By Anita Pascoe, MS, CIP, project coordinator at Intermountain Healthcare
“Check what box?” you may ask. Let me explain — without getting too hung up on a paraphrase of Shakespeare’s famous question.
In the wake of the 2014 AER Conference last December, I have spent considerable time reflecting on the current regulatory framework governing human subjects research. (Yes, I do have a life, but I am a Certified IRB Professional [CIP®], so matters like these interest me.) In the United States, federal regulations require that all research on human subjects be reviewed and approved by an institutional review board (IRB). IRBs have the authority to approve, disapprove, or require modifications to research protocols, which may be why many researchers consider submitting a proposal to the IRB akin to suffering “the slings and arrows of outrageous Fortune.” [There’s that Shakespeare again.]
One of the key elements underpinning a high-functioning IRB is its autonomy to make its determinations independent of other institutional goals or activities. This is an IRB prerogative that may cause consternation for some individual researchers and relief for others. In addition, institutions that conduct human subjects research sponsored by the federal government are required to provide written assurance to the Office of Human Research Protections (OHRP) that the research will be conducted in compliance with the regulations. Traditionally, most institutions have simplified matters by stipulating that all human subjects research conducted under its purview will comply with the federal regulations regardless of the funding source for the project. This practice has been referred to colloquially as “checking the box.”
However, the widespread availability of increasingly more sophisticated research technologies has left many institutions considering whether “unchecking the box” might be a better option. Today’s complex regulatory research environment contains increasing volumes of data-only projects and other so-called minimal risk research. These types of projects have been the catalyst for many institutions to opt for “unchecking” the box, thereby reducing the administrative burden of oversight and enabling institutional IRBs to customize policies and procedures that better facilitate workflows.
So, “to check or not to check.” That is the question many institutions are facing. To be sure, there are pros and cons to either choice. Keeping the box checked ensures continuity and stability, and unchecking opens up opportunities to customize frameworks to fit institution-specific needs. Institutions wresting with this issue may wonder, like Hamlet, whether to “rather bear those ills we have, than fly to others that we know not of?
Aye. There’s the rub.
Anita Pascoe is a member of the PRIM&R Blog Squad for the 2014 Advancing Ethical Research (AER) Conference. The PRIM&R Blog Squad included PRIM&R members who blogged here, on Ampersand, about the conference to give our readers an inside peek of what happened December 4-7 in Baltimore, MD, and how they have used what they’ve learned there since they returned home.