CLINICAL RESEARCH EDUCATION AND CAREER DEVELOPMENT IN MINORITY INSTITUTIONS

Release Date:  July 25, 2001 (see reissuance RFA-RR-03-007) 

RFA:  RFA-AR-01-009

National Center on Minority Health and Health Disparities
National Center for Research Resources
National Eye Institute
National Heart, Lung, and Blood Institute
National Institute on Aging
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Drug Abuse

Letter of Intent Receipt Date:  December 17, 2001
Application Receipt Date:       February 15, 2002

PURPOSE

The National Center on Minority Health and Health Disparities (NCMHD) 
joins the National Center for Research Resources (NCRR), the National 
Eye Institute (NEI), the National Heart, Lung, and Blood Institute 
(NHLBI), the National Institute on Aging (NIA), the National Institute 
of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the 
National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK), and the National Institute of Drug Abuse (NIDA) to invite 
minority institutions with professional schools offering doctoral 
degrees in one or more of the health care disciplines to apply for a 
clinical research education and career development grant.

The purpose of this Clinical Research Education and Career Development 
(CRECD) award is to support the development and implementation of 
curriculum-dependent programs in minority institutions to train 
selected doctoral and postdoctoral candidates in clinical research 
leading to a Master of Science in Clinical Research or Master of Public 
Health in a clinically relevant area.  A successful program will result 
in an accredited Master’s degree  program and will produce well-trained 
clinical researchers who can lead clinical research projects.

Applications for a one year planning grant were solicited through a 
previous  RFA (AR-00-009).  However, holding a planning grant is not a 
prerequisite for  applying under this RFA.

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), CLINICAL RESEARCH EDUCATION AND CAREER DEVELOPMENT 
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 applicant institution must be a 
domestic, non_Federal organization, such as a medical, dental, nursing 
or pharmacy school with graduate education programs, or a comparable 
institution with graduate education programs, or a research institution 
that has ongoing clinical research and clinical research training 
programs.  The applicant institution must be accredited to award master 
and doctoral graduate degrees.  Foreign institutions are not eligible 
for the Clinical Research Education and Career Development grants.  
Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators. 

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.  The applicant institution 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 an 
accredited Master of Science in Clinical Research degree or an 
accredited Master of Public Health degree in a clinically relevant 
area. An institution may submit only one application.  Applicants are 
encouraged to develop consortia in common geographic locations to 
enhance the depth of their faculty and participant pools, or to improve 
the quality of the educational experience.
				
B. Students. The goal is to promote the development of well-trained 
clinical researchers who can lead clinical research studies addressing 
health disparities among the American people.  The institution must 
document a cadre of doctorally qualified individuals to enroll in the 
proposed program.  Doctorally qualified individuals are those who have 
completed a doctoral degree or are in the final phase of completing a 
doctoral degree.  All  students must be U.S. citizens, non-citizen 
nationals or lawfully admitted permanent residents of the U.S.  The 
program can include as students junior faculty, post-doctoral trainees 
such as interns and residents, and doctoral candidates who seek to 
combine their clinical doctorate degree with a Master of Science in 
Clinical Research or a Master of Public Health in a clinically relevant 
area.  Relevant clinical doctorate degrees include:  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.  
Those individuals with a Ph.D. who want to become involved in clinical 
research may also participate. 
	
MECHANISM OF SUPPORT								

This RFA will use the National Institutes of Health (NIH) R25 
educational project grant mechanism.  The applicant will be responsible 
for the planning and direction of the proposed program.  The principal 
investigator and a co-director from each awardee institution will meet 
twice a year with NIH staff to review program development.   The total 
project period for an application submitted in response to this RFA may 
not exceed 5 years.  This RFA is a one-time solicitation.  The 
anticipated award date is September 1, 2002.

FUNDS AVAILABLE

A total budget for FY 2002 of approximately $2.7 million will be 
committed to fund applications submitted in response to this RFA.  An 
applicant may request a project period of five years and a budget for 
direct costs of up to $500,000 per year.  It is anticipated that 
approximately 5 awards will be made in FY 2002.  This funding level is 
dependent upon the receipt of a sufficient number of meritorious 
applications.

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.  There is a critical 
need for properly trained clinical researchers in certain health areas 
that disproportionately affect minority and underserved populations.  
Programs that include training specific to the unique knowledge, 
skills, and challenges needed to conduct clinical research in these 
areas are strongly encouraged.  These include drug abuse and addiction 
and dental health.  

The scope of clinical research is broad.  Clinical research has been 
defined in the NIH Director's Panel on Clinical Research Report (Nathan 
Report) of December 1997 (see http://www.nih.gov/news/crp/97report/index.htm).  
This report states that “Clinical research includes a) patient_oriented 
research, b) epidemiologic and behavioral studies, and c) outcomes research and 
health services research. Patient_oriented research is research 
conducted with human subjects (or on material of human origin such as 
tissues, specimens and cognitive phenomena) for which an investigator 
(or colleague) directly interacts with human subjects. This area of 
research includes: a) mechanisms of human disease; b) therapeutic 
interventions; c) clinical trials; and d) development of new 
technologies. Excluded from this definition are in vitro studies that 
utilize human tissues but do not deal directly with patients.”  

The NCMHD, NCI, NCRR, NCCAM, NEI, NIA, NIAID, NIAMS, NIDCR, NIDDK, 
NIDA, and NINR teamed to promote the first step in fostering the 
development of curricula in clinical research leading to a masters 
degree at minority institutions through RFA AR-00-009 for a one year 
planning grant in FY 2001.  

This RFA AR-01-009 is the second phase for development of curricula in 
clinical research leading to a masters degree at minority institutions.  
However, it is not necessary for an institution to have held a planning 
grant to apply for this RFA.

Program:  The award provides 5 years of support to a minority 
institution for a Clinical Research Education and Career Development 
(CRECD) program. The principal investigator leads a Curriculum Advisory 
Committee to design, develop, implement and evaluate a curriculum for 
an accredited Master of Science in Clinical Research or an accredited 
Master of Public Health in a clinically relevant area.  The award 
provides partial support for these activities and for external 
consultants and advisors.  The award also provides for partial salaries 
and stipends of doctoral and postdoctoral trainees and for other 
program_related research costs.  The CRECD program must include a 
curriculum-based, multi-disciplinary didactic and collaborative 
training for clinical research and for collaborative clinical research 
experiences for trainees to enhance clinical research skills.  Programs 
that include training specific to the unique knowledge, skills, and 
challenges needed to conduct clinical research in drug abuse and 
addiction and other behavioral clinical research are encouraged.

Environment:  The participating institution(s) must have 
well_established clinical research programs and faculty qualified in 
curriculum development, implementation and program evaluation to serve 
as faculty for the program.  The institution must demonstrate a 
commitment to provide sustained leadership and dedicated faculty time 
to the development and implementation of the program; and commitment to 
the development of clinical investigators as productive, independent 
clinical investigators.

D.  Allowable costs:
No application may exceed $500,000 in direct costs.

1.  Salary:  The principal investigator can request salary support for 
leadership, management, coordination and evaluation of the Clinical 
Research Education and Career Development (CRECD) Program, in 
accordance with the percent effort commitment.  This commitment should 
be at least a ten percent effort.  Faculty critical to the design, 
development, implementation and refinement of the specialized 
curriculum essential to the training and didactic needs of the CRECD 
Program may be provided salary support in accordance with the percent 
effort of unique commitment.  Salary support for Curriculum Advisory 
Committee members must be justified by their specific contributions to 
program development (see SPECIAL REQUIREMENTS).  However, in general, 
it is assumed that many of these activities are within the normal scope 
expected of academic faculty and are supported by the applicant 
institution.  The principal investigator and CRECD Program faculty may 
derive additional compensation from other Federal sources or awards 
provided the additional compensation does not exceed the maximum annual 
salary level for Federal employees (see INQUIRIES) and their total 
percent effort on all awards does not exceed 100 percent.

Compensation and expenses can be provided for external consultants and 
advisors.

Pre-doctoral appointees can be provided salaries/stipends of up to 
$20,000 per year plus fringe benefits commensurate with the 
institution's scale for persons of equivalent qualifications, 
experience and rank.  Up to two years of support can be provided for 
the master’s degree.  Salary and tuition may be applied only to those 
courses fulfilling requirements for the master’s degree.

Postdoctoral/Faculty appointees can be provided salaries of up to 
$75,000 per year plus fringe benefits commensurate with the 
institution's full_time salary scale for persons of equivalent 
qualifications, experience and rank.  Postdoctoral appointees may 
include junior faculty.  Junior faculty will be considered those within 
seven years of their first faculty appointment.  Up to two years of 
support can be provided for the master’s degree.  

The institution may supplement the NIH contribution to an appointee's 
salary up to a level that is consistent with the institution's salary 
scale.  Institutional supplementation of a salary must not require 
extra duties or responsibilities that would interfere with the purpose 
of the award.

2.  Other Expenses: Up to $20,000 in direct costs per year per trainee 
adjusted to the actual percent effort can be provided for the following 
types of expenses: (a) research expenses, such as supplies, equipment, 
and technical personnel; (b) tuition, fees, and books related to career 
development; (c) travel to research meetings or training; and (d) 
statistical services including personnel and computer time.  These 
costs must be specifically documented for each individual candidate and 
must be specifically and directly related to the candidate’s research 
activities.  

3.  Ancillary Personnel Support: Up to one full-time-equivalent in the 
personnel line may be appointed to provide administrative support for 
this program.

4.  Facilities and Administrative Costs:  These costs, which were 
formerly called indirect costs, will be reimbursed at 8 percent of 
modified total direct costs.

5.   This R25 educational project grant, as administered by NIH, is not 
subject to the Streamlined Non_competing Application Process (SNAP).  
In general, this means that all reporting of budgetary information and 
CRECD Program progress is provided in greater detail.  This R25 grant 
is subject to Expanded Authorities, the one exception is that carryover 
of funds from one fiscal year to the next must be approved by Program 
and Grants Administration staff.

6.  In general, funds should not be budgeted for equipment.

SPECIAL REQUIREMENTS

1.  The application must include a STATEMENT OF ELIGIBILITY of the 
applicant institution as a minority institution eligible for the CRECD 
Program with a cadre of doctorally qualified individuals to matriculate 
in the proposed program (see ELIGIBILITY REQUIREMENTS above).

2. A specialized curriculum leading to an accredited Master of Science 
in Clinical Research or an accredited Master of Public Health in a 
clinically relevant area, not otherwise available at the institution or 
other participating institutions, must be developed and linked to the 
training goals and objectives of the CRECD Program. 

3.  The principal investigator serves as the Program Director and 
should possess the leadership and administrative capabilities required 
to lead the development of a clinical research curriculum.  A minimum 
ten percent effort is expected from the principal investigator.  The 
Program Director must assemble and chair a permanent multidisciplinary 
Curriculum Advisory Committee (CAC) representing all of the 
disciplines, departments, schools, institutions etc. involved in this 
education and training program.  The CAC will be responsible for the 
recruitment and selection of candidates for the CRECD Program; the 
establishment and review of effectiveness of the curriculum; the 
approval of the education and training plans (e.g., curriculum, 
research experiences, mentors) for each candidate; interim monitoring 
and evaluation of each candidate's progress with recommendations for 
changes in the plan, if necessary, or termination of a candidate who is 
not making adequate progress; and monitoring and evaluation of the 
overall effectiveness of the CRECD Program.  The CAC will provide a 
summary report with each annual progress report that describes the 
Committee's actions, and discusses progress of the CRECD Program 
including evaluation of areas of strengths and weaknesses.  The use of 
external advisors or an external advisory committee is encouraged.

4.  All the mentors must be involved in clinical research or research 
methodologies clearly important to the clinical research focus and 
objectives of the proposed education and career development CRECD 
Program.

5.  The curriculum must include a clinical research component as a 
required part of the program.

6.  An evaluation plan must be provided for determining the performance 
of the processes and outcomes of the CRECD Program.  This plan must 
include the parameters and criteria that will be used to evaluate the 
CRECD Program.

7.  The budget must contain funds for the CRECD Principal Investigator 
and a co-director to attend a two day meeting twice yearly in Bethesda, 
MD.  The purpose of these meetings will be for R25 grantees to present 
their progress in the planning and implementation of their programs and 
to discuss common issues.  NIH may bring selected extramural and 
intramural staff as consultants/experts on scientific and training 
issues.  

8.  The NIH staff reserve the authority to recommend reductions in 
budget, withhold support, and to suspend and/or terminate the award if 
technical performance falls below acceptable standards for quality and 
timeliness.

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 are available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  
The revisions relate to NIH defined Phase III clinical trials and 
require: a) all applications or proposals and/or protocols to provide a 
description of plans to conduct analyses, as appropriate, to address 
differences by sex/gender and/or racial/ethnic groups, including 
subgroups if applicable; and b) all investigators to report accrual, 
and to conduct and report analyses, as appropriate, by sex/gender 
and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age 
of 21) must be included in all human subjects research, conducted or 
supported by the NIH, unless there are scientific and ethical reasons 
not to include them.  

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the Inclusion of Children as 
Participants in Research Involving Human Subjects that was published in 
the NIH Guide for Grants and Contracts, March 6, 1998, and is available 
at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of these policies from the program 
staff listed under INQUIRIES.  Program staff may also provide 
additional relevant information concerning the policy.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained 
within specified page limitations.  Unless otherwise specified in an 
NIH solicitation, internet addresses (URLs) should not be used to 
provide information necessary to the review because reviewers are under 
no obligation to view the Internet sites.  Reviewers are cautioned that 
their anonymity may be compromised when they directly access an 
Internet site.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  This policy announcement is found 
in the NIH Guide for Grants and Contracts Announcement dated June 5, 
2000, at the following website:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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 RFA 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 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 Freeman listed under 
INQUIRIES below, by December 17, 2001.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 
5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.pdf is to be used 
in applying for these grants. This version of 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 
301/435-0714, Email: GrantsInfo@nih.gov.

The RFA label available in the PHS 398 (rev. 5/01) 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 RFA label is also 
available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

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 must also be sent to:

Dr. C. William Angus
Scientific Review Administrator
National Center for Research Resources
6701 Rockledge Drive Room 6018
Bethesda, MD  20892-7965
Telephone:  (301) 435-0812
FAX: (301) 480-3660
Email: angusw@ncrr.nih.gov

Applications must be received by the application receipt date listed in 
the heading of this RFA.  If an application is received after that 
date, it will be returned to the applicant without review.

If the application submitted in response to this RFA is substantially 
similar to a grant application already submitted to the NIH for review 
but has not yet been reviewed, the applicant will be asked to withdraw 
either the pending application or the new one.  Simultaneous submission 
of essentially identical applications will not be allowed, nor will 
essentially identical applications be reviewed by different review 
committees.  An application, therefore, cannot be submitted in response 
to this RFA which is essentially identical to one that has already been 
reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.

Instructions for Preparing a CLINICAL RESEARCH EDUCATION AND CAREER 
DEVELOPMENT IN MINORITY INSTITUTIONS Grant Application:

Applications for CLINICAL RESEARCH EDUCATION AND CAREER DEVELOPMENT IN 
MINORITY INSTITUTIONS (R25) should use the Form PHS 398 and the 
modified instructions below, which take into account all of the special 
features and requirements of this grant.

1.  Face Page:   Use page AA of the form PHS 398.  On Line 1 include 
the title that best represents the nature of your education and career 
development program.  On line 2, provide the number (i.e., AR-01-009) 
and the title (i.e., CLINICAL RESEARCH EDUCATION AND CAREER DEVELOPMENT 
IN MINORITY INSTITUTIONS) of this RFA. 

2.  Description, Performance Site(s), Key Personnel: ((Page BB) of the 
form PHS 398):   Complete as directed in the form PHS 398 instruction 
package; this should include the Program Director, Curriculum Advisory 
Committee Members, Mentors and other faculty participating in the CRECD 
Program.  Please make sure that you denote each individual’s degree and 
departmental affiliation (or equivalent) AND, if a consortia of 
institutions, institutional affiliation. 

3.  Table of Contents to be organized as follows:

a.  Face Page 
b.  Description, Performance Site(s), Key Personnel
c.  Table of Contents 
d.  Detailed Budget Page for First Year 
e.  Budget for Entire Proposed Period of Support
f.  Budgets pertaining to Consortium/Contractual Arrangements
g.  Other sources of institutional training, education, and career 
development support 
h.  Research Support of the principal investigator and the mentors that 
is specifically relevant to this Clinical Research Education and Career 
Development Program 
i.  Biographical Sketches for:
_ Principal Investigator
_ Curriculum Advisory Committee Members
_ Mentors            
_ Other Participating Faculty
_ Initial Trainees (if known at the time of application)
j.  Statement of Eligibility (See SPECIAL REQUIREMENTS, item 1)
k.  Education and Career Development Plan (Not to exceed 25 pages, 
excluding tables) with:
i.    Purpose and Objectives
ii.   Core Requirements including:
_specialized curriculum
_other didactic experiences
_research experiences
iii.  Research Base/Resources and Facilities/Mentors
iv.  Program Management including:
_ Principal Investigator
_ Curriculum Advisory Committee
_ Recruitment Strategies/Pool of Potential Students
- Selection Criteria for Choosing Students
_ Sample Individual Candidate Training Plans
_ Program Evaluation Plan  
l. Human Subjects
m. Vertebrate Animals
n. Checklist
o. Appendices

4. Detailed Budget for the First Year: Use Form Page 4 (or DD) of the 
Form PHS 398. 

Under PERSONNEL break out the individuals as follows with percent 
effort, salary and fringe benefits:
A.  The Principal Investigator
B.  Faculty being paid from the Grant
C.  Pre-Doctoral Candidates by Name OR Position (when position is not 
filled)
D.  Postdoctoral/Junior Faculty Candidates by Name OR Position (when 
position is not filled)
For Research and Development Costs, maintain a separation between 
predoctoral and postdoctoral candidates.  For the budget categories 
other than salary specifically identify the requested costs under each 
budget category (e.g., supplies, travel) for each trainee by name or 
position (if the position is not filled), remembering that total for 
each individual cannot exceed $20,000.
E.  Under travel, include funds for the Principal Investigator and one 
co-director to attend two meetings each year in Bethesda, MD, each 
meeting lasting two days.

5.  Budget for the Entire Proposed Project Period of Support:  Use Form 
Page 5 (or EE) of the Form PHS 398 and provide projected future year 
budgets as instructed in the Form PHS 398.

6.  In a table, list all current and pending clinical research support 
and institutional training support available to the participating 
faculty, department(s), institution(s).  Examples could include T32, 
R25 or K grants.  Include funding source, complete identifying number, 
title of the program, name of the Principal Investigator, project 
period, number of training positions (doctoral, postdoctoral), and the 
amount of the award.  For each grant listed, name only those 
participating faculty members who are also named in this application, 
and indicate their percent effort in those programs.

7.  In a table, list all current and pending clinical research support 
relevant to this CRECD program available to the participating faculty, 
department(s), institutions(s). Examples could include R01 and other 
NIH mechanisms, contracts, VA, and private foundation grants.  Include 
funding source, complete identifying number, title of the program, name 
of the Principal Investigator, project period, number of training 
positions (doctoral, postdoctoral), and the amount of the award.  For 
each grant listed, name only those participating faculty members who 
are also named in this application, and indicate their percent effort 
in those programs.

8.  Biographical Sketches and Other Support: Provide biographical 
sketches using the forms provided in the PHS Form 398 package for the 
Principal Investigator, Curriculum Advisory Committee Members, Mentors, 
other participating faculty, and trainees (for those that are 
available).

9.  Immediately before beginning the CLINICAL RESEARCH EDUCATION AND 
CAREER DEVELOPMENT IN MINORITY INSTITUTIONS Plan (See item 10, next), 
the application must include a STATEMENT OF ELIGIBILITY of the 
applicant institution as a Minority institution eligible for this 
program with a cadre of doctorally qualified individuals to matriculate 
in the proposed program (see ELIGIBILITY REQUIREMENTS and SPECIAL 
REQUIREMENTS, item 1).

10.  CLINICAL RESEARCH EDUCATION AND CAREER DEVELOPMENT IN MINORITY 
INSTITUTIONS Plan:

a.  Purpose and Objectives: In this section provide background, purpose 
and objectives of the CRECD Program.

b.  Describe the requirements of this CRECD Program that each candidate 
is expected to complete that will lead to either an accredited Master 
of Science in Clinical Research or an accredited Master of Public 
Health in a clinically relevant area.

i. Specialized Curriculum: Describe the proposed core curriculum. 
Explain how the development and implementation of this curriculum is 
critically linked to the purpose and objectives of the CRECD Program 
and to the research career development of individual candidates.  
Explain how this curriculum is distinguished from other curricula 
within the existing educational infrastructure and framework of the 
applicant/participating institution(s);

ii. Other Didactic Experiences: utilization of any existing curricula 
within the institution(s).

iii. Research Experiences: Outline briefly the kinds of research 
experiences each candidate will receive from the mentors of this CRECD 
Program that will prepare them as independent clinical investigators.

c.  Research Base/Resources and Facilities/Mentors:
 
Research:  Describe the research activities and experiences that will 
be offered to the students by the mentors participating in the program.  
Discuss how an active research environment will be sustained to meet 
the needs and objectives of the CRECD Program.

Resources and Facilities: Briefly describe the research infrastructure, 
access to patient populations, community populations etc., and 
facilities that are available and accessible to this CRECD Program.

Mentors: Describe the qualifications of the faculty research mentors 
including information on their experiences in conducting clinical 
research.

d.  Program Leadership/Management:

i.  Principal Investigator: Describe the qualifications and role of the 
Principal Investigator to provide leadership and coordination of the 
CRECD Program.  A minimum of ten percent effort is required.

ii.  Curriculum Advisory Committee (CAC):  Describe how the CAC will 
function in providing oversight of the development, implementation and 
evaluation of recruitment strategies; recruitment and selection of 
candidates for the CRECD Program; establishment, implementation and 
evaluation of the core/specialized curriculum; approval of individual 
education and career development plan  (e.g., curriculum, 
research/methodology experiences, mentors); interim monitoring and 
evaluation of each candidate’s progress, including a determination of 
when a candidate has successfully completed the program, with 
recommendations for changes in the plan and, if necessary, termination 
of a candidate not making adequate progress; and monitoring of the 
overall effectiveness of the CRECD Program; role of external advisors. 

iii.  Recruitment and Selection Strategies: Within the multi-
disciplinary research environments covered by this Clinical Research 
Education and Career Development in Minority institutions Program, 
describe the characteristics of candidates who will be selected for 
participation.  Describe any recruiting strategies.  Comment on the 
size of the candidate pool expected, note any other institutional 
programs that might compete for this pool, and describe strategies for 
addressing this competition.

iv.  Individual Candidate Training Plans: Provide examples of 
individual plans that the CRECD Program will employ to provide a unique 
education and career development experience for candidates, preparing 
them to design, implement and participate in highly inter-disciplinary, 
collaborative clinical research.  Sample plans might address the needs 
of the combined degree doctoral student; a postdoctoral student who is 
an intern or resident; and a junior faculty member.  Provide plans for 
conducting the required review process for each candidate. 

v.  CRECD Program Evaluation Plan: Describe the information that will 
be used in, the periods for, and criteria to be used in evaluating this 
CRECD Program.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the 
Center for Scientific Review (CSR) and by the NIH program staff for 
adherence to the eligibility criteria for this RFA.  Applications not 
responsive to this RFA WILL BE RETURNED to the applicant without 
review.

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 Office of Review of NCRR in accordance 
with the standard NIH peer review procedures.  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 an Advisory Board of an NIH Institute or Center.

All applications in response to this announcement will be evaluated for 
scientific and technical merit using the criteria noted below:

Review Criteria

1.  Education Career Development Plan:

a.  Purpose and Objectives:

_ clarity and importance of the CRECD Program’s purpose and objectives

_ adequacy in meeting the NIH’s intent of supporting education and 
career development programs that prepare candidates to participate as 
independent investigators in clinical research.

b.  Core Requirements: 
_ Degree to which all of the core requirements combined satisfy the 
training and career development objectives of the CRECD Program.

_ Quality of the process for evaluating each candidate’s needs relative 
to the core requirements of the CRECD Program.

_ Adequacy of the subject matter and design of specialized curriculum; 
adequacy of the linkage of the specialized curriculum to the research 
training of the candidates; uniqueness of the specialized curriculum 
relative to other curricula available at the institution (s); adequacy 
of the faculty responsible for the specialized curriculum  

_ Strength and availability of other didactic experiences available for 
each candidate’s education and career development
 
_ Adequacy of the breadth and depth of research experiences available 
to candidates to achieve their multidisciplinary training objectives. 

c.  Research Base/Resources and Facilities/Mentors:

_ Adequacy of the research environment in the CRECD Program to support 
the proposed education and career development.

_ Adequacy of the available research infrastructure, patients, 
populations etc. to support the CRECD Program.

_ Quality of the mentors’ research experience and likelihood of their 
success in training clinical scientists in the CRECD Program.

d.  Program Leadership/Management:

_ Adequacy of the Program Director’s experience and qualifications to 
lead and coordinate the CRECD Program.

_ Recruitment (Adequacy of the pool of candidates, and the criteria for 
selecting high quality candidates)

_ Curriculum Advisory Committee: 
--  Appropriateness and experience of the membership
--  Adequacy of the CAC’s involvement as a quality control in selecting 
candidates for the CRECD Program; establishing appropriate training 
plans for each candidate based on their individual needs and the CRECD 
Program Core Requirements; monitoring the progress of candidates and 
making midcourse corrections to improve the quality and effectiveness 
of each candidate’s experiences; plans for evaluating a research 
thesis; terminating candidates for evident lack of performance or 
potential; and monitoring and evaluating the overall performance and 
effectiveness of the CRECD Program.

_ Individual Candidate Training Plans: Quality and completeness of the 
sample training plans relative to the purpose and objectives and core 
requirements of the CRECD Program.

_ Evaluation Plan: Adequacy of the criteria and process for evaluating 
the performance of the CRECD Program.

AWARD CRITERIA

Applications will compete for available funds with all other scored 
applications submitted in response to this RFA.  Following the initial 
peer review for scientific and technical merit, the second level of 
review will be conducted by an NIH Advisory Council.  The NIH will 
notify the applicant of the NIH Advisory Council's action.   Final 
funding decisions are made by the NIH based on the quality of the 
proposed CRECD Program, as determined by peer review, the availability 
of funds and priorities of the NIH. 

Schedule

Letter of Intent Receipt Date:    December 19, 2001
Application Receipt Date:         February 15, 2002
Peer Review Date:                 March/April 2002
Council Review:                   May/June 2002
Earliest Anticipated Start Date:  September 2002

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. Jean L. Flagg-Newton 
Coordinator, Minority Health Initiative
National Center on Minority Health and Health Disparities
Building 1 Room 256
Bethesda, MD 20892
Telephone: (301) 402-1366
Fax: (301) 402-2517
Email:  flaggnej@od.nih.gov

Dr. Sidney McNairy 
Director, Research Infrastructure
National Center for Research Resources
6705 Rockledge Drive
Rockledge 1, Room 6212
Bethesda, MD 20892
Telephone: (301) 435-0788
Fax: (301) 480-3770
Email: SidneyM@ncrr.nih.gov

Dr. Chyren Hunter
Training Officer
National Eye Institute
6120 Executive Blvd. Suite 350
Bethesda, MD 20892-7164
Telephone: (301) 496-5301
FAX: (301) 402-0528
Email:  clh@nei.nih.gov

Dr. Carl Roth
Associate Director for Scientific Program Operation
National Heart, Lung and Blood Institute
31 Center Drive Room 5A03
Bethesda, MD 20892-2482
Telephone: (301) 496-6331
Fax: (301) 402-1056
Email: rothc@nhlbi.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. 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

Direct inquiries regarding review issues to:

Dr. C. William Angus
Scientific Review Administrator
National Center for Research Resources
6701 Rockledge Drive Room 6018
Bethesda, MD  20892-7965
Telephone:  (301) 435-0812
FAX: (301) 480-3660
Email: angusw@ncrr.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.

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