RESEARCH ON METHODS IN MENTAL HEALTH RESEARCH

NIH GUIDE, Volume 23, Number 16, April 29, 1994



PA NUMBER:  PA-94-060



P.T.





Keywords:



National Institute of Mental Health



PURPOSE



The purpose of this program announcement is to encourage research

grant applications for work on the design, measurement, and

statistical challenges inherent in conducting mental health research.

The goal of this initiative is to build the methodological

infrastructure of mental health research by encouraging

statisticians, psychometricians, and other experts in research

methodology and data analysis to focus on these challenges.



This program announcement addresses recommendations set forth in the

Clinical Services Research section of Caring for People with Severe

Mental Disorders: A National Plan of Research to Improve Services and

in earlier National Institute of Mental Health (NIMH) initiatives

relating to specific populations and disorders, including children

and adolescents, the elderly, rural populations, and schizophrenia.



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.  This program

announcement, Research on Methods in Mental Health Research, is

related to the priority area 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 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 foreign and domestic, for-profit and

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

colleges, hospitals, laboratories, units of State or local

governments, and eligible agencies of the Federal government.

Foreign institutions are not eligible for First Independent Research

Support and Transition (FIRST) (R29) awards.  Applications from

minority individuals and women are encouraged.



MECHANISM OF SUPPORT



Research support may be requested through applications for regular

research grants (R01), small grants (R03), and FIRST awards (R29).

Since the R03 and R29 mechanisms have special requirements regarding

eligibility, application format, and review criteria, applicants are

strongly encouraged to consult with program staff (listed under

INQUIRIES) and obtain specialized announcements.



Applications may request support for up to five years for regular

research.  Small grants are limited to two years and may not be

renewed.  FIRST awards are for five years, but are not renewable.

Annual awards will be made, subject to continued availability of

funds and progress achieved.



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

this program announcement will vary, it is anticipated that the size

of the awards will also vary.



RESEARCH OBJECTIVES



Background.  Advances in mental health research are highly dependent

on the quality of research procedures, measures, and data analytic

strategies available to investigators.  As the knowledge base

broadens and deepens, questions of increasing subtlety and complexity

must be addressed.  To do so requires the development or adaptation

of increasingly more sophisticated and precise methods, measures, and

analytic strategies.



The NIMH is issuing this program announcement to ensure that

statisticians, psychometricians, and other experts in research

methodology and data analysis who are currently working on the

methodological issues in mental health research will continue to do

so and that those methodological experts who are not working on

mental health issues will be encouraged to enter the field, bringing

with them the insight that a fresh perspective can provide in finding

solutions to problems.



This program announcement makes explicit the determination of NIMH to

support the basic methodological work necessary for the advancement

of mental health research.



Research Issues.  Listed below are examples of research topic areas

that focus on methods, measurement, and statistical analysis in

mental health research.  The list of examples is illustrative, not

exhaustive; it is expected that additional important research topics

will be identified by researchers who respond to this program

announcement.  Design, measurement, and data analytic topics relevant

to any of the areas of inquiry funded by NIMH, including mental

health services, epidemiologic, prevention, basic behavioral, brain,

and clinical and treatment research, are encouraged.



o  Studies focusing on the development and refinement of instruments

and procedures for assessing both stable and unstable characteristics

of individuals (e.g., psychopathology, mental disorder,

positive/adaptive personality functioning) and environments (e.g.,

stressful and supportive conditions of home, workplace, social

networks, service systems), with particular attention to psychometric

indices of reliability and validity, including susceptibility to

response bias, gender differences, cultural relevance, and

applicability to diverse study populations



o  Research concerning the development of new or improved data

analytic strategies for handling the difficulties and challenges

encountered in analyzing data from longitudinal studies



o  Research to develop design, assessment, and data analytic methods

that address the shortcomings, for clinical decision making, of

sample-based statistical conclusions



o  Studies bearing on the use and/or combination of data from

multiple informants, including attention to (1) individual

characteristics and environmental context, and (2) how the influences

of these factors change as a function of the nature of the

information reported



o  Studies of the reliability and validity of instruments in multiple

outcome domains particularly for understudied populations, e.g.,

severely mentally ill persons who are homeless, minorities, rural

residents, and severely emotionally disturbed children



STUDY POPULATIONS



INCLUSION OF FEMALES 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) and supersedes and strengthens the previous policies

(Concerning the Inclusion of Women in Study Populations, and

Concerning the Inclusion of Minorities in Study Populations) which

have been in effect since 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 9, 1994 (FR 11146-11151), and reprinted in

the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23,

Number 11.



Investigators may obtain copies from these sources or from the

program staff or contact person listed below.  Program staff may also

provide additional relevant information concerning the policy.



APPLICATION PROCEDURES



Applicants are to use the research grant application form PHS 398

(rev. 9/91).  The number (PA-94-060) and the title of this program

announcement, Research on Methods in Mental Health Research, must be

typed in item number 2a on the face page of the PHS 398 application

form.  Applicants must also specify under which support mechanism

they are applying: R01, R29, R03.



Applicants should note that FIRST (R29) applications must include at

least three sealed letters of reference attached to the face page of

the original application.  FIRST applications submitted without the

required number of reference letters will be considered incomplete

and will be returned without review.



Application kits containing the necessary forms may be obtained from

the office of sponsored research at most universities, colleges,

medical schools, and other major research facilities or from the

Office of Grants Information, Division of Research Grants, National

Institutes of Health, Westwood Building, Room 449, Bethesda, MD

20892, telephone 301/496-7441.



The signed original and five copies of the completed PHS 398 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 primarily of 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 for consideration for funding by the Council

may be supported.  Summaries of IRG recommendations are sent to

applicants as soon as possible following IRG review.



Review Criteria.  Criteria to be considered in evaluating R01

applications for scientific/technical merit include:



o  Scientific, technical, or medical significance and originality of

the proposed research

o  Appropriateness and adequacy of the research approach and

methodology proposed to carry out the research

o  Qualifications and research experience of the principal

investigators and staff, particularly but not exclusively in the area

of the proposed research

o  Availability of resources necessary to the research

o  Appropriateness of the proposed budget and duration in relation to

the proposed research

o  Adequacy of the proposed means for protecting against or

minimizing adverse effects to human and/or animal subjects



Because the R03 and R29 mechanisms have some distinct review

criteria, applicants are strongly encouraged to consult with program

staff (listed under INQUIRIES) and obtain specialized announcements.



AWARD CRITERIA



Factors considered in determining which applications will be funded

include IRG and Council recommendations, PHS program needs and

priorities, and availability of funds.



As part of the NIMH Public-Academic Liaison (PAL) initiative,

preference may be given to applications that involve active

collaborations between academic researchers and public sector

agencies in planning, undertaking, analyzing, and publishing research

pertaining to persons with severe mental disorders.  The PAL

initiative is based on the premise that important new advances in

understanding and treatment of severe mental disorders can result

from improved linkages between the Nation's scientific resources and

the public sector agencies and programs in which many persons with

severe mental disorders receive their care.



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:



Ann A. Hohmann, Ph.D., M.P.H.

Services Research Branch

National Institute of Mental Health

5600 Fishers Lane, Room 10C-06

Rockville, MD  20857

Telephone:  (301) 443-3364



Direct inquiries regarding fiscal matters to:



Diana S. Trunnell

Grants Management Branch

National Institute of Mental Health

5600 Fishers Lane, Room 7C-08

Rockville, MD  20857

Telephone:  (301) 443-3065



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance 93.242.  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).  Grants must be

administered in accordance with the PHS Grants Policy Statement (Rev.

October 1990).  Federal Regulations at 42 CFR Part 52 and 66, "Grants

for Research Projects" and 45 CFR Parts 74 [and 92 when applicable

for State and local government.]  This program 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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