28
Feb2013

by Andrea Johnson, JD, CIP, Regulatory Specialist, Oregon Health & Science University Institutional Review Board

I don’t think many will disagree with me when I say that the institutional review board (IRB) process is complex. While some of us, including me, find navigating complex regulatory schema to be an enjoyable challenge, the regulations governing human subjects research create practical hurdles that cost time and money, and some would argue that they may even hinder scientific progress. There is a clear need to balance the protection of human subjects with a process that is accessible, consistent, and efficient.

The reforms to the Common Rule proposed in the Department of Health and Human Services (DHHS) Advance Notice of Proposed Rulemaking (ANPRM) have this goal in mind, but it is anyone’s guess when, or if, these changes will materialize.  A summary of public comments compiled by Edward E. Bartlett, PhD, of the Office for Human Research Protections (OHRP) indicates that there is widespread disagreement throughout the research ethics community on a number of important aspects of the ANPRM.  In the meantime, what can IRBs do to simplify and streamline their review process without running afoul of the regulations?

One of the most helpful sessions I attended at the 2012 Advancing Ethical Research Conference was titled Finding Flexibilities in the Federal Regulations:  Advanced Considerations and Applications.  The presenters, Lois Brako, PhD; Moira Keane, MA, CIP; and Irene Stith-Coleman, PhD, did a great job of bringing the attendees back to the text of the Common Rule and reminding us that there is not a “right” and “wrong” for every aspect of human subjects protections. It was reassuring to hear about areas where other institutions had found flexibility, and there were several great ideas that I was excited to share with my institution. On a broader level, the session reinforced the concept that, when searching for ways to improve efficiency, it is helpful to start with the regulations themselves. It is important to note not only what they say, but also what they do not say.

The Common Rule articulates seven criteria in 45 CFR 46.111(a) that must be satisfied in order for a research study to be approved by an IRB.  Sometimes, just realizing that I can count the approval criteria on my fingers helps bring all the nuances of the review process back into perspective. The rule doesn’t provide a list of documents that are required to show that these criteria are satisfied. It doesn’t say that each investigator must complete a 20-page questionnaire in order to demonstrate compliance.  There is certainly room to optimize the way we collect information to evaluate these criteria. It is easy to assume that more guidance, more standardization, and more clarification will make things better, but this session on flexibility was a good reminder that gray areas can be embraced as an opportunity to customize rather than feared as an opportunity for mistakes.

Are those seven criteria the whole picture? No, certainly not.  But they are a great place to start. It is helpful to realize that, even if the ANPRM never evolves into a final rule, we can still work toward a more efficient IRB review process.

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