Ready or Not Here They Come

The research world, and inevitably PRIM&R’s 2015 Advancing Ethical Research Conference (AER15), is abuzz with the proposed changes to the common rule. As most people are wondering what exactly these potential changes could mean for their research organizations, the question becomes “Are we ready?”

There is much to be said about single IRB review, but as P. Pearl O’Rourke, MD, pointed out during the pre-conference presentation “Single IRBs Are Here: Are You Ready?”, up to this point it has been voluntary to participate in a reliance agreement with another institution or organization. What the new rule will force is a relationship that many institutions lack the infrastructure to support. And both O’Rourke and Susan Z. Kornetsky, MPH, pointed out that single IRB review does not automatically lessen the workload of the IRB administration, though there is not enough data to know for sure how much the workload would increase compared to what it is now without a single IRB mandate.

And it’s not just the IRB administration that faces an influx of work. There are many organizations and institutions that have never executed a reliance agreement with another institution. David G. Forster, JD, MA, CIP, made it clear that there can be a lot of difficulties navigating the language of reliance agreements alone—being too vague or too specific can cause unanticipated issues. In order to avoid these potential problems due to wording, institutions need time to work out what needs to be included in reliance agreements and what needs to be left out, compared to their organization’s standard operating procedures. This and many other elements require the time and effort of staff members to be handled appropriately. And Kornetsky explained additional potential complications that I, personally, had never considered when it came to single review IRB protocols. For example, when an unanticipated event occurs, which IRB takes action? Is the local IRB informed?

Jamin Alexander, BA, also illustrated the trials and tribulations of single review IRB protocols from the principal investigator’s point of view. He worked as a study coordinator on a multisite study where his institution served as the central IRB of record. There is much regulatory work to be done as the coordinating site—Alexander pointed out that there is even a study nurse that works. 5 FTE solely on organizing and compiling research submissions, such as unanticipated events, data for continuing review, and other documentation.  But, he also provided data showing that, while initially single IRB submissions might not be processed much faster than local IRBs, amendments are processed at a fraction of the time.

The answer to the question at hand, which I discovered during this session, is that we will need more time and more funding should this become part of the final rule. The general conclusion in the session was that if the NIH is going to require single IRB review, they should provide the funding that a transition to single IRB review necessitates. There is nothing inherently wrong, or right, about single IRB review or local IRB review for that matter. We just can’t mandate adherence to the single IRB review structure without providing tools, education, and the time necessary to create the new infrastructure. So, are we ready? The answer for the time being is that while many institutions are, there are so many more that simply are not.

Courtney Zwieg, regulatory coordinator at NorthShore University HealthSystem, 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.