NIMH EXPLORATORY/DEVELOPMENTAL GRANT (R21) PROGRAM

Release Date:  March 6, 2000

PA NUMBER:  PA-00-073

National Institute of Mental Health

PURPOSE

The Division of Neuroscience and Basic Behavioral Science and the Division of 
Services and Intervention Research of the National Institute of Mental Health 
(NIMH)  invites applications for Exploratory/Developmental Grants (R21) that 
fall within their research interests.

The objective of this Exploratory/Developmental Grant (R21) mechanism is to 
encourage applications for one-time grants to support:  1) innovative 
research directions requiring preliminary testing or development; 2) 
exploration of the use of approaches and concepts new to a particular 
substantive area; 3) research and development of new technologies, techniques 
or methods; or 4) initial research and development of a body of data upon 
which significant future research may be built, i.e., the data should have a 
high level of impact on the field.

While this program announcement is intended to encourage innovation and high 
impact research, and while no preliminary data are expected to be described 
in the application, applications should make clear that the proposed research 
and/or development is scientifically sound, that the qualifications of  the 
investigators are appropriate, and that resources available to the 
investigators are adequate.

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 program announcement 
PA "NIMH EXPLORATORY/DEVELOPMENTAL GRANT (R21) PROGRAM," is related to the 
priority area of Mental Health and Mental Disorders.  Potential applicants 
may obtain a copy of "Healthy People 2010" at: 
http://www.health.gov/healthypeople

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic or 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.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 
investigators.

MECHANISM OF SUPPORT

Under this program announcement, applicants for the R21 award may request 
direct costs of up to $100,000 per year for up to two years.  Competitive 
renewals of grants awarded under this program announcement will not be 
accepted.

Specific application instructions have been modified to reflect the purpose 
and nature of this mechanism, as well as to accommodate the "Modular Grant" 
and "Just-In-Time" streamlining efforts being implemented by the NIH.  
Complete and detailed instructions and information on Modular Grant 
applications can be found at the website 
http://grants.nih.gov/grants/funding/modular/modular.htm.

RESEARCH OBJECTIVES

The R21 mechanism described in this program announcement may support research 
and/or development relevant to the mission of the Division of Neuroscience 
and Basic Behavioral Science and the Division of Services and Intervention 
Research of the NIMH.

The Division of Neuroscience and Basic Behavioral Science provides extramural 
support of basic and clinical neuroscience research, genetics research, 
development of therapeutics, basic behavioral science research, research 
training and career development, and research and development of scientific 
technologies relevant to any of these substantive areas.  The overarching 
goal of research supported in this Division is to increase understanding of 
basic behavioral mechanisms and the neural basis of normal and disordered 
mental function.  Specific research funding programs of this Division are 
housed within the following office and branches of the Division:  1) 
Translational Research and Scientific Technology Office, 3) Behavioral 
Science Research Branch, 4) Behavioral and Integrative Neuroscience Research 
Branch, 5) Clinical Neuroscience Research Branch, 6) Genetics Research 
Branch, and 7) Molecular and Cellular Neuroscience Research Branch.  The 
branches, offices and programs comprising the Division are described in more 
detail on the website http://www.nimh.nih.gov/diva/index.htm.

The Division of Services and Intervention Research (1) directs, plans, 
supports and conducts programs of research in prevention and treatment 
interventions, services research and clinical epidemiology.  These efforts 
include the support of  research, research training, research demonstrations, 
and research dissemination.  Specific research funding programs of this 
Division are housed within the following branches: 1) Adult and Geriatric 
Treatment and Preventive Intervention Research Branch, 2) Child and 
Adolescent Treatment and Preventive Intervention Research Branch, and 3) 
Services Research and Clinical Epidemiology Branch.  This announcement 
complements other announcements such as PA-99-134, but highlights the 
following substantive areas: quality of care, mixed research methods, and 
socio-cultural issues.  The branches, offices and programs comprising the 
Division are described in more detail on the website 
http://www.nimh.nih.gov/dsir/index.htm.

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 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which have been published in the Federal Register of March 28, 
1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 
23, No. 11, March 18, 1994 available on the web at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.html

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.

APPLICATION PROCEDURES

Applicants are strongly encouraged to contact the program contacts listed 
under INQUIRIES with any questions regarding their proposed project.

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) 435-0714, Email: 
GrantsInfo@nih.gov.  Applications are also available on the World Wide Web 
at: http://grants.nih.gov/grants/forms.htm.

When form PHS 398 is used, the following modifications should be included:

1.  Face Page of the application:

Item 2, Check the box marked “Yes” and type the number and title (NIMH 
Exploratory/Developmental Grant [R21] Program) of this program announcement.

2.  Description:

As part of the description, identify briefly how this application relates to 
the purpose of the R21 mechanism as stated in this program announcement 
(i.e., highly innovative research; exploration of the use of approaches and 
concepts new to a particular substantive area; research and development of 
new technologies, techniques or methods; or initial research and development 
of a body of data upon which significant future research may be built).

Research Plan:

The Research Plan may not exceed 10 pages.

Item a, SPECIFIC AIMS:

The instructions for this section suggest that the applicant state “the 
hypotheses to be tested.”  Since some applications submitted in response to 
this program announcement may also be design- or problem-driven (e.g., 
development of novel technologies), or need-driven (initial research to 
develop a body of data upon which future research will build).  In such 
instances, hypothesis testing per se may not be the driving force in 
developing such a proposal and, therefore, may not be applicable.  Thus, the 
application should state the hypotheses, design, problem and/or need which 
will drive the proposed research.

Item b, BACKGROUND AND SIGNIFICANCE:

In this section it is important to clearly elaborate upon how the application 
serves the purpose of this program announcement. 

Item c, PRELIMINARY STUDIES/PROGRESS REPORT

Although preliminary data are not expected for an Exploratory/Developmental 
Grant application, if such data exist they should be presented.

Item d, RESEARCH DESIGN AND METHODS

In many cases, an Exploratory/Developmental Grant mechanism will support 
novel research in an area or the research and development of new 
technologies.  Where appropriate, specific criteria by which to judge the 
feasibility of novel approaches (including milestones that will mark 
progress) should be explicitly described in this section.

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 $100,000 per year. 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 $100,000) 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 key 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 key 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.

Submit a signed original of the application and five exact photocopies, 
including the checklist, 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 that are complete will be evaluated for scientific and technical 
merit by an appropriate peer 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 and 
assigned a priority score and receive a secondary 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.  Funding decisions will be made based on the quality of the 
proposed project as determined by peer review, program priorities, and 
availability of funds.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.

A complete listing of contacts for both programmatic and 
fiscal/administrative 
inquiries may be found at:

http://www.nimh.nih.gov/grants/r21.cfm

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.

PHS strongly encourages all grant and contract recipients to provide a smoke-
free workplace and promote the nonuse 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.

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