Psychological association seeks to ease problems between IRBs, researchers

Communication is a two-way street

A special task force of the American Psychological Association studying the tensions between IRBs and psychology researchers has released a list of recommendations on how to address those tensions.

IRB members bracing for an angry denunciation of their work may find themselves pleasantly surprised.

While the committee does note complaints about IRBs overreaching and misunderstanding the nature of behavioral research, it also asserts that psychological researchers should do a better job of understanding IRBs and calls for collaboration to achieve the common goal of improving protection of research subjects.

"IRBs and psychologists who are doing research both have exactly the same goals in mind," says Thomas Eissenberg, PhD, associate professor of psychology at Virginia Commonwealth University in Richmond, VA, who served as the chairman of the APA Presidential Task Force on Institutional Review Boards and Psychological Science.

"They want to protect participants and they want to see the highest quality of research completed at their institution. That means they're on the same side. What we ought to be doing is working together to make sure that we protect participants as effectively as we can while maintaining the highest quality of science as we can. And we can do that if we work together in a collegial way."

The task force made five major recommendations to the association, focusing on helping each side understand the other better and working together to provide evidence-based IRB policies on how to best protect participants in psychological research.

"I think a lot more research has to be done about what the problem is and what the potential solutions are and whether those potential solutions are likely in fact to improve the problem," Eissenberg says.

Presidential interest

Eissenberg says he was drawn to the IRB project by his work on the APA's Committee to Advance Research (CAR), which handles a range of issues involving responsible and ethical conduct of research.

He says the association's 2007 president, Sharon Stephens Brehm, PhD, named IRB issues as one focus of her presidency, and discussed the matter with the CAR.

"She identified this tension as being important amongst her constituency, and she decided to appoint a presidential task force on IRBs and psychological science," Eissenberg says. "Because I was involved with the CAR discussions so much, I got nominated to chair the committee."

Eissenberg came at the issue not only as a psychological researcher but as a member of VCU's IRB. He says his experience with the board has generally been a good one but like other behavioral researchers, he's heard horror stories about out-of-control IRBs making unreasonable demands.

"My perspective was that I know it can work, I know we can review research in a way that preserves collegiality between the reviewers and the person who wrote the protocol being reviewed," he says. "But it doesn't seem to be happening as often as it might. My viewpoint was how do we make it work better?"

To better understand the problem, Eissenberg and the other task force members attempted to collect data on the extent of the problems facing psychology researchers. How often were they turned down by IRBs? What were the areas of research that seemed to raise the most ethical questions?

What they found were a lot of anecdotal stories, but little hard data, he says.

"There wasn't a lot of systematic data collection, and in places where there was some systematic data collection, it seemed that the anecdote was isolated, and the general impression (of IRB/psychological science dealings) was positive," Eissenberg says."And with some of these anecdotes, I wonder to what extent the story we hear now meshes with the story that actually happened, because the stories tend to get blown out of proportion year after year and they're the same anecdotes that get trotted out," he says.

Inherent flexibility

Based on his own experiences, Eissenberg says he believes that when IRBs and psychological researchers clash, the problem usually isn't the regulations themselves, which he finds to be quite flexible, but the interpretation by individual local IRBs.

"The flexibility inherent in the regulation isn't being applied as effectively as it could be," he says. "For instance, we've heard of some institutions that don't allow exempt review — it just doesn't occur at that institution."

Eissenberg says such a policy would be particularly burdensome for psychological researchers, who often do studies that would fall under an exempt review category, such as surveys that don't contain sensitive information, and whose data are never linked to individuals.

Requiring those investigators to go though unnecessary full board reviews and annual reviews following that can lead to tensions, he says.

"Because it seems like — and in fact according to the regulations what it might be is — meaningless paperwork that doesn't protect anybody."

Eissenberg also believes that there's far too little interaction between IRBs and the researchers whose work they review. More communication between them could head off problems before they escalate, he says.

When reviewing protocols on his own IRB, he often seeks out the researcher to ask questions or raise concerns.

"The first thing I do is pick up a phone and call the investigator and say, 'Here's my reading of what you want to do and I'm not comfortable with it,'" Eissenberg says. He engages the researcher to help him understand the protocol in a way he is comfortable with, and takes that information with him to the full board meeting.

"If I can work it out in advance, then I can just go to the full board and say, 'OK, I had this concern, it was addressed by the PI and now I'm comfortable and we can move on.'"

Eissenberg says there are not enough instances of IRBs making that kind of outreach attempt — or of investigators questioning an IRB's concerns in a collegial way.

"From an IRB member's perspective, we get caught up in regulations a lot and we sometimes forget that there's a researcher on the other side, who desperately wants to protect their participants and wants to do great science and just needs some help working through the regulations," he says. "We get so focused on the regulations that we forget to work with the other person."