Executive Director's Column

IRBs, Again

APA is committed to understanding what is happening with IRBs, and to do whatever we can to support researchers and IRBs in developing better relationships.

By Steven Breckler, PhD

In the November, 2006 issue of Psychological Science Agenda, I discussed the IRB "problem," and suggested that a grassroots effort is needed to focus our collective attention on understanding and solving the "problem." It was not the first time I raised the subject. It won't be the last.

I invited readers to send me an email, describing both positive and negative experiences with IRBs. I heard from many people, and want to share at least a few of their perspectives.

Problem, What Problem?

One set of responses challenged the very premise of my comments - that there is a problem at all. Many among us have not experienced significant difficulty with their IRBs, and some even enjoy a very positive and constructive relationship.

It is important for all of us to recognize that the "problem" with IRBs is not universal. One concern, and the reason for my comments in November, is the possibility that only a small number of "problem" IRBs exist. If this is the case, they may represent little more than squeaky wheels grabbing the majority of attention.

We can look at this in two ways. For those who have the good fortune of working with a good IRB, don't assume that all IRBs behave this way. For those who have the bad fortune of working with a dysfunctional IRB, you too should not assume that all IRBs behave this way. What we need to do, and the action for which I was advocating in November, is get a handle on the true magnitude of the "problem."

Don't Call It a Problem!

Some readers took offense at my characterization of the issue as a "problem." If researchers have complaints about IRBs, these readers suggested that we need to understand the basis for those complaints, and whether the blame lies with the IRB, with the investigator, or somewhere else. But calling it a "problem" implies, perhaps inappropriately or prematurely, that the problem is only with IRBs, that it is widespread, and that something needs to be fixed.

Fair enough. Perhaps I should not presume that we have a "problem" with IRBs until we are able to establish, with little doubt, that a problem exists. Yet, listening to those who have complaints about their IRBs suggests that there is an issue with IRBs.

Some readers described unbelievable difficulties with their IRBs. Projects being delayed for months, revocation of approval because of inconsequential changes in informed consent forms, and IRBs challenging the scientific merit of protocols - even those that had already been reviewed by federal funding agencies and judged to be of the highest scientific merit.

If these reports were merely isolated incidents, occurring at only a handful of institutions, I would agree that we may not have a "problem" on our collective hands. But the reports are widespread, and come from dozens of institutions, reported by some of the most respected scientists in our field. To me, this qualifies as a problem.

Don't Blame IRB Members

Several readers chastised me for criticizing the hard work of IRB members. If my comments were taken this way, I sincerely apologize. One of the points made by most observers of the situation is that individual IRB members are not to blame. Instead, most instances of IRB dysfunction can be traced to the institutional context in which the IRB is operating - pressure on IRBs to serve roles that they are not meant to serve, and for which they are not designed.

I doubt that much of the IRB "problem" can be traced to individual members of IRBs. If we are to make progress in getting a handle on what is happening, we need to engage those who have first-hand experience serving on IRBs. Far from pointing a finger of blame at them, we need to engage them in the national dialogue.

Moving Forward

APA is committed to understanding what is happening with IRBs, and to do whatever we can to support researchers and IRBs in developing better relationships. APA President Sharon Brehm has created a task force to look at the matter. It met for the first time earlier this month, and it will meet again later in the year. The ad hoc Committee to Advance Research is focusing on the subject, and providing ongoing guidance to the Science Directorate in developing programs and identifying advocacy needs.

I am glad that so many readers took the time to respond to my earlier comments. Feedback is always welcome, and the fact that so many of us are willing to get engaged is a good sign that we can get to the bottom of the matter.