This Program Announcement expires on August 1, 2004, unless reissued.

MECHANISM FOR TIME-SENSITIVE RESEARCH OPPORTUNITIES

Release Date:  September 5, 2001

PA NUMBER:  PAR-01-136 (This PAR has been reissued, see PAR-05-150)

National Institute of Mental Health
 (http://www.nimh.nih.gov/)

Letter of Intent Receipt Date:  4 weeks prior to the planned submission date
Application Receipt Date:       9th of each month

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS FOR ALL APPLICATIONS 
SUBMITTED IN RESPONSE TO THIS PA.  MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN 
SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The National Institute of Mental Health (NIMH) encourages investigator-
initiated research applications that seek to address problems of major public 
mental health significance in which the opportunity to conduct research is 
time limited.  This Program Announcement (PA) responds to recommendations made 
by the National Advisory Mental Health Council’s Bridging Science and Service 
Report (http://www.nimh.nih.gov/research/bridge.htm).  The purpose of this PA 
is to enhance research activity and enable portfolio development in rapidly 
evolving areas (e.g., service systems, health care financing, and policy 
research) in which research opportunities are fleeting.  This PA is intended 
to support innovative lines of inquiry through scientific partnerships between 
researchers and community partners (e.g., providers, payers, health 
authorities) the latter of whom cannot delay policy or program changes in 
order to allow investigators time to obtain baseline research data about such 
changes.  This PA provides a mechanism for accelerated review and award to 
support opportunities for such research.

All eligible applications responding to this PA will be subject to an 
accelerated review and award process.  Eligible studies selected for funding 
are intended to be awarded within 4-6 months after the application receipt 
date.  However, administrative requirements and other unforeseen circumstances 
may delay issuance dates beyond that timeline.

Investigators pursuing support for mental health research in the immediate 
aftermath of a disaster are referred to Rapid Assessment Post-Impact of 
Disaster (RAPID), October 1995 revision, at 
http://www.nimh.nih.gov/grants/research/910004.cfm.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS-led national 
activity for setting priority areas.  This PA, Mechanism for Time-Sensitive 
Research Opportunities, is related to on or more of the priority areas.  
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
providers, public and private health care purchasers, laboratories, units of 
State and local governments, and eligible agencies of the Federal government.
Foreign institutions are not eligible for this time sensitive mechanism. 
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) Small Grant (R03), 
Exploratory/Developmental Grant (R21), and Research Project Grant (R01) award 
mechanisms.  The Small Grant (R03) provides two years of funding with a 
maximum of $50,000 direct costs for each year.  Information and application 
instructions for the NIMH Small Grant are available in the NIH Guide for 
Grants and Contracts at 
http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html.  
The Exploratory/Developmental Grant (R21) provides up to two years 
of funding with up to $100,000 in total direct costs annually for one-time 
grants for studying innovations in research directions, approaches, concepts, 
technologies, techniques or methods.  Information and application instructions 
for the NIMH Exploratory/Developmental Grant are available in the NIH Guide 
for Grants and Contracts at 
http://grants.nih.gov/grants/guide/pa-files/PA-00-073.html.  
The Research Project Grant (R01) provides up to five years of 
funding that is commensurate with the science proposed.  This PA will provide 
support for the initial competing award.  Funding beyond that period may be 
requested through the regular research grant application process.

Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.

For all competing R03 and R21 applications, and those 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 that have been adopted by the NIH.  Complete and detailed 
instructions and information Modular Grant applications have been incorporated 
into the PHS 398 (rev. 5/2001).  Additional information on Modular Grants can 
be found at http://grants.nih.gov/grants/funding/modular/modular.htm.

R01s greater that $250,000 per year require detailed budgets and do not follow 
Modular Grant format.
 
RESEARCH OBJECTIVES

Background

In 1999, the National Advisory Mental Health Council of the National Institute 
of Mental Health (NAMHC) issued a report,  Bridging Science and Service,  
which discussed the need for NIMH to play a larger role in bridging the 
domains of efficacy, effectiveness, practice, and service systems research. 
The report noted that the usual time for grant review and funding has 
precluded seizing certain unique, but time-limited research opportunities, and 
has thus limited the scope or application of scientific knowledge under 
circumstances in which that knowledge was needed.  Specifically, in areas such 
as evolving service systems, changes in health care financing, and policy 
research, there are often opportunities for collaborations, particularly with 
purchasers and policy-makers, which would become unavailable by the time the 
existing review and award process was completed.  The NAMHC recommended that 
NIMH develop a means of responding rapidly to investigators who propose to 
take advantage of such opportunities.  This PA was developed in response to 
these recommendations.

Research Objectives and Scope

This PA encourages research grant applications that make use of time-limited 
opportunities for investigation, particularly with community partners (e.g., 
public mental health or health care systems, long-term care providers, 
prisons, jails and other correctional system settings, health care providers, 
payers, health authorities, etc.)  Specifically, the goal is to fund 
innovative research partnerships in which the expedited initiation of a study 
is necessary in order to take advantage of a rapidly evolving change in a 
health care system or public policy.  Eligible studies might propose a 
partnership in order to recruit research participants or to simply share data, 
methods and resources.  The distinguishing feature of an eligible study is 
that rapid review and funding significantly enhance the study’s scientific 
value and feasibility.  It should be clear that the research question(s) could 
only be answered if the project is initiated with minimum delay.

Examples

Examples of appropriate studies include, but are not limited to, the 
following:

o  Examining the impact of rapid changes in legislation that affect mental 
health systems

o  Evaluating the impact of systems interventions implemented as an immediate 
response to administrative or policy directives

o  Determining the impact of new payment mechanisms including the cost-
effectiveness of alternative treatments
 
o  Identifying, describing, or tracking individual and/or family outcomes 
resulting from changes in services or changes in eligibility for benefits
 
o  Determining the impact of new dissemination or implementation strategies 

o  Examining the impact of new quality improvement programs 

ADDITIONAL PROTECTIONS FOR PRISONERS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is not uncommon for persons receiving or in need of mental health services 
to come in contact with or be confined within the criminal justice system.  
Researchers must therefore be aware of the additional human subjects 
protections required for "prisoners," a term defined by the Department of 
Health and Human Services (DHHS) to include adults, adolescents, and children 
who are either confined or detained involuntarily in an institution or 
facility by virtue of criminal or civil statutes or commitment procedures.

All investigators proposing research involving prisoners or individuals who 
may enter prisoner status during study involvement should read the Code of 
Federal Regulations, Title 45, Public Welfare, Part 46 "Protection of Human 
Subjects," which is available on the web at the following URL address: 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

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.

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 sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided indicating 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 is 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.

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.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA. 
It is important for applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public archive, 
which can provide protections for the data and manage the distribution for an 
indefinite period of time.  If so, the application should include a 
description of the archiving plan in the study design and include information 
about this in the budget justification section of the application.  In 
addition, applicants should think about how to structure informed consent 
statements and other human subjects procedures given the potential for wider 
use of data collected under this award.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the number and title of this PA.  Although 
the letter of intent is not required, is not binding, and does not enter into 
the review of a subsequent application, the information that it contains 
allows NIMH staff to estimate the potential review workload and plan the 
expedited review.

The letter of intent is to be sent to Denise Juliano-Bult, M.S.W. at the 
address listed under INQUIRIES, approximately 4 weeks prior to the planned 
submission date.

APPLICATION PROCEDURES

Applicants are strongly encouraged to contact the program staff listed under 
INQUIRIES with any questions regarding their proposed project and the goals of 
this PA.

The PHS 398 research grant application instructions and forms (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in 
applying for these grants and will be accepted at the application deadlines 
described below.  This version of the PHS 398 is available in an interactive, 
searchable PDF format.  Although applicants are strongly encouraged to begin 
using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will 
continue to accept applications prepared using the 4/1998 revision until 
January 9, 2002.  Beginning January 10, 2002, however, the NIH will return 
applications that are not submitted on the 5/2001 version.  For further 
assistance contact GrantsInfo, Telephone 301/710-0267, Email: 
[email protected].

Applicants planning to submit an investigator-initiated new (type 1) grant 
application requesting $500,000 or more in direct costs for any year are 
advised that he or she must contact the Institute or Center (IC) program staff 
before submitting the application, i.e., as plans for the study are being 
developed.  Furthermore, the application must obtain agreement from the IC 
staff that the IC 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 or Center 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.

SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS PA

Applications must be received by the ninth of each month.  Applications which 
are received after the ninth will automatically be processed the following 
month.  Applications not received as a single package on the receipt date or 
not conforming to the instructions contained in PHS 398 Application Kit (as 
modified in and superseded by, the special instructions below, for the 
purposes of this PA), will be judged non-responsive and will be returned to 
the applicant.

Along with the specific aims, background and significance, preliminary 
studies, and research design and methods (Sections A to D), the research plan 
must include a justification for why the proposed study requires accelerated 
review and award.  Justification must include an explanation of how the 
study’s goals cannot be achieved without rapid review and award, or how rapid 
review and funding would significantly enhance the efficiency or scientific 
value of the study. 

Methods of data collection and analysis, and power calculations must be 
included, along with a justification for the required sample size.  There must 
also be a discussion of the statistical procedures that will be used to 
analyze the data.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

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 NIH staff. 
The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions beginning on page 
13 of the application instructions.  Applicants are permitted, however, to use 
the 4/1998 revision of the PHS 398 for scheduled application receipt dates 
until January 9, 2002.  If you are preparing an application using the 4/1998 
version, please refer to the step-by-step instructions for Modular Grants 
available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Submit a signed, typewritten original of the application, including the 
Checklist, and three 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)

At the time of submission, two additional copies of the application must be 
sent to:

Jean Noronha, Ph.D. 
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
ROCKVILLE, MD  20852 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned to NIMH.  An appropriate scientific review group 
convened by NIMH will evaluate applications for scientific and technical 
merit.  As part of the initial merit review, all applications will receive a 
written critique and may 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 National Advisory Mental Health Council.

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:  Is the research question one that cannot be adequately 
answered unless the review and funding of the project is expedited? Does the 
research opportunity address an important problem?  If the aims of the 
application are achieved, will scientific knowledge be significantly advanced? 
What will be the effect on the concepts or methods that drive the relevant 
fields?
 
(2) Approach:  Does the approach justify the need for rapid review and 
funding?  Is the approach likely to successfully develop the partnership(s) 
needed to carry out the study and complete work in the time period proposed?  
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 proposed 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:  Are the investigators appropriately trained and 
experienced, and well suited to carry out this work, including maintenance of 
the working partnership?  Do the collaborators adequately demonstrate both the 
capability and the commitment to carrying out the work proposed?  

(5) Environment:  Do the environment(s) in which the work will be done 
contribute to the probability of success?  Do the proposed investigations take 
advantage of unique features of the environment(s) and support the 
justification for rapid review and funding?  Is there evidence of 
institutional support from both sides of the partnership? Are collaborating 
community partners committed to the rapid nature of the project?

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  Evidence that all the research partners are committed to the success of the 
project. 

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research

o  The adequacy of the proposed protection for humans, to the extent they may 
be adversely affected by the project proposed in the application.

o  The adequacy of the proposed plan to share data, if appropriate.

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

Potential applicants are strongly urged to contact the Program Officer, Denise 
Juliano-Bult, before submitting an application under this program 
announcement, to determine whether the proposed work meets the guidelines 
described herein, particularly with respect to eligibility for rapid review 
and funding. 

Denise Juliano-Bult, M.S.W.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7137, MSC 9631 
Bethesda, MD  20892-9631
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-1638
FAX:  (301) 443-4045
Email:  [email protected] 

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:  [email protected] 

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, 45 CFR 66 and 45 CFR 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
NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
NIH... Turning Discovery Into Health®