CENTERS FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE RESEARCH

NIH GUIDE, Volume 26, Number 34, October 10, 1997

RFA:  OD-98-003

P.T.

Office of Alternative Medicine
National Institute of Child Health and Human Development
National Institute on Drug Abuse

Letter of Intent Receipt Date: December 1, 1997
Application Receipt Date: January 13, 1998

PURPOSE

The Office of Alternative Medicine (OAM) was mandated by Congress in 1991 and
permanently established within the Office of the Director, National Institutes
of Health (NIH), through the National Institutes of Health Revitalization Act
(Public Law 103-43, Section 404E).  The mission of the OAM is to encourage and
support the investigation of complementary and alternative medicine (CAM)
practices, with the ultimate goal of integrating validated alternative medical
practices into health and medical care.  The OAM also is charged with training
investigators who can help fulfill this mission. 

The demographics, prevalence, and patterns of use of alternative
unconventional medicine in the United States have been described (Eisenberg et
al., New England J. Med. 328: 246-352, 1993).  The most relevant findings are
the following: a) most people use CAM therapies for chronic rather than
life-threatening medical conditions; b) users of alternative therapies do not
inform their primary care physicians; c) extrapolation to the population of
the United States suggests that Americans made approximately 425 million
visits to providers of CAM therapy during 1990; and d) expenditures associated
with CAM therapies appear similar to non-reimbursed expenses incurred for all
hospitalizations in the United States.  These findings indicate that
alternative medicine modalities occupy a larger role in the health care of
U.S. citizens than previously understood.  The goal of this RFA initiative is
to encourage research of CAM by establishing Centers for CAM Research.  Such
Centers will make the resources necessary for the conduct of high quality
research available to investigators interested in CAM.

HEALTHY  PEOPLE  2000

The Public Health Service is committed to achieving the health
promotion and disease prevention objectives of "Healthy People
2000," an initiative for setting national health policy and
priorities.  Although "Healthy People 2000" does not specify a CAM
objective, this RFA reflects several different priority areas, such
as heart disease and stroke, maternal and infant health, substance
abuse and HIV infection. 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) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325 
(Telephone: 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and not-for-profit
organizations, public and private organizations such as universities,
colleges, hospitals, laboratories, units of State or local governments,
Federally recognized Indian Tribal organizations, and eligible agencies of the
Federal government.  Applications may include foreign components, but foreign
organizations are not eligible to apply.  Applications from minority and women
investigators are encouraged.

While applications must be submitted from a single institution, they may
include subcontracted collaborative scientific arrangements with scientists
from other institutions, as long as these arrangements are clearly delineated
and formally and officially confirmed by signed statements from the
responsible officials of each institution.  However, a full institutional
commitment must come from the parent institution receiving the award. 

Research conducted through the Center is expected to be multidisciplinary.  As
such, support will not be provided for applications with research activities
focused exclusively in one research domain, such as only basic research or
clinical research, or epidemiological research.

MECHANISM OF SUPPORT

Support of this program will be through the P50 Specialized Center Grant
mechanism.  This mechanism supports any part of the full range of research and
development from basic to clinical and intervention studies.  In addition to
support for research projects, support is also provided for career
development, for specialized resources and for shared core facilities. 
Applicants will be responsible for the planning, direction, and execution of
the proposed program.  Awards will be administered under PHS grants policy as
stated in the Public Health Service Grants Policy statement. 

Applications from institutions not previously funded for Centers for CAM
Research will compete on an equal basis with competing continuation
applications.  It is expected that RFAs similar to this one will be issued in
FY 1998 and FY 1999.

FUNDS AVAILABLE

Up to $2,400,000 in total costs (direct plus indirect) will be committed in
the first year to fund 2-4 awards from qualified applicants.  These awards may
be up to five funded years. 

This funding level is dependent on the receipt of applications of high
technical and scientific merit, and the continued availability of funds. 
Because the nature and scope of applications may vary, it is anticipated that
the award size could vary.

GENERAL OBJECTIVES

1.  Background 

Despite the broad use of alternative medicine treatments (NEJM, 1993,
328:246-252) there is a relative paucity of data available to demonstrate
convincingly whether many of these CAM practices lead to positive clinical
outcomes, improve quality of life, reduce or eliminate adverse symptoms,
prevent disease, or promote or enhance health, and are efficacious, safe,
and/or beneficial.  A similar conclusion was reached in a 1990 report on
unconventional cancer treatments by the U.S. Office of Technology Assessment. 
This report urges a systematic analysis of alternative treatments and their
effect on major disease, health and wellness (U.S. Office of Technology
Assessment, OTA-H-405, 1990, p.225).

2.  Center Concept:

The OAM currently supports ten Centers for CAM Research in cooperation with
five NIH Institutes.  The Centers are viewed as a first step in expanding the
national infrastructure for research of CAM.  The Centers are designed to
identify and evaluate promising CAM by establishing mechanisms for
investigators to have their research ideas reviewed, developed and executed in
a scientifically rigorous manner.  The Centers evaluate research opportunities
in their program area and prioritize research projects.  The Centers
facilitate collaborations between CAM practitioners and conventional
scientists to conduct specific research projects.  The results of these
projects are published in the scientific literature and disseminated to the
public.

3.  Objectives of the RFA

The expressed purpose of this RFA is to provide a mechanism to examine the
potential efficacy, effectiveness, safety and validity of CAM therapies, and
to provide scientific/technical assistance to investigators as they develop
their research projects.  The establishment and support of Centers for CAM
Research, under the auspices of the OAM, will meet these objectives.  The
Centers will support a multi-disciplinary group of researchers and clinicians
to perform basic, preclinical, clinical, epidemiologic and health services
research of CAM in one of four research theme areas.  The Centers will provide
many of the resources necessary for the conduct of high quality research,
including an environment for training future scientists.  Finally, the Centers
will encourage collaboration between basic and clinical scientists, and
between the CAM and conventional medical communities.  

In general, insufficient scientific data are currently available that address
safety and efficacy questions for CAM therapies.  Many CAM practitioners are
not currently affiliated with research institutions able to provide the
research infrastructure necessary to facilitate the study of CAM.  Research
conducted at the Centers for CAM Research will provide useful data to
determine the appropriateness of CAM approaches.  It is expected that work
begun at  the Centers will provide the basis for subsequent
investigator-initiated research grant applications to the NIH. 

Competing continuation (renewal) applications must demonstrate progress in the
above areas as indicated by scientific progress, success in the initiation of
competitively-supported research (both federal and non- federal sources of
support can be applied to this criterion), the development of new CAM
investigators, and collaborations with conventional scientists and CAM
practitioners.

Objectives:

Specific objectives for the current Center applications include:

o  Performing research related to CAM treatments in one of four research theme
areas:  cardiovascular disease, drug abuse, HIV/AIDS, or pediatric disorders;

o  Establishing an advisory committee to provide program direction and advice
to the principal investigator of the Center, including prioritization of
research protocols and utilization of core facilities;

o  Developing a mechanism for scientific/technical merit review of proposed
studies from investigators;

o  Developing workshops, seminars, etc. for training
purposes;

o  Establishing a system to identify and support junior investigators in their
career development;

o  Investigating basic mechanisms of CAM therapeutic and diagnostic
interventions;

o  Conducting controlled trials of sufficiently developed CAM interventions or
pilot trials for the purpose of developing controlled trials; and 

o  Acting as an institutional focus for training in research methodology,
bioethics, biostatistics, clinical trial design, epidemiological studies,
health services studies and basic laboratory methods as they relate to CAM;

RESEARCH ACTIVITIES

The overall goals and objectives of the Centerþs research agenda for the
requested funding period should be explicitly stated in the application.  This
should include identification of the Centerþs research direction, as well as
specific disease entities and target populations to be studies.

1.  Research Theme Areas

Applicants should develop a multidisciplinary research focus and five-year
research agenda in one of the four following themes.  The application should
describe how the Research Theme will be integrated with one or more of the
high priority CAM Program Areas (item 2).

o  HIV/AIDS

Background:  HIV/AIDS is the seventh leading cause of death in the United
Stated.  As of December 1995, the Centers for Disease Control and Prevention
(CDC) estimated that more than 500,000 individuals in the United States had
contracted AIDS.  While the number of HIV-positive individuals is not exactly
known, estimates have been placed as high as 900,000 in 1992 (JAMA, 1996,
276:126-131).  Worldwide figures for HIV/AIDS are even more staggering.  The
United Nations estimates that 21.8 million people are living with HIV/AIDS. 
This figure may grow to between 60 and 70 million adults infected with HIV by
the year 2000.  In 1995 alone, more than 1.3 million people worldwide died of
HIV-associated illnesses.  Although the newest combination anti-viral
therapies show great promise, issues of cost and compliance will almost
certainly prevent their general use worldwide.

Goal:  The goal of the Centers for CAM Research on HIV/AIDS is to identify and
support the development of improved interventions to prevent and treat HIV
infection and its sequelae, including cachexia, neuropathies, and
opportunistic infections.  The Center will validate that these approaches are
safe and effective.

o  Drug Abuse and Addiction

Background:  Although illegal drug use has steadily declined since the 1980s,
12% of the U.S. population reported use of an illegal drug in 1993.  In this
same year, about 35% of high school seniors reported having used marijuana or
hashish and 3.3% reported using cocaine.  Drug use in the U. S. resulted in
more than 400,000 drug- related emergency room episodes in 1993, a 10%
increase from 1991.  

According to the CDC, smoking tobacco remains the leading cause of preventable
deaths in the U.S.  It has been projected that there are 400,000 smoking
related deaths each year at a cost of approximately $50 billion in direct
medical care costs.  In the thirty years since the release of the Surgeon
General's initial report on the effects of smoking tobacco, 10 million U.S.
citizens have died from causes attributable to smoking, with 2 million deaths
occurring from lung cancer alone.  

Intensive efforts have been made to identify the actions of addictive drugs
and the mechanisms by which they affect fundamental brain process.  Despite
progress in these areas, safe and effective therapies to treat substance abuse
and addiction are still few, with pharmacotherapeutic approaches often proving
ineffective.  

Goal:  The Centers for CAM Research on Drug Abuse and Addiction will support
innovative, integrated research to identify potential CAM therapies to prevent
or treat drug abuse and addiction, and to validate that these approaches are
safe and effective.  The application should address both therapies to reduce
or stop substance abuse in the short-term, as well as those that can prolong
abstinence in the long-term.  

o  Pediatric Care

Background:  Eisenberg's survey on the prevalence of CAM use in the U.S.
(NEJM, 1993, 328:246-252) did not address use in those less than 18 years old. 
Yet anecdotal reports indicate that millions of children are treated with CAM
therapies.  In the only published survey documenting CAM use by children,
Spigelblatt et al., (Pediatrics, 1994, 94:811-814) reported that 11% of
children attending a university health clinic used some form of CAM, with
chiropractic, homeopathy, naturopathy and acupuncture being the most
frequently used modalities.  However, few studies have investigated the
efficacy of CAM in this patient population.

Goal:  The Centers for CAM Research in Pediatrics will provide an opportunity
for nurturing investigators in pediatrics interested in CAM.  The Centers
should assess the use of CAM in the pediatric population and develop research
opportunities accordingly.  The Centers will facilitate studies investigating
the safety and efficacy of CAM in the pediatric population.

o  Cardiovascular Disease 

Background:  About 22 million United States citizens suffer from some form of
heart disease, with one-third of all individuals over the age of 65 afflicted. 
Despite recent technologic and pharmacologic advances, ischemic heart disease
is still the leading cause of death in the United States with more than
700,000 deaths in 1995.  Congestive heart failure and angina are two of the
most common reasons for hospitalization, together being responsible for more
than 1.5 million hospitalizations per year.  The economic burden of ischemic
heart disease alone was estimated as $54.2 billion in 1992.

Goal:  The Centers for CAM Research in Cardiovascular Disease will develop an
innovative research approach to the study of cardiovascular disease according
to the following prioritization list:  1) congestive heart failure; 2)
coronary artery disease (including myocardial infarction); 3) atherosclerotic
manifestations (including peripheral artery disease); 4) hypertension; and 5)
the prevention and treatment of cardiovascular risk factors.  The Center's
goal is to reduce the mortality and/or morbidity associated with these
conditions through the development of safe and effective CAM  treatment and
prevention strategies.

2.  CAM Program Areas: 

For the purpose of this RFA, investigators must include modalities from at
least two of the following broad program areas in CAM:

o  Alternative Medical systems (e.g., oriental medicine, ayurvedic,  native
American, homeopathy, naturopathy); 
o  Manipulative and body-based systems (e.g., chiropractic, osteopathic,
massage therapy or unconventional applications of integrated conventional and
physical therapies); 
o  Biofield (e.g., energy healing, intentional effects on living systems); 
o  Bioelectromagnetics (e.g., diagnostic and therapeutic application of
electromagnetic fields including pulsed EM fields, magnetic fields, DC fields
etc.  Note:  This category does not include the study of electromagnetic
fields as risk factors for disease);
o  Pharmacologic Therapies (e.g., metabolic therapies, immunoaugmentative
therapies as used by CAM practitioners or the public);
o  Herbal Medicine (Note:  This category does not include isolation of the
active ingredients from herbal preparations for the purpose of drug
development) 

(Note:  Studies incorporating the following three CAM program areas must focus
on the more unconventional uses of these approaches and involve collaborations
with expert practitioners of these approaches);
o  Mind-Body Medicine (e.g., meditation, imagery,
hypnosis, biofeedback, music therapy, yoga, spirituality, and consciousness
and biological effects, with focus on their novel scientific and clinical
uses);
o  Health Promotion and Disease Prevention (e.g., changes in lifestyle,
including risk reduction, when applied as complete systems for chronic disease
management [prevention and treatment] across multiple diagnostic categories);
o.  Biological-based Therapies (e.g., diet-based therapies and nutritional
supplements as used in unconventional practices).
 
3.  Research Projects

Applications must include three research projects proposed for Center use. 
These projects may be up to three years in length and may include pilot
projects or subprojects of large, multicomponent studies.  Projects already
underway at the time of the application are applicable.  However, for each
project, a justification for use of the Center is required, including an
estimate of resources to be used and a description of how the project
contributes to the Center's stated goals.

The Center will provide limited support for these research projects.  A total
of $300,000 (total cost) will be available in Year One for the research
projects outlined in the application.  Additional projects may be added in
subsequent years up to $400,000 (total costs) per year for all projects

CENTER ACTIVITIES

1.  General:

On a continuing basis, the Centers will be expected to prioritize the top
research projects within their emphasized program area and research theme (see
above).  This could be accomplished by holding research agenda conferences,
conducting systematic reviews of the science in proposed areas of research, or
by performing meta-analyses where appropriate.

Within the first year, the Center should establish the infrastructure
necessary to perform the research outlined in the application and begin this
research.  The Center will be expected to disseminate research findings in a
timely manner through peer-reviewed publications.  It is expected that new
projects will begin by year three of the award up to a maximum of $400,000
(total costs) per year for all projects.  Center investigators are expected to
seek additional sources of research support.

The Center must propose a mechanism for prioritizing research projects within
its research theme area and utilization of core facilities, and a mechanism
for scientific/technical merit review of the projects.  This can be in the
form of a scientific advisory board or can employ independent reviewers, in a
manner similar to that used at NIH.  Center resources may only be used for
projects approved by the Center's Advisory Committee.

2.  Advisory Committee

Scientific and administrative Center oversight is charged to a
multidisciplinary Advisory Committee (AC) to be appointed by the Principal
Investigator on a rotating basis.  The AC shall not be chaired by the
Principal Investigator who will serve in an ex officio capacity only.  The AC
should meet at least quarterly and minutes of the meeting should be kept. 
These minutes shall be made available to NIH staff upon request.  The AC
should be a cross-section of at least eight individuals familiar with the
Center's research activities.  The AC shall include both a biostatistician and
epidemiologist to assist with the review of projects and the optimal
approaches for subsequent data analysis.  The AC shall have representation
from the scientific, practitioner and lay communities in both CAM and
conventional medicine.

Besides prioritizing research projects submitted by Center or, if applicable,
Consortium investigators, the AC should periodically review Center operations
to ensure that Center resources, especially core facilities, are used for the
most scientifically worthy projects.  The AC should take an active role in
encouraging younger faculty members to perform research and assist them in
applying appropriate research concepts and methods.  Support for the AC should
be explicitly budgeted and justified.

3.  Career Development

The Center is to serve as an environment for training scientists and health
professionals in research on topics related to CAM.  In addition, the Center
should implement a program designed to introduce students, residents and
fellows to both biomedical research and to CAM in an effort to attract these
individuals into research careers in CAM.  Formal courses or seminars may be
set up for this goal.  If applicable, existing institutional activities may
apply.  The courses should be relevant to diverse areas of research and could
include an array of topics, such as biostatistics, design of clinical trials,
computer skills and  bioethics. Support for these activities should be
explicitly budgeted and justified.

Up to $100,000 (total costs) can be dedicated to the salaries of junior
investigators who wish to pursue careers in CAM research.  Candidates should
be scientists or clinicians who have outstanding research potential, but who
need additional training in either CAM or research methodologies appropriate
to CAM.  The candidates are expected to devote full-time to research and
appropriate supplemental training.  The application should propose the number
of slots available, the criteria for eligibility and for selection of
candidates, and describe the selection process.  Also, the application should
indicate prospective mentors who are already in place at the proposed Centers,
briefly describe their research programs, provide examples of previous
mentorships, and describe institutional activities that contribute to the
environment for career development (e.g., existing training grants,
institutional activities, and other relevant programs).

The Center is expected to seek supplemental support for its training program
through such mechanisms as the NIH National Research Service Award
Institutional Research Training Grant (T32) or Individual Postdoctoral
Fellowships (F32).

4.  Core Facilities

The grant will support core facilities, such as a shared core laboratory or
computer facilities, to stimulate research contributing to the Center's stated
goals.  At least two Center projects must utilize each proposed core facility
at all times.  The core facilities can only be used for protocols that have
been reviewed and approved by the Advisory Committee.  The Principal
Investigator and Core Facility Director are  responsible for the efficient and
equitable utilization of the facility based upon recommendations of the
Advisory Committee.  No single investigator or laboratory (e.g., the Principal
Investigator's or Core Facility Director's) should be allowed to monopolize
the resources of the core facilities.

The justification for the core facilities should include the ways in which the
resources will facilitate investigations of CAM or help the Center achieve its
stated goals.  In addition, the applicant should describe how the core is
integrated into at least two of the three proposed research projects.  This
section should present a clear picture of the facilities, techniques and
skills that the core will provide.  The role of the Core Facility Director and
each key participant should be described.    

The applicant's institution has to demonstrate a commitment to the core
facility.  This commitment may take the form of alterations and renovations to
established the resource, the purchase of research equipment, the assignment
of space, and/or the support of personnel.  The core facility should not
duplicate facilities already available to individual Center investigators, nor
should core facility funds be used to support laboratories of individual
investigators.  However, the core facility funds may be used to support work
proposed in, but not fully supported by, other NIH grants.  The grant will
support professional supervision of the core facility (e.g., Core Laboratory
Director; up to 0.5 FTE), as well as technical assistance (up to 2.0 FTEs),
supplies (including animals), and equipment (including computers) purchase and
maintenance.  All such support must be adequately justified in the application
and detailed in the budget plan.  In year one of the grant, up to $300,000
(total costs), including personnel, may be allotted to the core facility.  In
subsequent years, support for the core facility can be increased up to
$400,000 (total costs), including personnel.  

5.  Key Personnel:  

Key personnel must have expertise in areas such as biostatistics, computer
processing, data management, protocol design, survey design, questionnaire
development, basic laboratory evaluations, patient record data analysis,
patient registries, development of databases, clinical and behavioral
epidemiology, health education, health promotion and clinical trial
methodology.  Examples of personnel positions supported by the Center grant
include, but are not limited to:  Principal Investigator/Center Director, Core
Facility Director, Core Facility Technicians, Administrative Manager/Executive
Director, Assistant/Secretary, Biostatistician/Epidemiologist,
Analyst/Computer Specialist.  Salaries of personnel should be charged to the
grant in proportion to the time dedicated to Center activities.  All positions
must be adequately justified in the application, including a detailed
description of the proposed duties and relevance to specific Center
objectives.

Institutions that do not have the full capability within their own institution
to respond to this RFA are encouraged to involve other institutions, both CAM
and conventional, through consortium agreements.

SPECIAL REQUIREMENTS

1.  Applicants should propose an appropriate structure for the Center to meet
the research goals and objectives stated above.

2.  The Principal Investigator (PI) must make a substantial commitment (50%
minimum) to the Center.  The PI should have the qualities, experience and
administrative skills necessary to oversee Center activities and provide
appropriate scientific expertise and mentorship.

3.  The PI or Director of the Center will be a member of a coordinating
committee consisting of all PIs or Directors of OAM-supported Research
Centers.  The purpose of the Committee is to share experiences, discuss common
problems and solutions, help in the development of networks of investigators,
establish common guidelines and procedures for pilot studies, share positive
and negative results, identify new research opportunities and associated
collaborations with other Centers.  New Centers must agree to use any common
guidelines and procedures developed and agreed upon by the Coordinating
Committee (e.g., process for systematic review of literature, bibliographic
database management, structure of research opportunity disposition summaries,
report formats, etc.).  The Chairperson will be selected annually by members
of the Committee.  The Director, OAM, or a designated other, will serve as an
ex officio member of the Committee.

The PI or Center Director is expected to attend and participate in at least
two, two-day Coordinating Committee planning/progress meetings per year in
Bethesda or Rockville, Maryland.  A scientific presentation of
Center-supported research is required once a year at these meetings.  Funds
should be included in the budget to cover these trips.

4.  An institution receiving this award should incorporate the Center within
its institutional priorities.  The institution should demonstrate a strong
commitment to the program's stability and success.  The application must
provide a plan that addresses how the institutional commitment will be
established and sustained; how it will maintain accountability for promoting
scientific progress; and how  the Center's research effort will be given a
high priority with the institution.  This institutional commitment may be in
the form of commitments to recruit scientific talent, provisions of
discretional resources to the Center Director, faculty appointments for Center
investigators, assignment of research space, cost sharing of resources,
release from teaching duties for Center investigators or other ways to be
proposed by the applicant.

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 subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided, 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
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Vol. 23,
No. 11, March 18, 1994.

Investigators may obtain copies from these sources or from the program staff
or contact person listed below.  Program staff may also provide additional
relevant information concerning the policy.

This policy applies to the pilot studies proposed under this RFA.

LETTER OF INTENT

Applicants are asked to submit, by December 1, 1977, a letter of intent that
includes a descriptive title of the proposed research, the name, address, and
telephone number of the Principal Investigator (s); the identities of other
key personnel and participating organizations or institutions, if any; and the
number and title of this RFA.  Although a letter of intent is not required, is
not binding, and does not enter into the review of applications, the
information that it contains will be especially helpful to the OAM in planning
for the review of applications, estimating the potential workload, and
avoiding conflicts of interest in the review process.

The letter of intent is to be sent to:

Richard L. Nahin, M.P.H., Ph.D.
Office of Alternative Medicine
National Institutes of Health
9000 Rockville Pike
Building 31, Room 5B-36
Bethesda, MD  20892-2182
FAX:  (301) 480-3519

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 5/95) is to be
used in applying for these grants.  Applications kits are available
at most institutional offices of sponsored research and from the
Division of Extramural Outreach and Information Resources, National
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD
20892-7910, telephone (301) 435-0714, email: ASKNIH@od.nih.gov.
Applications are also available on the World Wide Web at
http://grants.nih.gov/grants/funding/phs398/phs398.html.  Prior to writing the
application, applicants should carefully read the instructions
provided with PHS Form 398 and this RFA.

The total page limitation of the application, as specified  in the
instructions of the Form PHS 398, does not apply to this RFA.  Instead, the
following stipulations apply:  

Table of Contents:
Disregard the Table of Contents page from PHS 398 and, instead, write a Table
of Contents appropriate for this Center grant application.  The Table of
Contents should list all items for which funding is sought, in addition to
each specific activity required of the Center as outlined above.  Specifically
list the locations of the checklist and the various supporting documents,
including bibliographic sketches and other support pages.  
 
Bibliographic Sketches:
Bibliographic sketches and other support pages are required for all proposed
Center personnel and for all investigators associated with the three mandatory
research projects.  These pages should not be duplicated in the descriptions
of individual component projects and cores.  

Budget:
For preparation of the budget, the applicant should present a composite budget
for all years of support.  This composite budget should include the direct
costs for each Center activity (e.g., Advisory Committee, Assistance 
Activities, Career Development, etc.), as well as each  research project and
each core facility.  This composite  budget should be in tabular format and
independent of  Budget Form page 4 of the PHS Form 398.  However, a  Budget
Form page 4 of PHS Form 398 should be completed for each item listed in the
composite budget.

Research Projects and Core Facilities:
In addition, applicants may spend up to 25 pages to describe Center activities
and up to 25 pages each for each of the three research projects and for each
core facility, excluding bibliographies.  Descriptions of the three research
projects and the core facilities should follow the PHS 398 format, section 9
(Research Plan).  Each of the six points listed under Human Subjects in the
PHS 398 application must be addressed for those studies involving human
subjects.  Although not required at the time of the application, Institutional
Review Board and Institutional Animal Care and Use Committee must be obtained
for each project listed, if appropriate, within 60 days of submission.  

The RFA label available in the PHS 398 application package must be affixed to
the bottom of the face page of the application.  Failure to use this label
could result in delayed processing of the application.  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.

Submit a typewritten, signed original of the application, four signed
photocopies, and the completed checklist in one package 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 (for express/courier service)

At the time of submission, mail one additional complete copy of the
application to:

Richard L. Nahin, M.P.H., Ph.D.
Office of Alternative Medicine
National Institutes of Health
9000 Rockville Pike
Building 31, Room 5B-38
Bethesda, MD  20892-2182

Applications must be received by January 13, 1998.  If an application is
received after the date, it will be returned to the applicant without review. 
The Center for Scientific Review (CSR) will not accept any application in
response  to this announcement that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application.  The CSR will not accept any application that is essentially the
same as one previously reviewed.  This does not preclude the submission of a
substantial revision of an application already reviewed, but such an
application must follow the guidance in the PHS Form 398 application
instructions for preparation of revised applications, including an
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

General Considerations

Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the OAM.  Incomplete applications will be returned to the
applicant without further consideration.  If the application is not responsive
to the RFA, OAM staff will return the application to the applicant.

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 CSR in accordance with the 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
appropriate National Advisory Council.

Review Criteria
All applications submitted in response to this RFA will be reviewed according
to the following review criteria.  Reviewers will consider these criteria when
assigning a single overall score to each application.  This single score 
should reflect their judgement that the proposed center will have a
substantial impact on the pursuit of its goals.

1.  Institutional Commitment
(a)  Evidence of the applicant institution's commitment to
research and to the proposed Center; this can include, but is not limited to,
office and laboratory space, clinical support, administrative support, faculty
release from academic duties, support for Center training agenda, etc; 

(b) Adequacy of institutional procedures and plans for
monitoring, evaluating and assuming accountability for the general success of
the Center and for assessing the needs of the Center; 

2.  Overall Program Organization, Capability and Research Agenda
(a)  The scientific and administrative qualifications and leadership
capabilities of the Principal Investigator; adequacy of the time commitment of
the Principal Investigator;

(b)  Relevance to CAM and CAM research;

þ  Demonstration that the appropriate CAM community
linkages exist;

(d)  Ability to investigate research questions in multiple
CAM program areas;

(e)  Appropriateness of the match between the chosen
Research Theme and Program Areas;

(f)  Quality and timeliness of the Centerþs overall research agenda, as well
as its potential impact on the state of the science;  

3.  Individual Research Projects
Each research project will be reviewed according to the explicitly-stated set
of five review criteria recently adapted by the NIH:

(a)  Significance:  Does this study address an important problem?  If the aims
of the application are achieved, how will scientific knowledge be advanced? 
What will be the effect of these studies on the concepts or methods that drive
this field?

(b)  Approach:  Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

þ  Innovation:  Does the project employ novel concepts, approaches or method?
Are the aims original and innovative?  Does the project challenge existing
paradigms or develop new methodologies or technologies?
 
(d)  Investigator:  Is the investigator appropriately trained and well suited
to carry out this work?  Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?

(e)  Environment:  Does the scientific environment in which the work will be
done contribute to the probability of success?  Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements?  Is there evidence of institutional support

Each project will be reviewed for the adequacy of plans to include both
genders, minorities, and their subgroups as appropriate for the scientific
goals of the  research.  Plans for the recruitment and retention of subjects
also will be evaluated. 

The adequacy of the proposed protection for humans, animals or the environment
will be evaluate to the extent they may be adversely affected by the project
proposed in the application.

Each research project will be evaluated for relevance to the overall goals of
the Center and for appropriate utilization of Center resources;

4.  Core Facilities
(a)  Integration of cores into overall Center goals and individual research
projects;

(b)  Adequacy of proposed core facilities and personnel; scientific and
leadership ability of Core Facility Director;

þ  Potential of core to facility research on CAM;

(d)  Process for allocate of core resources;

(e)  Center oversight of core;

5.  Advisory Committee
The proposed organization and activities of the Advisory Committee will be
evaluated, including description of process to prioritize research proposals;
although it is not necessary to name members at this time, the process by
which members will be chosen should be specified; 

6.  Training and Career Development
(a)  Adequacy of the plan to introduce students, residents and fellows to both
biomedical research and to CAM;

(b)  Adequacy of the process for selecting candidates for career development
and plans for seeking out minority and women candidates;

þ  Adequacy of the individuals available to serve as possible mentors of
career development candidates; 

(d)  Complementary activities that contribute to the
environment for career development;

(e)  Capacity of the overall program to absorb career
development candidates and prepare them for independent careers investigating
CAM;

7.  Other Considerations

(a)  Appropriateness of the proposed budget;

(b)  Demonstrated willingness to work as part of the OAM Centers Coordinating
Committee;

þ  If a consortium is planned, the applicant must
demonstrate the effectiveness of the relationships among the member
institutions.  The applicant should address both current relationships, as
well as the functions and contributions of each consortium member in regards
to proposed Center activities.  In addition, the component institutions of the
consortium must demonstrate adequate commitment to the Center;

Additional factors to be considered in the evaluation of competing renewal
applications from current Centers for CAM Research
(a)  Success of the Center in meeting its original goals; 
(b)  Scientific accomplishments;
þ  Success in the initiation of competitively supported research (both federal
and non-federal sources of support can be applied to this criterion); 
(d)  The development of new CAM investigators; 
(e)  Collaborations with conventional scientists and CAM practitioners.

AWARD AND REPORTING REQUIREMENTS

Applications recommended by the NIH Initial Review
Group and by the appropriate national advisory council will be considered for
award based on,  a) scientific and technical merit as determined by peer
review, b) program relevance and balance, c) availability of funds, d)
responsiveness to the goals and objectives of the RFA. 

Award of funds for the approved future years of the grant will require
submission of a noncompeting continuation application, PHS form 2590, to the
appropriate Institute at least two months prior to the anniversary date of the
award.  In addition, an annual progress reports must be submitted to the OAM
in accordance with guidelines established by the Coordinating Committee. 
Failure to supply either the PHS form 2590 or the annual report in a timely
manner will impede release of outyear funding.  

Letter of Intent Due:  December 1, 1997
Application Receipt Date: January 13, 1998
Review by Advisory Council: May, 1998
Anticipated Award Date:  Summer, 1998

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.

Inquiries regarding programmatic issues should be directed to:

Richard L. Nahin, M.P.H., Ph.D.
Office of Alternative Medicine
National Institutes of Health
9000 Rockville Pike
Building 31, Room 5B-38
Bethesda, MD  20892-2182
Telephone:  (301) 496-4792
FAX:  (301) 480-3519
Email:  NahinR@OD31EM1.OD.NIH.GOV

AUTHORITY AND REGULATIONS

The Office of Alternative Medicine (OAM) was mandated by Congress in 1991 and
permanently established within the Office of the Director, National Institutes
of Health (NIH), through the National Institutes of Health Revitalization Act
(Public Law 103-43, Section 404E).  The congressional language states that
"the purpose of the Office is to facilitate the evaluation of alternative
medical treatment modalities. . ."  The language continues that "in carrying
out subsection b [its purpose], the Director of the Office [of Alternative
Medicine] shall - support research training - for which fellowship support is
not provided under section 487."

This program is described in the Catalog of Federal Domestic Assistance Nos.
93.213.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC
241 and 285) and administered under PHS grants policies and Federal
Regulations 42 CFR Parts 52 and 45 CFR Part 74 [and Part 92 when applicable
for State and Local governments].  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 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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