CLINICAL RESEARCH CURRICULUM AWARD

Release Date:  November 18, 1999

RFA:  OD-00-002

National Institutes of Health

Letter of Intent Receipt Date: March 24, 2000
Application Receipt Date: April 21, 2000

PURPOSE

The National Institutes of Health (NIH) invites educational and research 
institutions to apply for the new Clinical Research Curriculum Award (CRCA or 
K30).  This program will be supported by all NIH Institutes and Centers.
 
The CRCA is an award to institutions and addresses, in part, the NIH's 
initiative to improve the quality of training in clinical research.  The NIH 
recognizes that  highly trained clinical researchers are needed in order to 
capitalize on the many profound developments and discoveries in fundamental 
science and to translate them to clinical settings.  This RFA is intended to 
stimulate the inclusion of high-quality, multidisciplinary didactic training 
as part of the career development of clinical investigators.  The CRCA 
supports the 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 
researcher.  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 support the 
development  of new didactic programs in clinical research at 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 participants, so that upon completion of their 
training, they can more effectively compete for  research funding.


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. 

 HEALTHY PEOPLE 2000

The Public Health Service is committed to achieving the health promotion and 
disease prevention objectives of "Healthy People 2000," a PHS-led national 
activity for setting priority areas.  This RFA, Clinical Research Curriculum 
Award, is related to the priority area of human resource development.  
Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: 
 Stock No. 017-001-00474-0 or Summary Report:  Stock No. 017-001-00473-1) 
from the Superintendent of Documents, Government Printing Office, Washington, 
DC 20402-9325 (telephone 202/512-1800) or electronically 
(http://odphp.osophs.dhhs.gov/pubs/hp2000).

ELIGIBILITY REQUIREMENTS

Institution:  Applications will be accepted from domestic, non-Federal 
organizations, such as medical, dental or nursing schools, from comparable 
institutions of higher education, or research institutions that have strong, 
well-established clinical research and/or clinical research training 
programs.  The applicant institution must have a highly trained faculty that 
is active in clinical research, as evidenced by current research support, and 
have the commitment and capability to provide the core curriculum to 
individuals in the development of a clinical research career.  Institutions 
with a substantial clinical research portfolio along with a sufficiently 
large group of individuals in some aspect of clinical research training and 
career development are eligible to apply.  An institution may submit only one 
application.  Successful applicant institutions from the previous 
announcement are not eligible for this announcement.  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.

Participants: All 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 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, and others who could 
benefit from a core curriculum for clinical  research.  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. 

This program is intended to include individuals with NIH support (F32, T32, 
Ks, M01-CAPS, etc.) as well as non-NIH support for training and career 
development.

The National Heart, Lung, and Blood Institute will administer this program 
for the NIH.  All potential applicants are strongly advised to contact the 
NHLBI/NIH staff listed below to discuss their eligibility and the specific 
provisions of this award.

MECHANISM OF SUPPORT


Awards in response to this RFA will use the K30 mechanism.  The program award 
provides five years of support and is renewable.

FUNDS AVAILABLE

A total budget for FY 2000 of approximately $4 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 total cost per award will be $200,000 in all 
years.  It is anticipated that approximately 20 awards will be made in FY 
2000. 

TRAINING OBJECTIVES

Background:  The NIH is launching a new initiative to attract talented 
individuals to the challenges of clinical research and to provide them with 
the critical skills that are needed.  There is a core of knowledge and skills 
common to all areas of clinical research that should form the foundation of 
clinical research training.  These skills will also serve to improve the 
ability of new clinical investigators to develop hypotheses and draft sound 
research proposals for support.  This initiative is consistent with the 
recommendations of the NIH Director's Panel on Clinical Research 
(http://www.nih.gov/news/crp/97report/index.htm), as well as those from the 
Institute of Medicine Committee on Addressing Career Paths for Clinical 
Research.

Goals and Scope:  The objective of this RFA is to improve the quality of 
clinical research training by providing didactic courses in the fundamental 
skills needed for clinical research. The long-term goal is to produce 
clinical researchers who are competitive in seeking research  support and are 
knowledgeable about the complex issues associated with conducting sound 
clinical research.  This CRCA is open to educational and research 
institutions that do not currently provide such a didactic program, as well 
as to those that have well-established clinical research training programs.  
This award provides resources to allow institutions to conduct a 
comprehensive clinical research curriculum. A curriculum for each group of 
participants should be designed for two years, and the applicant institutions 
should justify the period and describe plans for enrolling a cohort of 
participants each year. The planning, direction, and execution of the 
instructional program will be the responsibility of the Program Director and 
the awardee institution, but must be consistent with the goals of the CRCA.  
The curriculum must span a variety of fields of research and encompass a 
broad range of clinical scientists who are interested in the mechanisms of 
human disease, the genetics of complex disorders, and therapeutic 
responsiveness. 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.
 

The program may also include advanced, specialized courses for epidemiology, 
outcomes research, pharmacokinetics, computer-based training for complex data 
management and analysis, effective use of the Internet for sharing or 
accessing data, medical applications of new technologies, etc.  In addition, 
institutions may propose providing support for appropriate  candidates to 
earn a master's degree in a relevant area - e.g., public health.  The 
proposed program should also have the flexibility to accommodate participants 
with different levels of experience.

Individuals participating in the program should demonstrate a high level of 
interest and the potential for the pursuit of innovative clinical research as 
a major focus in their career plan, and plan to enter into a long-term 
clinical research career.  Institutions or consortia applying for an award 
must be able to demonstrate a historical record of attracting and producing 
such individuals.  If not already ongoing, new programs should have the 
faculty and specific plans for recruiting participants to enter the didactic 
program.

Environment:  The institution must have high-quality clinical research and 
qualified faculty in clinical research.  The proposed faculty should be 
actively engaged in the design and conduct of such research, and also have 
demonstrated a successful record in obtaining peer reviewed federal and 
non-federal funding for such activities.  The institution must develop an 
innovative, multidisciplinary program to maximize the available research and 
educational resources.  Applicant institutions must describe the pool of 
participants and must demonstrate experience in preparing individuals for 
careers in clinical research.

Program: The program award provides five years of renewable support.  The 
award is intended to support the conduct of a high-quality didactic program 
in the fundamentals needed for independent clinical research.  Applicants 
must provide a detailed description of and justification for the program 
including courses offered, frequency and scheduled times of classes, 
selection criteria for participants entering the program, and target goal of 
enrollment into the program.  The program must be operational within one year 
of the award.

Program Director:  The Program Director should possess the clinical research 
expertise, leadership and administrative capabilities required to coordinate 
and supervise an interdisciplinary didactic program of this scope.  The 
Director should also be experienced in the design and management of programs 
for the development of clinical investigators, and should be able to 
demonstrate a superior record of preparing individuals for independent 
clinical research.  The Program Director should be the role model for the 
participants.  He or she should be personally engaged in clinical research as 
well as in the mentoring of new investigators.  A minimum of 25% of the PD's 
effort is required.

Faculty:  Faculty involved in the CRCA should have a record of providing the 
type of curriculum required under this award.  Generally, faculty will also 
be accomplished investigators.  The faculty records of teaching and mentoring 
as well as the percent of faculty effort planned for the courses should be 
described.
 
SPECIAL REQUIREMENTS

Advisory Committee:  The Program Director must establish an Advisory 
Committee for this program to provide ongoing assessment and monitoring. 
Clinical and basic science departments participating in this program should 
be represented on the committee.  The committee's responsibilities might 
include: selecting participants, evaluating each participant's progress, and 
monitoring the overall effectiveness of the didactic program and updating it 
as needed.  A detailed description should be provided of the committee's 
composition, function, and organizational structure.

Assessment:  Plans for an assessment of the program by the Advisory Committee 
should be described.  The Annual Progress Report of the grant should provide 
a summary of the program participants' progress.  Institutions should be 
capable of providing information about the career progression of all 
participants who receive training supported by the CRCA.

Allowable Costs:  Allowable costs may include personnel (support for the 
Program Director, faculty,  and administrative support), supplies, travel, 
honoraria and per diem for outside speakers, seminars, development of course 
materials, consultants, and other costs, such as printing, telephone, 
audio-visual, postage, recruitment materials, and computer software.  In 
addition, travel and related costs and tuition for program participants to 
attend courses (including courses at another site) are appropriate when 
necessary.  The facilities and administrative (F&A) cost rate for K30 awards 
is 8 per cent of modified total direct costs.

The compensation for the Program Director must not exceed the actual 
institutional salary rates for the effort being devoted to the CRCA.  In 
addition, salary rates must not currently exceed an annual salary level of 
$125,900 plus fringe benefits (a maximum of $62,950 for 50% effort).  The 
Program Director must devote at least 25% effort and no greater than 50% 
effort to this award and  may also be a principal investigator on other 
research awards.  The Program Director may devote up to a total of 100% 
combined effort on the CRCA and as an investigator on any other Federal or 
non-Federal awards and may receive remuneration from such sources 
accordingly.

Funds may not be requested to directly support the individual trainees. Their 
 activities  are expected to be supported by other Federal or non-Federal 
sources.
 
The NIH anticipates organizing annual meetings of Program Directors and other 
staff members to exchange information about effective approaches in the 
training of new clinical investigators, including the sharing of course 
materials that may be widely useful.  The first annual meeting will occur 
approximately one year after the initial date of award. Funds to support the 
travel of the PD and another faculty participant to the Washington, D.C. area 
to attend this meeting should be included in the budget.

LETTER OF INTENT


Prospective applicants are asked to submit, by March 24, 2000, 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 
names of other key personnel, the 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 subsequent applications, the information that it 
contains permits the NIH to estimate the potential review workload and avoid 
conflict of interest in the review.

The letter of intent is to be sent, FAXED, or E-mailed to:

C. James Scheirer, Ph.D.
Review Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7220
Bethesda, MD  20892-7924
Telephone:  (301) 435-0266
FAX:  (301) 480-3541
Email: js110j@nih.gov

APPLICATION PROCEDURES

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

Applications are to be submitted on grant application form PHS 398 (rev. 
4/98-use instructions in Section V as appropriate) and will be accepted on 
or before April 21, 2000.  Forms 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, Phone (301) 710-0267, FAX: (301) 480-0525, 
Email: grantsinfo@od.nih.gov

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.  

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

To identify the application as a response to this RFA, check "YES" on item 2a 
of page 1 of the application and enter OD-00-002, CRCA.

The completed, signed original and three legible, single-sided copies of the 
application must be sent or delivered to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH

6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817-7710 (for express/courier service)

Two additional copies of the application and five copies of the appendices 
must be sent or delivered to:

C. JAMES SCHEIRER, PH.D.
CHIEF, REVIEW BRANCH
NATIONAL HEART, LUNG & BLOOD INSTITUTE
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 7220
BETHESDA, MD 20892-7924
BETHESDA, MD 20817-7924   (for express/courier service)

The application must address the following issues:

1.  Didactic Courses:  Describe the content of the proposed courses and their 
potential benefits to the  participants.
2.  Institutional Commitment: Provide information establishing the commitment 
of the applicant institution, the Program Director, and the faculty to 
providing didactic experiences necessary for an independent career in 
clinical research.
3.  Career Development Plans:  Describe how the didactic experiences 
supported by this award will advance the career development plans for 
prospective participants.
4.  Available Participants:  Describe the pool of potential participants 
including information about the types of prior clinical and research 
training.  Also describe how appointments are made to the broader training 
program in clinical research, e.g., the Mentored Clinical Scientist 
Development Program Award (K12).  Describe the composition of the selection 
committee and the criteria to be used for selection.  Provide demographic 
data and the number of individuals participating in current training 
programs, e.g., T32, K12, K08, F32, K23, K24, etc. and others eligible for 
this program.  This information will be evaluated to determine whether a 
sufficient number of participants will be available for the proposed CRCA.
5.  Research Environment:  Describe to the extent possible the types of 
research experiences that will be available to the participants upon 
completion of the didactic training supported by the CRCA.
6.  Instruction in the Responsible Conduct of Research:  Applicants must 
include plans for instruction in the responsible conduct of research, 
including the rationale, subject matter, appropriateness, format, frequency 
and duration of instruction; and the amount and nature of faculty 
participation.  No award will be made if an application lacks this component.
7.  Career Outcomes of Former Participants:  At the time of renewal, 
applicants submitting renewal applications must include an account of the 
career outcomes of the participants who received training supported by the 
CRCA.  Include positions held, research involvement, publications, major 
accomplishments, current status of participants supported by this program and 
other evidence that the institution  is meeting the objectives described 
above.

8.  Program Effectiveness:  The applicant institution is to include a 
component to assess the effectiveness of the proposed curriculum, including 
benchmarks against which success of the program can be measured.  This 
component will be an essential review criterion against which renewal 
applications will be evaluated.


REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and 
for responsiveness by the NHLBI.  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 NHLBI 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 
Heart, Lung, and Blood Advisory Council.

Review Criteria

The review criteria for the Clinical Research Curriculum Award will include:

- Quality of the content of courses and adequacy of the syllabus.

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

- Qualifications of the faculty:  portfolio of on-going funded projects, 
publications and training experience in the context of achieving the 
objectives of this RFA.

- Criteria for selecting participants, publicizing the availability of the 
program to potential participants, and demonstration of a sufficient number 
of high quality participants.

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

- Adequacy of the membership and functions of the program Advisory Committee.

- Effective plans for program oversight and on-going assessment.

- Appropriateness of the requested budget for the proposed didactic program.

AWARD CRITERIA

Applications will compete for available funds with those submitted and 
reviewed in response to this RFA.  This is a trans-NIH program that is being 
administered and managed by the National Heart, Lung, and Blood Institute.  
An NIH Coordinating Committee will, therefore, be established to participate 
in all phases of this program. Funding decisions will be based on the 
recommendations of the initial review group,  the National Heart, Lung, and 
Blood Advisory Council (at its September, 2000 meeting), and the NIH 
Coordinating Committee regarding scientific and programmatic merit as well as 
the availability of funds.  The anticipated award date is September 30, 2000. 
 

INQUIRES

Written and telephone inquiries are encouraged.  The opportunity to clarify 
any issues or questions from potential applicants is welcome.

Inquiries regarding programmatic issues may be directed to:

Lawrence Friedman, M.D.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8100
Bethesda, MD  20892
Telephone:  (301) 435-0422
FAX:  (301) 480-1864
Email:  friedmal@nih.gov

Mr. Robert Carlsen
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7100
Bethesda, MD  20892
Telephone:  (301) 435-0260
FAX:  (301) 480-3460
Email: carlser@nih.gov

Belinda Seto, Ph.D.
Office of Extramural Research
National Institutes of Health
Building 1, Room 252
Bethesda, MD  20892
Telephone:  (301) 402-9128
FAX:  (301) 402-2642
Email:  bs11e@nih.gov

Direct inquires regarding fiscal matters to:

Ms. Jane Davis
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7174
Bethesda, MD  20892
Telephone:  (301) 435-0166
FAX:  (301) 480-3310
Email: jane_davis@nih.gov


Please also see the Web site at https://grants.nih.gov/training/k30.htm

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93. 855 and 93.856.  Awards are made under the authority of title III, 
Section 301 of the PHS Act as amended.  The Code of Federal Regulations, 
Title 42 Part 52 and Title 45 Part 74, are applicable to this program.  This 
program is not subject to the intergovernmental review requirements of 
Executive Order 12372 to 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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