RELEASE DATE:  March 18, 2004

PA NUMBER:  PAR-04-077  

EXPIRATION DATE:  October 14, 2006, unless reissued

Department of Health and Human Services (DHHS)

National Institutes of Health (NIH) 
Agency for Healthcare Research and Quality (AHRQ) 

National Institute of Child Health and Human Development (NICHD) 
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)

93.837, 93.866, 93.846, 93.173, 93.853, 93.361, 93.226 

APPLICATION RECEIPT DATES:  October 13, 2004, October 13, 2005, October 13, 2006  


o Purpose of this PA
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations


Participating Institutes and Centers (ICs) of the National Institutes of 
Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ) invite 
applications for R01 awards to support Research Partnerships for Improving 
Functional Outcomes (RPIFO) for basic, applied, and translational multi-
disciplinary research that addresses important biological, behavioral, 
medical, and/or psychosocial research problems related to rehabilitation or 
health maintenance of individuals with acute or chronic disease.  In the 
context of this program, a “partnership” is a multi-disciplinary research team 
that applies an integrative, systems approach to develop knowledge and/or 
methods to improve functioning, promote health, and increase participation in 
community life. The partnership must include appropriate individuals with 
clinical expertise related to rehabilitation in combination with biomedical, 
psychosocial-behavioral, engineering, epidemiological, and/or health services 
researchers. The Principal Investigator (PI) also serves as the project 
manager and must be capable of leading the proposed research and partnership. 
An RPIFO may propose outcomes-directed, developmental, discovery-driven, 
translational or hypothesis-driven research at universities, national 
laboratories, medical or nursing schools, large or small businesses, or other 
public and private entities or combinations of these entities. It is expected 
that an RPIFO will have a well-defined, public health-related goal that can be 
assessed based on objective milestones. 



An increasing proportion of the nation's health care expenditures is devoted 
to the care of individuals with chronic diseases and disorders, many of whom 
experience significant declines in their abilities to perform activities of 
daily living and participation in community life. Effective solutions for 
rehabilitation of these individuals have the potential to significantly 
improve the nation's utilization of increasingly constrained health care 
resources. Rehabilitation is by its very nature a multi-disciplinary activity. 
Solving many of the complex research problems in rehabilitation will require a 
multi-disciplinary approach that extends well beyond the traditional 
professional boundaries of rehabilitation, and incorporate interdisciplinary 
collaborations of investigators with broad-ranging technical, clinical, and 
research expertise. In addition, new, emerging technologies and resources that 
allow us to attack difficult, large-scale problems are becoming available from 
diverse technical and biomedical fields and cross the boundaries of many 
scientific disciplines represented throughout academia, laboratories, and 

Recognizing the importance of rehabilitation to all areas of medical care, 
Congress mandated the establishment of the NIH Rehabilitation Coordinating 
Committee in 1990. This committee has been active in organizing trans-NIH and 
trans-agency conferences to highlight issues in rehabilitation and establish 
research priorities. Abstracts of presentations from the most recent 
conference, "Physical Disabilities through the Lifespan," are available at 

A major recommendation of the conferees at the "Physical Disabilities through 
the Lifespan" conference is for NIH to develop a new mechanism to allow 
investigators to address difficult research problems in rehabilitation 
requiring multi-disciplinary teams. The NIH Rehabilitation Coordinating 
Committee has developed the current Program Announcement in an attempt to meet 
this need. 

Additionally, the NIH and AHRQ, as part of the U.S. Department of Health and 
Human Services, have been charged under Executive Order 13217, "The New 
Freedom Initiative," to help promote the full participation of individuals 
with disabilities in all areas of society. This Program Announcement is also 
designed to address the charge from this Executive Order. Researchers who are 
interested in the community integration of people with severe psychiatric 
disorders are encouraged to see PA 03-144 

Research Scope

The objective of this Program Announcement is to encourage basic, applied, and 
translational research directed towards improving the health of individuals 
with acute or chronic diseases who may benefit from rehabilitation. Examples 
of such research encouraged by the NIH include, but are not limited to: 

o Develop and test the efficacy of symptom-focused or holistic/integrated 
therapies for high prevalence conditions causing disability, such as low back 
pain, stroke, hearing loss, visual loss, and congestive heart failure, as well 
as for lower prevalence conditions with high levels of comorbidity, such as 
spinal cord injury, spina bifida, etc. Randomized clinical trials are 
especially encouraged. Applicants interested in proposing clinical trials that 
are of potential interest to the National Institute of Neurological Disorders 
and Stroke (NINDS) should contact the clinical trial group at NINDS 
( prior 
to submitting a formal application. 

o Determine the extent to which genetic, environmental, social, and 
psychological factors determine patient responses to specific rehabilitation 
interventions; develop and test methods or accommodations for augmenting 
responses of individuals with risk factors for poor responses. 

o Investigate the processes, at a molecular level, that lead to formation of 
muscle and skin contractures that occur due to inactivity and chronic disease; 
develop and test the efficacy of targeted interventions based upon these 
processes.  Applicants interested in submitting applications of potential 
interest to the National Institute of Arthritis and Musculoskeletal Disorders 
(NIAMS) should refer to the notices for applicants prior 
to submitting a formal application.

o Determine optimal physical and cognitive exercise patterns and schedules to 
improve functioning in individuals with specific disabilities ranging from 
inherited childhood disorders, such as muscular dystrophies, to late-life 
congestive heart failure and sarcopenia. 

o Define the optimal setting(s) and timing of rehabilitation strategies, 
optimal pain protocols, the role of passive range of motion, and the most 
cost-effective follow-up for patients undergoing hip and knee replacement 

o Develop algorithms that can be used to match available interventions and 
technologies to individual patients to optimize functional outcomes; test the 
validity of these models for clinical populations in diverse environments. 

o Using biomechanical modeling, develop and evaluate defined rehabilitation 
interventions based upon detailed biomechanical analyses of the patterns of 
muscle activation in specific conditions. 

o Test methods to promote the dissemination of evidence-based rehabilitative 
therapies and technologies from the laboratory or clinic to community 
environments; studies can include foci on family and community issues 
(including stigma), self-management and advocacy, health-care policy and 
financial constraints, and cost-effective sustainability. 

o Test methods to promote self-care, positive health behaviors, and health 
management through the use of behavioral, psychosocial, nutritional, and 
pharmacological strategies. 

o Develop and test the efficacy of alternative delivery systems (e.g., 
telemedicine), providers, and settings for the rehabilitation of patients with 
specific diseases or conditions. 

o Develop innovative engineering approaches that improve outcomes for 
individuals with acute stroke and other mobility disorders; investigate their 
cost-effectiveness and feasibility for use in various clinical settings. 

o Investigate the nature of disability and rehabilitation throughout the 
lifespan, particularly the special needs of the very young and elders when 
disability is superimposed on the developmental axis. These investigations may 
include studies on the interaction of the physiologies of aging and disability 
as well as studies of motor, sensory, cognitive, and psychosocial functional 

o Studies that evaluate the quality of rehabilitation care in current clinical 
settings, and link the rehabilitation and quality of care and specific 
policies and practices to functional and participatory outcomes.  Such studies 
could evaluate the effects of cost constraints on outcomes. 

o Studies related to the impact of reimbursement changes associated with 
rehabilitation since the Balanced Budget Act of 1997 and the impact of 
prospective payment on rehabilitation cost and outcomes. 

o Studies that include quality of life outcomes for rehabilitating patients 
and families; studies that address cost-effectiveness and how health care 
teams make clinical decisions, and how patients and their families are 
involved in these decisions.

o Studies investigating methods to improve the integration of rehabilitation 
services across multiple settings (e.g., hospitals, nursing homes, home care, 
primary care, etc.) and the coordination with other care received by patients. 
Such studies could address methods for improving how clinical information is 
shared as patients move from hospitals to rehabilitation centers, to homes, 
and back to hospitals, etc., and the impact on outcomes. 

o Studies that target priority populations (e.g., women, children, elderly, 
low income groups; minority groups; individuals with special health care 
needs, including those with disabilities and those who need chronic care or 
end-of-life health care) and the identification and reduction of disparities 
in health care. 


This PA will use the NIH Research Project Grant (R01) award mechanism.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant. The initial period of support of 
an RPIFO award may be up to five years. 

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.  Please note that applications assigned 
to AHRQ will be required to submit a nonmodular budget after the initial 
submission.  This program does not require cost sharing as defined in the 
current NIH Grants Policy Statement at 


You may submit an application if your institution has any of the following 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and national laboratories 
o Units of State and local governments 
o Eligible agencies of the Federal government  
o Domestic or foreign institutions/organizations  
o Faith-based or community-based organizations 


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.   


We encourage your inquiries concerning this PA and welcome the opportunity 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:  

Michael Weinrich, M.D., Director
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 402-4201    
FAX: (301) 402-0832

Noreen M. Aziz, M.D., Ph.D., M.P.H.
Program Director, Office of Cancer Survivorship
Division of Cancer Control & Population Sciences
National Cancer Institute
6130 Executive Boulevard, Room 4090, MSC 7340
Bethesda, MD 20892-7340 
Rockville, MD 20852 (for express/courier service)  
Telephone:  (301)-496-0598 
FAX:  (301)-594-5070  

Michael D. Oberdorfer, Ph.D.
Division of Extramural Research
National Eye Institute
6120 Executive Boulevard, Suite 350, MSC 7164
Bethesda, MD 20892-7164
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 451-2020
FAX:  (301) 402-0528

Suzanne Goldberg, R.N., M.S.N.
Clinical and Molecular Medicine Program
Division of Heart and Vascular Diseases
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Room 9174, MSC 7940
Bethesda, MD 20892-7940 
Bethesda, MD 20817(for express/courier service)
Telephone:  (301) 435-0532 
FAX:  (301) 480-1336

Sidney M. Stahl, Ph.D. 
Chief, Individual Behavioral Processes Branch 
Behavioral and Social Research Program 
National Institute on Aging 
7201 Wisconsin Avenue, 533, MSC 9205 
Bethesda, MD 20892-9205 
Telephone: (301) 402-4156 
FAX:  (301) 402-0051 

James S. Panagis, M.D., M.P.H.
Orthopaedics Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20892-4872
Telephone:  (301) 594-5055

Amy M. Donahue, Ph.D.
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400C, MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-3458
FAX:  (301) 402-6251 

Daofen Chen, Ph.D.
Program Director, Channels, Synapses, and Circuits
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2131, MSC 9523
Bethesda, MD  20892-9523
Telephone:  (301) 496-1917
FAX:  (301) 402-1501

Kathy Mann Koepke, Ph.D.
Program Director
National Institute of Nursing Research
6701 Democracy Boulevard, Suite 710, MSC 4870
Bethesda, MD  20892-4870 
Telephone:  (301) 496-9623
FAX:  (301) 480-8260

Rosaly Correa-de-Araujo, M.D., M.Sc., Ph.D.
Senior Advisor on Women’s Health
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone:  (301) 427-1550
FAX:  (301) 427-1651

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

Mr. Chris Robey
Lead Grants Management Specialist
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 435-6975
FAX:   (301) 402-0915

Ms. Crystal Wolfrey
Grants Management
National Cancer Institute
6120 Executive Boulevard, Room 234, MSC 7150
Bethesda, MD 20892-7150
FAX:  (301) 496-8601

William W. Darby
Chief, Grants management Branch
National Eye Institute
6120 Executive Boulevard, Suite 350, MSC 7164
Bethesda, MD 20892-7164
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 451-2020
FAX:  (301) 402-0528

Carol Lander
Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Room 7164, MSC 7926
Bethesda, MD  20892-7926
Telephone:  (301) 435-0150
FAX:  (301) 480-3310

Traci Lafferty
Grants & Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9025
Bethesda, MD  20892-9025
Telephone:  (301) 496-1472
FAX:  (301) 402-3672

Mr. Michael Morse
Deputy Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd., Suite 800, MSC 4872
Bethesda, MD 20892-4872
Telephone:  (301) 594-3506
FAX:  (301)480-5450

Sara Stone 
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400B, MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-0909
FAX:  (301) 402-1758

Ms. Karen Dunlap
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3290, MSC 9537
Bethesda, MD  20892-9537
Telephone:  (301) 496-7359
FAX:  (301) 402-0219

Ms. Diane E. Drew
Grants Management Specialist
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD  20892-4870  
Telephone:  (301) 594-2807
FAX:  (301) 451-5651 or (301) 402-4502

George 'Skip' Moyer
Grants Management Specialist
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone:  (301) 427-1452
FAX:  (301) 427-1462


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 The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 
is available at in an 
interactive format.  For further assistance contact GrantsInfo, Telephone 
(301) 710-0267, Email:

The title and number of this program announcement must be typed on line 2 of 
the face page of the application and the YES box must be checked.

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 includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at

Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application. 

Applicants requesting more than $500,000 must carry out the following steps: 

1) Contact the IC program staff at least six weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your application 
for consideration for award; and,

3) Identify, in a cover letter sent with the application, the staff member and 
IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised version 
of these grant application types.  Additional information on this policy is 
available in the NIH Guide for Grants and Contracts, October 19, 2001 at  

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the checklist, and five 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)

APPLICATION PROCESSING:  Applications must be received on or before the 
receipt dates listed on the first page of this announcement.  

The CSR will not accept any application in response to this PA 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 a substantial revision of an application 
already reviewed, but such application must include an Introduction addressing 
the previous critique.

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.


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
( will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate national advisory council 
or board.


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:

o Significance
o Approach
o Innovation
o Investigator
o Environment 

The scientific review group will address and consider each of these criteria 
in assigning the application's overall score, weighting them as appropriate 
for each application.  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.

SIGNIFICANCE:  If the specific aims of the RPIFO are achieved, will they 
provide significant advances in the selected area of rehabilitation research? 
Is the research likely to have a significant impact on other areas of 
research? Will the technological advances have a significant impact on human 

APPROACH:  Are the RPIFO rehabilitation, scientific, and clinical approaches 
and methods adequately developed, well-integrated, and appropriate to the aims 
of the project? Does the application address potential problem areas and 
consider alternative strategies? Is a timetable with adequate research 
milestones proposed? Are appropriate specifications and evaluation procedures 
provided for assessing progress? Is the proposed partnership adequate for the 
research? Is there evidence that the partnership will be effectively managed 
by the PI or project manager? Is the partnership strategy well-planned and 
documented? Is there evidence that the partners from academia or industry can 
work together effectively, have an impact on achieving the research goals, and 
disseminate the treatments, interventions, therapies and technologies 
developed (including through commercialization)? Is the plan for sharing or 
disseminating the developments of this proposal adequate? Is the plan for 
technology transfer involving each partnering organization adequate? Does the 
application describe arrangements that facilitate the fruitful participation 
of a partner at a distant site? If partnership with industry or small business 
is included, does this positively affect the research goals and technology 

INNOVATION:  Does the RPIFO propose new approaches, explore new research 
paradigms, or represent new concepts that combine rehabilitation, physical, 
psychosocial, behavioral, engineering, and clinical sciences? Will the 
proposed approaches or concepts solve current compelling public health 
problems in novel ways?

INVESTIGATOR:  Is the PI capable of coordinating and managing the proposed 
RPIFO? Are the investigators (partners) appropriately trained in their 
disciplines and capable of conducting the proposed interdisciplinary work? 

ENVIRONMENT:  Does the scientific, clinical, and technological environment in 
which the work will be done contribute to the probability of success? Does the 
proposed research take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements within the 
partnership? Is there evidence of institutional support? Does the partnership 
create potential opportunities to foster trans-disciplinary communication and 
training across traditional scientific and clinical boundaries?  

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:

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.)

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.)

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.


SHARING RESEARCH DATA:  Applicants requesting more than $500,000 in direct 
costs in any year of the proposed research are expected to 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.


Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities


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 

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the participants 
(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and 
Contracts, June 12, 1998: 

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 
(  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.

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 
a complete copy of the updated Guidelines is available at  
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 

INCLUSION OF PRIORITY POPULATIONS:  The Healthcare Research and Quality Act of 
1999 (see reauthorized the AHRQ and directed 
the Agency, in carrying out its mission, to conduct and support research and 
evaluations, and to support demonstration projects, with respect to the 
delivery of health care in inner-city and rural areas (including frontier 
areas); and health care for priority populations, which include low income 
groups; minority groups; women; children; the elderly; and individuals with 
special health care needs, including individuals with disabilities and 
individuals who need chronic care or end-of-life health care.  To implement 
this directive, AHRQ published a notice in the NIH Guide on February 28, 2003, 
establishing a new Agency policy on the Inclusion of Priority Populations in 
health services research 
Applicants under this PA who seek funding from AHRQ should address the 
requirements of including priority populations as specified in the Notice.

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

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at and at  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see    
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, 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 

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

Applicants may wish to place data collected under this PA 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.

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 
( 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

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 PA 
is related to one or more of the priority areas.  Potential applicants may 
obtain a copy of "Healthy People 2010" at

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance at 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  

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) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.