PA NUMBER: PA-02-111

RELEASE DATE:  May 30, 2002

EXPIRATION DATE:  May 31, 2005, unless reissued. 

National Institute of Nursing Research (NINR) 
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 
National Institute of Child Health and Human Development (NICHD) 
National Institute of Neurological Disorders and Stroke (NINDS) 


o Purpose of the PA
o Research Objectives
o Mechanisms 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

The National Institute of Nursing Research (NINR), the National Institute of 
Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National 
Institute of Child Health and Human Development (NICHD), and the National 
Institute of Neurological Disorders and Stroke (NINDS) seek research grant 
applications that will improve the quality of life for people living with 
mobility limiting disorders.   Persons with limited mobility may also 
experience secondary conditions that further limit mobility.  These secondary 
symptoms or sequelae include pain, fatigue, spasticity, weakness and 
depression.  This Program Announcement will focus on improving the quality of 
life in persons with limited mobility by managing the physical symptoms and 
psychosocial consequences that occur as a result of the primary or secondary 


There has been limited research on the psychosocial effects and the quality 
of life experienced by persons with conditions that limit mobility.   
Conditions that limit mobility include degenerative conditions such as 
multiple sclerosis, Parkinson's disease; injuries such as stroke, and 
traumatic brain or spine injuries; and congenital abnormalities such as 
cerebral palsy.  Other examples of conditions that may limit mobility are 
obesity, arthritis, lower limb ischemia, pulmonary disorders and balance 

In addition to limited mobility, symptoms of pain and fatigue are common and 
may have a synergistic negative effect on psychosocial and physical 
functioning.  Severe uncontrolled spasticity as found in multiple sclerosis, 
amyotrophic lateral sclerosis, spinal cord injury and cerebral palsy may 
cause further pain and affect the individual's physical functioning and 
quality of life.  Interventions are needed to reduce spasticity and maintain 
functioning of muscles.  Other persons may have chronic pain that can disrupt 
sleep, which has a further impact upon the fatigue that patients may be 
experiencing.  In addition, limited mobility, pain, fatigue and sleep 
disruption may be associated with depression.  Interventions are needed to 
address this symptom complex.

Strategies to improve coping with symptoms in conditions with limited 
mobility will improve quality of life for these individuals.  However, there 
may be a varying progression of the symptoms found in primary mobility 
disorders that may require additional strategies to cope both physically and 
psychologically with the disease.  Examples of a varying course include the 
abrupt onset of symptoms, a waxing and waning of symptoms, a progressive slow 
decline in symptoms or stability of symptoms throughout the course of the 
disease.  For example, stroke patients may experience an abrupt loss in their 
ability to move and perform activities of daily living.  This abrupt change 
in ability to perform activities of daily living suggests the need for 
interventions to promote additional coping strategies that are not necessary 
in a mobility condition that has been stable for many years.   

Other chronic conditions may exhibit steady progression or may have a waxing 
and waning course.  These include multiple sclerosis, amyotrophic lateral 
sclerosis, and Parkinson's disease.  The ability to adjust and cope with the 
course of these diseases may require different coping strategies in 
comparison to conditions in which there is no progressive decline.  The 
unpredictability of the course of the disease may require additional coping 
strategies to maintain positive psychosocial and physical functioning.  
Active problem focused coping has been found to be associated with a better 
psychosocial adjustment in a variety of conditions.  Research determining 
whether there are unique strategies to cope with varying courses of disease 
or stages of disease or if there are certain strategies that work best across 
all diseases is needed.  

Maintaining of/or improving functional ability and preventing secondary 
symptoms or sequelae is hypothesized to improve quality of life in persons 
with limited mobility.  Quality of life is closely associated with 
independent living, but independence is not always possible with some 
mobility limiting disorders.  Thus, there may be a need for caregivers to 
help accomplish activities of daily living.  The anticipation of becoming 
dependent and being dependent upon others may be an additional stressor for 

Other psychosocial consequences are the decreased employment and financial 
status that may accompany conditions with limited mobility.  In addition, 
limited mobility may increase feelings of anxiety, depression, and social 
isolation, and decrease feelings of self-esteem.  Depression and anxiety are 
often under diagnosed in individuals with conditions with limited mobility 
and are significant contributors to decreased quality of life.  In general, 
depression and anxiety demonstrate a weak association with the severity of 
the limitation of mobility.  Identification of the factors or individual 
differences associated with mood disturbances that can influence quality of 
life is needed in persons with limited mobility. 

Quality of life in individuals with limited mobility needs to be improved 
across the lifespan and across different ethnic/cultural groups.  Little 
research has been conducted to determine whether there are gender and 
cultural/ethnic influences in response to diagnosis and adherence to 
treatment regimens in conditions of limited mobility.  

Research to improve functional ability in children with limited mobility has 
been conducted.  However, in certain conditions such as severe cerebral palsy 
and cystic fibrosis, the survival rate is now longer due to medical advances.  
Little is known about the psychosocial and medical needs of these adults and 
how their shift from a focus on premature death to living with some chronic 
functional limitation such as immobility influences quality of life.  

As individuals age, there is an association with increasing immobility.  The 
weakness, stiffness and pain associated with the impairment of 
musculoskeletal functioning results in decreased mobility and potentially a 
decreased quality of life.  Interventions to maintain strength and endurance 
in physical functioning may delay some of the disabilities associated with 
aging as well as improve psychosocial functioning.  Studies are needed on 
approaches to preventing, maintaining and restoring functional ability in 
elderly and other populations with limited mobility.  

Listed below are examples of studies that would be responsive to this program 
announcement.  However, these are only illustrative examples and applicants 
are encouraged to propose other topics consistent with the goals of this 

o  Identify innovative interventions to improve and/or maintain physical 
functioning in conditions with limited mobility across the lifespan
o  Identify unique interventions to maintain physical functioning in 
challenging populations such as the cognitively impaired elderly with limited 
o  Identify strategies to improve quality of life and psychosocial adjustment 
in individuals with limited mobility
o  Identify unique coping strategies to manage the varying course of symptoms 
found in waxing and waning conditions, a steadily progressive decline, or an 
abrupt onset, versus a stable condition
o  Develop strategies to minimize the secondary symptoms of pain and fatigue 
that may be found in persons with limited mobility
o  Explore whether gender and racial/ethnic influences occur in response to 
the physical and psychosocial functioning in persons with limited mobility
o  Develop and test interventions to address the fear of functional 
dependence and reduce the need for relying upon others for accomplishing the 
activities of daily living
o  Determine the factors contributing to quality of life and positive 
outcomes for individuals experiencing a mobility disorder
o  Determine factors associated with successful adaptation to a sudden 
decrease in mobility
o  Identify barriers to maximal physical and psychosocial functioning in 
persons with limited mobility
o  Identify unique factors that promote quality of life in people who have 
mobility limitation secondary to conditions such as pulmonary disease and 
o  Identify innovative interventions to improve/and or maintain physical 
functioning in conditions with limited mobility in children, adolescents and 
young adults making their transition to the workforce
o  Determine the factors contributing to quality of life and positive 
outcomes for individuals with mental retardation experiencing a mobility 
o  Identify physical or psychosocial factors and coping strategies associated 
with use of assistive devices or neural prostheses and their effectiveness in 
helping patients to overcome limited mobility
o  Evaluate the impact on psychosocial functioning or quality of life of the 
use of assistive devices or neural prostheses in managing mobility 

For all proposed research, appropriate methods should be applied for the 
quantitative assessment of the psychosocial and quality of life components in 
research on mobility limitation and intervention strategies for this 


This PA will use the NIH R01 and R21 award mechanisms.  As an applicant, you 
will be solely responsible for planning, directing, and executing the 
proposed project.  The objective of the exploratory/developmental mechanism 
(R21) is to encourage applications from individuals who are interested in 
testing innovative or conceptually creative ideas that are scientifically 
sound and may advance our understanding of quality of life in mobility 
disorders.  Investigators are encouraged to explore the feasibility of an 
innovative research question or approach that will provide a basis for future 
research project applications.  Exploratory/developmental grants (R21) are 
limited to 2 years of support and up to $150,000 per year in direct costs.

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.


You may submit (an) application(s) 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 or foreign
o Faith Based Organizations


Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is 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.


We encourage your inquiries concerning this PA and welcome the opportunity to 
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:

Dr. Karin Helmers
Office of Extramural Programs
National Institute of Nursing Research
Building 45, Room 3AN12
Bethesda, MD  20892-6300
Telephone:  (301) 594-2177
FAX: (301) 480-8260

Dr. Deborah N. Ader
Director, Behavioral and Prevention Research Program
45 Center Dr., Building 45
Rm 5As19H
Bethesda, MD  20892
Tel: (301) 594-5032
Fax: (301) 480-4543

Dr. Louis Quatrano
Behavioral Sciences and Rehabilitation Engineering 
National Institute of Child Health and Human Development 
6100 Executive Boulevard, 2A03, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 402-4221
FAX: (301) 496-0832

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

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

Ms. Cynthia McDermott
Office of Grants and Contracts Management
National Institute of Nursing Research
Building 45, Room 3AN12
Bethesda, MD  20892-6300
Telephone: (301) 594-6869
FAX: (301) 480-8260

Ms. Melinda Nelson
Chief Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building Room 5AS.49F - MSC 6500
Bethesda, MD 20892-6500
Telephone: (301) 594-3535
FAX: (301) 480-5450

Mr. Christopher Myers
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Telephone:  301-435-6996
FAX:  301-402-0915

Ms. Aricia Cottman
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3290
Bethesda, MD 20892
Telephone: 301-496-9231
Fax: 301-402-0219


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at  Application 
deadlines are also indicated in the PHS 398 application kit.

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:

Contact the IC program staff at least 6 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 by or mailed on or 
before the receipt dates described at  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 


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

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 

(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?

(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 (if any)?

(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 

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

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.

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)

DATA SHARING:  The adequacy of the proposed plan to share data. 

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


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, 

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 (
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 
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 

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 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.

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 Nos. 93.361 (NINR), 93.846 (NIAMS), 93.929 
(NICHD), 93.853 (NINDS) 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) and administered under NIH 
grants policies described at 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

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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