Reliance and Single IRB Review

To encourage collaboration, reduce duplicate study submissions, and minimize the impact of multiple IRB reviews for the same protocols, HRPP offers IRB reliance opportunities.

Researchers at the health science center may rely on an external IRB (commercial, academic, etc.) to review studies. The external IRB must meet federal regulations for the IRB review and the relying institution will ensure the conduct of the study meets requirements under the institution’s Federal-wide Assurance.

Reliance agreements allow the IRB of one institution to rely on the IRB review of another.  The HSC HRPP is willing to rely on the review of another specified IRB in most circumstances.

Reliance Agreements

Smart IRB

Smart IRB is a reciprocity agreement signed by hundreds of institutions across the United States. It is the preference of HSC to use the SMART IRB agreement as the basis of reliance for all studies where we rely on an external IRB or serve as the IRB of record.

IRB Authorization Agreement

In cases where an institution does not meet the eligibility criteria to sign onto the SMART IRB agreement, HSC may use an IRB Authorization Agreement to establish a reliance relationship with an external institution.

Master Agreements

HSC has executed broad reliance agreements with commercial IRBs such as WCG/WIRB and Advarra. If you believe your study may fall under the scope of an existing master reliance agreement, please contact the HRPP office for additional information.

 

Requesting for HSC to defer their IRB oversight to another IRB or serve as the IRB of record for a multisite study

 The Health Science Center at UT Tyler will review requests to rely on an external IRB as well as serve as the IRB of record. Typically, requests for reliance are submitted to the HRPP at two time points:

  1. When studies are in the planning stages (i.e., grant submission)
  2. When studies are ready to be submitted for IRB review

 

Submission Process for Reliance

A member of the research study team (PI, coordinator, research staff) will draft and submit an External IRB Review Request through IRBManager. The HRPP office will review the information provided in the reliance request and will contact the PI with next steps/instructions. You may submit any questions about reliance or the feasibility of UTHSCT serving as the IRB of record for a multi-site study to or call 903-877-7632.