INVESTIGATOR-INITIATED INTERACTIVE RESEARCH PROJECT GRANTS

NIH Guide, Volume 22, Number 16, April 23, 1993



PA NUMBER:  PA-93-078



P.T.





Keywords:



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 Center for Nursing Research

National Center for Research Resources



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



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

underrepresented in individual research project (R01) and First

Independent Research Support and Transition (FIRST) (R29) 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 solicitation 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 share a common theme and

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 or R29 applications.  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 institution or may include

arrangements with several institutions if appropriate.  Applications

from or involving minority institutions, individuals, and women are

encouraged.



Applicants for IRPGs may not concurrently submit additional R01 or R29

applications (either investigator-initiated or in response to a Request

for Applications) that represent significant duplication of the efforts

described in the IRPG.  Concurrent submission of program project (P01)

or cooperative agreement (U01) applications that request support for

essentially similar work is also prohibited.



MECHANISM OF SUPPORT



Support of this program will be by the traditional research project

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

minimum of two independent applications.  An IRPG package may consist

of a combination of R01s and R29s, or R01s 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 (ICs) within NIH may issue

additional Program Announcements on topics that include the IRPG as a

mechanism of response.  The RFA may also be used, in limited

circumstances, to solicit applications for IRPGs 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 announcement.



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

applications received in response to this announcement.



This announcement supersedes any previous announcement regarding IRPGs.

Future IRPG applications must follow the instructions presented in this

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 and Centers listed above.

Applications submitted as part of an IRPG package must be tightly

focused, and the interactions and benefits of the proposed linkages

must be made explicit.  The IRPG mechanism 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 mechanism may fit well with clinical

applications that propose limited, testable research questions or

focused therapeutic and related correlative laboratory studies.

However, the IRPG mechanism is not appropriate for large epidemiologic

studies or for multi-institutional clinical trials using common

protocols.



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

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

agreements (U01) to encourage multidisciplinary collaboration in areas

requiring integration and central 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

announcement is meant to address and facilitate this class of research

activity.



The IRPG offers a means of promoting collaborative efforts between or

among projects with a common theme, 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).  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) and the transferability of awards

made to individual investigators are other benefits.



R01 grantees (and R29 awardees) previously unable or unwilling to join

in P01s may wish to participate in an IRPG.  One reason given by some

grantees for reluctance to participate in P01s is the potential loss of

autonomy.  Such concerns are not pertinent with the IRPG because each

investigator retains autonomy over his/her project.  At the same time,

each investigator may benefit because the IRPG mechanism establishes a

larger framework of reference for the proposed work and facilitates

formal collaborations tailored to achieving investigator-initiated

research objectives.



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

applications for the IRPG mechanism, applicants are encouraged to

discuss the issues with NIH staff contacts listed at the end of the

announcement.



STUDY POPULATIONS



If human subjects are involved, each component application must address

these issues.



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH policy is that applicants for NIH clinical research grants and

cooperative agreements are required to include minorities and women in

study populations so that research findings can be of benefit to all

persons at risk of the disease, disorder, or condition under study;

special emphasis must be placed on the need for inclusion of minorities

and women in studies of diseases, disorders, and conditions that

disproportionately affect them.  This policy is intended to apply to

males and females of all ages.  If women or minorities are excluded or

inadequately represented in clinical research, particularly in proposed

population-based studies, a clear compelling rationale must be

provided.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of the

study.  This information must be included in the form PHS 398 in the

Research Plan Sections 1-4 AND summarized in Section 5, Human Subjects.

Applicants are urged to assess carefully the feasibility of including

the broadest possible representation of minority groups.  However, NIH

recognizes that it may not be feasible or appropriate in all research

projects to include representation of the full array of United States

racial/ethnic minority populations (i.e., Native Americans [including

American Indians or Alaskan Natives], Asian/Pacific Islanders, African

Americans, Hispanics).  The rationale for studies on single minority

population groups must be provided.



For the purpose of this policy, clinical research is defined as human

biomedical and behavioral studies of etiology, prevention (and

preventive strategies), diagnosis, or treatment of diseases, disorders,

or conditions.



The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including

minorities.



If the required information is not contained within the application,

the review will be deferred until the information is provided.



Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the selected

study population is inadequate, it will be considered a scientific

weakness or deficiency in the study design and will be reflected in the

priority score assigned to the application.



All applications for clinical research submitted to NIH are required to

address these policies.  NIH funding components will not award grants

or cooperative agreements that do not comply with these policies.



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 Inquiries, Division

of Research Grants, National Institutes of Health, 5333 Westbard

Avenue, Room 449, Bethesda, MD  20892; telephone (301) 435-0714.



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

PHS 398 face page, citing this announcement, PA-93-078, and including

the phrase "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 returned without

review.



The receipt dates for IRPG applications, whether new (Type 1),

competing renewal (Type 2), or revised applications, are February 15,

June 15, and October 15 of each year.  For each component IRPG, a

signed, typewritten 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.



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 applications should not be collated

into an IRPG "package."  For each application, the original, five

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

identified.  Failure to follow the instructions regarding submission

date and packaging may lead to a delay in review.



The IRPG 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.



Special Instructions



Particular attention must be paid to completion of Section 7,

Consultants and Collaborators, for each IRPG application.  In addition

to those collaborations that would be necessary to carry out the

proposed research, whether or not the IRPG mechanism is involved,

within Section 7, each application that is a component IRPG must

provide an identical statement (titled "IRPG INTERACTIONS") regarding

the IRPG collaboration.  This section should list each application that

is part of the IRPG, including title, Principal Investigator, and other

participating scientists.  The single Program Coordinator, responsible

for coordinating the collaborative efforts among the research projects

and for promoting interaction and communication among the Principal

Investigators, should be identified here.  This section should further

discuss the intended interactions among the components of the IRPG and

the perceived benefits of supporting all of the components of the IRPG

as a combined effort.



Requests for limited shared resources, if any, should be included in

this part of Section 7.  This should include costs and full budget

justification.  To further clarify the utilization of shared resources,

additional succinct information is needed and it is suggested that two

tables be included.  Table I would be identical in all applications of

the IRPG cohort; it will specify the percent utilization and dollar

amount requested of each interactive resource by each IRPG in the

proposed cohort.  Table II will detail the distribution of effort for

all of that application's personnel (professional, technical and

clerical) on all shared activities and/or resources.  (A sample format

may be obtained from the IC contacts listed at the end of this

announcement.)  The utilization of these resources by each IRPG will be

evaluated independently by the study section and any appropriate

modifications recommended.



REVIEW PROCEDURES



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.



Applications will be reviewed independently for scientific and

technical merit by initial review groups (IRGs) according to standard

NIH review procedures.  Most often these reviews will be conducted in

Study Sections of the Division of Research Grants.  Following

scientific and technical merit review, applications will receive a

second level review by the appropriate national advisory council(s).



Both IRG (study section) and Institute/Center assignment 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 study sections for initial

review and to different Institutes/Centers for funding consideration.

This reemphasizes the need for each application to be complete within

itself and for all IRPGs to have identical statements regarding the

special interactions of the IRPG.



The initial review for scientific and technical merit will focus on

each application independently.  Reviewers will read Section 7 and will

assess the intended collaborations just as they do the proposed

collaborative arrangements in any other application.  As appropriate,

the effectiveness and merit of the collaborations may contribute to the

overall assessment of each application.  In addition, budget

recommendations related to the appropriateness of collaborative

arrangements and core utilization will be assessed for each

application.



Further consideration of these special interactions will be given by

the appropriate advisory council or board and Institute/Center staff.



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/Center will have the opportunity to fund some or all of

the component IRPGs assigned to it.  If the components are assigned to

more than one Institute/Center, co-funding may be considered.  If some

component IRPGs are considered not supportable, the collaborative plans

may need to be changed.  If an Institute/Center chooses to fund an

entire IRPG package, a review of the collaborative plans in toto will

be conducted by an appropriate advisory council.



INQUIRIES



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. Anthony Pollitt

Associate Director for Extramural Policy

National Institute of Mental Health

Telephone:  (301) 443-4673



Dr. Mary Lucas

Acting Director, Division of Extramural Programs

National Center for Nursing Research

Telephone:  (301) 594-3290



Dr. Louise Ramm

Director, Biological Models and Materials Research Program

National Center for Research Resources

Telephone:  (301) 594-0630



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No 93.3   .  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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