GUIDELINES for preparation of Research Protocols to the Research Registry for Neonatal Lupus (RRNL)

The RRNL welcomes applications from investigators interested in basic and clinical research related to neonatal lupus.  Written requests for acquisition of data from the RRNL  should follow the organization detailed below.  The application must not exceed three pages (Parts A-G), exclusive of references, IRB approval and investigator’s C.V.

A. TITLE

Your project title should be succinct and match the project title on your IRB approval.

B. SPECIFIC AIMS

Briefly state the hypothesis being addressed and list the specific aims proposed.

C. PREVIOUS EXPERIENCE

Briefly describe the principal investigator’s previous research experience (basic or clinical) in the are of neonatal lupus.  If not directly related, describe any expertise, which might be applicable to the current proposal.  Preliminary data supporting the objectives of the application should be included.

D. METHOD OF STUDY

Provide a brief explanation of how you plan to execute the specific aims.  Include the expected numbers of patients needed and justification of why your laboratory or clinical setting is uniquely situated to perform the proposed investigations.  Include a time frame for project execution.

E. ESTIMATED COSTS AND PROPOSED SOURCE(S) OF FUNDING

The RRNL does not provide funding for approved projects.

F. LAY SUMMARY

The lay summary will be used to facilitate understanding of the project by the patient representative on the Review Committee as well as any potential patients to be included in the proposed studies.

G. INVESTIGATOR’S C.V.

This should include a two-page biographical sketch (NIH style) with publications of the last five years.

H. IRB APPROVAL OF THE PROJECT

This can be final approval or notification that review is pending.  A sample of the informed consent describing the study must be included.  Registry information will not be released until a copy of IRB approval is received.

Applications will be reviewed by the Review/Advisory Committee of the RRNL, which includes members with expertise in the disciplines of rheumatology (adult and pediatric), cellular biology and immunology, dermatology, pediatric cardiology and echocardiography, maternal/fetal medicine (high risk pregnancies/CHB), and biostatistics.  Applications will be considered at all times during the year without restriction.  It is estimated that it should take 4-6 weeks from receipt of a proposal to formal approval.  If a proposal is not approved, the investigator will be provided with the reviewer’s comments in order to provide the opportunity for re-application. 

Two original copies of all materials should be mailed to:

Peg Katholi
NYU Medical Center
560 First Avenue, TCH-407
New York, NY  10016

Tel: 212-263-0743
Fax: 212-263-0759

In addition, please e-mail your Research Protocol and CV to: peg.katholi@nyumc.org

IMPORTANT NOTE:

• Article H.11 of NIAMS Contract:  Publication and Publicity “The Contractor shall acknowledge the support of the National Institutes of Health whenever publicizing the work under this contract in any media by including an acknowledgement substantially as follows:
  
  

  “This project has been funded in whole or in part with Federal funds from the National Institute of Arthritis and Musculoskeletal and skin Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. N01-AR-4-2271.”

  All publications resulting from data/specimens obtained through an approved protocol  should acknowledge the Research Registry for Neonatal Lupus - NIAMS Contract N01-AR-4-2271. 

• A copy of all accepted manuscripts and/or reprints of articles resulting from the data/specimens obtained from the Research Registry for Neonatal Lupus should be forwarded to Dr. Buyon as soon as available.  Progress and resultant manuscripts/publications of approved research protocols are included in our bi-annual Progress Reports to NIAMS.