PREVENTIVE INTERVENTION RESEARCH CENTERS

NIH GUIDE, Volume 23, Number 7, February 18, 1994



PAR NUMBER:  PAR-94-038



P.T. 34



Keywords:

  Disease Prevention+ 

  Mental Disorders 



National Institute of Mental Health



PURPOSE



The National Institute of Mental Health (NIMH) invites applications

for Preventive Intervention Research Centers (PIRCs) whose main goal

is to bridge basic and clinical sciences, state-of-the-art

methodologies, and public health research approaches, in order to

address pressing prevention research problems that require

multi-disciplinary, integrated research strategies.



This program announcement is responsive to recommendations from the

Institute of Medicine (Reducing Risks for Mental Disorders:

Frontiers for Preventive Intervention Research) and the National

Prevention Conference (The Prevention of Mental Disorders:  A

National Research Agenda).  It also addresses recommendations

outlined under "The National Plan for Research on Child and

Adolescent Mental Disorders."



HEALTHY PEOPLE 2000



The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  The PA,

Preventive Intervention Research Centers, is related to the priority

areas of suicide and mental disorders.  Potential applicants may

obtain a copy of "Healthy People 2000" (Full Report:  Stock No.

017-001-00474-0) or" Healthy People 2000" (Summary Report:  Stock No.

017-001-00473-1) through the Superintendent of Documents, Government

Printing Office, Washington, DC 20402-9325, (telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by public and private for-profit and

non-profit domestic organizations such as universities, colleges,

hospitals, laboratories, research institutions, units of State or

local governments, and eligible agencies of the Federal government.

Women and minority investigators are encouraged to apply.



MECHANISMS OF SUPPORT



Applications may be submitted using the developing center (P20) and

mature center (P30) funding mechanisms.  Support for a Developing

PIRC (P20) may be requested for a single, non-renewable five-year

period only, with a maximum request of $300,000 per year, plus

negotiated institutional indirect costs.  Support for a Mature Center

(P30) can be requested for renewable five-year funding periods, with

a maximum request of $1,000,000 per year, plus negotiated

institutional indirect costs.



Because the nature and scope of the research proposed in response to

this PA may vary, it is anticipated that the size of an award will

also vary.



RESEARCH OBJECTIVES



Background



Since 1982, the NIMH has supported a number of Preventive

Intervention Research Centers (PIRCs) with the aim of providing

productive research environments where teams of investigators from a

variety of disciplines would interact and develop focused programs of

research on the prevention of mental and behavioral disorders and

dysfunctions, and the promotion of mental health.  To date, the PIRCs

have included both infrastructure or core functions, as well as

support for a set of interrelated research projects.  Under the

current announcement, PIRCs will move to a core function model;

Center grants will cover cross cutting research functions such as

data management, field coordination, and research planning and

development activities around a substantive theme or set of themes.

Costs for fully developed projects emerging from the Centers will be

covered through regular research grant mechanisms.



PIRC Characteristics and Functions



Although the specific structure and organization of individual

Centers will vary, all PIRCs are expected to help build the field of

mental health prevention and promotion research by providing

scientific leadership, an environment of research excellence, and

models of community outreach and collaboration.



To fulfill the mission outlined above, PIRCs are expected to perform

a number of critical functions.  These functions may be represented

as individual core units of the Center, or they may be clustered

together.  In either case, all of the functions must be addressed in

PIRC applications, although the relative emphasis of functions may

vary from site to site.  Functions include, but are not limited to:



o  Research agenda and theory development.  PIRCs are expected to

develop an organizing prevention/promotion research theme or set of

themes and a research agenda that define the mission of the Center.

For each theme, PIRC applications are expected to review the relevant

empirical and theoretical literature, identify major unresolved

issues, and present a plan for developing a rigorous, theory driven,

multi-disciplinary research program to address these outstanding

questions and clarify theory.



o  Methodology.  PIRCs are expected to provide state-of-the-art,

sophisticated methodological expertise to all Center related research

projects.  This function includes, but is not limited to, sample

development, methods and instrument development, assessment and

diagnosis, research design, statistics, and primary and secondary

data analysis.  PIRCs can also support relevant biological and

behavioral research laboratories.



PIRCs are strongly encouraged, where appropriate, to include a focus

on methodological research aimed at solving design and statistical

problems of critical importance to longitudinal field trials.



o  Data management.  PIRCs are expected to provide state-of-the-art

data management efforts in order to facilitate all aspects of data

processing and analysis, and timely production of research

publications.



o  Knowledge and technology transfer.  PIRCs are expected to sponsor

meetings and symposia in their thematic area, produce a variety of

scientific publications and other outreach activities to disseminate

findings and successful intervention technologies, and highlight

ethical issues in preventive intervention research.



o  Mentoring.  PIRCS are expected to provide prevention research

scientist opportunities to new and established investigators.

Special attention should be given to the recruitment of minority

investigators.  Centers are encouraged to apply for grants available

to support developing scientists.



The number of personnel awarded will depend upon the capacity of the

Center's scientists, but will not exceed 15 percent of the awarded

direct costs for the Center.



o  Opportunities for research collaboration.  PIRCs are strongly

encouraged to capitalize on opportunities for cross site and cross

research project collaborations, where appropriate.  Collaborative

research planning activities, including piloting, can be included as

PIRC sponsored activities.  Fully developed collaborative projects

will be funded through regular research grant mechanisms.



o  Community sanction/liaison.  PIRCs are expected to develop and

disseminate model processes for achieving community sanction and

cultural competence for all aspects of prevention field experiments.



Developing and Mature Centers



There are two categories of grant applications under the PIRC

program:  applications for Developing Centers (P20) and applications

for Mature Centers (P30).  Although there is no absolute criterion to

distinguish who should apply in which category, the following

guidelines apply:



o  The category of Developing Centers (P20) is appropriate for

institutions that are either (a) interested in developing a critical

mass of research scholars necessary to conduct state-of-the-art

prevention research, or (b) already have a critical mass of

researchers from relevant disciplines, who are interested in

re-focusing and integrating their research around a preventive

intervention theme.  Applicants in this category must have strong

track records in research (although not necessarily in prevention

research) and show promise of developing into fully functioning

prevention research Centers.



Developing Centers have research themes and existing collaborations,

but need funds to recruit additional scientists, expand core

functions, or fully develop a multi-disciplinary prevention research

agenda.



Each Developing PIRC will provide research experiences for at least

two preceptees annually, to be selected from scientific disciplines

related to the goals of the Center.  Preceptorships are defined as

supervised research experience.  Each Center should relate

functionally with relevant departments of professional and graduate

schools, as are appropriate to the needs of the preceptees.



o  Mature Centers (P30) are fully developed entities that have the

capacity to rapidly become mature, state-of-the-art research Centers

by virtue of previous commitments of institutional resources,

recruitment and/or development of an existing critical mass of

prevention research scholars, the presence of substantial recent

prevention publications in peer-reviewed research journals, active

preventive intervention research grants, etc.



In Mature PIRCs, funds can be requested to support research career

development candidates at the same level of experience as would be

appropriate for NIMH-supported scientist development and academic

awards.



Specific Research Topics



In keeping with the public health mission of prevention research,

PIRC research programs will generally focus on randomized controlled

intervention trials, but may include studies that span the entire

scientific continuum.  For example, PIRCs can include generative risk

factor and model building research to inform theory on the etiology

and development of psychopathology (hypothesis development).  The

research program can also include methods development relevant to the

design and testing of a new intervention model, or to the development

of innovative design and analytical approaches for the field as a

whole.  Centers are also strongly encouraged to include

cost-effectiveness and cost-benefit studies wherever appropriate in

their research agenda.



Intervention trials should be of two types:  experimental tests of

efficacy (controlled intervention trials of new intervention

strategies) and of effectiveness (testing of efficacious

interventions in controlled trials involving representative, defined

populations.)  Because of their logistical and methodological

complexities, tests of effectiveness are particularly appropriate for

inclusion in PIRC research programs. Similarly, PIRCs are encouraged,

where appropriate, to include in their research programs plans for

dissemination and/or services research once interventions have

demonstrated effectiveness and are ready for adoption by service

systems.



Centers may direct their efforts to well defined single, multiple, or

co-morbid conditions, and test intervention strategies aimed at

individuals and/or families, schools, communities, service systems,

or other relevant domains. The following are examples of areas within

this framework that might serve as a focus for Centers.  The list is

neither exhaustive, nor exclusive:



o  Development of prevention trials aimed at changing risk factors

and/or mediators associated with mental disorder and pre-clinical

behavioral dysfunctions in children, adolescents, and their families.



o  Methodologic development and experimental testing of promotive

interventions, with emphasis on identification and independent

assessment of relevant mental health outcomes.



o  Establishment of prevention trials aimed at risk factors common to

a number of disorders and/or maladaptive outcomes.



o  Generation of ecologically valid prevention trials with multiple

intervention components that target risk and protective factors

across a number of domains simultaneously.



o  Development of trials aimed at understanding optimal timing or

scope of interventions, or subgroup differences in response to

different intervention strategies.



o  Generation of prevention trials involving embedded universal,

selected, and indicated intervention strategies.



o  Development of multi-component intervention strategies through

systematic testing of individual modules which are later tested in

combinations.



STUDY POPULATIONS



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 will be 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 should be placed on the need for

inclusion of minorities and women in studies of diseases, disorders

and conditions which 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 should 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 should be included in the form PHS 398

in Sections 1-4 of the Research Plan 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, Blacks, Hispanics).



The rationale for studies on single minority population groups should

be provided.



For the purpose of this policy, clinical research includes human

biomedical and behavioral studies of etiology, epidemiology,

prevention (and preventive strategies), diagnosis, or treatment of

diseases, disorders or conditions, including but not limited to

clinical trials.



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 application will be returned.



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 assigning the priority score 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



It is strongly encouraged that potential applicants contact the

Centers program staff very early in the planning process.



NIMH staff will offer each potential applicant advice and information

regarding program relevance and purpose so that applications will

comply with administrative requirements, meet program standards, and

contain sufficient information to permit an adequate Center program

review.



Applications are to be submitted on the grant application form PHS

398 (rev. 9/91) and will be accepted at the standard center

application deadlines as indicated in the application kit.  The

number and title of this Program Announcement, Preventive

Intervention Research Centers, PAR-94-038, must be typed in item

number 2a on the face page of the PHS 398 application form.  PHS

regulations concerning application page-length apply to PIRC

applications.  In general, 25 pages of text are allowed for each core

and research component of the Center.  A submitted application will

be reviewed within the category that it requests (i.e., Developmental

or Mature); the IRG will not change categories as part of its review.

Applicants should note that the metric system of measurement must be

used if weights and measures are involved in the proposed research.



Application kits containing the necessary forms and instructions are

available at most institutional offices of sponsored research and may

be obtained from the Office of Grants Information, Division of

Research Grants, National Institutes of Health, Westwood Building,

Room 449, Bethesda, MD 20892, telephone 301/710-0267.



The signed original and five legible copies of the completed

application must be sent to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW CONSIDERATIONS



Applications will be assigned on the basis of established phs

referral guidelines.  Applications will be reviewed for scientific

and technical merit by study sections of the National Institute of

Mental Health, in accordance with the standard NIH peer review

procedures.



The following criteria will be considered when assessing the merit of

a PIRC application:  intrinsic merit of the proposed intellectual

focus and research agenda, appropriateness of the Center approach,

presence of high-quality research investigators from several fields,

Center Director qualities, adequacy of research resources and

environment, quality and appropriateness of the infrastructure and

research career development components of the PIRC's activities,

appropriateness of PIRC organization, quality of Center functions,

adequacy of plans to achieve community sanction, feasibility and

budget, inclusion of women and minorities, adequacy of protection of

human and animal subjects.



Applicants from institutions that have a General Clinical Research

Center (GCRC) funded by the NIH National Center for Research

Resources may wish to identify the GCRC as a resource for conducting

the proposed work.  If so, a letter of agreement from either the GCRC

program director or principal investigator could be included with the

application.



All PIRC applications will be reviewed according to the procedures

and criteria outline above.  However, for the special case of

applications for Developing PIRCs, the above criteria will be

modified by the following:  the nature and level of resource

commitments from the home institution/department and from other

participating institutions/departments are of necessity not of the

level of the Mature PIRC; the quality of plans to recruit excellent

new research faculty, or to further integrate the work of existing

investigators around preventive intervention trials; the likelihood

that the establishment of a Developing PIRC will facilitate existing

research activities and serve as a mechanism to expand the proposed

prevention research theme into a fully developed prevention research

agenda.



Following scientific-technical review, the application will receive a

second-level review by the National Mental Health Advisory Council.



AWARD CRITERIA



Applications received in response to this announcement will compete

with others submitted to NIMH for funding.  In granting awards, the

following criteria are considered:



o  Program relevance

o  Quality of application as documented by IRG and Council

recommendations

o  Program balance

o  Availability of funding

o  Institute priorities



Grants must be administered in accordance with the PHS Grants Policy

Statement (rev. October 1, 1990).



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Doreen Spilton Koretz, Ph.D.

Prevention Research Branch

Parklawn Building, Room 10-85

5600 Fishers Lane

Rockville, MD  20857

Telephone:  (301) 443-4283



For further information on grants management issues, applicants may

contact:



Diana Trunnell

Grants Management Branch

National Institute of Mental Health

5600 Fishers Lane, Room 7C-15

Rockville, MD  20857

Telephone:  (301) 443-3065



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance 93.242, Mental Health Research Grants.  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 announcement is not

subject to the intergovernmental review requirements of Executive

Order 12372, as implemented through DHHS regulations at 45 CFR Part

100, or Health Systems Agency Review.



.

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