CHIROPRACTIC AND OSTEOPATHIC CLINICAL TRIAL PILOT GRANTS

Release Date:  November 6, 1998

PA NUMBER:  PA-99-013

P.T.

National Center for Complementary and Alternative Medicine
National Institute of Arthritis and Musculoskeletal and Skin Disorders
National Institute of Child Health and Human Development

PURPOSE

The National Institutes of Health (NIH) is committed to investigating the
efficacy and effectiveness of chiropractic and osteopathy for treatment of,
and rehabilitation associated with, musculoskeletal injuries and disorders by
supporting well-designed, well- executed, randomized clinical trials (RCT). 
Before proceeding to a full-scale, definitive RCT (Phase III trial) in which
the main objective is to determine whether the intervention is more effective
than that used in a control (or comparison) group, pilot clinical studies are
often required.  In the present program announcement (PA), the NIH announces
its interest in supporting pilot studies to establish the methodological
feasibility and strengthen the scientific rationale for proceeding to full-
scale RCTs on the use of chiropractic or osteopathy to manage or treat
musculoskeletal injuries and disorders.  The emphasis of these pilot trials
should be placed on the development of appropriate study designs to
investigate safety and efficacy.  These "proof of concept" trials could
potentially lead to subsequent, large RCTs. For the purposes of this PA,
trials of chiropractic and osteopathy are limited to manual manipulations.

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 have a chiropractic objective, this PA involves priority areas within
the "Healthy People 2000" objectives, such as the area of chronic disabling
conditions.  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) through the Superintendent of Documents, Government Printing
Office, Washington, DC 20402-9325 (telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government.  Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as principal
investigators.

MECHANISM OF SUPPORT

The mechanisms of support will be the NIH research project grants (R01). 
Responsibility for the planning, direction, and execution of the proposed
project will be solely that of the applicant.  Since the proposed research is
pilot in nature, grants may not exceed $150,000 per year in direct costs.

RESEARCH OBJECTIVES

The objective of Chiropractic and Osteopathic Clinical Trial Pilot Grants is
to increase the quality of clinical research evaluating the efficacy of
chiropractic and osteopathy for the management of musculoskeletal injuries and
disorders, and their accompanying symptoms, particularly in children and in
the physically disabled.  To meet this objective, the proposed pilot study
must successfully incorporate creative and realistic solutions to difficult
problems in clinical research for the particular disease/condition under
study.  The focus should be on diagnostic and treatment procedures for
specific musculoskeletal injuries and disorders that are selected according to
public health and clinical significance, scientific rationale as provided by
the appropriate research literature, and availability of a patient population.

The application should directly address how the pilot grant will advance the
design of a subsequent full-scale RCT (Phase III trial).  In preparing for the
definitive RCT, these pilot studies should address questions that are
formulated to optimize the design of the eventual RCT rather than address the
clinical question with lower power.  The application should also address the
intrinsic scientific merit of the study conducted under the pilot grant,
regardless of whether a full-scale trial is eventually performed.  For the
purposes of this PA, trials of chiropractic and osteopathy are limited to
manual manipulations.  Full-scale RCTs (Phase III trials in which the main
objective is to determine whether the intervention is more effective than that
used in a control or comparison group) will not be accepted under this 
Program Announcement.

Applications in response to this program announcement may include, but are not
limited to:

1.  Studies to refine the intervention strategy including:  duration and
frequency of treatment; type of treatment; evaluations of different systems of
manipulation.

2.  Studies to refine the control strategy including comparisons of different
types of controls (e.g., invasive control [sham] versus non-invasive control
[placebo, standard therapy, wait list, etc.]).

3.  Studies to define and refine the target population (e.g.,
inclusion/exclusion criteria) and develop adequate recruitment procedures.

4.  Collection of preliminary data for establishing measures of efficacy and
safety.

5.  Studies to determine the feasibility and/or safety of the treatment
strategy and develop realistic protocols.

6.  Studies to establish the anticipated benefit of the treatment and to
ascertain even rates (success and complications).

7.  Studies to establish the clinical usefulness (validity, reliability,
responsiveness and utility) and appropriateness of commonly used assessment
procedures, especially quality-of-life measures, as well as functional and
physiological measures of manipulation;

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 20, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23,
No. 11, March 28, 1994.

NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN
RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://www.nih.gov/grants/guide/notice-files/not98-024.html

APPLICATION PROCEDURES

Applications are to be submitted on grant application form PHS 398 (rev. 5/95)
and will be accepted at the standard application deadlines as indicated in the
application kit. Application kits are available at most institutional offices
of sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267,
email: Grantsinfo@nih.gov.

The title and number of the program announcement must be typed in section 2 on
the face page of the application.

The complete original application and five legible copies 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 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral
guidelines.  Applications that are complete will be evaluated for scientific
and technical merit by an appropriate peer review group convened in accordance
with the standard NIH peer review procedures.  As part of the initial merit
review, all applications will receive a written critique.  Applications will
also undergo a process in which only those 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 or board, when applicable.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In
the written comments, reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.  Each of these
criteria will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application.  Note that the application
does not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score.  For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.

(1)  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?

(2)  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? 

(3)  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?

(4)  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)? 

(5)  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?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

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

o  The reasonableness of the proposed budget and duration in relation to the
proposed research

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

AWARD CRITERIA

The following will be considered in making funding decisions:  Quality of the
proposed project as determined by peer review, availability of funds, and
program priority.

INQUIRIES

Applicants are strongly encouraged to contact the individuals designated
below, in advance of preparing an application, for additional information
concerning the areas of research and other types of pre-applications
consultation.

Dr. Richard L. Nahin
National Center for Complementary and Alternative Medicine
National Institutes of Health
Building 31, Room 5B36
Bethesda, MD  20892-2182
Telephone:  (301) 435-5042
FAX:  (301) 594-6757
Email:  NahinR@OD31EM1.OD.NIH.GOV

Dr. James Panagis
Orthopaedics Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building,  Room 5AS-37K - MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-5055
FAX: (301) 480-4543
Email:  panagisj@ep.niams.nih.gov

Dr. Stephen M. Tuel
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
Building 61E, Room 2A03
Bethesda, MD  20892-7510
Telephone:  (301) 402-2242
FAX:  (301) 402-0832
Email:  tuels@exchange.nih.gov

Direct inquiries regarding fiscal matters to:

Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
Building 61E, Room 8A17
Bethesda, MD  20892-7510
Telephone:  (301) 496-1303
FAX:  (301) 402-0915
Email:  mc113b@nih.gov

Irene Grissom
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-43J
Bethesda, MD  20892-7510
Telephone:  (301) 594-3507
FAX:  (301) 480-5450
Email:  grissomi@mail.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos.
93.213, 93.846, and 93.929.  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 52 and 45 CFR Part 74.  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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