Full Text HD-95-010

PAIN MANAGEMENT FOR PERSONS WITH PHYSICAL DISABILITIES

NIH GUIDE, Volume 23, Number 45, December 23, 1994

RFA:  HD-95-010

P.T. 34

Keywords: 
  Pain 
  Rehabilitation/Therapy, Physical 
  Treatment, Medical+ 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  March 15, 1995
Application Receipt Date:  May 16, 1995

PURPOSE

The National Center for Medical Rehabilitation Research (NCMRR)
invites applications for program projects to conduct rehabilitation
research to improve the prevention and management of chronic pain
experienced by persons with designated physical impairments.  The
chronic pain of interest is a secondary condition associated with the
primary impairments of spinal cord injury, amputation, cerebral
palsy, spina bifida, or traumatic brain injury.  Program project
applications are encouraged that take into account the
pathophysiological, subjective, behavioral, cognitive, and social
manifestations of chronic pain as a secondary condition.  The award
of at least two program projects is anticipated.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This request
for applications (RFA), Pain Management for Persons with Physical
Disabilities, is related to the priority areas of other disabling
conditions.  Potential applicants may obtain a copy of "Healthy
People 2000" (Full Report:  Stock No. 017-001-00474-0, or "Healthy
People 2000" (Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by 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

This RFA will use the National Institutes of Health (NIH) program
project (P01).  Applicants should be familiar with NICHD program
project guidelines.  A copy may be obtained from the NICHD office
listed under INQUIRIES.  Responsibility for the planning, direction,
and execution of the proposed program will be solely that of the
applicant.  Awards will be administered under PHS grants policy as
stated in the Public Health Service Grants Policy Statement (rev.
April 1994).  The total project period for applications submitted in
response to this RFA may not exceed five years.  The anticipated
award date is December 1, 1995.  Because the nature and scope of the
research proposed in response to this RFA may vary, it is anticipated
that the size of the awards will vary also.  This RFA is a one-time
solicitation for applications for new awards.  Future unsolicited
continuation applications will compete with other applications and be
reviewed according to the customary peer review procedures.

FUNDS AVAILABLE

Approximately $1 million direct cost for the first year will be
committed to fund applications submitted in response to this RFA.  It
is anticipated that two applications will be funded.  The number of
awards is dependent on the receipt of a sufficient number of
applications of high scientific merit.  Although this RFA is provided
for in the financial plans of the NCMRR, awards pursuant to this RFA
are contingent upon the availability of funds for this purpose.

RESEARCH OBJECTIVES

Background

This initiative builds directly on recommendations emanating from an
NCMRR workshop on management of chronic pain that was conducted in
March of 1993.  A panel of experts evaluated the state of science,
determined research needs and opportunities, and made recommendations
for rehabilitation research in the area of chronic pain.  To receive
a copy of the panel report ("Chronic Pain Management:  Developing A
Treatment System For People with Disabilities," March 1-3, 1993,
National Center For Medical Rehabilitation Research, Bethesda,
Maryland (Unpublished Report)), send a mailing label and request to
the program administrator listed under INQUIRIES.

This RFA is focused on research to improve the prevention and
management of chronic pain experienced by people with spinal cord
injury, amputation, cerebral palsy, spina bifida or traumatic brain
injury.  This RFA encompasses the five domains of investigation that
are identified in the "Research Plan for the National Center for
Medical Rehabilitation Research" as being relevant to medical
rehabilitation (Research Plan for the National Center for Medical
Rehabilitation Research, March 1993, National Institutes of Health,
Bethesda, MD, NIH Publication No. 93-3509).  These are:
pathophysiology, impairment, functional limitation, disability, and
societal limitation.

Scope

The objectives of this RFA are to stimulate the establishment of
program projects that are multidisciplinary research approaches to
chronic pain and to bring together, on a cooperative basis, clinical
and basic science investigators in a manner that will foster
communication, innovation, and high quality research.  To accomplish
these objectives, the applicant institution or collaborating
institution must be conducting an ongoing program of excellence in
biomedical research related to the study of chronic pain.  This
research should be in the form of NIH-funded research projects (R01),
FIRST Awards (R29), program projects (P01), or other peer reviewed
research supported by federal or non-federal sources.  Applications
on behalf of more than one institutions should include documentation
demonstrating the capacity of each to participate in the program and
their willingness to implement common protocols targeting
rehabilitation- specific research questions.

The theoretical bases for proposed studies must be clearly
explicated.  Interventions to be tested must be clearly defined in
terms of their purpose, sample composition, means of implementation
and anticipated effects.  Particular attention should be paid to
ensuring that the anticipated effects are linked with well defined
outcome measures.  These might include but are not limited to:
reduced medication dependency, reduced psychosocial disruption,
increased functional activity, fewer reports of pain, reduced health
care costs, and a return to age-appropriate activities.

Applications must address one or both of the following research
themes.

1.  Examining the effectiveness of specific treatments (either
pharmacological or non- pharmacological) that are currently used to
manage different types of chronic pain in different populations of
people with physical disabilities.

2.  Developing and evaluating new or improved treatments (either
pharmacological or non-pharmacological) to manage different types of
chronic pain in different populations of people with physical
disabilities.

Current Treatments

Subprojects to evaluate interventions (e.g., pharmacological,
surgical, physiotherapeutic, or behavioral) that are used currently
to manage different types of chronic pain in different populations
may include, but are not limited to:

o  evaluating the pathophysiology of different types of pain from a
basic science perspective to elucidate relationships among pathology,
pain intensity, and potential treatments of pain;

o  developing and testing conceptual models to specify the mechanisms
responsible for the prevention and management of chronic pain; and,

o  investigating effects of interventions on functional, psychosocial
or quality-of-life issues for persons with disabilities who
experience chronic pain.

New or Improved Treatments

Subprojects to evaluate new or improved interventions (e.g.,
pharmacological, surgical, physiotherapeutic, or behavioral) to
prevent or manage different types of chronic pain may include, but
are not limited to:

o  evaluating the pathophysiology of different types of pain from a
basic science perspective to elucidate relationships among pathology,
pain intensity, and potential treatments of pain;

o  developing and testing conceptual models to specify the mechanisms
responsible for the prevention and management of chronic pain; and,

o  investigating effects of interventions on functional,
psychosocial, or quality-of-life issues for persons with disabilities
who experience chronic pain.

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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.

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, Volume 23, Number 11, March 18,
1994.  Investigators also may obtain copies from the program staff
listed under INQUIRIES.  Program staff may also provide additional
relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by March 15, 1995, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.  Although a letter of intent
is not required, is not binding, and does not enter into the review
of a subsequent application, the information that it contains allows
NICHD staff to estimate the potential review workload and avoid
conflict of interest in the review.

The letter of intent is to be sent to:

Louis A. Quatrano, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
Executive Building, Room 2A03
6100 Executive Boulevard MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 402-2242

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
to prepare the application.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301-435-0714, and from the program administrator listed
under INQUIRIES.

Grant applications will be supported through the program project
(P01) mechanism.  The application should be prepared in a manner
consistent with the general guidelines in the publication "NICHD P01
PROGRAM PROJECT GUIDELINES," which are available from the NICHD
office listed under INQUIRIES.

The RFA label available in the PHS 398 (rev. 9/91) application form
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 such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Susan Streufert, Ph.D.
Acting Director
Division of Scientific Review
National Institute of Child Health and Human Development
Executive Building,Room 5E01
6100 Executive Boulevard MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1485

Applications must be received by May 16, 1995.  If an application is
received after that 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 already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NICHD.  Incomplete applications will be
returned to the applicant without further consideration. If the
application is not responsive to the RFA, DRG staff may contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next review cycle.

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 NICHD in accordance with the review
criteria stated below.  As part of the initial merit review, a
process (triage) may be used by the initial review group in which
applications will be determined to be competitive or non-competitive
based on their scientific merit relative to other applications
received in response to the RFA.  Applications judged to be
competitive will be discussed and be assigned a priority score, and
will also receive a second level of review by the NICHD Council.
Applications determined to be non-competitive will be withdrawn from
further consideration and the Principal Investigator/Program Director
and the official signing for the applicant organization will be
notified.

Peer Review Criteria

The scientific and technical merit peer review of program projects
focuses on two areas:  (1) review of the overall program as an
integrated, synergistic effort; and, (2) review of the component
research projects and core units.

Overall Program Criteria

The criteria for reviewing the program as an integrated effort are:

o  the coordination, interrelationship, cohesiveness, and synergism
among the individual research projects and core components;
relationship of the program objectives to the common theme; the
advantages of pursuing the proposed research as a program project
rather than through individual research grants;

o  relevance of the program to the NCMRR mission;

o  leadership ability and scientific stature of the program director
and his/her ability to meet the program's demands of time and effort;

o  participation of a suitable number of responsible, experienced
investigators;

o  an appropriate organizational and administrative structure for
effective attainment of program objectives;

o  arrangements for internal quality control of ongoing research, the
allocation of funds, day-to-day management, contractual agreements,
and internal communication and cooperation among program
investigators;

o  the institutional environment in which the research will be
conducted, including the availability of space, equipment and
subjects; physical proximity of investigators and the potential for
interaction with scientists from other areas;

o  the appropriateness of the program size:  small enough to afford
effective interaction focused on a specific central theme and large
enough to achieve synergy and economies not provided by regular
research grants;

o  institutional commitments to the program requirements.

Individual Projects and Core Unit Criteria

The review criteria for the component research projects and core
units are:

o  the scientific merit of each individual project in the program
context;

o  the specific scientific objectives of each project that will
benefit significantly from or depend upon, collaborative interactions
with other P01 projects (e.g., objectives that can be uniquely
accomplished, specific contributions to the accomplishments of
objectives in other projects, objectives that can be accomplished
with greater effectiveness, and/or economy of effort);

o  accomplishments and progress to date of the component research
projects, if appropriate;

o  qualifications, experience, and commitment of the investigators
and their ability to devote the required time and effort to the
program;

o  the appropriateness of the budget for each component research
project and core unit; cost effectiveness and quality control of core
units;

o  the appropriateness of the research projects use of core services;

o  the adequacy of the means proposed for protecting against risks to
human subjects, animals, and the environment;

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

The review of program project applications assigned to NICHD may
include a site visit or applicant interview.  However, these are not
review requirements and should not be depended upon to supplement an
incomplete written application.  If a site visit is planned, the
principal investigator will be contacted by the Scientific Review
Administrator.

AWARD CRITERIA

The following will be considered in making funding decisions:

o  quality of the proposed project as determined by peer review;
o  availability of funds;
o  geographical location of the applicant organization;
o  program balance among research areas of this announcement; and,
o  relevance to medical rehabilitation.

INQUIRIES

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

Direct inquires regarding programmatic issues to:

Louis A. Quatrano, PhD
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
Executive Building, Room 2A03
6100 Executive Boulevard MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 402-2242
Email:  quatranl@hd01.nichd.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Mary Ellen Colvin
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Building, Room 8A17G
6100 Executive Boulevard MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1303
Email:  colvinm@hd01.nichd.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.929-Medical Rehabilitation Research.  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 Part 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 Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use
of all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.

.

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