IRB INFORMATION

In order to use TIES at your institution, a TIES deployment IRB protocol will be needed that will cover use of TIES at your institution. In addition, your institution needs to determine what types of TIES studies need their own IRB protocol. For instance, for local TIES users at University of Pittsburgh, an IRB protocol is only needed for studies that require tissue.

The materials provided below can be used as a model for your own institution and modified as needed. Included is the TIES deployment IRB protocol from the University of Pittsburgh, the IRB form used at Pitt for TCRN studies, and guidelines for how users should fill out their IRB protocols for studies using TCRN.

Sample TIES Deployment IRB Medical Records Exempt Form – IRB exempt form that is part of the TIES deployment IRB at University of Pittsburgh

TCRN form for no human subjects determination – the IRB form used at Pitt  for TCRN studies. This form could be used as a model for the information your IRB needs investigators to provide about studies that use TIES.

IRB Guidelines for TCRN Data Only Projects – guidelines for how users at Pitt should fill out IRB protocols needing TCRN data. These guidelines could be modified to reflect what is needed by the IRB at your institution.

IRB Guidelines for TCRN Data and Tissue Projects – guidelines for how users should fill out IRB protocols needing TCRN data and tissue. These guidelines could be modified to reflect what is needed by the IRB at your institution.

Data Security Assessment – guidelines for how users should fill out Data Security Assessment protocol needing TCRN data. These guidelines could be modified to reflect what is needed by the IRB at your institution.

Request for Determination that Project does not involve Human Subjects:  TCRN Protocols ONLY– guidelines for how users will fill out this document if needed by the IRB protocol. These guidelines could be modified to reflect what is needed by the IRB at your institution.