CLINICAL RESEARCH CURRICULUM AWARD

Release Date:  April 6, 1998

RFA NUMBER:  OD-98-007

P.T.

National Institutes of Health

Letter of Intent Receipt Date:  September 23, 1998
Application Receipt Date:  October 21, 1998

PURPOSE

The National Institutes of Health (NIH) invites educational and research
institutions to apply for the new Clinical Research Curriculum Award (CRCA)
(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 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, 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 or
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) for which an investigator directly interacts with human
subjects.  This area of research includes the development of new technologies,
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, or 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.  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 other similar categories 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.Ds 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 1999 of $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 average annual
total cost per award is expected to be $200,000.  It is anticipated that
approximately twenty awards will be made in FY 1999.  The NIH plans to reissue
this RFA again next year.

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 hypothesis 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/index.html),
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 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 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, technologies, data visualization, 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 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 the program including courses offered, frequency 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 (PD) 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.  For example, faculty trained in
biostatistics, data analyses and data management are recommended.  Generally,
faculty will also be accomplished investigators.  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, or at the actual F&A cost rate, whichever is less.

The compensation for the PD must not exceed the actual institutional salary rates
for the effort being devoted to the CRCA.  In addition, salary rates must not
exceed an annual salary level of $125,000 plus fringe benefits (a maximum of
$62,500 for 50% effort).  The PD 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 PD 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. Requests for 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 application.

LETTER OF INTENT

Prospective applicants are asked to submit, by September 23, 1998, 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 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@gwgate.nhlbi.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.

To identify the application as a response to this RFA, check "YES" on item 2a of
page 1 of the application and enter OD-98-007, CRCA.

Applications are to be submitted on grant application form PHS 398 (rev. 5/95-use
instructions in Section IV as appropriate) and will be accepted on or before
October 21, 1998.  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) 435-0714, FAX: (301) 480-0525, Email:  asknih@od.nih.gov.

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

CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants)
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817-7710 (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,
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 receive 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
award 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.

BUDGET

The review group will critically examine the proposed budget and recommend an
appropriate budget for each recommended application within the guidelines stated
above.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR (formerly
DRG) 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 May 1999 meeting), and the NIH Coordinating Committee regarding
scientific and programmatic merit as well as the availability of funds.  The
anticipated award date is July 1, 1999.  The NIH policy on submission of revised
(amended) applications limits the number of such applications to two.

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@gwgate.nhlbi.nih.gov

Ronald G. Geller, Ph.D.
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:  rg33k@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. Marie Willett
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7128
Bethesda, MD  20892
Telephone:  (301) 435-0144
FAX:  (301) 480-3310
Email:  willettm@gwgate.nhlbi.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 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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