DESIGN, MEASUREMENT, AND STATISTICAL ANALYSIS IN MENTAL HEALTH RESEARCH
Release Date: November 15, 2000
PA NUMBER: PA-01-018 (see replacement PA-04-150)
National Institute of Mental Health
THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS PA INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA.
PURPOSE
The purpose of this program announcement (PA) is to encourage research grant
applications for work on the design, measurement, and statistical challenges
inherent in conducting mental health services research. The goal of this
initiative is to build the methodological infrastructure of mental health
services research by encouraging statisticians, psychometricians, qualitative
researchers, and other experts in research methodology and data analysis to
focus on these challenges.
This program announcement supercedes PA-94-060 and addresses recommendations
set forth in the NIMH report, Bridging Science and Service: A Report by the
National Advisory Mental Health Council’s Clinical Treatment and Services
Research Workgroup Applicants may obtain a copy of the report at
http://www.nimh.nih.gov/research/bridge.htm
HEALTHY PEOPLE 2010
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 PA, Design,
Measurement, and Statistical Analysis in Mental Health Research, is related
to one or more of the priority areas. Potential applicants may obtain a copy
of "Healthy People 2000" at http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, 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 are not eligible
for small grant awards. Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as principal investigators.
MECHANISM OF SUPPORT
This PA will use the National Institutes of Health (NIH) research project
grant (R01) and the Small Grant (R03) award mechanisms. Responsibility for
the planning, direction, and execution of the proposed project will be solely
that of the applicant. The total project period for an application submitted
in response to this PA may not exceed five years for an R01 application and
two years for an R03 application.
For all R03 applications and all competing R01 applications requesting up to
$250,000 direct costs per year, specific application instructions have been
modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts
being undertaken at NIH. More detailed information about modular grant
applications, including a sample budget narrative justification pages and a
sample biographical sketch, is available via the Internet at:
http://grants.nih.gov/grants/funding/modular/modular.htm. Applications that
request more than $250,000 in any year must use the standard PHS 398 (rev.
4/98) application instructions.
Because the small grant (R03) mechanism has special eligibility requirements,
application formats, and review criteria, applicants are strongly encouraged
to consult with program staff (listed under INQUIRIES) and to obtain the
appropriate additional announcement for that mechanism. Special instructions
and information for the R03 are found at
http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html
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.
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 Studies examining the effects of multiple administrations of
measures/procedures over time on the reliability, validity, and
interpretability of responses relative to the construct or phenomenon under
study
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 assessing the relative utility of assessment batteries and
protocols, including their cost and ease of administration, acceptability to
respondents, and usefulness in advancing the knowledge base
o Research on the applicability to mental health research of methodologies
and analytic strategies such as decision analysis, meta-analysis, diary
studies, and ethnography
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
o Research assessing the relative utility, including costs and ease of
administration, of various packages of instruments to assess mental health
outcomes and to assess and predict costs of care
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 policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-
048.html), a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable, and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
APPLICATION PROCEDURES
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit. Application kits are available at most institutional
offices of sponsored research and from the Division of Extramural Outreach
and Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email:
GrantsInfo@nih.gov. Applications are also available on the World Wide Web
at: http://grants.nih.gov/grants/forms.htm.
SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS
The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The
just-in-time concept allows applicants to submit certain information only
when there is a possibility for an award. It is anticipated that these
changes will reduce the administrative burden for the applicants, reviewers
and Institute staff. The research grant application form PHS 398 (rev. 4/98)
is to be used in applying for these grants, with the modifications noted
below.
BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in $25,000 modules, up
to a total direct cost request of $250,000 per year. (Applications that
request more than $250,000 direct costs in any year must follow the
traditional PHS 398 application instructions.) The total direct costs must
be requested in accordance with the program guidelines and the modifications
made to the standard PHS 398 application instructions described below:
PHS 398
o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs
(in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular
Total Direct plus Facilities and Administrative (F&A) costs] for the initial
budget period Items 8a and 8b should be completed indicating the Direct and
Total Costs for the entire proposed period of support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page
4 of the PHS 398. It is not required and will not be accepted with the
application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required
and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for
sample pages.) At the top of the page, enter the total direct costs
requested for each year. This is not a Form page.
o Under Personnel, List all project personnel, including their names,
percent of effort, and roles on the project. No individual salary
information should be provided. However, the applicant should use the NIH
appropriation language salary cap and the NIH policy for graduate student
compensation in developing the budget request.
For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the
nearest $1,000. List the individuals/organizations with whom consortium or
contractual arrangements have been made, the percent effort of all personnel,
and the role on the project. Indicate whether the collaborating institution
is foreign or domestic. The total cost for a consortium/contractual
arrangement is included in the overall requested modular direct cost amount.
Include the Letter of Intent to establish a consortium.
Provide an additional narrative budget justification for any variation in the
number of modules requested.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual"s qualifications for a
specific role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for
all key personnel, following the instructions below. No more than three
pages may be used for each person. A sample biographical sketch may be
viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form page,
- List position(s) and any honors,
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations,
o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the
type of agreement and the date. All appropriate exclusions must be applied
in the calculation of the F&A costs for the initial budget period and all
future budget years.
o The applicant should provide the name and phone number of the individual
to contact concerning fiscal and administrative issues if additional
information is necessary following the initial review.
Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised that he or she must contact the
Institute program staff before submitting the application, i.e., as plans for
the study are being developed. Furthermore, the application must obtain
agreement from the Institute staff that the Institute will accept the
application for consideration for award. Finally, the applicant must
identify, in a cover letter sent with the application, the staff member and
Institute who agreed to accept assignment of the application.
This policy requires an applicant to obtain agreement for acceptance of both
any such application and any such subsequent amendment. Refer to the NIH
Guide for Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html
Any application subject to this policy that does not contain the required
information in a cover letter sent with the application will be returned to
the applicant without review.
The title and number of the program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
Submit a signed, typewritten original of the application, including the
Checklist, and five signed photocopies in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
REVIEW CONSIDERATIONS
Applications will be assigned on the basis of established PHS referral
guidelines. Applications will be evaluated for scientific and technical
merit by an appropriate scientific review group convened in accordance with
the standard NIH peer review procedures. As part of the initial merit
review, all applications will receive a written critique and undergo a
process in which only those applications deemed to have the highest
scientific merit, generally the top half of applications under review, will
be discussed, assigned a priority score, and receive a second level review by
the appropriate national advisory council or board.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals. Each
of these criteria will be addressed and considered in assigning the overall
score, weighting them as appropriate for each application. Note that the
application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
(1) Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
AWARD CRITERIA
Applications will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:
Quality of the proposed project as determined by peer review, availability of
funds, and program priority.
INQUIRIES
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.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7135, MSC 9631
Bethesda, MD 20892-9631
Telephone: (301) 443-4235
Email: ahohmann@nih.gov
Direct inquiries regarding fiscal matters to:
Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: Diana_Trunnell@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
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) 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.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
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