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 > Research > Human Subjects Research > NYUCD Human Subjects Protocol >  IX. Confientiality Agreements, Contracts, Material Transfer Awards

IX. Confientiality Agreements, Contracts, Material Transfer Awards

A. Purpose
The purpose of these documents is to protect the needs, interests, and liability of investigators, the University, and sponsors. In order to protect both faculty publication rights and the University's patent rights, the sharing and transmittal of any research-related materials should be governed by agreement. Some of these policies extend to donated materials that may be used for clinical care, teaching, research purposes, in order to protect the faculty and the University.

Confidentiality Agreement
This agreement is implemented when investigations are sponsored by industry. It is designed to protect patents and other proprietary information held by the sponsor.

Commercial Agreement/Research Contract
This contract governs the responsibilities of the investigator, University, and sponsor regarding the conduct of the study. This includes indemnification of the investigator and NYU from any defects in drugs/materials/devices. It also indemnifies the sponsor from any investigator/University-related errors. The contract outlines the nature of data collection/analysis/publication, confidentiality issues, payment schedules, use of investigator and/or University name.

The major guidelines for a commercial agreement/research contract are:

  • freedom from interference in the conduct of the research;
  • no limitation on publications or the right to publish;
  • support for the ongoing research project;
  • obtaining a royalty-bearing license to practice the invention and/or the results of the research.

Material Transfer Award (MTA)
Protects the proprietary technology of the sponsor while indemnifying the investigators and University from defects in product.

Expedited Material Transfer Award for Donated Materials
This is applicable for donated materials, drugs, devices, and any other materials used in clinical care, teaching, and research. It includes indemnification of the investigator and NYU from any defects in any of the materials. It also indemnifies the sponsor from any investigator/University-related errors. This Expedited MTA outlines publication issues, and use of investigator and/or University name.

B. Process
All contracts, MTAs, Expedited MTAs, and Confidentiality Awards are processed thru the Bluestone Center for Clinical Research (Rene Lopez) and then routed through the Office of Industrial Liaisons (OIL) at the School of Medicine where they will undergo legal evaluation. No contract or agreement should be signed by a Principal Investigator until it has received legal approval from the OIL. Contact Rene Lopez (998-9892; rene.lopez@nyu.edu) for further information and assistance.

OSP IRB Applications
No standard forms exist for the OSP IRB. Therefore, use the NYUSM websites for further information and contact Rene Lopez (998-9892).

NYUSM IRB Applications
Guideline for Commercial Agreements. Retrieve from:
http://research.med.nyu.edu/research-resources/important-forms-researchers