14
Nov2015

I attended Thursday’s Single IRB AER15 Pre-Conference program and found it educational, thought-provoking, and beneficial. While my institution (Cincinnati Children’s Hospital) has been steadily expanding into the realm of single IRBs, in my role as an educator, I’ve only recently become involved.  That’s why I chose this topic.

Let’s jump in with some terminology….

So what is a single IRB as compared to a central IRB? I’ve been calling all studies involving reliance on multiple IRBs central IRBs, so learning that I had it wrong was my first surprise. Proper terminology is key. The difference is that networks and/or consortia use a central IRB for the whole entity. When there are multiple, likely unaffiliated sites and one is simply taking the lead IRB role, this is a single IRB scenario.

So, while this was new information, my biggest “Aha!” moment came when the topic of monitoring was discussed. I’ve heard a lot of talk about reliance, but I’ve never considered the implications on monitoring (auditing). 

At our institution, we have a research compliance office that completes a number of randomly selected audits in addition to audits based on the IRB’s request. I imagine this holds true for most academic health centers.  So what does this mean in the context of a single IRB?  Here are some questions to consider:

  • Do all (relying) institutions require some amount of auditing?
  • When a study that is part of a reliance agreement is audited, should their audit findings go to the relying IRB, the relied-upon IRB, or both?
  • Can (or should) the single IRB require that audits be conducted at relying sites? If so, who would conduct them? 
  • When monitoring a study that is reviewed by a single IRB, what would such an audit look at?
  • Do the reliance agreements specify who is responsible for conducting audits?  Report findings?

I have more questions than answers, but from the discussion, there seems to be some consensus. The institution conducts the audits, according to its Human Research Protection Program obligations. The responsibility lies here, at the institutional level, more than with the IRB itself. Accredited institutions (e.g., those with AAHRPP accreditation) commit to auditing and that does not exclude those studies that are part of reliance. However, all institutions (regardless of accreditation status) should have established policies that address monitoring/auditing and those policies need to be followed first and foremost. 

What’s done with audit findings will depend largely on the reliance agreement.  In the session, actual short (two page) and long (eight page) reliance agreements were shared. While the shorter ones were less likely to address audit requirements and sharing of results, the longer ones most likely would cover these aspects. 

The reliance agreement would also likely spell out the required activities of each IRB in regards to sharing information with the single IRB (or relying sites). Typically, concerns would be shared directly from one IRB to another.

I left this session feeling much more educated about single IRBs, but still have a host of questions to continue my growth back in Cincinnati.

Mina Busch, program manager, research education and outreach at Cincinnati Children's Hospital Medical Center, is a member of the PRIM&R Blog Squad for the 2015 AER Conference. The PRIM&R Blog Squad is composed of PRIM&R members who blogged here, on Ampersand, to give our readers an inside peek of what happened at the conference in Boston, MA.

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