RESEARCH ON RAYNAUD'S PHENOMENON AND SYSTEMIC SCLEROSIS

NIH GUIDE, Volume 21, Number 44, December 11, 1992



PA NUMBER:  PA-93-30



P.T. 34



Keywords:

  Biology, Cellular 

  Pathogenesis 



National Institute of Arthritis and Musculoskeletal and Skin Diseases



PURPOSE



The National Institute of Arthritis and Musculoskeletal and Skin

Diseases (NIAMS) invites research grant applications for studies of

basic biological and clinical aspects of Raynaud's phenomenon, focusing

particularly on microvascular control mechanisms, collagen synthesis,

and other aspects of fibroblast biology, endothelial cell function, and

immunological abnormalities associated with Raynaud's phenomenon.  The

goal of this program announcement (PA) is to promote research that

contributes to the understanding the pathogenesis of Raynaud's

phenomenon and its relationship to other pathogenetic mechanisms in

systemic sclerosis.



HEALTHY PEOPLE 2000



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 PA,

Research on Raynaud's Phenomenon and Systemic Sclerosis, is related to

the priority area of 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 20402-9325 (telephone

202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by foreign and domestic, for-profit and

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

universities, colleges, hospitals, laboratories, units of State and

local governments, and eligible agencies of the Federal government.

Applications from minority individuals and women are encouraged.

Foreign institutions are not eligible for First Independent Research

Support and Transition (FIRST) awards (R29).



MECHANISM OF SUPPORT



Applications are requested under the following mechanisms:  traditional

research grants (R01), FIRST awards (R29).  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.



RESEARCH OBJECTIVES



The goal of this PA is to encourage research that will elucidate the

relationship between Raynaud's phenomenon and systemic rheumatic

illness.  Raynaud's phenomenon consists of intermittent blanching,

reactive hyperemia, and cyanosis of fingers, toes, ears, and nose in

response to cold, emotion, and other external events.  More than 90

percent of patients with scleroderma (systemic sclerosis) and

approximately 25 percent of patients with systemic lupus erythematosus

develop Raynaud's phenomenon, often as the first symptom, but the

relationship between this abnormality and the associated rheumatic

illness remains unknown.  Recent studies have suggested that the

primary abnormality may reside in control mechanisms for microvascular

blood flow, endothelial cell injury, or pathologic biology of

endothelial cells or fibroblasts.  In scleroderma, Raynaud's phenomenon

is closely associated with excessive skin fibroblast synthesis of skin

collagen.  Several autoantibodies occur in patients with scleroderma

and with systemic lupus erythematosus; whether these autoantibodies

cause, follow, or are unrelated to the occurrence of Raynaud's

phenomenon is unknown.



Research proposed in response to this Program Announcement may be at

any level of biological organization, but must in some way address the

pathophysiology of Raynaud's phenomenon and/or its relationship to

systemic sclerosis or other rheumatic disease.  Possible topics

include, but are not limited to, the following:



o  Up- and down-regulator mechanisms of microvascular blood flow;

o  Neurogenic mechanisms in microcirculatory abnormalities;

o  Immunologically-mediated endothelial cell injury;

o  Control mechanisms of fibroblast function as it relates to the

occurrence of scleroderma; and

o  Relationship of specific autoantibodies to Raynaud's phenomenon.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



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

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 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 policies.



APPLICATION PROCEDURES



Applications 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.  Application kits 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 PA must

be typed in Section 2a on the face page of the application.



The completed original application and five legible copies must be sent

or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW PROCEDURES



Applications will be assigned on the basis of established PHS referral

guidelines.  Applications will be reviewed for scientific and technical

merit by initial review groups (study sections) of the Division of

Research Grants (DRG), NIH, in accordance with the standard NIH peer

review procedures.



Following scientific-technical review, the applications will receive a

second-level review by the National Arthritis and Musculoskeletal and

Skin Diseases Advisory Council or by other relevant advisory boards

and/or councils.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications assigned to NIAMS.  The following will be considered in

making funding decisions:



o  quality of the proposed project as determined by peer review;

o  availability of funds; and

o  program balance among research areas of the announcement.



INQUIRIES



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:



Director, Arthritis Program

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Westwood Building, Room 405

Bethesda, MD  20892

Telephone:  (301) 402-3340



Direct inquiries regarding fiscal matters to:



Diane M. Watson

Chief, Grants Management Branch

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Westwood Building, Room 732A

Bethesda, MD  20892

Telephone:  (301) 402-3352



AUTHORITY AND REGULATIONS



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 52 and 45 CFR Part 74.  This program is not subject

to the intergovernmental review requirements of Executive Order 12372

or Health Systems Agency review.



.

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