28 - Single IRB (sIRB): Transferring the IRB of Record (the Good, Bad and Ugly)

Background: In the IRB world “it depends” seems to be the most common answer to almost every question. This project aims to analyze the process of transitioning of sIRB review mid-trial, including what factors IRBs and investigators should consider and whether rights and welfare of participants are affected.

Program

Description: Switching IRBs for ongoing trials can happen for various reasons--the most common is a principal investigator moving to a new organization. To avoid confusion, our office created a clear guidance flow-chart for investigators to explain the process. First step is setting a reliance consult with lead study team after all questions and concurs are discussed a reliance request is submitted for review via Redcap, then it moves to the next step, finalizing review fees, the document explains that a new study must be initiated to avoid any pause/gap in recruitment while transfer is being processed. It is strongly recommended to use a document management system such as IRB exchange (IREx) for easier communication and collection of agreements, finally meeting with reviewing IRB and relying sites to ensure that all sites are on the same page to keep the sIRB at current main site and simultaneously work on the IRB process transfer.

Program

Assessment: Positive feedback was observed, and having a process in place made it easier for investigators, study personnel, and IRB staff to understand the required steps without having repeated meetings or various email chains. The program created explains most common scenarios that can be encountered during IRB transition (i.e., for IRBs to keep track of two submissions for same protocol, get required agreements and reliance documents without confusing the two submissions). For participants, re-consent consideration as new consent form will be approved for new study since local context for new institution will be different and for investigator and study team to consider the extra fees included with new submission, re-consenting process, communication plan, follow up with participants, etc. The program is still in progress. The document did not reach its final state as we are still editing the process as new issues arise, including issues from participating sites done with enrollment and IRB charges for these sites.

Limitations: Finding an effective way to set reasonable turnaround time for transiting multiple sites engaged in different levels of study progress is a major limitation. Another contributing factor is lack of training and understaffing of IRBs and research coordinators. To address this issue our team started with internal training for HRPP staff for sIRB as well as having lectures dedicated to sIRB topics for the research community to become familiar with different aspects of sIRB review.

Discussion: Transitioning review can have a positive impact for the lead principal investigator as it can facilitate approval of documents. However, transition of ongoing trial is not necessarily practical. While sIRB is no longer a new concept, many investigators, study teams and IRBs are not familiar with sIRB process and the responsibility that comes with it. Having guidance for investigators and external IRBs to follow helps provide a clear process for all parties involved, as switching IRBs requires constant communication and clear expectations not only from the lead the principal investigator and reviewing IRB, but also with all study investigators and IRB offices involved.