Science Directions

For those of us who do research with human participants, institutional review boards (IRBs) represent an integral component of the research enterprise. IRBs were created to ensure that researchers and their institutions pay careful attention to protecting the safety and welfare of study participants. When they work properly, IRBs provide an important set of safeguards.

Yet, it seems that a frenzy is building over the behavior of many IRBs. Increasingly, we hear horror stories about IRBs that are imposing incredible burdens on researchers, creating bureaucratic nightmares and otherwise hindering the progress of research. Many are charging that, rather than protecting the safety and welfare of research participants, IRBs have become too focused on protecting their institutions from exposure to liability or bad press.

Understanding the problem

Before we get carried away, we need proof that a problem exists and a deeper understanding of its nature. We need to look beyond the sensational stories and anecdotes. Along these lines, several recent approaches are worth knowing about.

The National Academy of Sciences issued a report in 2003 titled "Protecting Participants and Facilitating Social and Behavioral Sciences Research." The report offers a contemporary and balanced perspective, both on the role of IRBs in human research and the problems associated with them.

In November of this year, the Center for Advanced Study at the University of Illinois released a white paper titled "Improving the System for Protecting Human Subjects: Counteracting IRB 'Mission Creep.'" The white paper (available at www.cas.uiuc.edu) summarizes the work of a group of ethics and IRB experts, and offers valuable perspective on what is happening with the structure and functioning of IRBs. One of the problems, according to the report, is that many IRBs are taking on responsibilities that interfere with their main mission of protecting research participants.

Some point the finger of blame at university administrations, who are accused of using IRBs to protect their institutions from lawsuits and bad press. If this is the case, it represents a major failure of universities to support and enable the research of their faculty. Everyone wants to make sure that human participants in research are treated with respect, beneficence and justice. When they work as intended, IRBs help researchers achieve this goal. When they get saddled with other responsibilities, IRBs can no longer be ensured of achieving the goal, and they impose burdens that get in the way of research progress.

What is APA doing?

Many people ask what APA is doing about this. The Science Directorate already supports an office for research ethics and regulation (Science and Research). It is an area that we have targeted for growth at APA, mainly in response to concerns in the research community that many IRBs are creating inappropriate difficulty for researchers.

One area in which APA is devoting attention is developing guidance for researchers and for IRBs. For example, the federal regulations specify that expedited review procedures apply for certain kinds of research involving no more than "minimal risk." The problem, of course, is that IRBs interpret minimal risk in different ways; there is no uniformity or strong guidance on this. APA convened a workshop last spring, bringing together experts from research ethics, IRBs and federal agencies to build some consensus on how to guide IRBs in defining minimal risk. The result will be a procedure that IRBs can use in making minimal risk determinations. This particular problem is only one aspect of the current concern with IRBs, and clearly similar and continuing efforts will be needed to make the system work better.

Another area in which we are focusing attention follows from the recommendations of many of the recent reports-a call for empirical research on the problem. We know very little about how IRBs around the country operate, what they demand, what procedures they classify as minimal risk, and so on. As scientists, we need to be approaching the problem systematically and empirically. We hear sensational stories, but we need to be careful to ground the vivid, attention-grabbing examples against the true base rates.

For the social and behavioral sciences, institutional review boards represent an important infrastructure. We all need to play a part in making them work, and work well. We need to take ownership of IRBs, and we need to make university administrations understand that the success of their faculty depend on well-functioning IRBs.

The challenge right now is the absence of a nationally focused cohesive approach to the problem. Grassroots efforts are moving us in the right direction. Now is the time to take these efforts to the next level. The APA Science Directorate will help.