NIH GUIDE, Volume 21, Number 23, June 26, 1992

PA NUMBER:  PA-92-87

P.T. 34




  Clinical Medicine, General 

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Fogarty International Center


The National Institute of Arthritis and Musculoskeletal and Skin

Diseases and the Fogarty International Center invite

investigator-initiated grant applications and supplemental applications

to explore hypotheses concerning the etiology, pathogenesis, treatment,

and prevention of systemic lupus erythematosus (SLE) in Caribbean

populations.  The NIAID also has interest in research projects on the

subject of systemic lupus erythematosus.  The customary referral

guidelines will apply.  Applications meeting NIAID referral criteria

may be assigned to that institute.  Research proposed in response to

this announcement may involve clinical, epidemiologic, genetic, or

behavioral studies.  In addition to SLE, studies of other rheumatic

diseases in these populations will be considered.


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, Clinical and Epidemiologic Research on Systemic Lupus

Erythematosus in Caribbean and African Populations, is related to the

priority area of diabetes and chronic disabling conditions.  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 20402-0325 (telephone



Research grant applications may be submitted by domestic and foreign

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

institutions of higher education, research institutions, units of State

and local government and eligible agencies of the Federal Government.

Applications from minority individuals and women are encouraged.  U.S.

and foreign investigators are encouraged to collaborate.  Foreign

institutions are not eligible for the First Independent Research

Support and Transition (FIRST) Award (R29).


Applications considered appropriate responses to this announcement are

the traditional research project grant (R01) and the FIRST Award (R29).

In addition, the Fogarty International Research Collaboration Award

(FIRCA) funding mechanism may be used by NIH grantees from the U.S. to

collaborate with foreign investigators.  Joint efforts between U.S. and

Caribbean investigators are strongly encouraged.



SLE, a chronic inflammatory disease, appears to result from an

immunoregulatory disturbance brought about by the interplay of genetic,

hormonal, and environmental factors.  During the past three decades,

SLE has emerged worldwide as a major rheumatic disease.  There is a

marked female predominance, with most series reporting a 9:1

female-to-male ratio and an even higher ratio during the childbearing

years.  Systemic lupus erythematosus appears to be more common in

certain racial groups, particularly blacks.  Racial differences have

also been reported in the natural history and clinical manifestations

of SLE.

Research Objectives and Experimental Approaches

Studies of the general population at risk for SLE and other diseases,

as well as on patient populations who have been diagnosed as having the

diseases, will be accepted.  The research focus may be on clinical,

genetic, epidemiologic, or behavioral studies.  Subject matter to be

encouraged include:

o  Clinical research oriented to the cellular, organ, or human level

o  Clinical trials as well as projects to develop outcome assessment

tools to define the impact of different medical approaches

o  Studies to quantify the side effects of new therapies and identify

subpopulations of patients who are at increased risk for serious

adverse reactions to treatment

o  Genetic studies, including studies associating susceptibility and

clinical subsets with genetic markers

o  Cross-sectional as well as longitudinal epidemiologic studies

o  Studies of the natural history of lupus as well as case-control


o  Studies of migrant populations in the U.S. versus those remaining in

their country of origin and urban/rural comparisons

o  Studies examining the impact of comorbid conditions, behavioral,

environmental, and socioeconomic factors are encouraged


The Caribbean islands are particularly well-suited for studies of

systemic lupus and other diseases that disproportionately affect

individuals of African decent.  Each island has a substantial minority

population.  Among the more populated islands, Jamaica has a current

population of 2.4 million, 76.3 percent are of African decent.

Trinidad and Tobago have a population of 1.3 million with 43 percent

African and 40 percent East Indian descent.  Africans comprise 80

percent of the Barbados population.  Certain diseases, such as lupus,

which is known to be more frequent in African-American populations than

in Caucasians, can be more readily studied on islands where it may be

feasible to attain complete ascertainment of cases.  On the Caribbean

islands a small number of specialists see patients with certain

diagnoses, thus facilitating identification and follow-up of cases.

Also, most of the care is provided by a small number of medical


While new research projects are desired, applications based on current

studies are also encouraged.




NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical

research grants and cooperative agreements will be 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 should 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 should be provided.

The composition of the proposed study population must be described in

terms of gender and racial/ethnic group, together with a rationale for

its choice.  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 should be

included in the form PHS 398 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 should 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.

This policy applies to all studies submitted under this program

announcement.  The usual NIH policies concerning research on human

subjects also apply.  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 minorities.

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 are required

to address these policies.  NIH funding components will not award

grants that do not comply with these policies.


Applicants are to use the research project application form PHS 398

(rev. 9/91) that is available at the applicant's institutional research

office and 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.  To expedite the

application's routing, check the box on the application face sheet

indicating that the application is in response to this announcement and

type (next to the box) "Clinical and Epidemiologic Research on Systemic

Lupus Erythematosus in Caribbean Populations, PA-92-87."  The National

Institute of Allergy and Infectious Diseases (NIAID) also has interest

in research projects on the subject of systemic lupus erythematosus.

Normal referral guidelines will apply, and applications meeting NIAID

referral criteria may be assigned to that institute.

The application (with five copies) must be mailed to:

Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**

Receipt dates for new Research Project Grants, FIRST Awards and FIRCA

applications are February 1, June 1, and October 1 of each year.


R01 and R29 applications will be reviewed for scientific and technical

merit by an appropriate Initial Review Group of the Division of

Research Grants.  FIRCA applications will be reviewed by a Fogarty

International Center initial review group.  Secondary review will be by

the assigned National Advisory Council.  Applications compete on the

basis of scientific merit.


Applications will compete for available funds with all other approved

applications assigned to that institute, center, or division.  The

following will be considered in making funding decisions:

o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement


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 732-A

Bethesda, MD  20892

Telephone:  (301) 402-3352


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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