Empowering researchers, educating IRB members

Recommendations try to bring two sides together

The recommendations of the American Psychological Association's Task Force on IRBs and Psychological Science focus on giving IRBs and psychological researchers a better understanding of each other's methods and motivations, as well as generating more useful data about how the two groups interact.

Recommendations included:

Empower researchers. Help researchers engage with IRBs by educating them better about how IRBs work, what the regulations require, and how to deal with them in a collaborative, rather than confrontational way.

Task force chairman Thomas Eissenberg, PhD, associate professor of psychology at Virginia Commonwealth University in Richmond, VA, says this type of education would go well beyond the typical human subjects protection training most investigators receive.

"I think that is a very different educational exercise," he says. "What I'm talking about is what the regulations mean to the IRB, how they're applied by the IRB, and how your research can fit into those regulations."

Eissenberg says he believes that the regulations are extremely flexible, if looked at properly. If investigators understand that, they can better respond to IRB concerns, he says.

"If the IRB says 'No, you can't do that,' what an investigator needs to say is 'OK, that's important feedback — the way that I structured the protocol doesn't seem to fit your needs in terms of the regulations. Let's work together from my understanding of the regulations and your understanding of the regulations to see where what I want to do or some modification of it can be done.'"

Help IRBs understand psychological science. The task force recommended that the APA take more substantive steps to explain the risks and benefits of psychological research — particularly the risks, which often are not as great as IRB members may think they are.

"It's often the case even at my IRB, which I think is a great IRB, where one or two reviewers hear about a procedure in a psychological study and begin to worry about possible [adverse consequences]," Eissenberg says. "And when an IRB goes down that road, there's an opportunity to perhaps misidentify the probability of risk in a psychological study."

He says the APA could work with organizations such as Public Responsibility in Medicine and Research (PRIM&R) to develop IRB workshops on topics such as risk assessment, use of deception, and community-based participatory research.

Beyond that, Eissenberg says, there's an opportunity for the psychology research community to apply existing research on group decision making to the IRB process itself.

"We in psychology have studied how small groups make decisions and determine risk," he says. "What can happen, the research says, is that one person starts discussing a risk and another person agrees with that risk and then starts talking about the worst-case risk that can happen on a protocol and the whole IRB kind of piles on and goes down that path.

"What you can end up with is a biased process," Eissenberg says. "Chairs and administrators need to be aware of how small groups make decisions and need to be aware of how they can be biased in ways that are either too risk aversive or too risk tolerant."

Collaborate with IRBs to develop evidence-based IRB policies and procedures. Because of the lack of hard data on the IRB/psychological researcher divide, it's hard to know whether there are numerous instances of conflicts over protocols, or simply a collection of compelling anecdotes.

"We need to know more about how often these seemingly unjust reviews occur and whether there's a pattern and what surrounds them," Eissenberg says.

The task force suggested that the APA advocate for funding of studies of the issue, arguing that if there is a real breakdown in the relationship between investigators and IRBs, there are more chances not just for escalating tension but for regulations that don't get followed as closely as they might. We need to do some more research to figure out what the problem is and fix it."

Write scholarly articles. These articles should suggest models that might better accommodate behavioral research while still maintaining high standards of human subjects protection.

For example, Eissenberg says his own institution has set up a special exempt review panel to handle only exempt protocols.

"The panel in fact never meets, but all the exempt protocols go to those people," he says. "They're highly trained in determining whether something is exempt or not and because that's the only thing they focus on, the turnaround is extremely rapid. Also other panels who are looking at expedited and full board [protocols] aren't bothered by these exempt protocols."

He says other models of review may be even more effective, and calling scholarly attention to them could help make them more prevalent among IRBs.

Establish a continued APA focus on IRB issues. The task force recommended a continuing committee on the subject, to help implement the other recommendations, and to be a resource for researchers trying to navigate the IRBs.

"It seems obvious that this is a long-term issue," Eissenberg says. "There's going to be psychologists doing research for a long time and there's going to be IRBs for a long time. We need to continually watch this to see what we can do to improve the interaction between these two groups who have the same goals."