Social, behavioral, and educational research (SBER) studies can sometimes reveal risks that are unanticipated and unimagined.
Handling informed consent for these studies requires an IRB and research team to be flexible and able to adjust quickly as issues arise.
“Ninety percent of our research is behavioral,” says Cynthia Monahan, MBA, CIP, director of Charles River Campus IRB at Boston University in Boston.
“With biomedical research, you identify the risk and make sure it’s appropriately told to subjects,” she says. “With behavioral research it’s not that easy. Sometimes there’s a behavioral intervention or some other type of interview where someone could become upset, so how do you quantify that?”
When reviewing SBER studies, IRBs need to know appropriate ways to handle these reviews and how to look for issues related to particular populations being studied, she notes.
For instance, if researchers are going to conduct a study involving a questionnaire that asks participants about past traumas, alcohol use, illicit drug use, or similar past behaviors and experiences, they should state up front about these questions in the consent, Monahan says.
“We require it to be right up front in the second section of what will happen in the study,” Monahan says. “We let people know up front that we’ll ask these types of questions so the subject can say, ‘It will be too upsetting, so I won’t be in your study.’”
When researchers are interviewing a vulnerable population — which often happens with SBER studies — they should inventory the resources they have in place to help participants when they’re upset, she suggests.
“We want to see that a licensed clinician is available to help them,” Monahan says. “This is easier if the survey is taking place face-to-face.”
For behavioral surveys and questionnaires online, there can be two impediments to handling problems as they arise:
• First, there could be a lengthy time frame between when the survey is accessed and when the study team is made aware of a problem. The solution to this issue is to make certain survey answers are reviewed fairly promptly so if a participant gave an answer about being upset over a question, the researcher will be able to follow up on that quickly, Monahan says.
• Secondly, surveys conducted online as not greater than minimal risk studies might be entirely anonymous, so investigators are unable to follow up on a participant’s written comments or responses about trauma unless the participant also took the step to call the IRB or research team.
Monahan knows of an example of that scenario playing out with a SBER study. “We had one study we reviewed that we thought was not greater than minimal risk, and we thought there was appropriate information about the study in the consent form,” she says.
Participants could answer the survey in a lab or online.
“One subject who did it online became so upset that the person contacted the investigator and contacted me,” Monahan says. “The person explained how the questions and photos were extremely upsetting.”
Immediately, the investigator put the study on hold, and the IRB took a second look at the study. The IRB also asked university faculty with experience in psychology to look at it, and they had the IRB re-review the consent form, she adds.
“We determined that the necessary information was in the consent form,” Monahan says. “One thing we always question is whether people read the informed consent.”
It appeared possible that the distraught participant had skipped over the informed consent language about the nature of the photographs that would be viewed. So the IRB and researcher decided that it would be wise to add a separate page to the survey that would remind people that some questions in it might be upsetting to them, she explains.
“After signing the informed consent, another page comes up,” Monahan says. “We had information in the risk section, so we put that same information back up.”
In this example, the IRB had waived documentation of consent because the study wasn’t greater than minimal risk, although there still was a consent document for people to read. The study involved asking people about how advertisements have changed over the decades, and so it involved viewing some ad photos and copy.
“The consent form had all of the required elements, and then people would click on a button that says, ‘I agree to participate,’” she adds.