DEVELOPMENTAL PLANNING GRANTS FOR MUSCULAR DYSTROPHY RESEARCH CENTERS 

RELEASE DATE:  October 31, 2002

RFA: AR-03-002
 
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)  
 (http://www.niams.nih.gov/)
National Institute of Child Health and Human Development (NICHD)  
 (http://www.nichd.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)  
 (http://www.ninds.nih.gov/)
 
LETTER OF INTENT RECEIPT DATE: January 15, 2003

APPLICATION RECEIPT DATE: February 24, 2003
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:

PURPOSE OF THIS RFA

The National Institute of Arthritis and Musculoskeletal and Skin Diseases 
(NIAMS), the National Institute of Neurological Disorders and Stroke (NINDS) 
and the National Institute of Child Health and Human Development (NICHD) seek 
developmental planning grant applications for the establishment of an 
infrastructure for eventual Muscular Dystrophy Cooperative Research Centers 
(MDCRCs).  This initiative supports the planning of new or expansion of 
existing resources for future competitive MDCRCs.  These planning grants will 
enable applicants to effectively organize and integrate multidisciplinary 
research capacities and core resources to enhance collaborations of basic, 
clinical, and behavioral science in muscular dystrophy research and to 
promote cross-disciplinary research training.  

Participation in this RFA will not itself be a factor in the review of any 
Center application.  Investigators may respond to current (e.g., RFA AR03-
001) or future solicitations for center grant applications without first 
having participated in this developmental planning initiative.  

Investigators interested in applying for support of muscular dystrophy 
research using mechanisms other than centers or this developmental planning 
initiative should see NIH PAS01-041, "Therapeutic and Pathogenic Approaches 
for the Muscular Dystrophies" 
(http://www.niams.nih.gov/rtac/funding/grants/pa/pas_01_041.pdf).

RESEARCH OBJECTIVES

Background and Rationale

Muscular dystrophies collectively have a high impact on health, affecting 
tens of thousands of people in the United States alone.  The diseases are 
characterized by progressive weakness and wasting of muscles.  Many cases of 
muscular dystrophy represent new occurrences of disease, where there is no 
prior family history.  Though research has recently revealed much about 
genetic defects associated with many forms of muscular dystrophy, treatment 
for the diseases has not changed significantly.  There is a need to learn 
more about pathogenesis of the diseases and improve early detection and 
screening, diagnosis, treatment, and prevention.  Summaries of recent NIH 
sponsored meetings on this subject may be found at: 
http://www.ninds.nih.gov/news_and_events/dmdmtngsummary.htm; 
http://www.niams.nih.gov/ne/reports/sci_wrk/2000/fshdexsummary.htm; and 
http://www.niams.nih.gov/ne/reports/sci_wrk/2002/mdmeet.htm.

Given the promising growth of research relevant to muscular dystrophy, the 
National Institute of Arthritis and Musculoskeletal and Skin Diseases 
(NIAMS), the National Institute of Neurological Disorders and Stroke (NINDS), 
and the National Institute of Child Health and Human Development (NICHD) have 
initiated a program of Muscular Dystrophy Cooperative Research Centers to 
promote interaction among investigators in the field.  Multidisciplinary, 
multifaceted research is of paramount importance in better understanding the 
etiology, pathophysiology, and insightful treatment of muscular dystrophy.  
The program was initiated with the release of RFA AR03-001, which may be 
found at http://www.niams.nih.gov/rtac/funding/grants/rfa/ar_03_001.pdf.  The 
MDCRC program represents a quantum increase in the organization and scope of 
the scientific enterprise related to muscular dystrophy.  This RFA, AR03-002, 
is intended to increase the number and quality of teams and/or sites fully 
prepared to organize the scientific and infrastructure resources necessary to 
generate outstanding applications to become Muscular Dystrophy Cooperative 
Research Centers.  

Developmental planning grants are a proven method of facilitating 
collaborations among teams of researchers who need to interact intensively in 
order to formulate integrative strategies.  Following such focused 
preparation, research groups are in a far better position to submit well 
conceptualized and comprehensive center applications. 

Therefore, the primary goal of this request is to support early and mid-stage 
development of interdisciplinary teams of accomplished investigators focused 
on basic and clinical issues related to muscular dystrophy.  This support 
will provide them with the opportunity to define common goals and objectives, 
prove the feasibility of their working as a cohesive, interactive research 
team, and aid in the acquisition of resources, equipment, or administrative 
support needed to operate an interdisciplinary center.  Demonstrating the 
planning and development interaction of such teams to produce innovative, 
potentially high-impact approaches to important research problems would 
position these teams well to apply for support as MDCRCs. 

Research Objectives

These developmental planning grants will provide institutions with the 
resources to set in place detailed plans for all of the components that would 
potentially make them competitive for MDCRC support (see RFA AR03-001, which 
may be found at 
http://www.niams.nih.gov/rtac/funding/grants/rfa/ar_03_001.pdf).  An 
appropriate Director with expertise in basic or clinical research relevant to 
muscular dystrophy must be selected as Principal Investigator (PI).  In 
addition, the application must identify a Co-Director with expertise in a 
complementary field.  The PI should have a demonstrated capability to 
organize, administer and direct the team.  It is expected that the Director 
(PI) and Co-Director will have a substantial investment in this developmental 
effort, with the goal of assembling and organizing an outstanding center 
application.  Investigators with the qualifications to be members of the 
research team, and to contribute to such a unique enterprise, may be located 
in different geographic locations.  Therefore, collaborations among different 
institutions are encouraged, if scientifically appropriate.  The lead 
investigators should represent major scientific components that will be 
involved in the relevant proposed Muscular Dystrophy Cooperative Research 
Center, and each must have demonstrated scientific accomplishment, but they 
do not need to demonstrate prior interactive research amongst themselves.  
Plans for center development are encouraged to involve both researchers and 
potential clinical populations from diverse groups.  The Director, using the 
advice of the lead investigators, will be responsible for the definition of 
the research goals and objectives of the developmental enterprise, as well as 
ongoing activities.  

Characteristics of Responsive Applications

Critical elements of any application submitted in response to this RFA will 
include (1) an overview of the proposed team, (2) a description of the 
potential center's central theme and goals, (3) an explanation of how the 
research team could eventually constitute the backbone of a center, and (4) a 
plan of development activities.  The applicants should describe how the team 
would achieve its major objectives during the period of support provided 
under this RFA, and the team's vision of how the center would develop over a 
period of several years. The discussion would explain the proposed 
contribution of each team member and the synergism with other team members 
and research programs. 

It is expected that most of the teams that compete for support under this RFA 
will submit applications for an MDCRC for a future re-issuance of RFA AR03-
001, which may be found at  
http://www.niams.nih.gov/rtac/funding/grants/rfa/ar_03_001.pdf.  However, 
some teams may be successful in the present competition and decide that their 
research programs are more suitable for support by R01 or other NIH 
mechanisms and proceed accordingly.  Other teams may decide that they are 
prepared to apply for full center support without responding to this RFA. 

Since the duration and total amount of support provided under the present 
mechanism are limited, it is not anticipated that totally new or substantial 
research projects will be entirely funded from this support.  However, 
support for pilot projects of limited scope, or pivotal funding of partially 
completed projects critical to a future MDCRC application would be 
appropriate.

Activities During Funding Period

It is anticipated that the next request for applications for Muscular 
Dystrophy Cooperative Research Centers will be issued during summer, 2004, 
for funding in FY 2005.  Since the likely receipt date will be December 2004, 
applications for the current developmental grants should plan activities and 
budget funds so that work is completed by that time. 

During the course of the developmental planning grant award, the leadership 
team will be responsible for the design and implementation of planning 
activities that will lead to a well-developed, conceptually sound application 
for an MDCRC.  The application must include a proposed plan through which 
scientific synergy can occur on a stable and continuing basis that will 
incorporate:  1) an organizational structure specifically designed to 
facilitate intellectual cross-fertilization among team members; 2) a detailed 
description of core facilities that would support research activities; 3) a 
plan for the distribution and management of developmental planning grant 
funds for feasibility testing of new projects; 4) strategies for promoting 
career development opportunities for new and established investigators and 
seminars for students and researchers, and a visiting scientists program or 
other type of training or educational approaches. 

The planning activities should emphasize the interface between clinical and 
basic research and should be structured to meet the needs and level of 
maturity of the ongoing efforts.  Organizational activities must occur, 
during which the group will be expected to define: 

-  The organization and operational structure of the team.  This will include 
planning for leadership by senior investigators, who will be responsible for 
the overall scientific direction of the program and will also involve 
delineating mechanisms for involving a dynamic group of investigators at all 
levels of experience.

-  A plan for interactive activities that will occur regularly over the 
entire course of the developmental planning grant award.  Emphasis should be 
placed on establishing creative, productive interactions designed to promote 
the cross-fertilization between basic and clinical subdisciplines of research 
relevant to muscular dystrophy.

- The relationship of the proposed center research to other clinical and 
epidemiological activities at the host institution(s) where there are 
possibilities for interaction, for example the ability to participate in 
clinical trials.  There should be discussion of the clinical patient 
population that can be accessed for studies, including any ongoing muscular 
dystrophy clinics or surveillance systems. 

-  A description of the core facilities necessary to support the scientific 
goals of the program.  Access to equipment and resources is often a problem, 
especially for multi-disciplinary programs.  The establishment of core 
resources dedicated to team-related projects will provide this access.  
Initially, core resources may simply be extensions of existing laboratories 
or facilities, and the definition of a core resource would vary considerably 
depending on the projects, existing facilities, and the scientific focus of 
the team.

MECHANISM OF SUPPORT

This RFA will use NIH Exploratory/Developmental Grant R21 award mechanism. As 
an applicant you will be solely responsible for planning, directing, and 
executing the proposed project.  This RFA is a one-time solicitation.  Future 
unsolicited, competing-continuation applications based on this project will 
compete with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures. The anticipated award date 
is September 2003.  

This RFA uses just-in-time concepts.  It also uses the modular budgeting 
format. (See http://grants.nih.gov/grants/funding/modular/modular.htm).  

FUNDS AVAILABLE

NIAMS, NINDS, and NICHD intend to commit approximately $1,000,000 in FY 2003 
to fund 4-5 new grants in response to this RFA.  Funding for each award will 
be limited to 6 modules ($150,000 direct costs) and a project period of one 
year.  An additional module may be requested to accommodate F&A costs for 
consortium arrangements.  Awards are not renewable and supplements are not 
allowed.  Grantees may request a no-cost extension of an R21.  Because the 
nature and scope of the proposed research will vary from application to 
application, it is anticipated that the size and duration of each award will 
also vary.  Although the financial plans of NIAMS, NINDS, and NICHD provide 
support for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications.  There are no plans to reissue this RFA.

Funds provided under this RFA are intended to support activities such as 
travel for group meetings, partial support for administrative personnel to 
facilitate the logistics of intensive interaction among investigative teams, 
support for critical ongoing pilot projects that could demonstrate 
feasibility in a future MDCRC proposal, development of resource cores, and/or 
other expenses that are reasonably incurred in activities that are crucial to 
developing a quality proposal for a center. 

ELIGIBLE INSTITUTIONS

Applications may be submitted by domestic organizations with any of the 
following characteristics:
	
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Individuals with the skills, knowledge, and resources necessary to carry out 
the proposed research are invited to work with their institution to develop 
an application for support.  Individuals from underrepresented racial and 
ethnic groups as well as individuals with disabilities are always encouraged 
to apply for NIH programs. 

SPECIAL REQUIREMENTS

Applications for the present RFA will be expected to propose developmental 
activities in some substantial subset of topics relevant to a possible future 
muscular dystrophy research center.  Only applications that include both 
basic and clinical research components will be considered responsive to this 
RFA.  The current MDCRC program requires an integrated basic and clinical 
research program focused on improving knowledge and treatment of muscular 
dystrophy.  Close interaction between basic researchers and clinicians is 
expected to accelerate the translation of fundamental advances to the clinic. 

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

Richard W. Lymn, Ph.D.
Chief, Muscle Biology Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases 
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD  20892-4872
Telephone:  (301) 594-5128
FAX:  (301) 480-4543
Email: LymnR@mail.nih.gov

James W. Hanson, M.D.
Chief, Mental Retardation and Developmental Disabilities Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Blvd, Room 4B09    MSC 7510		
Bethesda, MD 20892-7510
Telephone:  (301) 496-1383
FAX: (301) 496-3791
Email: hansonj@mail.nih.gov				

Giovanna M. Spinella, M.D.
Neurogenetics and Development Program
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd.  Rm. 2132
Rockville, MD 20892-9527
Telephone:  (301) 496-5745
FAX:  (301) 401-1501
Email:  gs41b@nih.gov

o Direct your questions about peer review issues to:

Chief, Review Branch
Extramural Programs
National Institute of Arthritis and Musculoskeletal and Skin Diseases 
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892-4872
Telephone:  (301) 594-4952
FAX: (301) 402-2406
Email: nrb@mail.nih.gov

o Direct your questions about financial or grants management matters to:

Michael G. Morse
Deputy Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases 
One Democracy Plaza
6701 Democracy Blvd. Suite 800
Bethesda, MD  20892-4872
Telephone:  (301) 594-3535
FAX:  (301) 480-5450
Email:  morsem@mail.nih.gov

Christopher Myers
Grants Management Officer
National Institute of Child Health and Human Development
Building 6100E/Room 8A17
6100 Executive Blvd. MSC 7510
Bethesda, MD 20892-7510
Email: cm143g@nih.gov

Sheila Simmons
Grants Management Specialist
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd.  Rm. 3250
Rockville, MD 20892
Telephone: (301) 496-9231
FAX: (301) 402-0219
Email: simmonss@ninds.nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o 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 IC staff to estimate the potential review workload and plan 
the review.					
 
The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Richard W. Lymn, Ph.D.
Chief, Muscle Biology Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases 
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD  20892-4872
Telephone:  (301) 594-5128
FAX:  (301) 480-4543
Email: LymnR@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.
 
SUPPLEMENTAL INSTRUCTIONS: 

RESEARCH PLAN 
The research plan is limited to 25 pages for R21 applications (exclusive of 
cited references). Applications that exceed the page limit will be returned 
without review. Applicants may include up to three relevant appendices to 
establish background information, but should include no information unique to 
the application; the appendices are not to be used to circumvent the page 
limit of the research plan. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

A.  FACE PAGE

Complete all items on the face page (Form Page 1) as directed. In the title 
block, item 1, put "DEVELOPMENTAL PLANNING GRANT FOR MUSCULAR DYSTROPHY 
RESEARCH CENTER."   Mark item 2 "yes" and write in the RFA code AR03-002, as 
listed in the NIH Guide to Grants and Contracts, and "DEVELOPMENTAL PLANNING 
GRANTS FOR MUSCULAR DYSTROPHY RESEARCH CENTERS" for the title.

B.  BUDGET:  Funding under this developmental RFA will be for a maximum of 
$150,000 direct costs, which may be budgeted for one year.  For those 
applications that include more than one institution, direct costs of up to 
$175,000 may be requested to allow for F&A costs on consortium arrangements.  

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  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. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: 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, 
including all appendix material, must be sent to:

Chief, Review Branch
Extramural Programs
National Institute of Arthritis and Musculoskeletal and Skin Diseases 
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892-4872
[Bethesda, MD 20817 (for express/courier service)]

APPLICATION PROCESSING: Applications must be received by the application 
receipt date listed in the heading of this RFA.  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.

PEER REVIEW PROCESS  
 
Applicants should keep in mind that the written application is the basis for 
the merit review.  Site visits are not anticipated. Upon receipt, 
applications will be reviewed for completeness by the CSR and responsiveness 
by the NIH program staff. 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 evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by NIH in accordance with the review criteria stated below.  As part 
of the initial merit review, all applications will:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Councils for NIAMS, 
NINDS, and NICHD. 

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 your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your 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, you 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 your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
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?  Do you acknowledge potential problem areas and consider alternative 
tactics?  What is the likelihood that support of the proposed developmental 
activities will improve the quality of a subsequent application for a 
Muscular Dystrophy Cooperative Research Center, and increase the likelihood 
of success?  The review will not emphasize detailed protocols or methods.

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?  Special 
emphasis will be placed on integration of basic and clinical research 
components relevant to muscular dystrophy into promising synergistic 
proposals.  The review will not emphasize detailed protocols or methods.

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers?  The quality of the 
research team will be given special emphasis in this review.  The inclusion 
of appropriate outstanding investigators, who have not previously been 
associated with NIH-supported research directly relevant to muscular 
dystrophy, is encouraged, when the research team as a whole has expertise in 
muscular dystrophy.
 
(5) ENVIRONMENT:  Does the scientific environment in which your 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?  Are there strong potential resources available at the performance 
site(s)?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o CAREER DEVELOPMENT PLANS: Adequacy of plans for promoting career 
development opportunities for new and established investigators, such as 
seminars for students and researchers, a visiting scientists program, or 
other types of training and educational approaches. What is the likelihood of 
the success of the proposed strategies?

o PROTECTIONS:  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.

o INCLUSION:  The adequacy of plans to include subjects from both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate for 
the scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
included in the section on Federal Citations, below)

o BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: January 15, 2003
Application Receipt Date: February 24, 2003
Scientific Review Date: May/June 2003
Advisory Council Date: September 2003
Earliest Date of Award: September 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include: 

o  Scientific merit (as determined by peer review)
o  Availability of funds
o  Programmatic priorities, including balance among muscular dystrophy 
research and scientific resource areas

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 
available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.   
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

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.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

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 
RFA is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance Nos. 93.846 (NIAMS), 93.853 (NINDS), and 93.865 
(NICHD) and is not subject to the intergovernmental review requirements of 
Executive Order 12372 or Health Systems Agency review.  Awards are made under 
authorization of Sections 301 and 405 of the Public Health Service Act as 
amended (42 USC 241 and 284)(or other authorizations) and administered under 
NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm (cite other relevant policies) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 (cite 
other relevant regulations). 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.