IRBs that predominantly review biomedical protocols might find it less clear in determining risks when reviewing socio-behavioral research.
“Risk is much less obvious and clear-cut,” says Jeffrey Cohen, PhD, senior advisor at HRP Consulting Group in Lake Success, NY.
In working with IRBs since the late 1970s, Cohen has found that IRBs often misunderstand the concept of risk in socio-behavioral research. “In biomedical research, you have an intervention, certain side effects, and the biomedical risks usually are much clearer,” he says.
“With socio-behavioral research risks, while there’s rarely any possibility of physical harm, we’re talking about possible social and psychological harms that are not always obvious,” Cohen adds. “The implications for subjects are more subtle, more difficult to establish, and that presents a problem.”
Cohen offers the following example: “Years ago, at a university, we had a study where the researcher was going to interview subjects about normal child development,” he recalls. “The researcher was not going to ask about any kind of past trauma or abuse, so the study was considered minimal risk and received an expedited review from the IRB.”
The researcher began to enroll subjects, and, suddenly, an unexpected problem arose: Three of the first five subjects had acute emotional breakdowns.
“So we stopped the study and sent the questions he was asking to a child psychologist,” Cohen says. “The psychologist said, ‘The way you’ve worded the questions would trigger an emotional reaction in someone who had a traumatic experience as a child.’”
With that expert advice, the researcher reworded the questions and included a sentence in the informed consent telling potential participants that if they have had a traumatic experience as a child, then they might not want to be in the study, Cohen says.
“We never had another problem,” he adds.
This example highlights how subjective potential socio-behavioral harm can be. The investigator and IRB members lacked child psychology expertise and personal childhood experience with trauma; the study’s questions appeared innocuous to them, Cohen explains.
“That leads to another issue about unanticipated problems in social and behavioral research,” he adds. “Researchers have to be alert to what’s going on and how subjects are reacting to a study and know what to do if there is a problem.”
They might not be able to anticipate how people will react, but they can have a plan in place to help participants when something in a study does cause an adverse reaction.
Also, IRBs and researchers should keep in mind that adverse reactions to socio-behavioral studies might not occur immediately after the intervention as you would expect in biomedical research, Cohen says.
“Psychological and social implications can be delayed; they don’t happen right away,” Cohen says. “Psychological effects are subtle.”
The potential for a delayed reaction makes it especially important that the informed consent process emphasizes who a subject can call if he or she is experiencing a problem as a result of the study. The names and numbers listed on the informed consent form might also include a counselor’s contact information, Cohen says. “It might say, ‘After the study’s over, if you are having concerns about being in the study, then here’s who you should call.’”
It’s also difficult to anticipate and outline potential adverse effects in the informed consent form because some risks are ones that only the study participant can evaluate, he says.
“The informed consent should empower the subjects and give them enough information so they can decide for themselves what the risks are,” Cohen says. “One person could look at a given study and say, ‘This is fine.’ Another person could look at the same study and say, ‘I don’t want to be in this study.’”
When principal investigators submit a socio-behavioral protocol to the IRB, they should address the literature and what it has to say about risks involving similar types of studies, and IRBs should consider literature findings as well, Cohen suggests.
“They need to go back to evidence-based decision-making,” he says.
For example, in the 1980s, a number of studies focused on depression inventories, and IRBs sometimes would say that researchers couldn’t ask study subjects about suicidal ideation or those kinds of questions because it might push people over the edge, Cohen explains.
“But there has been quite a lot of research done that shows that not only did that problem not happen, that asking about suicide did not increase the risk, but that it was even beneficial,” he adds. “So our IRBs now would say about one of those studies, ‘OK, we’re not concerned about this.’”
Also, IRBs should pay close attention to the study’s subject population, Cohen advises.
“Risk is very much dependent on individual subjects, social situations, and psychological situations, so IRBs often need more information about who the subjects are going to be,” he explains. “Instead of just saying it will be 10 males and 10 females or ‘I’m interviewing college students,’ IRBs will need to probe more into who the subjects are before making a determination about how they’ll react.”
According to Cohen, the following are three chief points to keep in mind when reviewing a socio-behavioral study:
- Don’t assume you know what will trigger a reaction.
- Have a process ready to handle unanticipated reactions, including calling the principal investigator.
- Be aware that reactions can occur weeks or months later.
“This is about an IRB’s need to recognize that social and behavioral risks are not as obvious as medical risks, and so they should take care,” Cohen says. “Don’t overreact, but really look closely at the possibilities.”