8
Nov2013

by Stephanie Pyle, MFA, Manager of Community and Communications, Schulman Associates IRB

PRIM&R is pleased to continue our posts from members of the PRIM&R Blog Squad at the 2013 Advancing Ethical Research (AER) Conference. The Blog Squad is composed of PRIM&R members who blog here, on Ampersand, to give you an inside peek of what's happening at the conference on November 7-9 in Boston, MA.

Research institutions have felt the pressure to utilize central IRBs (CIRBs) for years. During Wednesday’s pre-conference workshop, Central IRB Models: Benefits, Challenges, and Role in Clinical Research, presenter Andrew Chase creatively compared the CIRB to a tornado: it’s on the horizon, and our first reaction is, “I hope the tornado doesn’t come my way.” But the tornado continues to approach, and there’s the instinct to run for shelter—but where’s the shelter to run to?

Hopefully, utilizing a central IRB isn’t quite as destructive as the storm metaphor suggests. But, throughout the day, panelists and attendees returned to the idea of building that shelter—establishing a solid infrastructure to handle the inevitable CIRB relationship.

P. Pearl O’Rourke and her co-panelists made it clear that centralized IRB review is the way of the future. Most contemporary research is conducted at multiple sites, and, in this context, the traditional model of multiple institutional IRBs reviewing the same protocol proves inefficient and inconsistent.

 
Several options for centralized IRB review are available, and many in the room indicated their institutions worked with the National Cancer Institute’s CIRB, commercial IRBs, regional CIRBs, and/or CIRBs established through grant-funded research networks. In discussing these CIRB models, several crucial questions kept coming up:
  • How do institutions modify their infrastructure to support a CIRB relationship?
  • What are the CIRB’s responsibilities, and what responsibilities does the institution retain?
  • How do institutions fund the infrastructure modifications needed to interact with a CIRB?

The panelists stressed that bringing in centralized IRB review does not reduce workload. Rather, it’s different work: while the IRB review has been moved outside the institution, the institution is still responsible for activities like institutional regulatory compliance, conflict of interest review, investigator and staff education, and other important oversight activities. Support staff is also needed to manage CIRB interactions. In order to accommodate a CIRB, traditional institutional research offices need to be rethought.

Many sponsors and funding agencies strongly encourage that all sites in a given study utilize a CIRB, and the Advanced  Notice of Proposed Rulemaking suggests that the Office for Human  Research Protection may soon encourage CIRB review as well. Some grants suggest creating a CIRB to serve the network of participating sites—which creates the challenges of establishing a CIRB from scratch. In requiring that sites utilize a CIRB, those sponsors and agencies must realize that they are also asking institutions to redesign the way their research enterprises operate. Agreements between the institution and CIRB must be carefully developed to establish clear responsibilities and communication strategies. New policies must be developed to manage the new CIRB process, and staff must be trained on the new policies. Resources are required to not only implement these changes but also to manage them long-term.

The resource cost of establishing this type of infrastructure is a real concern, and it’s clear we need to do something tangible to make working with CIRBs a real possibility. Perhaps the PRIM&R community can come together to analyze the data and work out practical solutions—after all, the storm’s a-coming.

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