COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) CLINICAL RESEARCH CURRICULUM AWARD

Release Date:  December 13, 1999

PA NUMBER:  PAS-00-024

National Center for Complementary and Alternative Medicine

Letter of Intent Receipt Dates: December 15, 1999; December 15, 2000; 
December 15, 2001
Application Receipt Dates: February 1, 2000; February 1, 2001; February 1, 
2002

PURPOSE

The National Center for Complementary and Alternative Medicine (NCCAM)
invites educational and research institutions to apply for the new 
Complementary and Alternative Medicine (CAM) Clinical Research Curriculum 
Award (CRCA; K30). 

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 
NCCAM recognizes that a larger cohort of highly trained CAM clinical 
researchers is needed to address the many questions of efficacy and safety 
remaining in CAM.  This Program Announcement (PA) is intended to stimulate 
the inclusion of high-quality, multidisciplinary didactic training as part of 
the career development of CAM 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, clinical trial design, and the legal, cultural, 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 be more effective CAM clinical 
scientists and can compete successfully for research funding. This goal, 
while applicable to all academic institutions, is particularly timely for 
institutions training CAM practitioners.

For the purpose of this award, clinical research includes:  patient-oriented
research, epidemiologic and behavioral studies, and outcomes or health 
services research.  The NCCAM defines patient-oriented research as research 
in which the 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 PA, Complementary and Alternative 
Medicine 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 chiropractic, naturopathic, osteopathic, medical, 
dental or nursing schools, or from other accredited CAM institutions of 
higher education, or research institutions that have strong, well-established 
CAM clinical research and/or clinical research training programs.  The 
applicant institution or consortium must have a highly trained faculty that 
is currently active in CAM clinical research, as evidenced by current 
research support or peer-reviewed publications, and have the commitment and
capability to provide the core curriculum to individuals interested in the 
development of a CAM clinical research career.  Institutions or consortia 
with a substantial CAM clinical research portfolio along with a sufficiently 
large group of individuals experienced in some aspect of CAM 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.

Faculty: The faculty must include licensed CAM practitioners as well as 
individuals trained in biostastics, epidemiology, data management, clinical 
trial design and analysis, outcomes research, etc.

Participants: This program is intended to include participants who hold the 
following degrees: D.C., N.D., D.O., M.D., D.D.S., D.M.D., O.D., 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.

All potential applicants are strongly advised to contact the NCCAM
staff listed below under INQUIRIES to discuss their eligibility and the 
specific provisions of this award.

MECHANISM OF SUPPORT

Awards in response to this PA will use the K30 mechanism.  The CAM CRCA 
provides up to five years of support and is renewable.

FUNDS AVAILABLE

A total budget for FY 2000 of $1.5 million will be committed to fund 
applications submitted in response to this PA.  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 $300,000.  
It is anticipated that a total of approximately five awards will be made in 
FY 2000-2002.

TRAINING OBJECTIVES

Background:  The NCCAM proposes to launch this new initiative to attract 
talented individuals to the challenges of CAM clinical research and to 
provide them with the critical skills that are needed to succeed.  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 CAM 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), Public Law 
105-277 which established the NCCAM, as well as with the recommendations from 
the Institute of Medicine Committee on Addressing Career Paths for Clinical 
Research.

Goals and Scope:  The objective of this PA is to improve the quality of CAM 
clinical research training by providing didactic courses in the fundamental 
skills needed for clinical research. The long-term goal is to produce CAM 
clinical researchers who are knowledgeable about the complex issues 
associated with conducting sound clinical research and who are competitive in 
seeking research support.  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 CAM institutions or consortia 
incorporating CAM and conventional 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 will be 
expected to 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, including CAM 
research, and encompass a broad range of clinical scientists who are 
interested in the mechanisms of human disease and therapeutic responsiveness. 
The core curriculum is to include an array of clinical research-related 
topics of general interest such as biostatistics, bioethics, pharmacology and 
pharmacognosy, 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), and scientific writing for publication and 
competitive grants.  Other topics may include patenting and material transfer
agreements as well as legal, cultural, ethical, and social issues related to 
clinical research. The scope of the core curriculum can be flexible to meet 
the perceived needs of the institution, but training in CAM or conventional 
medical practice is not allowed as a component of this program.

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, including current faculty who may want 
to expand their scientific training.

Individuals participating in the program should demonstrate a high level of
interest and the potential for the pursuit of innovative and independent 
clinical research in CAM as a major focus in their career plan.  If not 
already ongoing, new programs should have the faculty and plans for 
recruiting participants to enter the didactic program.

Environment:  The institutions or consortia applying for this award must be 
currently involved in CAM clinical research and have qualified CAM faculty.  
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/or non-federal funding for such activities.  The 
institution or consortium 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 CAM 
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.  
Ideally, the PD should also be experienced in the design and successful  
management of programs for the development of  CAM clinical investigators.  
The PD 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 and must include 
licensed CAM practitioners.  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.  In addition, a significant number of CAM 
clinicians/researchers must be members of 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. Minutes of the Committee's meetings will be made available to 
NCCAM staff within six weeks of each meeting.

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 percent 
of modified total direct costs.
 
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 $125,900 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 NCCAM anticipates organizing annual meetings of Program Directors and 
other staff members to exchange information about effective approaches in the 
training of new CAM clinical investigators, including the sharing of course 
materials that may be widely useful.  The first annual meeting will occur 
approximately six months 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 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 PA 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 will permit the 
NCCAM to provide programmatic guidance to the applicants.  The letter of 
intent is to be sent to Dr. Neal West at the address listed under INQUIRIES 
on the letter of intent receipt dates indicated in the heading of this PA.

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.

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

Applications are to be submitted on grant application form PHS 398 (rev. 
4/98).  Use instructions in Section IV as appropriate. Applications will be 
accepted on the application receipt dates indicated in the heading of this 
PA.  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:  
GrantsInfo@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
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 CAM 
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, K08, K12, K23, 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 CAM 
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 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 and 
for responsiveness by the NCCAM.  Applications that are complete and
responsive to the PA will be evaluated for scientific and technical merit by 
an appropriate peer review group convened by NCCAM in accordance with the 
standard NIH peer review procedures.  As part of the initial merit review, 
all applications will be discussed, will receive a written critique, will be 
assigned a priority score, and will receive a second level review by the 
NCCAM Advisory Council.

Review Criteria

The review criteria for the CAM 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; experience in CAM research.

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

- 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 others submitted and 
reviewed in response to this PA.  Funding decisions will be based on the 
recommendations of the initial review group and the NCCAM Advisory Council 
based on scientific and programmatic merit as well as the availability of 
funds.  The first anticipated award date is September 30, 2000.  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:

Neal B. West, Ph.D.
Program Officer
National Center for Complementary and Alternative Medicine
Building 31/ Room 5B58
Bethesda, MD  20892-2182
Telephone:  (301) 402-5867
FAX:  (301) 402-4741
Email:  westn@od.nih.gov

Direct inquires regarding fiscal matters may be directed to:

Ms. Suzanne White*
Grants Operations 
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7150
Bethesda, MD  20892-7926
Telephone:  (301) 435-0170
FAX:  (301) 480-3301
Email:  whitesa@qwgate.nhlbi.nih.gov

*Note: NHLBI is the Grants Management Service Center for the NCCAM.

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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