MEDICAL REHABILITATION CLINICAL TRIAL PLANNING GRANTS

NIH GUIDE, Volume 26, Number 37, November 7, 1997

RFA:  HD-98-001

P.T.

National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  December 22, 1997
Application Receipt Date:  January 21, 1998

PURPOSE

The National Center for Medical Rehabilitation Research (NCMRR) of
the National Institute of Child Health and Human Development
(NICHD) seeks to fund high quality clinical trials of medical
rehabilitation interventions.  The purpose of the Medical
Rehabilitation Clinical Trial Planning Grant is to provide support
for the organization of an effective research group and development
of essential elements of a successful clinical trial, including
plans for recruitment of patients, experimental design and
protocols, testing of procedures, data management, analytical
techniques, facilities, administrative procedures, and
collaborative arrangements.  The purpose of the planning grant is
not to obtain preliminary data nor to conduct studies to support
the rationale for the clinical trial.

Detailed information regarding the rationale of the clinical trial,
based on preclinical science and preliminary clinical research,
must be included in the application for the Medical Rehabilitation
Clinical Trial Planning Grant. Involvement of representatives from
the targeted patient population in planning and conducting the
trial is highly recommended.

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), Medical Rehabilitation
Clinical Trial Planning Grants, is related to the priority 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 domestic for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals; units of State or local governments, and eligible
agencies of the Federal government.  Foreign institutions and
organizations are not eligible as applicants, but may participate
in collaboration.  Applications may include collaborative
arrangements between scientists from a single institution or
multiple institutions.  Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as Principal
Investigators.

Clinical trial planning support is for new projects and may not be
used to supplement research projects already being supported or to
provide interim support of projects under review.  Simultaneous
submissions of both planning and regular clinical trial grant
applications (R01) on the same topic will not be accepted.  Only
one Clinical Trial Planning Grant application from an individual
principal investigator will be considered.

MECHANISM OF SUPPORT

This program will use the exploratory/developmental grant (R21)
mechanism.  Applicants will be responsible for the planning,
direction, and execution of the proposed project. All PHS and NIH
grants policies will apply to applications received and awards made
in response to this request for applications.  Support may be
requested for a single year for up to $50,000 in direct costs, not
including facilities and administrative costs for collaborating
institutions, if any.  These grants are not renewable and
continuation of projects developed under this program will be
through traditional unsolicited investigator-initiated grant
programs (e.g., R01, P01).  Funds may be included to support travel
for the collaborators and/or the purchase of equipment, as
justified by the needs of the proposed research.  All information
for review must be included in the body of the application;
appendices may not be used to circumvent the page limitations.

FUNDS AVAILABLE

It is anticipated that up to eight awards totalling $400,000 direct
costs will be made for Clinical Trial Planning Grants.  Although
this program is provided for in the financial plans of NICHD, the
award of grants pursuant to this RFA is contingent on the
scientific and technical merit of the applications and on the
availability of funds for this purpose.

RESEARCH OBJECTIVES

Background

Millions of people in the United States suffer disabling injuries
or diseases each year.  Over 50 million individuals live with
chronic physical impairments and disabilities due to conditions
such as cerebral palsy, metabolic disorders, burns, arthritis,
AIDS, amputation, cancer, injury to the brain or spinal cord, spina
bifida or muscular dystrophy. These conditions are managed by a
variety of rehabilitation therapies including physiotherapeutic
interventions, medication, and the provision of adaptive equipment
such as prostheses, orthoses, and wheelchairs.  Although these
interventions are widely used, very little systematic information
exists regarding the effectiveness of many of them.

Current constraints on clinical researchers make the complex and
time-consuming process of planning Phase III clinical trials
problematic, especially in fields such as medical rehabilitation
where there is not a well-established clinical research
infrastructure.  These planning grants will provide a mechanism for
early peer review of the rationale and design of the potential
clinical trial, and provide successful applicants resources to
assist development of detailed clinical trial study plans and
collaborations.

This RFA is directly responsive to recommendations of the National
Advisory Board on Medical Rehabilitation Research that NCMRR
implement a strategy of encouraging Phase III clinical trials
relevant to medical rehabilitation.

Scope

The following items provide examples of subject areas that are
within the scope of the RFA.  This list is not exhaustive, and
applicants are encouraged to communicate with program staff
regarding the responsiveness of other topics to this RFA.

1.  Evaluation of interventions to improve the functional mobility
of persons with chronic disability, including physiotherapy,
medication, prosthetics and orthotics, electrical stimulation and
other physical modalities.

2.  Evaluation of interventions such as medication, cognitive
rehabilitation, and memory prosthetics to improve the cognitive
functioning of people with disabling conditions such as traumatic
brain injury or stroke.

3.  Evaluation of interventions to prevent and/or ameliorate
secondary conditions with a higher prevalence among people with
physical disabilities.  These conditions include depression, memory
loss, muscle atrophy, pressure ulcers, cardiopulmonary
deconditioning, and bowel, bladder, and sexual dysfunction.

4.  Evaluation of models of the rehabilitation treatment process
such as the involvement of various professional disciplines, team
approaches, and treatment settings.

Supported Activities

Types of activities supported include:

o Development of a detailed experimental design, including: - 
translation of the clinical question into a statistical hypothesis,
-  determination of the sample size and duration of the
-  trial, selection of endpoint(s) and data to be collected, -  and
creation of inclusion/exclusion criteria;

o Development of specific protocols, including:
-  patient selection and informed consent procedures,
-  randomization and masking procedures,
-  data collection techniques,
-  treatment administration and dose/quantity measurements, -  and
follow-up and quality control procedures;

o Development of detailed plans for patient recruitment and
retention, including women and minority individuals, and plans for
recruitment outreach;

o Identification of other personnel necessary to perform the
proposed research, including statisticians, data managers, and
study coordinators;

o Identification of the physical resources necessary to perform the
proposed research, including clinical space and equipment which is
accessible to subjects and researchers with disabilities;

o Selection of specific methods of data analysis;

o Travel and salary support for the principal researchers for
planning meetings.

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 are 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.  The Guidelines are available on the
Internet at .

LETTER OF INTENT

Prospective applicants are asked to submit by December 22, 1997, 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 (HD-98-001) and title
(MEDICAL REHABILITATION CLINICAL TRIAL PLANNING GRANTS) of this
RFA.  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 staff to estimate the potential
review workload and avoid conflict of interest in the review.

The letter of intent is to be sent to Dr. Stephen M. Tuel at the
address listed under INQUIRIES.

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 may be
obtained from the Office of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone 301/435-0714, E-mail:
asknih@od.nih.gov. The PHS 398 may also be downloaded over the
Internet from http://grants.nih.gov/grants/funding/funding.htm.

The following instructions are to be used in conjunction with the
information accompanying application form PHS 398 (rev. 5/95). 
They refer only to selected items in the application form.  All PHS
398 requirements should be adhered to, with the exception of those
items affected by the following instructions; for example, the
Research Plan is limited to 20 pages.  Applications not conforming
to the requested format will be returned to the applicant without
review.  Please note that some of the information to be omitted
from the application at submission may be requested following
review if the possibility of funding exists.

Face Page:
- The RFA label available in the application form PHS 398 (rev. 
5/95) 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.  - Item 2, Response to Specific
Request for Applications:  Check the box marked YES.  Enter the RFA
number (HD-98-001) and title (MEDICAL REHABILITATION CLINICAL TRIAL
PLANNING GRANTS).

Detailed Budget for Initial Budget Period (Page 4):  Do not
complete or submit this page.

Budget for Entire Proposed Period of Support (Page 5):  - Composite
budget table:  Enter total direct costs requested, up to a maximum
of $50,000, for a single year of support. Please include subtotals
by budget category.  - Provide a narrative justification for each
proposed personnel position, including role on the project and
proposed level of effort.  - Provide narrative justification for
any additional resources requested for the conduct of the project.

Biographical Sketch (Page 6) (Complete for each of the key
personnel listed on Form Page 2.):  - List current position(s) and
those previous positions directly relevant to the application.  -
List selected peer-reviewed publications directly relevant to the
proposed project, with full citations.  - Provide information on
research projects completed and/or research grants in which the
investigator participated during the last 5 years which are
relevant to the proposed project.  For each project or grant
listed, provide title, name of principal investigator, funding
source, and role on project (if not principal investigator).

Other Support (Page 7): Do not complete or submit this section.

Research Plan:
- Items a - d of the Research Plan (Specific Aims, Background and
Significance, Preliminary Studies, and Research Design and Methods)
may not exceed a total of 20 pages.
- Please note that a Progress Report is not needed; no competing
continuation applications will be accepted.

Appendix: Appendix material may not be used to circumvent the
application limits.

Checklist: The Checklist should not be submitted.

Submit a signed, typewritten original of the application and three
signed, exact photocopies, in one package 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)

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

Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03 MSC-7510
Bethesda MD  20892-7510
Rockville MD 20852-7510 (for express/courier service)

Applications in response to this RFA must be received by January
21, 1998.  If an application is received after that date, it will
be returned to the applicant.  The Center for Scientific Review
(CSR) 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 CSR
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 CSR
and responsiveness by the NICHD.  Incomplete, non-responsive, or
ineligible applications will be returned to the applicant without
further consideration.

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 Division of Scientific Review,
in accordance with the review criteria stated below.  As part of
the initial merit review, a process 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 this RFA.
Applications judged to be competitive will be discussed in depth
and assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration.  A
summary statement will be prepared, and the Principal Investigator
and the official signing for the applicant organization will be
notified.

Review Criteria

o  Scientific and clinical significance of the proposed clinical
intervention, including analysis of the need and potential impact
on health care, comparison with competitive therapies, and
relevance of the proposed clinical trial to outcomes desired by the
target patient population;

o Basis or grounding of the project in the relevant literature,
including biological mechanisms and supporting clinical data;

o  Qualifications and research experience of the principal
investigator, and for multi-center trials, a core of potential
center investigators, and a clear statement of the leadership and
proposed organization and committee structures of the clinical
trial;

o  The potential of the proposed planning activity to lead to a
full-scale clinical trial, including:
-  adequacy of collaborative linkages,
-  likelihood of successfully recruiting research participants, - 
likelihood of sustaining participant cooperation throughout the
trial, and -  capability to standardize data collection and follow-
up procedures;

o  Adequacy of the provisions for protection of human subjects and
the environment;

o  Adequacy of plans to address NIH policy on inclusion of women
and minorities;

o  Reasonableness/appropriateness of the requested budget in
relation to the proposed planning process.

AWARD CRITERIA

The anticipated award date is August 1, 1998.  Applications
recommended by the NICHD Advisory Council will be considered for
award based upon (a) scientific and technical merit of the
application as determined by peer review; (b) program priorities;
and (c) availability of funds.

Schedule

Letter of Intent Receipt Date:     December 22, 1997
Application Receipt Date:          January 21, 1998
Review by NICHD Advisory Council:  June 2, 1998
Anticipated Award Date:            August 1, 1998

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is
welcome.  Additional information on the National Center for Medical
Rehabilitation Research is available on the Web at
http://silk.nih.gov/silk/NCMRR/.

Direct inquires regarding programmatic issues to:

Stephen M. Tuel, MSE, MD
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
Building 61E, Room 2A03 MSC-7510
Bethesda, MD 20892-7510
Telephone:  (301) 402-2242
FAX:  (301) 402-0832
Email:  tuels@box-t.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 MSC-7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1303
FAX:  (301) 402-0915
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 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 to 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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