NTR IRB Reliance Agreement
Reliance agreements for NTR IRB affiliated researchers (from UNTHSC, JPS, etc.) are done on a case-by-case basis and require acceptance from NTR IRB leadership, as well as Institutional Leadership.
Investigators who request for another IRB to be the IRB of record for a multi-site human subject research study they are engaged in, or vice versa (request the NTR IRB be IRB of record for a multi-site human subject research study) should first complete the IRB Reliance Agreement Request form (below), explaining the situation/request and reason for the reliance agreement. Occasionally, the NTR IRB may be contacted by the other IRB as well. In either situation, it is important for the PI to keep the IRB updated regarding their plans/needs and follow all procedures/processes as instructed by the IRB.
Additional Guidance Resources for Reliance Agreements:
- Refer to the “NTR IRB Worksheet: Communication & Responsibilities for Collaborative Projects” guidance document to help all parties involved in a collaborative/reliance agreement (relying and reviewing IRBs and staff, lead PI and study team, and relying PI and study team) define their role and responsibilities as well as a communication plan when conducting a multi-site research project.
- For federally-funded, multi-site (non-exempt) projects where the investigators are relying on the NTR IRB, please refer to the checklist titled “NTR IRB Considerations for Serving as the sIRB”, which outlines the specific responsibilities for the Principal Investigator of the Lead Study Team.
- For complete guidance/information regarding reliance requests and collaborative research, please see Chapter 20 of the NTR IRB Manual Standard Operating Principles and Procedures.
- For projects in which the NTR IRB will be serving as the IRB of Record (or sIRB or Reviewing IRB), please note that the IRB Exchange (aka “IREx”) system will be used to document the reliance (using the appropriate reliance agreements) and to collect local context information from all relying sites – note that the use of IRB Exchange will be mandatory for all relying sites if the NTR IRB is serving as the IRB of Record. The NTR IRB will review the local context information provided in IRB Exchange for each relying site and will conduct the IRB review accordingly.
This page was last modified on December 19, 2024