CLINICAL TRIAL PLANNING GRANTS FOR PEDIATRIC REHABILITATION

Release Date:  November 21, 2000

RFA:  HD-01-006
 
National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov)
National Institute of Arthritis and Musculoskeletal and Skin Diseases
 (http://www.nih.gov/niams/) 

Letter of Intent Receipt Date:  December 29, 2000
Application Receipt Date:  February 22, 2001

THIS RFA USES THE “MODULAR GRANT” AND “JUST-IN-TIME” CONCEPTS.  IT INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE
 
The National Center for Medical Rehabilitation Research (NCMRR) of the 
National Institute of Child Health and Human Development (NICHD) and National 
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) intend 
to support clinical trials of rehabilitation interventions focused on 
pediatric injuries and trauma, including burn wounds.  In addition, the NIAMS 
is interested in rehabilitation interventions that are focused on chronic 
musculoskeletal disorders (e.g., juvenile rheumatoid arthritis and heritable 
disorders of connective tissue) and genetic skin disorders.  The purpose of 
the Clinical Trial Planning Grant is to provide support for the organization 
of an effective research group and development of elements essential for a 
successful clinical trial.  Applications may address the development of 
activities relevant to such elements as plans for recruitment of patients, 
experimental design and protocols, testing of procedures, data management, 
analysis techniques, facilities, administrative procedures, and collaborative 
arrangements.  Detailed information regarding the rationale for the clinical 
trial based on preclinical and preliminary clinical research must be included 
in the application for the Clinical Trial Planning Grant for Pediatric 
Rehabilitation.  The purpose of the planning grant is neither to obtain 
preliminary data nor to conduct studies to support the rationale for the 
clinical trial. 

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas.  This Request for 
Applications (RFA) is related to one or more priority areas.  Potential 
applicants may obtain "Healthy People 2010" at: 
http://www.health.gov/healthypeople.

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.

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 RFA will use the National Institutes of Health (NIH) Individual 
Exploratory/ Developmental Research Grant (R21) award mechanism.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  This RFA is a one-time 
solicitation.  Applicants may apply for continuation of projects developed 
under this program using traditional, unsolicited grant mechanisms (e.g., 
R01, P01).  Future unsolicited competing continuation applications will 
compete with all investigator-initiated applications and be reviewed 
according to the customary peer review procedures.  The anticipated award 
date is September 2001.

Specific application instructions have been modified to reflect “MODULAR 
GRANT” and “JUST-IN-TIME” streamlining efforts being examined by the NIH.  
Complete and detailed instructions and information on Modular Grant 
applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

FUNDS AVAILABLE

The NICHD intends to commit approximately $750,000 in total costs [direct 
plus Facilities and Administrative (F&A) costs] in FY 2001 to fund up to 
seven new grants in response to this RFA.  The NIAMS intends to commit 
approximately $250,000 in total costs [direct plus Facilities and 
Administrative (F&A) costs] in FY 2001 to fund two or three new grants in 
response to this RFA.  An applicant may request a project period of one year 
and a budget for direct costs of up to $75,000.  Although this program is 
provided for in the financial plans of NICHD and NIAMS, awards pursuant to 
this RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications.

RESEARCH OBJECTIVES

Background

Traumatic injury is the leading cause of death for children and adolescents 
in the United States.  Age is a significant epidemiological factor because 
the causes of the injury differ according to the developmental stage of the 
individual.  Overall, accidents are the largest cause of morbidity and 
mortality during childhood.  Accidents and violence are the most frequent 
causes of death in five- to 18-year-old children.  Traumatic Brain Injury 
(TBI) alone has an incidence of 90/100,000 with the majority of these 
individuals experiencing long-term disability. 

With technical advances in medicine and emergency services, the number of 
children surviving their injuries has increased, but consequently so have the 
disabilities and long-term effects on quality of life.  Long-term care for 
such children extends beyond the rehabilitation facilities and touches all 
aspects of their lives.  Children with disability require attention to allow 
them to continue in school, maximize their participation in social and family 
activities, and develop into productive, healthy adults.  Their conditions 
are managed by a variety of rehabilitation interventions including physical 
therapy, 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. 
 
Although disorders in adults and children may be similar in causality, 
diagnosis, and treatment, it is the wide range of developmental phenomena 
that distinguishes the rehabilitation of infants, children, and adolescents 
from that of adults.  The developmental process forms the template for 
establishing appropriate interventions and rehabilitation goals.  However, 
the identification of objective and effective rehabilitation interventions is 
complicated not only by the adaptation and recovery processes taking place at 
different stages following the injury, but also by the additional 
uncertainties of the process of biological maturation.
 
Current constraints on clinical researchers make the complex and time-
consuming process of planning Phase III clinical trials problematic, 
especially in the fields of 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.

Research Scope

The range of activities that may be supported by this Clinical Trial Planning 
Grant includes:

1.  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; creation of inclusion/exclusion criteria.

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

3.  Development of detailed plans for patient recruitment and retention, 
including women and minority individuals, and plans for recruitment outreach.

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

5.  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.

6.  Selection of specific methods of data analysis.

7.  Evaluation of models of the rehabilitation treatment process, including:  
involvement of various professional disciplines, team approaches, and 
treatment settings; coordination of health care systems and resources.

Research Topics

It is hoped that these Planning Grants will help to facilitate clinical trial 
projects in areas of research need relevant to the National Center for 
Medical Rehabilitation Research (NCMRR), NICHD, and to the National Institute 
of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).  Examples of 
research areas within the scope of the RFA include, but are not limited to, 
the following: 

o development and evaluation of rehabilitation interventions and new 
treatment strategies to improve the functional outcome in children following 
traumatic injury; 

o evaluations of interventions to improve the functional mobility of children 
with chronic disability including physical therapy, medication, prosthetics 
and orthotics, electrical stimulation, and other physical modalities; 

o evaluations of interventions to improve functional mobility of children 
with chronic musculoskeletal disorders, burn wounds, and genetic skin 
disorders, including physical therapy, medication, electrical stimulation, 
and other physical modalities;	

o evaluation of interventions including medication, cognitive rehabilitation, 
and memory prosthetics to improve the cognitive functioning of children with 
disabling conditions; 

o evaluation of interventions to prevent and/or ameliorate secondary 
conditions with a higher prevalence among children with physical 
disabilities.

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 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines are available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require:  a) 
all applications or proposals and/or protocols to provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) all investigators to report accrual, and to conduct and report 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.  

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,”  published in the NIH Guide for Grants 
and Contracts, March 6, 1998, and available on the Internet at:  
http://grants.nih.gov/grants/guide/notice-files/not98-024.html. 

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, Internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit 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 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 NICHD staff to estimate the potential review workload and 
plan the review.

The letter of intent is to be sent to Dr. Beth Ansel at the address listed 
under INQUIRIES, below, by December 29, 2000.

APPLICATION PROCEDURES 

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research, on the Internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html, 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, E-mail:  Grantsinfo@nih.gov.  

Application Instructions

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award.  It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers, and NIH 
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants, with the modifications noted below.

For responses to this RFA, Modular Grant applications will request direct 
costs in $25,000 modules, up to a total direct cost request of $75,000 for 
one year.  The total direct costs must be requested in accordance with the 
program guidelines and the modifications made to the standard PHS 398 
application instructions described below:

o FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs 
(in $25,000 increments up to a maximum of $75,000) and Total Costs [Modular 
Total Direct plus Facilities and Administrative  (F&A) costs] for the initial 
budget period.   Items 8a and 8b should be completed indicating the Direct 
and Total Costs for the entire proposed period of support, identical to the 
figures in Items 7a and 7b for this RFA.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD:  Do not complete Form Page 
4 of the PHS 398.  It is not required and will not be accepted with the 
application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT:  Do not complete the 
categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION:  Prepare a Modular Grant Budget Narrative 
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages.)  At the top of the page, enter the total direct costs 
requested for the project year.  This is not a Form Page.

o Under Personnel, list ALL project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should 
be provided.  However, the applicant should use the NIH appropriation 
language salary cap and the NIH policy for graduate student compensation in 
developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus F & A), rounded to the nearest $1,000.  List the 
individuals/organizations with whom consortium or contractual arrangements 
have been made, the percent effort of all personnel, and the role on the 
project.  Indicate whether the collaborating institution is foreign or 
domestic.  The total cost for a consortium/contractual arrangement is 
included in the overall requested modular direct cost amount.  Include the 
Letter of Intent to establish a consortium.

o BIOGRAPHICAL SKETCH:  The Biographical Sketch provides information used by  
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three 
pages may be used for each person.  A sample biographical sketch may be 
viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm.  

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

o CHECKLIST:  This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date.  All appropriate exclusions must be applied 
in the calculation of the F&A costs for the budget period.

o The applicant should provide the name and telephone number of the 
individual to contact concerning fiscal and administrative issues if 
additional information is necessary following the initial review.

Submission Instructions  

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
stapled to the bottom of the face page of the application and must display 
the RFA number HD-00-025.  A sample RFA label is available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.   Please note this 
is in the pdf format.  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 2 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:

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 copies of the application should be 
sent to:

L. R. Stanford, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03F, MSC 7510
Bethesda, MD 20892-7510
Bethesda, MD 20854 (for express/courier service)

Applications must be received by February 22, 2001.  If an application is 
received after that 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 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 for 
responsiveness to this RFA by NICHD and NIAMS.  Incomplete and/or non-
responsive applications will be returned to the applicant without further 
consideration.

Applications that are complete and responsive to the RFA will be reviewed for 
scientific and technical merit by a review group convened by the NICHD, in 
cooperation with the NIAMS, in accordance with the review criteria stated 
below.  As part of the initial merit review, all applications will receive a 
written critique and may undergo a process in which only those applications 
deemed to have the highest scientific merit will be discussed, assigned a 
priority score, and receive a second level review by the National Advisory 
Child Health and Human Development Council and/or the National Arthritis and 
Musculoskeletal and Skin Diseases Advisory Council.

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 frameworks, 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, 
applications also will 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 also will 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, and the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

Schedule

Letter of Intent Receipt Date:    December 29, 2000
Application Receipt Date:         February 22, 2001
Peer Review Date:                 June/July 2001
Council Review:                   September 2001
Earliest Anticipated Start Date:  September 2001

AWARD CRITERIA 

Funding decisions will be based on scientific and technical merit as 
determined by peer review, program balance and need, and the availability of 
funds.

INQUIRIES

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

Beth M. Ansel, Ph.D., CCC-SLP
Director, Clinical Practices Research Program 
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 402-2242
FAX:  (301) 402-0832
E-mail:  Beth_Ansel@nih.gov 

James S. Panagis, M.D., M.P.H.
Director, Orthopaedics Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6500 Center Drive, Room 5AS-37K, MSC 6500
Bethesda, MD 20892-6500
Telephone:  (301) 594-5055
FAX:  (301) 480-4543
E-mail:  jp149d@nih.gov 
 
Direct inquiries regarding fiscal matters to:

Ms. Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17H, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1304 
FAX:  (301)  402-0915
E-mail:  mc113b@nih.gov

Ms. Melinda Nelson
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6500 Center Drive, Room 5AS-49F, MSC 6500
Bethesda, MD 20892-6500
Telephone:  (301) 594-3535
FAX:  (301) 480-5450
E-mail:  mn23z@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.929 and 93.846.  Awards are made under authorization of Sections 301 and 
405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies and Federal Regulations 42 CFR 52 and 
45 CFR Parts 74 and 92.  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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