Full Text OD-97-005
 
CENTER FOR CHIROPRACTIC RESEARCH
 
NIH GUIDE, Volume 26, Number 8, March 14, 1997
 
RFA:  OD-97-005
 
P.T. 34

Keywords: 
  Chiropractic 
  0715184 
  Musculoskeletal System 

 
Office of Alternative Medicine
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Child Health and Human Development
 
Letter of Intent Receipt Date:  April 9, 1997
Application Receipt Date:  May 9, 1997
 
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 of 1993 (Public Law 103-43, Section
209).  The mission of the OAM is to encourage and support the
investigation of complementary and alternative medical (CAM)
practices, with the ultimate goal of integrating validated
alternative medical practices into health and medical care.
 
The demographics, prevalence, and patterns of use of unconventional
medicine in the United States have been described (New England J.
Med. 328:246-352, 1993).  The most relevant findings are the
following: a) most people use unconventional 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 United States population suggests that Americans
made approximately 425 million visits to providers of unconventional
therapy during 1990; and d) expenditures associated with alternative
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 self-
health care of U.S. citizens than previously understood.
 
Chiropractic is one of the most used forms of CAM by the U.S. Public.
The goal of this RFA initiative is to encourage research of
chiropractic by establishing a Center for Chiropractic Research.
Such a Center will make available to investigators interested in
chiropractic the resources necessary for the conduct of high quality
research.
 
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 currently specify a CAM or
Chiropractic objective, this RFA involves priority areas within the
Healthy People 2000 objectives, which involve alternative medical
health care.  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 Colleges of Chiropractic or
other chiropractic training institutions, either alone or in
collaboration with other chiropractic institutions or with a
conventional biomedical institution, including 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.  As
the focus of this RFA is chiropractic medicine, substantive
involvement of a College of Chiropractic or other chiropractic
training institution is highly encouraged.  Applications may include
foreign components, but foreign organizations are not eligible to
apply.  Applications from minority and women investigators are
encouraged.
 
MECHANISM OF SUPPORT
 
The administrative and funding instrument to be used for this program
will be a cooperative agreement (U24), an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial NIH
scientific and/or programmatic involvement with the awardee is
anticipated during performance of the activity.  Under the
cooperative agreement, the NIH purpose is to support and/or stimulate
the recipient's activity by involvement in and otherwise working
jointly with the award recipient in a partner role, but it is not to
assume direction, prime responsibility, or a dominant role in the
activity. Details of the responsibilities, relationships and
governance of the study to be funded under cooperative agreement(s)
are discussed later in this document under the section "Terms and
Conditions of Award."
 
FUNDS AVAILABLE
 
Approximately $500,000 in total costs (direct plus indirect) will be
committed in the first year to fund one award from a qualified
applicant.  This award 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.
 
RESEARCH OBJECTIVES
 
Background
 
The Office of Alternative Medicine (OAM) is mandated by Congress to
identify and evaluate unconventional health care practices used by
members of the U.S. public.  Of these practices, chiropractic care is
one of the mostly widely used by the public.  Chiropractors are
licensed in all fifty states, and chiropractic treatments for
musculoskeletal disorders are often reimbursed by health insurance
plans.  It has been estimated that 5-10% of the U.S. population use
chiropractic services at a cost of approximately $2 billion dollars,
annually.  One third to one half of these visits are for low-back
pain.  In recent years, there has been increased research on
chiropractic care, some of which suggests the efficacy of spinal
manipulation for certain type of low back pain. Although not
systematically studied, major complications from chiropractic care
appear to be rare.  Nevertheless, there is a relative paucity of
research on the efficacy and effectiveness of such chiropractic care
for musculoskeletal disorders, including chronic pain, and little
preclinical work on the biological mechanisms underlying chiropractic
manipulation of the vertebral column.
 
Purpose of the RFA
 
A variety of health care providers employ the modalities of
manipulation and mobilization for the treatment of musculoskeletal
disorders; however, the expressed purpose of this RFA is to provide a
mechanism to examine the potential effectiveness and validity of
chiropractic therapies, and to provide clinical/scientific/technical
assistance to chiropractic investigators as they develop their
research projects.  The establishment and support of a Center for
Chiropractic Research, under the auspices of the OAM, will meet these
objectives.  The Center will support a multi-disciplinary group of
researchers and clinicians to perform basic, preclinical, clinical,
epidemiologic and or health services research of chiropractic.  The
Center will provide many of the resources necessary of the conduct of
high quality research, including an environment for training future
scientists.  Finally, the Center will encourage collaboration between
basic and clinical scientists, and between the chiropractic and
conventional medical communities.
 
In general, insufficient scientific data are currently available that
address safety and efficacy questions for chiropractic care of
musculoskeletal disorders, including chronic pain.  Many chiropractic
practitioners are not affiliated with research institutions currently
able to provide the research infrastructure necessary to facilitate
the study of chiropractic manipulations. Research conducted at the
Center for Chiropractic Research will provide useful pilot data to
determine the appropriateness of conducting larger studies on
chiropractic approaches for the treatment of back maladies and
related musculoskeletal disorders.  It is expected that work begun at
the Center will provide the basis for subsequent investigator-
initiated research grant applications to the NIH.
 
Center Concept
 
The Center for Chiropractic Research is viewed as a first step in
expanding the national infrastructure for research of chiropractic.
It will support planning for new interdisciplinary programs involving
experienced investigators from chiropractic and conventional
medicine.  It will provide clinical/scientific/technical assistance
to investigators both on and off site.
 
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.  The following personnel
positions may be supported by the Center grant:  Principal
Investigator/Center Director (0.5 FTE), Administrative
Manger/Assistant/Secretary (0.5 FTE),Computer Specialist/
Analyst/Biostatistician/Epidemiologist (0.5 FTE). 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.
 
Specific objectives for the Center include:
o  Establishing linkage of academic centers with Chiropractic
investigators;
o  Establishing a network of Chiropractic clinicians and
investigators in specific topic areas;
o  Prioritizing performing research related to the chiropractic
treatment of musculoskeletal disorders;
o  Linking investigators with common clinical interventions to each
other and to technical expertise necessary to pursue research goals;
o  Establishing an advisory committee to provide program direction
and advice to the principal investigator of the Center, including
prioritization of research protocols;
o  Evaluate the feasibility of using data from chiropractic
practitioners for research projects;
o  Developing a mechanism for scientific/technical merit review of
proposed studies from investigators;
o  Developing a bibliographic resource on chiropractic topics to be
made accessible to the public;
o  Develop workshops, seminars, etc. for training purposes; 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.
 
Chiropractic institutions that do not have the full capability within
their own institution to respond to this RFA are encouraged to
involve other institutions, both chiropractic and conventional,
through consortium agreements.
 
Research Focus
 
Applications must include two research projects proposed for Center
use.  These projects may be up to three years in length.  Projects
already underway at the time of the application are applicable if not
currently supported by the NIH.  In addition, for each project, a
justification for use of the Center is required, including an
estimate of resources to be used.
 
The Center will provide limited support for these research projects.
A total of $200,000 (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 $350,000 (total
costs) per year for all projects.  General purpose equipment, such as
computers, and personnel will not be supported with these funds.  It
is expected that the project investigators will obtain additional
funding to support their research and salaries through federal or
other sources.
 
Research topics include, but are not limited to, randomized,
controlled clinical trials of chiropractic care for the treatment of
musculoskeletal disorders, studies examining the rates and types of
treatment complications, the amount and type of treatment necessary
to achieve significant outcomes, cost-effectiveness analysis of
chiropractic care and projects examining the underlying,
biomedical/pathophysiological basis of chiropractic therapies.
 
CENTER ACTIVITIES
 
On a continuing basis, the Center will be expected to prioritize the
top research areas concerning chiropractic medical treatments for
musculoskeletal disorders including acute and chronic pain.  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.  As part
of the prioritization process, the Center is to establish and
maintain a comprehensive bibliographic database on Chiropractic.  The
OAM will assist the Center in this endeavor.  Eventually, the public
will have access to this database through the Internet
 
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 $350,000 (total costs) per year
for all projects.  Center investigators are encouraged to seek
additional sources of research support.
 
The Center must propose a mechanism for prioritizing research
projects 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 prioritized
and approved by the Center's Advisory Committee.
 
Advisory Committee
 
Center oversight is charged to an 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 kept.  These minutes shall be made
available to NIH staff upon request.  The AC should be a cross-
section of eight to twelve individuals familiar with the Center's
research activities.  It is encouraged that the AC includes both
faculty and non-faculty. However, all AC members should have training
in either chiropractic medicine, conventional medicine or biomedical
research.  The AC shall include a biostatistician and epidemiologist
to assist with the review of projects and the optimal approaches for
subsequent data analysis.
 
Besides prioritizing research projects submitted by Center or, if
applicable, Consortium investigators, the AC should periodically
review Center operations to ensure that Center resources are used for
the most scientifically worthy projects.  The AC should take an
active role in encouraging younger faculty member to perform research
and assist them in applying appropriate research concepts and
methods.  Support for the AC should be explicitly budgeted and
justified.
 
Clinical/scientific/technical Assistance Activities
 
Each application must demonstrate the ability to provide
clinical/scientific/technical assistance to potential chiropractic
investigators and propose a plan for providing assistance to
chiropractic investigators in the chosen program areas.  These
activities may include, but are not limited to, the following
examples of assistance:
 
o  Choice of research methods appropriate to the chiropractic
intervention;
o  Development of appropriate chiropractic protocols;
o  Study design;
o  Methods of data collection, management, and data analysis;
o  Quality control procedures;
o  Development of appropriate methods to assure safety of human
subjects involved in research protocols;
o  Safety issues;
o  Case review methods;
o  Provide guidelines for applicants to use for clinical evaluation
and data collection, e.g., NCI best case series;
o  Develop procedures for reporting adverse effects;
o  Preparation for Institutional Review Board approvals and FDA
Investigational New Drug applications; and
o  Preparation for workshops, seminars, etc. for chiropractic
investigators on relevant research topics.
 
One purpose of this research program is to assist Chiropractic
investigators in determining whether they have adequate preliminary
data to propose specific defined pilot studies or make other
applications for peer-reviewed research support.
 
Training
 
The Center is to serve as an environment for training health
professionals in research on topics related to chiropractic.  In
addition, the Center should implement a program designed to introduce
chiropractic students, residents and fellows to biomedical research
in an effort to attract these individuals into research careers.
Formal courses or seminars may be set up for this goal. 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.  Student participation in ongoing
research projects is also encouraged.  Support for training should be
explicitly budgeted and justified.
 
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).
 
SPECIAL REQUIREMENTS
 
Applicants should propose an appropriate structure for the center
application to meet the research goals and objectives stated above.
 
The Principal Investigator (PI) must make a substantial commitment
(e.g., 30%) to the Center.
 
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 and, where feasible, other
activities.  The Center for Chiropractic Research must agree to use
any common guidelines and procedures 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 PI or 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.
 
Any publications involving this OAM project must follow NIH
publication policies, including citation of the NIH grant.
 
The following terms and conditions will be incorporated into the
award statement and provided to the Principal Investigator(s) as well
as the institutional official at the time of award.
 
TERMS AND CONDITIONS OF AWARD
 
The administrative and funding instrument used for the Centers is a
cooperative agreement (U24), an "assistance" mechanism in which
substantial NIH scientific and programmatic involvement with the
awardee is anticipated during the performance of the agreement.
 
Under the cooperative agreement, the OAM purpose is to assist and
stimulate the Center's planning and implementation by involvement in
and working with the Center in a partner role.  The OAM role is not
to assume primary direction, responsibility, or a dominant operating
role in the Center.  Consistent with this concept, the primary role
and total responsibility for Center programs resides with each
Center.  The Center and the OAM as noted below will share specific
tasks and activities in completing the agreement.
 
These special Terms of Award are in addition to and not in lieu of
applicable U.S. Office of Management and Budget administrative
guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74
and 92, and other HHS, PHS, and NIH Grant Administration policy
statements.
 
1.  Awardee Rights and Responsibilities
 
The Awardee will have primary and lead responsibilities for the
project as a whole, but are expected to collaborate and cooperate
with the Coordinating Committee, as well as with OAM and National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
staff.  The Awardee is expected to prioritize, facilitate and support
research, provide clinical/scientific/ technical assistance to
potential Center (Consortium) investigators and initiate a training
program as outlined in the application.
 
The Awardee will establish an Advisory Committee to provide
scientific and administrative oversight.  The Advisory Committee will
be composed of a cross-section of individuals knowledgeable in
chiropractic medicine, conventional medicine or biomedical research,
including a biostatistician and epidemiologist.  These individuals
are not limited to Center, or, if applicable, Consortium, faculty.
The AC is expected to meet at least quarterly, with minutes of the
meeting kept.  The minutes will be made available to NIH staff upon
request.
 
The Advisory Committee is charged with both prioritizing projects
submitted to the Center (or Consortium) and periodically reviewing
Center (Consortium) activities to ensure that Center objectives, as
outlined in the application, are being met.
 
The Awardee is expected to initiate and maintain a comprehensive
bibliographic database on chiropractic, with public access being the
eventual goal.. Approximately every six months, the Center and OAM
will electronically exchange collected citations
 
The Awardee will retain custody of, and have primary rights to, the
data developed under these awards, subject to Government rights of
access consistent with current HHS, PHS, and NIH policies.
 
2.  NIH Staff Responsibilities
 
The OAM Project Scientist will have substantial scientific and
programmatic involvement in assisting the Awardee in the project,
participating in technical assistance activities, referring members
of the public to the Center for information or  assistance, assisting
in the development of bibliographic resources in Chiropractic,
coordinating and involving NIH resources of clinically relevant
activities outside of Chiropractic. NIAMS will designate a Program
Officer and a Grants Management Specialist to provide administrative
oversight of the grant, and will serve as scientific, technical, and
programmatic advisors to the OAM during administration of this award.
 
OAM Staff will assist the Center with the establishment and
maintenance of the bibliographic database on Chiropractic.
Approximately every six months, the OAM and Center will
electronically exchange collected citations.  Eventually, the public
will have access to this database through the Internet.
 
3.  Collaborative Responsibilities
 
A Center Coordinating Committee, composed of the PIs of each OAM-
supported Research Center and the OAM Director, or designated
representative, has the primary responsibility for developing and
implementing common procedures, guidelines, and criteria across
centers, establishing common procedures and guidelines for pilot
studies and other activities where feasible.  The Center for
Chiropractic Research agrees to use any common guidelines and
procedures 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 OAM Director, or designated
representative, is a voting member of the Center Coordinating
Committee and will serve as Chair.
 
The Coordinating Committee will establish subcommittees as
appropriate; OAM staff will provide assistance and support to the
sub-committees as appropriate.
 
The OAM Project Scientist will coordinate NIH Alternative Medicine
activities with Center activities.
 
4.  Arbitration
 
Any disagreement that may arise on scientific and programmatic
matters within the scope of the cooperative agreement and between
award recipients and the OAM may be brought to arbitration.  An
arbitration panel will be composed of three members:  one selected by
the Center Principal Investigator; a second member selected by the
OAM; and, the third member selected by the two prior selected
members.  This special arbitration procedure in no way effects the
awardee's right to appeal an adverse action that is appealable in
accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS
regulation at 45 CFR Part 16.
 
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 18, 1994 (FR 59 14508-
14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18,
1994, Volume 23, Number 11.
 
LETTER OF INTENT
 
Applicants are asked to submit, by April 1, 1997, a letter of intent
that includes the number and title of this RFA; 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 a title describing the proposed research.
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 work-load, and
avoiding conflicts of interest in the review process.
 
The letter of intent is to be sent to:
 
Richard L. Nahin, Ph.D.
Office of Alternative Medicine
National Institutes of Health
Building 31, Room 5B-38
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 this cooperative agreement.  These forms are
available at most institutional offices of sponsored research, from
the OAM program administrator named above or from the World Wide Web
at http://grants.nih.gov/grants/funding/funding.htm.  Prior to writing
the application, applicants should carefully read the instructions
provided with form PHS 398 and this RFA.
 
The total page limitation of the application, as specified in the
instructions of the Form PHS 398, do not apply to this RFA.
Applicants may spend up to 25 pages to describe Center activities
and, in addition, up to 25 pages for each of the two research
projects, excluding bibliographies.  The two research projects should
follow the PHS 398 format..  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:
 
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 the following RFA program administrator:
 
Richard L. Nahin, Ph.D.
Office of Alternative Medicine
National Institutes of Health
Building 31, Room 5B-38
Bethesda, MD  20892-2182
 
Applications must be received by May 9, 1997.  If an application is
received after the date, it will be returned to the applicant without
review.  The Division of Research Grants (DRG) will not accept any
application in response to this RFA that is essentially the same as
one currently pending initial review, unless the applicant withdraws
the pending application.  The DRG 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
DRG 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 DRG 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 National Advisory Council for NIAMS.
 
Review Criteria
 
An initial review group convened by the NIH DRG will assess the
technical and scientific merit of the applications submitted based on
three general areas:  1) the technical merit of the research
proposals; 2) the institutional commitment and environment; and 3)
the potential of the proposed center to enhance the level of
chiropractic research.  Below are specific criteria that will be
evaluated by the reviewers.  The final priority score will reflect
the peer reviewers' overall assessment based on their judgements of
these criteria:
 
o  Relevance to chiropractic and chiropractic research
 
o  Degree of substantive involvement of chiropractic training
institutions
 
o  Scientific and technical merit of the proposed approaches for
conducting the research projects
 
o  Adequate statistical, methodological and other appropriate
scientific expertise, as dictated by the proposed research projects
 
o  Qualifications and clinical/research training and experience of
the Principal Investigator and staff
 
o  Demonstration that the appropriate chiropractic community linkages
exist
 
o  Availability of resources necessary to perform research assistance
activities
 
o  Proposed organization and activities of the Advisory Committee,
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;.
 
o  Plans for the initiation and maintenance of a comprehensive
bibliographic database on chiropractic;
 
o  Appropriateness of the proposed budget;.
 
o  Appropriateness of the proposed training plan;.
 
o  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
 
o  Demonstrated willingness to work as part of the OAM Centers
Coordinating Committee and with OAM and NIAMS staff; and
 
o  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.
 
AWARD CRITERIA
 
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 NIAMS 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.
 
Schedule
 
Letter of Intent Receipt Date:  April 9, 1997
Application Receipt Date:       May 9, 1997
Review by Advisory Council:     September 4-5, 1997
Anticipated Award Date:         September 30, 1997
 
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, 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
 
Direct inquiries regarding fiscal matters to:
 
Vicki L. Maurer
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building Room 5AS.49A - MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-3504
FAX:  (301) 480-5450
Email:  maurerv@ep.niams.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 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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