RELEASE DATE:  January 15, 2003

PA NUMBER: PA-03-054

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Eye Institute (NEI)
National Institute of Environmental and Health Sciences (NIEHS)


o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
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 Arthritis and Musculoskeletal and Skin 
Diseases (NIAMS) invites applications for research to promote the 
design, development and testing of hypothesis-driven innovative 
approaches to eliminating health disparities in rheumatic, 
musculoskeletal, and skin diseases. Attention is to be focused on 
potentially modifiable environmental, social, and behavioral factors, 
and on gene-environment interactions, that may underlie ethnic/racial 
disparities in disease prevalence and outcome. In addition, descriptive 
and analytic epidemiologic studies are needed to characterize further 
the health disparities in rheumatic, musculoskeletal, and skin 
diseases. This PA is based on the many scientific opportunities 
identified in the conference "Health Disparities in Arthritis and Skin 
Diseases". A summary of the conference and research questions raised 
can be found at:


Rheumatic, musculoskeletal, and skin diseases are the most frequent 
chronic health problems in the United States, but not all population 
groups are equally affected. Marked differences in the incidence, 
prevalence, severity, process of care, and outcome of a number these 
conditions exist among racial and ethnic groups. For conditions such as 
systemic lupus erythematosus (SLE), vitiligo, keloids, and scleroderma, 
the burden is greatest in particular ethnic groups. Research is needed 
to increase understanding of these disparities and their causes, and to 
provide direction for improving standards of care, informing public 
policy, and identifying strategies aimed at improving the health status 
and health outcomes of racial and ethnic minorities. Research is needed 
to enhance our understanding of the underlying factors (i.e., 
socioeconomic, cultural, societal, behavioral and biologic) that 
influence the health status of racial and ethnic minority populations 
across the lifespan.  

The NIAMS Strategic Plan for Reducing Health Disparities 
planhd.htm) outlines five "Areas of Research Focus":  Lupus, Scleroderma,
Osteoarthritis, Vitiligo, and Keloids.  Some of these diseases were covered in
a NIAMS-sponsored conference, Health Disparities in Arthritis and
Musculoskeletal and Skin Diseases".  A summary of this conference is posted at
the URL
A summary of this conference has also been published [Jordan JM, Lawrence R, 
Kington R, Fraser P, Karlson E, Lorig K, and Liang MH:  Ethnic Health 
Disparities in Arthritis and Musculoskeletal Diseases, Report of a 
Scientific Conference. Arthritis & Rheumatism 46(9): 2280-2286, 2002].

Racial/ethnic disparities in rheumatic, musculoskeletal, and skin 
diseases have been identified; Non-Caucasian populations not only have 
a higher overall occurrence of systemic lupus erythematosus (SLE), but 
also seem to have lower survival rates. SLE-related organ damage occurs 
more frequently in Hispanics than in African Americans  or Caucasians. 
Kidney damage is more prevalent in Hispanics and African Americans 
compared to Caucasians; and there is increased incidence of 
organ/tissue damage in Hispanics as compared to both Caucasians and 
African Americans. Neuropsychiatric problems account for the greatest 
proportion of damage in Hispanics and Caucasians, while hair loss and 
skin damage account for the greatest proportion in African Americans. 
The most important variables influencing early mortality, however, have 
been found to be socioeconomic and demographic, rather than 
ethnic/racial or genetic factors. In scleroderma, incidence and 
prevalence is increased in women of color, with increased disease-
related morbidity and mortality. Ethnic disparities in the prevalence, 
severity, and treatment of osteoarthritis (OA) have been documented as 
well. African-American women have a higher prevalence of radiographic 
knee OA than Caucasian women. African-American men of lower 
socioeconomic status have been found to have more radiographic hip OA 
and more bilateral hip OA than Caucasian and higher-socioeconomic 
status African-American men. African Americans, Hispanics, and Asians 
appear to be less likely than Caucasians to undergo total joint 
replacements (TJR) for OA of the hip. Further study is needed to 
determine the nature and mechanisms of these disparities, and to 
ameliorate them.

Much less is known about the frequency and impact of skin diseases in 
specific racial/ethnic populations. Keloids, overgrowth of scar tissue 
after a skin injury, occur more often in African Americans than among 
other groups, and anecdotal data suggest atopic dermatitis is more 
prevalent and more severe in African American and Asian/Pacific 
Islanders. The skin manifestations of lupus, sarcoidosis, and a number 
of other diseases are more common and more severe in African Americans, 
in parallel to the findings for SLE. In addition, some racial/ethnic 
disparities in treatment of skin diseases have been identified. For 
example, acne vulgaris is a common skin condition in African Americans 
and isotretinoin is considered an effective therapy, however, the drug 
is less often prescribed for African-American acne patients than for 
Caucasians. Finally, the social and psychological burden of some skin 
diseases is likely to vary depending on skin pigmentation (e.g., the 
impact of vitiligo, an acquired skin disease characterized by patches 
of unpigmented skin, on dark-skinned vs. light-skinned individuals), 
but little research has been directed at elucidating disparities in the 
burden of disease. 

Despite improvements in health care, some of the racial/ethnic 
disparities seen in the treatment and management of rheumatic, 
musculoskeletal, and skin diseases may be explained by differences in 
availability and quality of health services. Individual beliefs, 
attitudes, and behavior with regard to health care utilization, self-
care practices and health-related habits may be important factors to 
consider. In a study of total joint replacement in African-American and 
Caucasian male veterans with OA, significant differences in awareness 
and understanding of this intervention, and in perceptions of the risks 
and benefits of the procedure were identified. Family variables, 
culture, socioeconomic status, social support, and other factors no 
doubt influence these individual beliefs, attitudes, and behaviors, and 
these factors may vary systematically across racial/ethnic groups. 
Little is known about how such factors influence the prevalence, 
severity, course, or outcomes of rheumatic, musculoskeletal, and skin 

Finally, common approaches to research design, methodology, and 
measurement may require adaptation to enhance access to minority and 
lower SES populations, and to increase the validity and reliability of 
research data. For example, widely used measures of health-related 
quality of life are written at the sixth- to ninth-grade reading level. 
Approximately 20% of adults read at or below the fifth grade level, and 
literacy rates in minority and lower-SES populations can be 
significantly lower. 

The purpose of this announcement is to encourage investigator-initiated 
research projects (R01) that explore new approaches and hypotheses for 
understanding and eliminating health disparities in rheumatic, 
musculoskeletal, and skin diseases. Areas of interest include but are 
not limited to:

o Epidemiological studies to determine the nature and source of 
racial/ethnic differences in the rates and patterns of disease 

o Studies investigating the interaction or additive effects of genetic 
and environmental factors in health disparities 

o Studies examining the underlying causes of health disparities for 
specific diseases of joints, muscle, bone, or skin that 
disproportionately affect ethnic or minority populations

o Studies examining knowledge, attitudes, behaviors, and social factors 
relating to differential access to and utilization of health care

o Development and testing of interventions to decrease disparities in 
the management of disease

o Identifying socioeconomic, educational, and behavioral risk factors 
for increased disability and preventive intervention strategies that 
target at-risk populations 

o Development and testing of measurement tools and approaches to 
characterize disease-related health status, health quality of life, or 
health-related attitudes and beliefs in racial/ethnic and/or low SES 

o Studies investigating cultural competence of health care providers 
and its impact on treatment provision, patient behaviors (e.g., 
decision-making, adherence), and health outcomes 


This PA will use the NIH Research Project Grant (R01) award mechanism.  
As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project.  The total project 
period for an application submitted in response to this PA may not 
exceed 5 years. 

This PA uses just-in-time concepts.  It also uses the modular as well 
as the non-modular budgeting formats
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 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 or her 
institution to develop an application for support.  Individuals from 
underrepresented racial and ethnic groups, faith-based organizations, 
and individuals with disabilities are always encouraged to apply for 
NIH programs. Partnerships between principal investigators and faith-
based organizations are encouraged as well.  


Investigators who wish to establish new collaborative research programs 
in health disparities research with laboratories at the NIAMS 
Intramural Research Program, and apply for funding under this PA, are 
encouraged to contact Dr. Barbara Mittleman, Director, Office of 
Scientific Interchange, NIAMS (


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:

Deborah N. Ader, Ph.D.
Behavior and Prevention Research Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, Suite 800 
Bethesda, MD 20892-4872
Telephone:  (301) 594-5032
Fax:  (301) 480-4543

Richard S. Fisher, Ph.D.
Corneal Diseases Program
National Eye Institute
Bldg EPS, Suite 350
6120 Executive Blvd
Rockville, MD  20892
Telephone:  (301) 451-2020
Fax:  (301) 402-0528

Gayle Lester, Ph.D.
Osteoarthritis Initiative and Diagnostic Imaging Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, Suite 800 
Bethesda, MD 20892-4872
Telephone:  (301) 594-5055
Fax:  (301) 480-4543

Richard Lymn, Ph.D.
Muscle Biology Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, Suite 800 
Bethesda, MD 20892-4872
Telephone:  (301) 594-5128
Fax:  (301) 480-4543

Joan McGowan, Ph.D.
Bone Diseases Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, Suite 800 
Bethesda, MD 20892-4872
Telephone:  (301) 594-5055
Fax:  (301) 480-4543

Alan N. Moshell, M.D.
Skin Diseases Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, Suite 800 
Bethesda, MD 20892-4872
Telephone:  (301) 594-5017
FAX:  (301) 480-4543

James Panagis, M.D.
Orthopaedics Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, Suite 800 
Bethesda, MD 20892-4872
Telephone:  (301) 594-5055
Fax:  (301) 480-4543

Bernadette Tyree, Ph.D.
Cartilage and Connective Tissue Program Director 
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, Suite 800 
Bethesda, MD 20892-4872
Telephone:  (301) 594-5032
Fax:  (301) 480-4543

Frederick Tyson, Ph.D.
Division of Extramural Research and Training 
Office of Program Development 
Chemical Exposures and Molecular Biology Branch
National Institute of Environmental Health Sciences 
MD EC-21 
P.O. Box 12233 
Research Triangle Park, NC 27709
Telephone:  (919) 541-0176

o Direct your questions about financial or grants management matters 

Melinda Nelson
Grants Management Officer
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, Suite 800 
Bethesda, MD  20892-4872
Telephone:  (301) 594-3535
FAX:  (301) 480-5450


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, Email:

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.

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

YEAR: 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 the NIH institutes or centers who has agreed to accept 
assignment of the application.   

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

1) 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 an application must include an 
Introduction addressing the previous critique.


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 
o Receive a second level review by the appropriate national advisory 


The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to discuss the 
following aspects of your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your application does not need to 
be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, 
you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the 
aims of your application are achieved, how do they advance scientific 
knowledge?  What will be the effect of these studies on the concepts or 
methods that drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project?  Do you acknowledge potential problem areas and 
consider alternative tactics?

(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 

(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 support?

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


components involving Phase I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous 
data management, quality assurance, and auditing procedures.  In 
addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (NIH Policy for Data Safety and Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998: 
Further Guidance on Data and Safety Monitoring for Phase I and Phase II Trials 
(released on June 5,2000) provides the detailed description of these 
policies. The establishment of a NIAMS-initiated DSMB and the DSMB's 
responsibilities and operating procedures are guided by a charter. The 
NIAMS has developed a template for the charter as shown in DSMB 

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 

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 
(; a 
complete copy of the updated Guidelines is available at
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 

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 

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

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

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.

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 

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 No. 93.846, 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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