RESEARCH INFRASTRUCTURE SUPPORT PROGRAM

NIH GUIDE, Volume 21, Number 35, October 2, 1992



PA AVAILABLE:  PA-93-003



P.T. 14



Keywords:

  Mental Disorders 

  Clinical Medicine, General 

  Biomedical Research, Multidiscipl 



National Institute of Mental Health



THE PROGRAM ANNOUNCEMENT (PA) ANNOUNCED IN THIS NOTICE CONTAINS

ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION.  POTENTIAL

APPLICANTS MAY OBTAIN THE PROGRAM ANNOUNCEMENT FROM THE CONTACT NAMED

IN INQUIRIES, BELOW.



PURPOSE



The National Institute of Mental Health (NIMH) is committed to

expanding the number of institutions capable of supporting

state-of-the-art clinical and services research and thus increasing the

number of investigators obtaining extramural funding for their

research.  Expansion of the clinical research infrastructure is a major

priority of the NIMH; the Research Infrastructure Support Program

(RISP) is a direct response of the NIMH to recommendations made by the

National Advisory Mental Health Council and by the NIMH Extramural

Science Advisory Board.  The purpose of this PA is to stimulate the

development of new resources at institutions capable of developing and

maintaining programs of clinical and services research directed at the

major 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,

Research Infrastructure Support Program, is related to the priority

areas of mental health and mental disorders.  Potential applicants may

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

017-001-00474-0 or 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, non-profit and

for-profit organizations such as universities, colleges, hospitals,

laboratories, units of State and local governments, and eligible

agencies of the Federal government, except for those institutions with

NIMH research support exceeding $3,000,000 (in total costs) in fiscal

year 1991.  Women and minorities are encouraged to apply.



MECHANISM OF SUPPORT



Grants awarded in the RISP program will use the Resource-Related

Research Project mechanism (R24) to contribute to the improvement of

the capability of resources to serve biomedical research.



RESEARCH OBJECTIVES



Many institutions with access to large and varied populations of

individuals with mental disorders are not able to launch research

programs because of limited technical and scientific support available

within their research environment.  This program will assist in the

development of these and other resources that will form part of the

institution's clinical research infrastructure.



Applicant institutions must describe a comprehensive and coherent plan

of improvement to the institution's current research environment that

will expand the capacity of investigators at the institution to carry

out extramurally supported mental health research.  The plan must have

a focus on  particular mental health clinical populations or diagnostic

groups and must demonstrate accessibility of the population to

institution-based investigators.  The plan must also demonstrate the

actual commitment of institutional resources which may include senior

faculty release time, support staff, research bed costs, equipment

costs assumed by the institution, and waiver of overhead costs.



A central philosophical principle underlying this program is that

different institutions will require different types of infrastructure

development activities and initiatives.  Therefore, this announcement

does not prescribe in any detail the nature of the activities to be

applied for or supported.



The following types of support may be requested under this program:



o  Partial salary support for junior faculty, particularly women and

minorities



o  Training expenses for junior faculty



o  Research patient recruitment, diagnosis, assessment, and follow-up



o  Clinical and scientific consultation, including expenses incurred by

an external review and scientific advisory committee



o  Biostatistical and data-base management services



o  Small equipment and research instruments



o  Research technicians and assistants



o  Developmental, feasibility, or pilot studies



STUDY POPULATIONS



NIH POLICY CONCERNING INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS IN

RESEARCH



Applications for grants and cooperative agreements and proposals for

contracts that involve human subjects are required to include

minorities and both genders 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 applies to all research involving human subjects and human

materials, and applies to males and females of all ages.  If one gender

and/or minorities are excluded or are inadequately represented in this

research, particularly in proposed population-based studies, a clear

compelling rationale for exclusion or inadequate representation should

be provided.  The composition of the proposed study population must be

described in terms of gender and racial/ethnic group, together with a

rationale for its choice.  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.



Applicants are urged to assess carefully the feasibility of including

the broadest possible representation of minority groups.  However, the

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., American Indians or

Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics).

Investigators must provide the rationale for studies on single minority

population groups.



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

Sections 1-4 of the Research Plan AND summarized in Section 5, Human

Subjects.



Applications for support of research involving human subjects must

employ a study design with minority and/or gender representation (by

age distribution, risk factors, incidence/prevalence, etc.) appropriate

to the scientific objectives of the research.  It is not an automatic

requirement for the study design to provide statistical power to answer

the questions posed for men and women and racial/ethnic groups

separately;  however, whenever there are scientific reasons to

anticipate differences between men and women, and racial/ethnic groups,

with regard to the hypothesis under investigation, applicants should

include an evaluation of these gender and minority group differences in

the proposed study.  If adequate inclusion of one gender and/or

minorities is impossible or inappropriate with respect to the purpose

of the research, because of the health of the subjects, or other

reasons, or if in the only study population available, there is a

disproportionate representation of one gender or minority/majority

group, the rationale for the study population must be well explained

and justified.



All applications for clinical research submitted to the NIH are

required to address these policies.  NIH funding components will not

award grants that do not comply with these policies.



APPLICATION PROCEDURES



Applicants are to use the research grant application form PHS 398 (rev.

9/91) in applying for these grants.  The number and title of this PA,

Research Infrastructure Support Program, must be typed in item 2a on

the face page of the PHS application form.



Applications kits containing the necessary forms and instructions may

be obtained from business offices and offices of sponsored research at

most universities, colleges, medical schools, and other major research

facilities.  If such a source is not available, the necessary

application materials may be obtained from the Grants Management

Branch, National Institute of Mental Health, 5600 Fishers Lane, Room

7C-05, Rockville, MD  20857 (telephone  301/443-4414).



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 reviewed for scientific and technical merit by an

initial review group (IRG) composed of primarily non-Federal scientific

experts.  Final review is by the appropriate National Advisory Council,

review by Council may be based on policy considerations as well as

scientific merit.  By law, only applications recommended by the Council

may be considered for funding.  Summary statements of IRG discussions

are sent to applicants as soon as possible following IRG review.



Review Criteria



o  Past research training record for both the program and the

designated preceptors in terms of the rate at which former trainees

establish independent and productive research careers



o  Past research training record in terms of the success of former

trainees in obtaining individual awards such as fellowships, career

awards, and research grants for further development



o  Objectives, design, and direction of the research training program



o  Caliber of preceptors as researchers including successful

competetion for research support



o  Training environment including the institutional commitment, the

quality of the facilities, and the availability of research support



o  Recruitment and selection plans for appointees and the availability

of high quality candidates



o  The record of the research training program in retaining health-

professional post-doctoral trainees for at least two years in research

training or other research activities



o  When appropriate, the concomitant training of health-professional

post-doctorates (e.g., individuals with the M.D., D.O., D.D.S.) with

basic science post-doctorates (e.g., individuals with a Ph.D., Sc.D.)

will receive special consideration



Following scientific-technical review, the application will receive a

second-level review by the appropriate National Advisory Council.



AWARD CRITERIA



Applications recommended for approval by the appropriate National

Advisory Council will be considered for funding on the basis of overall

scientific and technical merit of the research as determined by peer

review, program needs and balance, and availability of funds.



INQUIRIES



Written and telephone inquiries concerning this PA are encouraged.  The

opportunity to clarify any issues or questions from potential

applicants is welcome.



Direct inquiries regarding programmatic issues to:



Grayson S. Norquist, M.D., M.S.P.H.

Deputy Director, Division of Epidemiology and Services Research

National Institute of Mental Health

Parklawn Building, Room 18C-26

5600 Fishers Lane

Rockville, MD  20857

Telephone:  (301) 443-3683



Direct inquiries regarding fiscal matters to:



Stephen J. Hudak

Chief, Grants Management Section

National Institute of Mental Health

Parklawn Building, Room 7C-23

5600 Fishers Lane

Rockville, MD  20857

Telephone:  (301) 443-4456



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 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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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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