MEDICAL REHABILITATION RESEARCH INFRASTRUCTURE

RELEASE DATE:  April 9, 2004

RFA NUMBER:  RFA-HD-04-005

Update: The following update relating to this announcement has been issued: 

June 24, 2009 - This RFA has been reissued as (RFA-HD-09-013).  


EXPIRATION DATE:  November 17, 2004

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:   
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.865

LETTER OF INTENT RECEIPT DATE: October 18, 2004
APPLICATION RECEIPT DATE:  November 16, 2004

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 Child Health and Human Development (NICHD), through 
the National Center for Medical Rehabilitation Research (NCMRR), invites 
applications for grants to build research infrastructure by providing access 
to expertise, technologies, and resources from allied fields such as 
neurosciences, engineering, applied behavior, and the social sciences. Medical 
rehabilitation involves basic and clinical studies in the domains of 
pathophysiology, impairment, functional limitation, disability, and societal 
interaction. Increasingly, research breakthroughs and potential therapeutic 
strategies are the result of integrating expertise from allied fields as well 
as building up a core understanding of rehabilitative mechanisms and clinical 
outcomes. Access to technologies and approaches from allied fields is key to 
promoting multidisciplinary collaborations and developing research 
opportunities. Centralized research infrastructure will enhance the capability 
of medical rehabilitation investigators to understand mechanisms of functional 
recovery, develop therapeutic strategies, and improve the lives of people with 
disabilities. 

The aim of this Request for Applications (RFA) is to create a national network 
of research cores that will provide access to collateral expertise in 
biomedical, behavioral, and/or psychosocial fields that is particularly 
relevant to current opportunities in medical rehabilitation research. 
Applicants should propose a program of training, research resources, and 
collaborative opportunities in a specific content area. This may be 
accomplished through a combination of didactic interactions (workshops, 
courses, written material, and websites), consultations, sabbatical 
opportunities, and pilot funding. In addition, the research core may support 
intramural activities related to technique development, adaptation, and 
validation. Although examples of relevant expertise and content are provided 
below, additional areas may be proposed provided they are complementary to 
what is typically available in rehabilitation-related departments and 
appropriate for promoting medical rehabilitation research and improving 
outcomes. 

To aid potential applicants, a special website has been established to address 
administrative or logistical issues and to respond to frequently asked 
questions (FAQs). Potential applicants are encouraged to consult this website 
(http://www.nichd.nih.gov/RFA/HD-04-005/HD-04-005.htm) for additional 
information. 

RESEARCH OBJECTIVES

Background

The mission of the NCMRR is to enhance the quality of life for people with 
disabilities through research (NCMRR website available at 
http://www.nichd.nih.gov/about/ncmrr/ncmrr.htm). The NCMRR provides support 
for scientists to conduct research on impairments and functional changes 
associated with chronic physical conditions as well as rehabilitative 
strategies to reduce disability, improve health, and increase participation. 
Relevant conditions include stroke, brain or spinal cord injury, orthopedic 
injuries, developmental and degenerative disorders, and other chronic 
conditions. Investigations supported by NCMRR attempt to promote improvement 
at many levels:  from reducing pathophysiology and physical impairment, to 
enhancing functional adaptation, to reducing disability and societal barriers. 
This requires an integration of biological, engineering, and sociobehavioral 
approaches to understand the basis of the chronic condition, secondary 
implications, and the interaction of the individual with his/her environment. 
A multidisciplinary approach to these goals is fundamental to medical 
rehabilitation practice. 

In 1999, the NCMRR solicited applications for four regional research networks 
to promote resources, information, and networking in order to expand the 
capabilities and numbers of investigators who pursue research in medical 
rehabilitation. The current RFA represents the next step in that process, with 
more of a focus on providing national access to specific expertise and 
research resources.

Scientific opportunities have emerged in many areas relevant to medical 
rehabilitation with the potential for:  (1) improving our understanding of 
pathological processes and secondary complications; (2) promoting plasticity, 
recovery, and adaptation; (3) developing assistive technologies and 
engineering solutions; (4) understanding the role of family, community, and 
other environmental factors; and (5) providing long-term treatments to reduce 
disability and promote health and well-being. Centralized research 
infrastructure will not only increase access to resources and expertise, but 
will also promote collaborations among rehabilitation researchers, clinicians, 
and investigators from allied fields. 

Scope

The purpose of the national medical rehabilitation research infrastructure 
program is to provide access to specialized expertise and resources not 
typically available to rehabilitation-related research departments. This 
includes the introduction from allied fields of cutting-edge technologies and 
approaches that are particularly timely for understanding physiological and 
psychosocial processes and promoting rehabilitative outcomes. The emphasis 
should be on approaches that are relevant to current opportunities in medical 
rehabilitation research and those that can be transmitted through a concerted 
program of didactic and collaborative interactions. 

The aim of this RFA is to create a national network of medical rehabilitation 
research infrastructure cores that will provide access to collateral expertise 
that is particularly relevant to current opportunities in medical 
rehabilitation research. Applicants should propose a program of training, 
research resources, and collaborative opportunities in a specific content 
area. Although examples of relevant expertise and content are provided below, 
additional areas may be proposed provided they are complementary to what is 
typically available in rehabilitation-related departments and appropriate for 
promoting medical rehabilitation research and improving outcomes. 

Examples of possible cores include, but are not limited to:

o Molecular, cellular, and/or biophysical support of plasticity and recovery 
of function:  Neuroplasticity (tissue interactions, neurotrophic factors, 
extracellular matrix); cellular and gene therapies; implants and (chronic) 
delivery systems; biophysical, electrical, and activity-driven mechanisms; 
angiogenesis and support of tissue function.

o Rehabilitation engineering:  Orthotics and prosthetics; robotics; assistive 
technologies; bowel and bladder function; remote sensing; environmental 
control; enhancing access and participation.

o Biomaterials:  Biocompatibility and tissue interactions; tissue 
replacements; electrical and computer implants; nanotechnology. 

o Applied behavior and psychosocial support:  Behavioral/social/emotional 
aspects of chronic disabilities; longitudinal study design; enhancing 
compliance and health-promoting activities; ecological validity; transfer of 
clinical therapies to community settings; support of telemedicine; health 
services research.

o Imaging technologies:  Anatomical and biochemical approaches (e.g., PET, 
SPECT, NIRS); functional approaches (e.g., fMRI, EEG/MEG, TES/TMS); imaging 
non-neuronal tissues (skin, bone, muscle)

o Pharmacological approaches:  Mechanisms of drug actions (e.g., pain 
management, enhancing sensory and motoric function, treating cognitive and 
behavioral deficits); pharmacokinetics; studies of chronic treatments and drug 
interactions; safety and efficacy studies; clinical trial design. 

o Animal models:  Understanding pathophysiological processes, adaptation, and 
recovery; functional consequences of anatomical abnormalities; motor and 
behavioral testing; evaluating therapeutic interventions and chronic 
treatments; extrapolating animal results to human conditions.

A national medical rehabilitation research infrastructure core will have the 
following responsibilities:

o Courses, workshops, demonstrations, and other didactic programs:  These may 
occur at the applicant institution or at national meetings, as appropriate. 
When possible, activities should be available for remote viewing and archived 
for possible screening at a later date. 

o Website and a library of research resources:  The core should develop 
research manuals, background information, reference articles, databases, 
contact information, and other research resources. The core is also 
responsible for providing access to consultative services and expertise, as 
appropriate. 

o Pilot studies:  Each infrastructure program may set aside pilot funds up to 
$150,000 per year (direct costs) to support small research studies by 
qualified investigators who are accessing core resources. There should be a 
formal process to solicit and review pilot proposals, and evaluate their 
potential to develop into successful NIH applications. Researchers associated 
with the infrastructure grant may be considered for pilot funding, but first 
priority should be researchers from other locations. 

o Sabbatical and collaborative opportunities:  The core should provide 
opportunities for visiting rehabilitation investigators to work with experts 
at the grantee institution, as appropriate. There should be a formal plan for 
promoting and supporting a limited number of sabbatical interactions that 
provide hands-on research experience and collaboration. It is expected that 
the home institution of the visiting investigator will share substantial 
responsibility for financial support of the candidate's extended visit. 

o Techniques development:  Research cores may propose intramural activities to 
further develop, adapt, and/or validate core research techniques, tools or 
other resources. Up to $150,000 per year (direct costs) may be directed toward 
these activities provided they are focused on improving access, utility, and 
validity of these approaches for the medical rehabilitation research 
community. 

o Promoting expertise in the rehabilitation research community:  The core has 
the responsibility to make its activities, resources, and opportunities known 
to the basic and clinical rehabilitation research community. This may be 
accomplished through some combination of advertisements in professional 
journals, newsletters and websites; contacts with relevant research 
departments and funded researchers; presentations at professional meetings; 
and other means, as appropriate. 

o Administrative oversight:  The research core must develop formal plans for 
prioritization of resources, access guidelines, quality control, 
responsiveness to the research community, and documentation of overall 
effectiveness. Oversight must include the use of an external advisory board.

o Subcontracts may be used to provide access to key expertise or resources  
essential for the overall goals of the research core.  

MECHANISM OF SUPPORT

This RFA will use the NIH Resource-Related Research Project (R24) 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. The anticipated award date is July 01, 2005.

FUNDS AVAILABLE

The NICHD intends to commit approximately $4 million in total costs [Direct 
plus Facilities and Administrative (F & A) costs] in FY 2005 to support three 
to five new and/or competing continuation grants in response to this RFA.  An 
applicant may request a project period of up to five years and a budget for 
direct costs of up to $700,000 per year.  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 the 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. 

ELIGIBLE INSTITUTIONS

You may submit an application if your institution has 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  
o Domestic institutions/organizations. Foreign institutions are not eligible 
to apply. Only institutions located within the boundaries of the United States 
and its territories may apply for support under this RFA.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with his/her 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.   

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:  

Ralph Nitkin, Ph.D.
Biological Sciences and Career Development
National Institute of Child Health and Human Development
6100 Executive Boulevard, 2A03, MSC 7510
Bethesda, MD  20852-7510
Telephone: (301) 402-4206
FAX: (301) 402-0832
Email: rn21e@nih.gov

o Direct your questions about peer review issues to:  

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email:  stretchr@mail.nih.gov

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

Christopher Robey
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 435-6996
FAX: (301) 480-4783
Email:  robeyj@mail.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 NICHD 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:  

Ralph Nitkin, Ph.D.
Biological Sciences and Career Development Program
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, 2A03, MSC 7510
Bethesda, MD  20852-7510
Telephone: (301) 402-4206
FAX: (301) 402-0832
Email: rn21e@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 
document is available at 
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS:  Instructions accompanying the PHS 398 form should 
be followed.  In the Research Plan section, applications for Medical 
Rehabilitation Research Infrastructure grants should address the following:

Introductory Overview and Core Description (no more than 10 pages) 

Discuss the philosophy, objectives, and potential impact on medical 
rehabilitation research of the proposed research core. Describe how it builds 
on resources and expertise of the applicant institution. Provide some 
background on the broader field(s) of expertise involved, including recent 
advances, limitations, and overall impact on biomedical research. Make clear 
why this expertise would be particularly appropriate and timely for medical 
rehabilitation researchers. Describe the scope of the research core proposed, 
including the techniques, approaches, resources, and opportunities that it 
will provide to the rehabilitation community. Indicate which rehabilitation 
researchers would be the primary target(s) of this core and what sort of 
background would be required to take advantage of these opportunities. 
Indicate how readily this expertise or technology could eventually be 
franchised out to interested researchers and their departments. 

Didactic Interactions (no more than 15 pages)

Describe the specific mix of courses, conferences, and workshops proposed. For 
each activity, provide details on content, format, relevant expertise and 
resources, target audience, and planned venue. Discuss how often these 
activities will be offered and how they will be promoted and evaluated. 
Describe the development of a website and distribution of written material 
(e.g., manuals, references, contacts, and databases). Provide details on 
access to supplementary consultative services and expertise. 

Pilot Projects and Sabbatical Opportunities (no more than 10 pages)

Provide a plan for soliciting and evaluating requests for pilot funding and 
sabbatical interactions. Include details on eligibility criteria, evaluation, 
prioritization, and administration of funds. Discuss laboratories and projects 
that could offer sabbatical and collaborative opportunities and how these 
interactions would be sustained (i.e., potential benefits to the host 
laboratory or project that sponsors such interactions and the appropriate time 
commitments required). Discuss how the logistics of a sabbatical would be 
negotiated with the home institution of the visiting researcher. 

Technology Development (no more than 5 pages) 

Describe the state of the technologies proposed and whether further 
modification would be required and/or warranted. Discuss plans for technology 
development, adaptation, and validation to better serve the rehabilitation 
research community. This may include plans to modify technologies and 
resources to make them more appropriate for specific clinical conditions, 
populations (e.g., children or minorities), or other specialized applications. 
Some validation studies may be appropriate, but large-scale studies and 
clinical trials are beyond the scope of these infrastructure grants and should 
be supported by other means.

Key Personnel (no more than 5 pages)

Describe the role of key scientific and administrative personnel. Include 
sufficient background on their scientific expertise, research experience, and 
commitment to the infrastructure activities. 

Administrative Oversight (no more than 10 pages)

Describe the administrative organization of the research infrastructure core. 
Include plans to interface with the medical rehabilitation research community, 
promote access to resources, deal with competing demands on facilities, 
evaluate quality control, improve responsiveness, and document overall 
effectiveness and impact on medical rehabilitation. Include plans for an 
independent advisory board to provide guidance on resources, didactic 
interactions, and interactions with the medical rehabilitation community (do 
not propose specific advisory board members at this time, but indicate the 
types of people who would be appropriate for these roles).

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: 
https://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 and all 
copies of the appendix material must be sent to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD 20852 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received on or before 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.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within eight weeks.

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.  
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application.  That is, the application for the 
RFA must not include an Introduction describing the changes and improvements 
made, and the text must not be marked to indicate the changes from the 
previous unfunded version of the application.  

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NICHD.  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 
the NICHD in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will: 

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 written critique
o Receive a second level review by the National Advisory Child Health and 
Human Development Council.

REVIEW CRITERIA

The goal of this program is to develop research infrastructure to advance our 
understanding of biological systems, interactions with the environment, and 
other psychosocial processes that contribute to improving function, reducing 
secondary consequences and disability, and promoting participation and overall 
quality of life for persons with chronic physical disabilities.  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, particularly in 
the area of medical rehabilitation:

o QUALITY OF EXPERTISE AND RESOURCES:  Qualifications of the applicants in the 
proposed content area and the availability of appropriate resources. This may 
include access to unique resources, equipment, expertise, or patient 
populations. 

o COMMITMENT OF KEY PERSONNEL:  Adequacy of their commitment to the core 
research mission and their ability to devote the required time and effort to 
the program.

o POTENTIAL OF THE PROPOSED CONTENT AREA to further medical rehabilitation and 
respond to the needs of the research community. 

o POTENTIAL FOR TRANSMITTING EXPERTISE to the rehabilitation research 
community through didactic interactions, research collaborations, and resource 
infrastructure. 

o OPPORTUNITIES FOR SABBATICAL INTERACTIONS AND OTHER COLLABORATIONS at the 
applicant site.

o Where applicable, CORE PLANS TO FURTHER DEVELOP, ADAPT, MODIFY, AND/OR 
VALIDATE the technologies and expertise available to the medical 
rehabilitation community.

o OVERALL ADMINISTRATION:  Strength of the plans for promoting access, 
prioritization of demands on core resources, quality control, administration 
of pilot funds, responsiveness to the medical rehabilitation research 
community, and documentation of research support and overall effectiveness.

o INSTITUTIONAL SUPPORT AND OTHER RESOURCES:  Documentation of institutional 
support and adequacy of resources available to enhance the functioning of the 
research core, especially the leveraging of funds and connection to additional 
resources and opportunities.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed.  (See criteria included in the section 
on Federal Citations, below.)

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below.)

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.

ADDITIONAL CONSIDERATIONS 

SHARING RESEARCH DATA:  Applicants requesting more than $500,000 in direct 
costs in any year of the proposed research must include a data sharing plan in 
their application. The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the reviewers. 
However, reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score.

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:  October 18, 2004
Application Receipt Date:  November 16, 2004
Peer Review Date:  March 2005
Council Review:  June 2005
Earliest Anticipated Start Date:  July 01, 2005

AWARD CRITERIA

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
o Uniqueness of proposed core (it is possible that two cores with similar 
content areas will be funded depending on the uniqueness of their approaches 
and the overall distribution of meritorious applications).

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained 
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking $500,000 or more in direct 
costs in any single year are expected to include a plan for data sharing or 
state why this is not possible 
(https://grants.nih.gov/grants/policy/data_sharing).  Investigators should seek 
guidance from their institutions, on issues related to institutional policies, 
local IRB rules, as well as local, state and Federal laws and regulations, 
including the Privacy Rule. Reviewers will consider the data sharing plan but 
will not factor the plan into the determination of the scientific merit or the 
priority score.

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 "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 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines is available at 
https://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 
https://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 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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 
https://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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH processes 
involving the review, funding, and progress monitoring of grants, cooperative 
agreements, and research contracts can be found at 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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 at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
https://grants.nih.gov/grants/policy/policy.htm.  

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.

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NIH Funding Opportunities and Notices

Department of Health and Human Services

National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892