NIH GUIDE, Volume 21, Number 36, October 9, 1992

PA NUMBER:  PA-93-005

P.T. 34, FF



  Skin Diseases 

National Institute of Arthritis and Musculoskeletal and Skin Diseases


The National Institute of Arthritis and Musculoskeletal and Skin

Diseases invites investigator-initiated grant applications and

supplemental applications to carry out clinical and epidemiologic

studies on the etiology, treatment, and prevention of arthritis,

musculoskeletal, and skin diseases in minority populations and other

populations at special risk.


The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  This program

announcement, Arthritis and Skin Diseases (Minority Populations), is

related to the priority area of chronic disabling conditions and

surveillance objectives.  Potential applicants may obtain a copy of

"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or

"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)

through the Superintendent of Documents, Government Printing Office,

Washington, DC 20402-9325 (telephone 202-783-3238).


Research grant applications may be submitted by domestic and foreign

for profit and non-profit organizations, public and private, such as

local governments, and eligible agencies of the Federal Government.

Applications with minority individuals and women as Principal

Investigators are encouraged.  Foreign institutions are not eligible

for First Independent Research Support and Transition (FIRST) Awards

(R29).  Applicants for the Clinical Investigator Awards (K08) and

Individual National Research Service Awards (F32) must be U.S.

citizens, non-citizen nationals, or non-citizens lawfully admitted

for permanent residence.  Applicants for the F32 Award must have

received a doctorate degree as of the beginning date of the NRSA

appointment.  Applicants for the K08 Award must have an M.D. or

equivalent degree.  Applicants for the Fogarty International Research

Collaboration Award (FIRCA) Award must be U.S. scientists who are

Principal Investigators of NIH Research Project Grants (R, P, or U01

series) that are active and funded during the proposed FIRCA grant

award period.  Recipients of K awards are not eligible.  For the

FIRCA Award, the foreign collaborator's institution must be located

in a country in the geographical regions commonly known as Central

and Eastern Europe (including the former USSR), Latin America, and

the non-US Caribbean.


Applications for the following mechanisms are considered appropriate

responses to this announcement:  the traditional research project

grant (R01) and the FIRST Award (R29), the Clinical Investigator

Award (K08), and the Individual National Research Service Award

(F32).  In addition, the FIRCA funding mechanism may be used by NIH

grantees in the U.S. to collaborate with foreign investigators.

Joint efforts between U.S. and foreign investigators are encouraged.

Because the nature and scope of the research proposed in response to

this RFA may vary, it is anticipated that the size of an award will

vary also.


o  Background

Major gaps in knowledge still exist about the incidence, prevalence,

and natural history of most of the rheumatic, musculoskeletal, and

skin diseases. The skin diseases in particular have lacked

epidemiologic research.  Although both cross-sectional and

longitudinal studies are lacking for many diseases, the greatest need

is for longitudinal investigations.  Some population-based

longitudinal data sources are available for studies of rheumatic

diseases and osteoporosis, e.g., Framingham, Massachusetts;

Rochester, Minnesota; NHANES I and Followup; and the Study of

Osteoporotic Fractures (SOF).

In the past decade, epidemiologic studies have made some progress in

describing the frequency of osteoarthritis and some skin diseases,

based upon nationally collected data by the National Center for

Health Statistics.  Epidemiologic studies from defined populations

have contributed knowledge about cohorts at increased risk of

disease, e.g., rheumatoid arthritis in Pima Indians and the higher

incidence, prevalence, and mortality of systemic lupus erythematosus

in Black females than in Caucasian and male populations.  However,

the key question, why some cohorts remain at increased risk of

disease, is still unanswered.

In general, less is known about the occurrence of arthritis,

musculoskeletal, and skin diseases in American Blacks than in whites.

Even less is known about other American minority groups.  Data are

also lacking on these diseases in children and the elderly.

o  Research Objectives and Scope

The primary objective of this program announcement is to foster

epidemiologic research in minority groups and other populations at

special disease risk.  Studies to be encouraged include:

o  The descriptive pattern of arthritis, musculoskeletal and skin

diseases in populations

o  The etiology and modes of transmission of these diseases,

including the relative contribution of both genetic and environmental

factors influencing both the onset and course of the disease

o  Studies of disease burden, specifically on the frequency, cost,

and personal and social sequelae of arthritis and musculoskeletal and

skin diseases

o  New diagnostic technologies to update or develop criteria for the

diagnosis and staging of many rheumatic and skin diseases and to

define homogeneous clinical subsets for epidemiologic and basic

science studies

o  Studies to generate and test etiologic hypotheses, especially for

less studied rheumatic, musculoskeletal, and skin diseases

o  Family studies to evaluate the interplay of genetic and

environmental contributions to the development and progression of

rheumatic, musculoskeletal, and skin diseases

o  Longitudinal studies to describe the prognosis and outcomes among

patients with rheumatic, musculoskeletal, and skin diseases, and to

identify risk factors for disease onset, progression, and disability

o  Practical outcome assessment tools to define the impact of

different medical, surgical, and rehabilitation management approaches

for arthritis, musculoskeletal and skin diseases


Epidemiologic studies of the general population at risk for disease,

as well as patient populations that have been diagnosed to have the

diseases, will be accepted.  Although new research projects are

desired, applications based on on-going studies that were conceived

for reasons other than the purposes of this program announcement are

also encouraged.




NIH policy is that applicants for NIH clinical research grants and

cooperative agreements are required to include minorities and women

in study populations so that research findings can be of benefit to

all persons at risk of the disease, disorder or condition under

study; special emphasis must be placed on the need for inclusion of

minorities and women in studies of diseases, disorders and conditions

which disproportionately affect them.  This policy is intended to

apply to males and females of all ages.  If women or minorities are

excluded or inadequately represented in clinical research,

particularly in proposed population-based studies, a clear compelling

rationale must be provided.

The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of

the study.  This information must be included in the form PHS 398

(rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in

Section 5, Human Subjects.  Applicants are urged to assess carefully

the feasibility of including the broadest possible representation of

minority groups.  However, NIH recognizes that it may not be feasible

or appropriate in all research projects to include representation of

the full array of United States racial/ethnic minority populations

(i.e., Native Americans (including American Indians or Alaskan

Natives), Asian/Pacific Islanders, Blacks, Hispanics).  The rationale

for studies on single minority population groups must be provided.

For the purpose of this policy, clinical research is defined as human

biomedical and behavioral studies of etiology, epidemiology,

prevention (and preventive strategies), diagnosis, or treatment of

diseases, disorders or conditions, including but not limited to

clinical trials.

The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including


If the required information is not contained within the application,

the review will be deferred until the information is provided.

Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the

selected study population is inadequate, it will be considered a

scientific weakness or deficiency in the study design and will be

reflected in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required

to address these policies.  NIH funding components will not award

grants or cooperative agreements that do not comply with these



Applications for the R01, R29, K08, and FIRCA awards are to be

submitted on the grant application form PHS 398 (rev. 9/91) and will

be accepted at the standard application deadlines as indicated in the

application kit.  FIRST (R29) Award applications must include at

least three sealed letters of reference attached to the face page of

the original application.  First Award applications submitted without

the required number of reference letters will be considered

incomplete and will be returned to the applicant without review.  The

receipt dates for applications for AIDS-related research are also

found in the PHS 398 (rev. 9/91) application kit.  Supplemental

application instructions for the K08 Award and the application dates

are available in the publication "The K Awards" (rev. 10/91).

Supplemental application instructions for the FIRCA award are

available from the John E. Fogarty International Center.

Applications for the FIRCA Award must include a letter of

collaboration from the foreign investigator and the foreign

investigator's biographical sketch, resources, and environment.

Applications for the F32 Award are to be submitted on form PHS 416-1

and must include letters of reference and other supplemental


Application kits and information booklets including relevant receipt

dates are available at most institutional offices of sponsored

research and may be obtained from the Office of Grants Inquiries,

Division of Research Grants, National Institutes of Health, Westwood

Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441.  The

title and number of the announcement must be typed in Section 2a on

the face page of the application.

The completed original application and the appropriate number of

legible copies, as specified in the application kits, must be sent or

delivered to:

Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**


Applications will be assigned on the basis of established Public

Health Service referral guidelines.  Applications will be reviewed

for scientific and technical merit in accordance with the standard

NIH peer review procedures.  FIRCA Award applications will be

reviewed by an initial review committee convened by the Fogarty

International Center.

Following scientific-technical review, the applications will receive

a second-

level review by an appropriate advisory council.


Applications will compete for available funds with all other approved

applications.  The following will be considered in making funding


o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement

Additional criteria for R29 and F32 applications include the

potential for the applicant to carry out independent research, the

quality of education, scientific training, research experience, and

commitment to a research career, as well as the institutional

commitment.  Further criteria for F32 applications include the

quality of the sponsor and training environment and the reference



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Ms. Reva C. Lawrence

Epidemiology/Data Systems Program Officer

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Building 31, Room 4C-13

Bethesda, MD  20892

Telephone:  (301) 496-0434

Direct inquiries regarding fiscal matters to:

Ms. Diane M. Watson

Grants Management Officer

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Westwood Building, Room 4A15C

Bethesda, MD  20892

Telephone:  (301) 496-7257


This program is described in the Catalog of Federal Domestic

Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases

Research.  Awards will be made under the authority of the Public

Health Service Act, Title III, Section 301 (Public Law 410, 78th

Congress, as amended, 42 USC 241) and administered under PHS grants

policies and Federal regulations 42 CFR Part 52 and 45 CFR Part 74.

This program is not subject to intergovernmental review requirements

of Executive Order 12372 or Health Systems Agency review.


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