that are substantially different from the 1990 policies.



All investigators proposing research involving human subjects should

read the "NIH Guidelines For Inclusion of Women and Minorities as

Subjects in Clinical Research," which have been published in the

Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted

in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18,

1994.

Investigators may obtain copies from these sources or from the contact

person listed below.  The contact person may also provide additional

relevant information concerning the policy.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS 398

(rev. 9/91).  These forms are available at most institutional offices

of sponsored research and from the Office of Grants Information,

Division of Research Grants, National Institutes of Health, 5333

Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301)

435-0714.



Before preparing an IRPG application, applicants should obtain the

brochure "Special Instructions for Preparing Applications for

Investigator-Initiated Interactive Research Project Grants,"  available

from the Office of Grants Information, Division of Research Grants,

NIH, 301-435-0714, and from the Institute or Center contacts.



Each application must be identified by checking "YES" on line 2a of the

PHS 398 face page, citing this IRPG program announcement number, and

including the title: "Investigator-initiated IRPG."



All requirements with regard to type size, page limitations, appendix

material, etc., must be followed or applications will be returned

without review.  FIRST applications (new and revised) must be

accompanied by three letters of reference.  FIRST applications without

these letters will be considered incomplete and will be returned

without review.



IRPG applications, whether new (Type 1), competing renewal (Type 2), or

revised applications, will have common receipt dates as shown in the

table below.  Receipt dates for AIDS and AIDS-related applications also

are given.  For each component IRPG application, a signed, printed

original, five exact single-sided copies, and five sets of appendix

material must be submitted.



Each application must be complete in itself, with all necessary

approvals, budgets, and signatures from the appropriate officials of

the applicant institution.  Each application must have its own

descriptive title and a separate Principal Investigator.  Since each

component project of an IRPG application is an independent R01 or R29

application, the component projects should NOT be presented as

subcontracts to one parent project.  Each requested shared resource

must be included in one of the component applications; no shared

resource may be submitted separately.  If the shared resource is in

other than an applicant institution, the shared resource may be

supported as a subcontract to one of the component institutions.



All information about the interactive nature of the projects should be

included in a subsection of Section 7 of the Research Plan of each

component IRPG application.  Specific detailed instructions for

completing all parts of Section 7 of the Research Plan, are provided in

the brochure, "Special Instructions for Preparing Applications for

Investigator-Initiated Interactive Research Project Grants."  In

addition to a description of project-specific collaborations, each

component application of the IRPG Group must contain an identical

subsection (entitled "IRPG INTERACTIONS") and identical information

showing utilization of any requested shared resources.   The IRPG

INTERACTIONS subsection of Section 7 should address the intended

interactions among the component projects of the IRPG group and the

perceived benefits of supporting all of the components of the IRPG

group as a combined effort.



Description of the shared resources that will be supported through one

of the IRPG component applications, if any, should be inserted as a

separate section of the application after Section 8 (Consortium/

Contractual Arrangements) of the Research Plan and before Section 9

(Literature Cited).  As described in detail in the instructions

brochure, this should include an explicit description of the methods

and procedures to be used, the services, tests, animals, facilities,

etc. to be provided, and a description of the involvement and

protection of human subjects or vertebrate animals, if appropriate.

Extensive shared resources, or those with large budgets, may be more

appropriate for full-fledged Cores in program projects.  Applicants are

urged to contact the NIH staff listed under INQUIRIES to discuss the

nature and extent of proposed shared resources in an IRPG group.  In no

case should a resource be submitted as a separate application.



All R01 or R29 applications constituting the proposed IRPG cohort must

be submitted in a single package, whether or not the applications arise

from the same institution.  Each application within the package must be

clearly identified and a cover letter must list the total number of

applications submitted for the IRPG cohort, indicating the Principal

Investigator of each.  The various projects comprising the IRPG

application should not be collated together, as is done for a program

project.  For each application of the IRPG group, the original, five

copies, and the appendix material must be bundled together and clearly

identified.



If two or more, but not all, applications within an IRPG Group receive

initial funding as an IRPG, and unfunded applications within that group

are subsequently amended and submitted on later receipt dates, the

awarded IRPG component(s) should be identified and may be cited in the

amended applications.  In such cases, those amended R01/R29

applications must make reference to being part of a partially funded

IRPG.  They may, however, request support to extend beyond the end date

of the already awarded component R01(s), consistent with the scientific

goals of the application.



Revised applications should highlight the changes made in the Research

Plan in response to the previous critique, and also should indicate in

Section 7 how the delay in initiating the collaboration will be

addressed.  This is particularly important if some projects in the IRPG

group were awarded and research on those projects already has begun.



If the IRPG group is not fundable as such, any individual application

within the IRPG group may be considered as a possible candidate for

funding as an individual R01.



IRPG Receipt and Review Schedule



Application Receipt Date:   Feb 15      Jun 15      Oct 15

Initial Review:             Jun         Oct         Feb

Council Review:             Sep/Oct     Jan/Feb     May/Jun

Anticipated Date of Award:  Dec 1       Apr 1       Jul 1



Instructions for AIDS and AIDS-related applications



IRPG applications for AIDS-related research must be identified as such,

and should be submitted in accordance with the AIDS expedited review

process.  The receipt and review schedule for AIDS-related IRPG

applications is given below.



Application Receipt Date:   Jan 2       May 1       Sep 1

Initial Review:             Mar/Apr     Jul         Nov

Council Review:             May/Jun     Sep/Oct     Jan/Feb

Anticipated Date of Award:  Jul 1       Dec 1       Apr 1



Failure to follow the instructions regarding submission date and

packaging may lead to a delay in review.



The IRPG application package must be sent or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



Any questions regarding the format for submission of an IRPG package

may be directed to the Referral Office, Division of Research Grants,

Westwood Building, Room 248, telephone (301) 594-7250.



REVIEW CONSIDERATIONS



Upon receipt, applications and supporting material will be examined by

the Division of Research Grants for completeness.  Incomplete

applications will be returned without further consideration.



Each application in an IRPG Group will be referred to the most

appropriate Initial Review Group (IRG), according to standard NIH

referral and review procedures, for scientific and technical merit

review.  The IRG could be either a DRG Study Section or an Institute or

Center-managed review committee, depending on the referral guidelines

for the particular research proposed.  Since applications in the IRPG

might be referred to different IRGs, the IRPG INTERACTIONS part of

Section 7 must be complete so that reviewers can understand the

collaborations and interactions without necessarily seeing any of the

other applications in the Group.  Following scientific and technical

merit review, applications that may be considered for award will

receive a second level review by the appropriate national advisory

council(s).



Institute or Center assignment of each component application in the

IRPG also will be governed by established PHS referral guidelines.

Therefore, depending on the subject matter of each IRPG, it is possible

that the component applications will be assigned to different NIH

Institutes or Centers for funding consideration.  This underscores the

need for each application to be complete within itself and for all

component applications to have identical subsections on IRPG

INTERACTIONS in Section 7 of the Research Plan.  As with any R01 or R29

application, each component of the IRPG Group must be able to stand on

its own merit.  Consequently, the application must be prepared with the

same detail as a traditional R01 or R29 application.



The initial review for scientific and technical merit will focus on

each application independently, using standard review criteria for R01

and R29 applications generally, and each application will be assigned

its own priority score.  In addition, the reviewers will read Section

7 and will assess the intended IRPG interactions.  In an Administrative

Note, the reviewers will indicate the effectiveness and feasibility of

the proposed IRPG interactions and whether they enhance the prospects

for reaching the stated objectives of the Group, and the extent of

synergy between the various projects derived from the interactions.

The appropriate national advisory council or board and the program

staff in the Institute or Center to which the applications are assigned

will consider these comments on the proposed collaborations in making

award decisions.



The IRG will evaluate the requested Shared Resource component(s) in the

application (qualifications of key personnel; adequacy of approaches,

methods, and facilities; appropriateness for the IRPG Group; and

utilization by component IRPGs) independently from the research

project.  The IRG may also make recommendations about the Shared

Resource(s) or the reasonableness of the budget.  These recommendations

will be taken into account when funding decisions are made by the

awarding Institute or Center.  The actual amount of Shared Resource(s)

awarded may depend on the number of component projects actually

awarded.



AWARD CRITERIA



Applications will compete for available funds with all other

applications found to have significant and substantial merit.  The

following will be considered in making funding decisions:



o  Quality of the proposed project as determined by peer review

o  The interactive nature of the program and of the component IRPGs

o  Availability of funds

o  Program balance among research areas



Each Institute or Center will have the opportunity to fund some or all

of the component IRPG applications assigned to it.  If the components

are assigned to more than one Institute or Center, co-funding may be

considered.  If some component IRPG applications are considered not

supportable, the collaborative plans may need to be changed.  If an

Institute or Center chooses to fund an entire IRPG package, a review of

the collaborative plans in toto will be conducted by an appropriate

advisory council.  As stated above, if the IRPG group is not fundable

as such, any individual application within the IRPG group may be

considered as a possible candidate for funding as an individual R01 or

R29.



INQUIRIES



Additional written instructions for the preparation of applications are

available upon request.  This document, "Special Instructions for

Preparing Applications for Investigator-Initiated Interactive Research

Project Grants," is available from the Office of Grants Information,

Division of Research Grants, NIH, 301-435-0714.  Applicants should be

aware that not all Institutes or Centers are participating in this

program.  Contact any of the following individuals for further

information:



Dr. Kenneth Warren

Director, Office of Scientific Affairs

National Institute on Alcohol Abuse and Alcoholism

Telephone:  (301) 443-4375



Dr. Miriam Kelty

Associate Director, Extramural Affairs

National Institute on Aging

Telephone:  (301) 496-9322



Mr. Allan Czarra

Director, Office of Program Coordination and Operations

National Institute of Allergy and Infectious Diseases

Telephone:  (301) 402-0160



Dr. Michael Lockshin

Director, Extramural Program

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Telephone:  (301) 496-0802



Dr. Marvin Kalt

Deputy Director, Division of Extramural Activities

National Cancer Institute

Telephone:  (301) 496-4218



Ms. Hildegard Topper

Special Assistant to the Deputy Director

National Institute of Child Health and Human Development

Telephone:  (301) 496-0104



Dr. Norman Braveman

Assistant Director for Program Development

National Institute of Dental Research

Telephone:  (301) 594-7648



Dr. Walter Stolz

Director, Division of Extramural Activities

National Institute of Diabetes and Digestive and Kidney Diseases

Telephone:  (301) 594-7277



Ms. Eleanor Friedenberg

Director, Office of Extramural Program Review

National Institute on Drug Abuse

Telephone:  (301) 443-2755



Dr. Thor Fjellstedt

Deputy Director, Division of Extramural Research and Training

National Institute of Environmental Health Sciences

Telephone:  (919) 541-0131



Dr. Milton Corn

Acting Associate Director, Division of Extramural Programs

National Library of Medicine

Telephone:  (301) 496-4621



Dr. Hugh Stamper

Director, Division of Extramural Activities

National Institute of Mental Health

Telephone:  (301) 443-3367



Dr. Theresa S. Radebaugh

Director, Division of Extramural Programs

National Institute of Nursing Research

Telephone:  (301) 594-7590



Dr. Louise Ramm

Deputy Director

National Center for Research Resources

Telephone:  (301) 496-6023



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

Nos. 93.113, 93.114, 93.115, 93.121, 93.198, 93.306, 93.333, 93.371,

93.393, 93.394, 93.395, 93.396, 93.397, 93.847, 93.848, 93.849, 93.855,

93.856, 93.864, 93.865, 93.929, 93.866, 93.879, 93.361, 93.846, 93.242,

93.273, and 93.279.  Awards are made under authorization of the Public

Health Service Act, Title IV, Part A (Public Law 78-410, as amended by

Public Law 99-158, 42 USC 241 and 285) and administered under PHS

grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74.

This program is not subject to the intergovernmental review

requirements of Executive Order 12372 or Health Systems Agency review.



.


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