NIH Guide: DEVELOPMENTAL GRANTS FOR MINORITY COLLABORATIVE PROJECTS

DEVELOPMENTAL GRANTS FOR MINORITY COLLABORATIVE PROJECTS

Release Date: April 3, 2000

PA NUMBER: PA-00-085

National Institute on Alcohol Abuse and Alcoholism

THIS PROGRAM ANNOUNCEMENT (PA) USES "MODULAR GRANT" AND "JUST-IN-TIME"
CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION
INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO
THIS PA.

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking
applications for exploratory/developmental (R21) grant applications for
collaborative research projects to encourage new or strengthen existing
cooperative relationships between established alcohol research scientists and
scientists in minority and/or predominantly minority institutions. Awards
under this program are intended to enhance and extend the alcohol research
activities of minority scientists. It is expected that projects will be
mutually beneficial to the collaborating scientists and to the advancement of
research on alcoholism and alcohol abuse. Exploratory/developmental grants
(R21) are intended to develop new research activities that could serve as the
foundation for the development of more intensive and larger research studies.
Normally grants supported under this PA will be for $50,000 or $75,000 per
year (direct costs) for two years. Exceptional proposals can be considered
for up to $100,000 in direct costs per year, for a maximum of three years.

The issues related to alcohol abuse, alcoholism, and reduction of alcohol-
related problems are complex. The NIAAA supports alcohol relevant basic and
applied research involving a wide array of health science fields and related
academic disciplines. Because the United States is a multi-cultural, multi-
ethnic Nation with wide diversity in the patterns, trends, and practices
around alcohol use and abuse, much can be gained from research partnerships
in this field.

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), Developmental Grants for Minority Collaborative Projects, is related to
one 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,
laboratories, units of State and local governments, and eligible agencies of
the Federal Government. Foreign institutions are not eligible for these
grants. Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.

One scientist must apply as principal investigator with a colleague from a
laboratory or research site in the collaborating institution. It is
recognized that scientific opportunities may arise that warrant a formal
collaborative effort between the principal investigator and individuals from
more than one institution. The collaborator must hold a position at a public
or private non-profit institution that will allow him or her adequate time
and provide appropriate facilities to conduct the proposed research. The
linkages for collaborative efforts must be between institutions in the United
States. Simultaneous submissions of both an exploratory/developmental and a
regular research grant (R01) application on the same topic will not be
accepted.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) R21 award mechanism.
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 3 years.

Applicants may request up to $100,000 in direct costs per year for up to
three years through the NIAAA Exploratory/ Developmental Grant (R21)
mechanism. Facilities and Administrative (F&A) costs will be awarded based
on the negotiated rate at the time of the award. These awards are not
renewable; however, a no-cost extension of up to one year may be granted to
the grantee institution prior to expiration of the project period.
Investigators are encouraged to seek continued support for their research
projects through a research project grant (R01).

Awards are made to the applicant institution to support a collaborative
research project that will be performed, in part, at the collaborator's
research site. Funds may be included to purchase supplies for the
collaborator's laboratory and to support travel for the collaborators as
justified by the needs of the research proposed. Annual awards will be made
subject to continued availability of funds and progress achieved.

Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.
Complete and detailed instructions and information on Modular Grant
applications can be found at
https://grants.nih.gov/grants/funding/modular/modular.htm.

RESEARCH OBJECTIVES

The purpose of this program announcement is to encourage exploratory/
developmental studies that will complement and enhance existing alcohol
research efforts. The establishment of this program will provide
opportunities for attracting additional scientists to the alcohol field.
This program will establish a process for making the accumulated knowledge
and experience of alcohol investigators available to colleagues in
historically and predominantly minority institutions to address relevant
issues and problems. The number of scientists who are identified as members
of underrepresented minority groups and who are engaged in alcohol research
is extremely small. Clearly there is a need to develop ways to assist and
encourage minority scientists to become active in the conduct of studies that
can advance the rapidly growing knowledge base in the alcohol field. It is
anticipated that this program will provide support to enhance research
capabilities in research oriented minority institutions; to
collaboratively pilot test a hypothesis before a larger more complex project
is developed; to develop new technology or methodologies to facilitate the
study of appropriate research problems; and to create opportunities for
collaborating scientists to acquire knowledge and skills that enable them to
submit competitive research grant applications. The intent is to advance
understanding, contribute meaningfully to the literature, and to
significantly advance alcohol research efforts in minority institutions.
Minority investigators may also apply directly for an
exploratory/developmental grant from NIAAA.

It is anticipated that collaborative efforts established through this program
will:

a) facilitate development of alcohol relevant epidemiologic, biomedical,
behavioral, treatment, prevention, and policy research activities in minority
institutions;

b) provide opportunities to scientifically explore biological, behavioral,
and socio-cultural phenomena that may help to explain differing degrees of
severity and disease progression of alcohol induced adverse effects observed
among and within minority groups and subgroups;

c) enhance development of talent, scientific expertise and resources capable
of making unique contributions to the field;

d) stimulate development of alcohol focused research training programs in
schools of medicine and other doctoral degree programs in minority and
predominantly minority institutions; and

e) facilitate development of the foundation for the coordinated conduct of
scientifically sound studies and interventions on a broad and inclusive basis
that reflects the multi-ethnic, multi-cultural heterogeneity of the U.S.
population.

Applications may be made for support of research in any scientific area
relevant to alcohol abuse. While applications may involve a wide variety of
biomedical, biobehavioral, or clinical disciplines, relevance to the mission
of the Institute must be clear. Applications for studies aimed at problems
outside these areas will be returned without review. Areas of interest to
NIAAA are described in program announcements that can be obtained on the
NIAAA web page http://www.niaaa.nih.gov.

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 are 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 and is available on the web at the following URL
address: https://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: https://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 may be obtained 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 at:
https://grants.nih.gov/grants/forms.htm.

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, reviewer's 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 https://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:
https://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.

Applications not conforming to these guidelines will be considered
unresponsive to this PA and will be returned without further 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 National
Advisory Council on Alcohol Abuse and Alcoholism.

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 method?
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.

In addition, applications will be evaluated by criteria specifically related
to the intentions of this Program Announcement as outlined above. These
include the effectiveness of the planned collaboration, and the potential for
scientific advancement regarding issues related to health disparities among
various minority populations and subpopulations.

Additional consideration pertinent to the review of Exploratory/Developmental
Grant (R21) applications:

- Pilot/feasibility studies may contain little or no preliminary data.
Review should focus on whether the rationale for the study is well developed
and whether the proposed research is likely to generate data that will lead
to a regular research project grant or full-scale clinical trial. Adequate
justification for the proposed work may be provided through literature
citations, data from other sources, or investigator-generated data.

AWARD CRITERIA

Applications will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:
scientific merit 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 inquires regarding programmatic issues to:

Ernestine Vanderveen, Ph.D.
Division of Basic Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 402
Bethesda, MD 20892-7003
Telephone: (301) 443-2530
FAX: (301) 594-0673
Email: tvanderv@niaaa.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Linda Hilley
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003
Bethesda, MD 20892-7003
Telephone: (301) 443-0915
FAX: (301) 443-3891
Email: lhilley@niaaa.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.273. 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, 285 and 290) and administered under NIH grants policies and
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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.

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