PLANNING GRANT FOR CLINICAL RESEARCH TRAINING IN MINORITY INSTITUTIONS

Release Date:  September 26, 2000

RFA:  AR-00-009

Office of Research on Minority Health
National Cancer Institute
National Center for Research Resources
National Center for Complementary and Alternative Medicine
National Eye Institute
National Institute on Aging
National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Dental and Craniofacial Research
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Drug Abuse
National Institute of Nursing Research

Letter of Intent Receipt Date:  October 23, 2000
Application Receipt Date:  December 19, 2000

THIS RFA USES THE "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 RFA/PA.

PURPOSE

The Office of Research on Minority Health (ORMH) joins the National Cancer 
Institute (NCI), National Center for Research Resources (NCRR), National 
Center for Complementary and Alternative Medicine (NCCAM), National Eye 
Institute (NEI), National Institute on Aging (NIA), National Institute of 
Arthritis and Musculoskeletal and Skin Diseases (NIAID), National Institute of 
Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of 
Dental and Craniofacial Research (NIDCR), National Institute of Diabetes and 
Digestive and Kidney Diseases (NIDDK), National Institute of Drug Abuse 
(NIDA), and the National Institute of Nursing Research (NINR) to invite 
Minority Institutions with professional schools in one or more of the health 
care disciplines to apply for a planning grant to develop a Master of Clinical 
Research or a Master of Public Health in a clinically relevant area.  

This RFA is intended to stimulate the inclusion of high-quality, 
multidisciplinary didactic training as part of the career development of 
clinical investigators being trained in Minority institutions.  The planning 
grant supports the initial assessment needed to begin development and/or 
improvement of core courses designed as in-depth instruction in the 
fundamental skills, methodology, theories, and conceptualizations necessary 
for the well-trained, independent, clinical investigator.  While many NIH 
programs support research experiences for new clinicians, not all of these 
trainees have the opportunity to receive formal course work in the design of 
clinical research projects, hypothesis development, biostatistics, 
epidemiology, disease mechanisms, medical technology, human genetics, and the 
legal, ethical and regulatory issues related to clinical research.  This award 
is intended to initiate the development of new didactic programs in clinical 
research at minority institutions that do not currently offer such programs 
or, in institutions with existing didactic programs in clinical research, to 
support and expand their programs or to improve the quality of  instruction.  
The goal of this program is to improve the training of the clinical 
investigators, so that upon completion of their training, they can more 
effectively compete for research funding.

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 Request for Applications (RFA), 
PLANNING GRANT FOR CLINICAL RESEARCH TRAINING IN MINORITY INSTITUTIONS, 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

A.  Minority Institution.  The institution must be a domestic, non-Federal 
organization, such as medical, dental or nursing schools, from comparable 
institutions of higher education, or research institutions that have ongoing 
clinical research and/or clinical research training programs.  The applicant 
institution must serve students from minority ethnic groups underrepresented 
in the biomedical sciences (e.g. African Americans, Hispanics, American 
Indians, Alaskan Natives, Native Hawaiians, and Pacific Islanders) comprising 
a majority (more than 50%) of the institution’s enrollment.  It must have 
faculty and facilities for the proposed program and must conduct ongoing 
clinical research.  The institution must demonstrate the commitment and 
capability to develop a core curriculum leading to a Master of Clinical 
Research degree or a Master of Public Health in a clinically relevant area. An 
institution may submit only one application.  Applicants are encouraged to 
develop consortia in a common geographic location to enhance the depth of 
their faculty and participant pool, or to improve the quality of the 
educational experience.

B.  Potential Participants.  The institution must document a cadre of 
doctorally qualified individuals for the proposed program.  All potential 
participants must be U.S. citizens, non-citizen nationals or lawfully admitted 
permanent residents of the U.S.  This program is intended to include 
participants who hold or have matriculated for the following degrees: M.D., 
D.D.S., D.M.D., D.O., D.C., O.D., N.D. (Doctor of Naturopathy), doctorally 
prepared nurses, Ph.D. with clinical responsibilities, or Pharm.D.  Since 
clinical research is multidisciplinary, participants in this program should 
represent diverse academic backgrounds.  Interactions during the early years 
of career development may serve to enhance the team approach necessary to meet 
the multidisciplinary challenges of clinical research.  Ph.D.s who want to 
become involved in clinical research may also participate. 

MECHANISM OF SUPPORT

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/Just in 
Time applications can be found at           
http://grants.nih.gov/grants/funding/modular/modular.htm

This RFA 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 program award 
provides one year of support.  The award is not renewable, but institutions 
may request a second year without additional funds. This RFA is a one-time 
solicitation.   

FUNDS AVAILABLE

A total budget for FY 2001 of approximately $1.2 million will be committed to 
fund applications submitted in response to this RFA.  This funding level is 
dependent upon the receipt of a sufficient number of applications of high 
merit.  The maximum annual direct cost per award will be $150,000. It is 
anticipated that approximately 5 awards will be made in FY 2001. The 
anticipated award date is July 1, 2001. 

OBJECTIVES

Background

As part of the Federal effort to eliminate racial and ethnic disparities in 
health, a need has been identified to expand the training of clinical 
researchers at Minority Institutions as one approach to fostering careers in 
clinical research addressing health disparities.  Minority Institutions  
conduct high quality programs for educating ethnic minorities, and they 
represent a rich resource of talent with the appropriate cultural sensitivity 
and perspectives needed in clinical research.  However, Minority Institutions 
have had difficulties developing and sustaining independent clinical research, 
and there is a paucity of ethnic minority clinical researchers who are 
pursuing successful clinical research careers.

Program

The ORMH, NCI, NCRR, NCCAM, NEI, NIA, NIAID, NIAMS, NIDCR, NIDDK, NIDA, and 
NINR have teamed to promote the first step in fostering the development of 
curricula in clinical research leading to a masters degree in Minority 
Institutions through this one year planning grant.  This planning grant is 
seen as the first phase.  The second phase, to be announced through a RFA in 
FY 2001, will be an award to assist in the actual development and 
implementation of the clinical research curriculum.  

The planning grant will provide successful institutions funds to assess the 
resources, both at their home institution and potential affiliate 
institutions, for development of a curriculum for a Master of Clinical 
Research degree or Master of Public Health in a clinically relevant area. The 
curriculum is to focus on patient- or population-based research.  For the 
purpose of this award, clinical research includes:  patient-oriented research, 
epidemiologic and behavioral studies, and outcomes or health services 
research.  The NIH defines patient-oriented research as research conducted 
with human subjects (or on material of human origin such as tissues, 
specimens, and cognitive phenomena) that requires direct interactions with 
human subjects.  Patient-oriented research includes the development of new 
technologies, understanding mechanisms of human disease, therapeutic 
interventions and clinical trials.
 
The core curriculum is to include an array of clinical research-related topics 
of general interest such as biostatistics, bioethics, clinical trials design, 
observational study design, Federal policies and regulations that address  
research with human subjects (e.g., 45CFR46, FDA INDs, inclusion of women and 
minorities as well as children in clinical research projects), scientific 
writing for publication and competitive grants.  Other topics may include 
human genetics, pharmacology, patenting and material transfer agreements, as 
well as legal and social issues. The scope of the core curriculum can be 
flexible to meet the perceived needs of the institution.

SPECIAL REQUIREMENTS

The narrative section (Research Plan) is restricted to 15 pages for this 
planning grant.

Critical elements of the Research Plan include the Program Director, the 
Curriculum Development Committee, the Institutional Environment, and the plan 
for developing a clinical research curriculum.  The applicant must address the 
REVIEW CRITERIA listed in this RFA.

Program Director: The Program Director should possess the clinical research 
expertise, leadership and administrative capabilities required to lead the 
development of a clinical research curriculum.

Curriculum Development Committee: The Program Director must establish a 
Curriculum Development Committee that brings together key expertise for 
establishing the curriculum.  This expertise should be documented by research 
accomplishments and/or teaching and mentoring records.

Institutional Environment: The Program Director should document the 
institutional environment for developing a clinical research curriculum.  This 
includes current courses and programs which can be incorporated as well as the 
pool of potential participants (see ELIGIBILITY, above).  Support of 
institutional officials should be documented.  In addition, the Program 
Director is encouraged to bring in consultants from other institutions to 
provide input and/or critical review.  Potential collaborations with other 
institutions may also be documented.

Plan: The Program Director should describe a plan for developing a clinical 
research curriculum, including use of existing resources, building 
partnerships with other institutions, use of consultants, and plans for 
critical review of the curriculum.  The plan should include documentation of 
potential participants for the curriculum.

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.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed program, the name, address, telephone, FAX, 
and E-mail numbers of the Program Director, the identities of other key 
personnel and participating institutions, and the number and title of the RFA 
in response to which the application may be submitted.  Although a 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 NIH staff to 
estimate the potential review workload and plan the review.

The letter of intent is to be sent to Dr. Julia B. Freeman, listed under 
INQUIRIES below, by October 23, 2000.

APPLICATION PROCEDURES

It is strongly recommended that prospective applicants contact the staff 
person listed under INQUIRIES early in the planning phase of the planning 
grant application.  Such contact will help ensure that applications are 
responsive to the overall intent of this award.

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  THE NARRATIVE PORTION (Research Plan) IS 
RESTRICTED TO 15 PAGES for this RFA. See SPECIAL REQUIREMENTS above. 

Copies of application form PHS 398 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, and on the internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

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. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

BUDGET INSTRUCTIONS

Direct costs may be requested in $25,000 modules, up to a total direct cost 
request of $150,000, ONLY ONE YEAR OF SUPPORT MAY BE REQUESTED.  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 $150,000) and Total Costs [Modular Total 
Direct plus Facilities and Administrative (F&A) costs] for the budget period 
Items 8a and 8b should be completed indicating the Direct and Total Costs for 
the proposed one year 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 one 
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), 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. 

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title and number must be typed on 
line 2 of the face page of the application form and the YES box must be 
marked.

The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed, photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW (CSR)
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:

Dr. Tommy L. Broadwater
Extramural Program Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Building 45, Room 5AS.25U
Bethesda, MD  20892-6500
Telephone:  (301) 594-4952
FAX: (301)-402-2406
Email: broadwat@exchange.nih.gov

Applications must be received by the application receipt date of December 19, 
2000.  If an application is received after that date, it will be returned to 
the applicant without review.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the Center for 
Scientific Review and responsiveness by Institute staff.  Incomplete and/or 
non-responsive applications will be returned to the applicant without further 
consideration.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NIAMS in accordance with the review criteria stated below.  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 the applications under review, 
will be discussed, assigned a priority score, and receive a second level 
review by the National Arthritis and Musculoskeletal and Skin Diseases 
Advisory Council.

Review Criteria

The review criteria for the Planning Grant for Clinical Research Training in 
Minority institutions are:

- Clinical, scientific and administrative leadership qualifications and 
experience of the Program Director.

- Qualifications of the Curriculum Development Committee members, including 
the portfolio of on-going funded projects, publications and training 
experience in clinical research.

- Adequacy and availability of any necessary institutional facilities and 
resources.

- Adequacy of the plan for developing a clinical research curriculum, 
including use of existing resources, building partnerships with other 
institutions, use of consultants, and plans for critical review of the 
curriculum.

- Documentation of potential participants for the curriculum.

Schedule

Letter of Intent Receipt Date:    October 23, 2000
Application Receipt Date:         December 19, 2000
Peer Review Date:                 March/April 2001
Council Review:                   May/June 2001
Earliest Anticipated Start Date:  July 1, 2001

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities.

INQUIRIES

Inquiries concerning this RFA are encouraged.  NIAMS will be the lead in 
answering all inquiries.  The opportunity to clarify any issues or answer 
questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Julia B. Freeman
Director for Women’s and Minority Health Issues, Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Building 45, Room 5AS.19F
Bethesda, MD 20892-6500
Telephone: (301) 594-5052
FAX: (301)-594-5052
Email: freemanb@exchange.nih.gov

Contacts for Institutes and Centers participating in this RFA:

Dr. Sanya A. Springfield
Chief, CMBB, OCTR, ODDES
National Cancer Institute
6116 Executive Blvd.
Suite 700
Bethesda, MD 20892-8347
Telephone: (301)496-7344
Fax: (301)402-4551
Email: springfs@mail.nih.gov

Irene Grissom
Grants Management Specialist
National Center for Research Resources
6705 Rockledge Drive
Rockledge 1, Room 6212
Bethesda, MD 20892
Telephone: (301)435-0848
Fax: (301)480-3777
Email: grissomi@ncrr.nih.gov

Morgan N. Jackson, M.D., M.P.H.
Program Officer
National Center for Complementary and Alternative Medicine
National Institutes of Health 
6707 Democracy Blvd., Room 106
Bethesda, MD  20892-5475
Telephone:  301-402-1278
Fax:  301-480-3621
Email:  mj145m@nih.gov

Dr. Richard Mowery
Director, Collaborative Clinical Research
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd., MSC 7164
Bethesda MD 20892-7164
Telephone: (301)496-9110
Fax: (301)402-0528
Email: rlm@nei.nih.gov

Dr. Sidney M. Stahl
Behavioral and Social Research Program
National Institute on Aging
Gateway Building, #533
7201 Wisconsin Ave.
Bethesda, MD  20892-9205
Telephone:  (301) 402-4156
FAX:  (301) 402-0051
Email: Sidney_Stahl@nih.gov

Dr. Norman Braveman
Assistant Director for Program Development
National Institute of Dental and Craniofacial Research
Natcher Building
45 Center Drive Room 4AN-24B
Bethesda, MD 20892
Telephone: (301)594-2089
Fax: (301)480-8318
Email: bravemann@de45.nidr.nih.gov

Dr. Lawrence Agodoa
Director of Minority Health Research Coordination
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy, Room 930
6707 Democracy Blvd.
Bethesda, MD 20892-5458
Telephone: (301)594-9652
Fax: (301)480-4237
Email: agodoal@extra.niddk.nih.gov

Dr. Lula Beatty
Special Populations Office
National Institute of Drug Abuse
6001 Executive Blvd. MSC 9567
Bethesda, MD 20892-9567
Telephone: (301)443-0441
Fax: (301)480-8179
Email: lbeatty@ngmsmtp.nida.nih.gov

Dr. Janice Phillips
Program Director
National Institute of Nursing Research

Building 45, Room 3AN12A
Bethesda, MD 20892-6300
Telephone: (301)594-6152
Fax: (301)480-8260
Email: phillips@mail.nih.gov

Dr. Milton J. Hernandez
Director
Office of Special Populations and Research Training
National Institute of Allergy and Infectious Diseases
Room 2133
6700-B Rockledge Drive
Bethesda, MD 20892-7610
Tel: (301) 496-3775
FAX (301) 496-8729
mh35c@nih.gov

Direct inquiries regarding review issues to:

Dr. Tommy L. Broadwater
Chief, Review Branch, Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Building 45, Room 5AS.25U
Bethesda, MD  20892-6500
Telephone:  (301) 594-4952
FAX: (301)-402-2406
Email: broadwat@exchange.nih.gov

Direct inquiries regarding fiscal matters to:

Melinda Nelson
Chief Grants Management Officer, Extramural Program 
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS.49B
Bethesda, MD  20892-6500
Telephone: (301) 435-5278
FAX: (301)-480-5450
Email: nelsonm@exchange.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.855 and 93.856.  Awards are made under authorization of title III, Section 
301 of the Public Health Service Act as amended. The Code of Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 are applicable to this 
program. 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 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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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