IRBs can teach researchers how to create informed consent forms, but perhaps what they most need are lessons in how to handle the consent process.
“In the past we’ve done training sessions on informed consent,” says Michele Antisdel, MBA, CIP, senior IRB regulatory analyst at Yale University Human Investigation Committee in New Haven, CT.
The sessions included common problems coordinators might have, how to notify subjects of significant new findings, and how to write informed consent forms.
“Those were very well received,” Antisdel says. “But what we were hearing from the research community is they wanted more training on how to actually consent subjects, and that’s where we came up with this training program.”
The consent consult program started out as a group of 15 people who had responded to an email about the new training session on consent. “We asked them to bring us one of their consent forms, and we’d work on it,” Antisdel says.
“It didn’t work very well because the so-called subjects were other study coordinators, so giving feedback didn’t work,” she explains.
So the IRB changed the training sessions to feature smaller groups of less than five people. Each person would provide one informed consent form in advance. This way, the consent consultants could become familiar with the forms and highlight the most important elements — all before the meeting took place, she says.
The training begins with the Belmont Report, including the principle of respect for persons, and discusses autonomy, comprehension, voluntary participation, and the informed consent process.
Then IRB trainers go over each person’s informed consent form, showing them the highlighted sections and the most important details, Antisdel says.
“We help them develop a checklist of things they can go over with the subject,” she adds. “We have a standard checklist with the required elements of consent.”
They also teach study coordinators the teach-back method. “Don’t make subjects feel like they’re being taught in school and are being tested,” Antisdel says. “Say to subjects, ‘Just to make sure I’m doing a good job explaining it to you, would you tell me what I’m talking about?’”
This method makes people more comfortable, she notes.
These small-group training sessions also include role-playing. “That’s when the fun starts,” Antisdel says.
“The trainers know the consent forms and for most studies we’re familiar with them anyway, so we would be the subject and start the role-playing,” she explains. “In taking on the role of the subject, we would ask interesting questions.”
For example, Antisdel once partnered in role-playing with a younger colleague, and they played parent and adolescent receiving consent for the teenager’s study participation.
“We did bantering back and forth,” she recalls. “As the mother of two daughters, it was easy for me to step into the role.”
They portrayed the kind of scenario a coordinator might encounter, including dialogue about what would happen if the daughter became pregnant while enrolled in the study. The “mother,” as portrayed by Antisdel, wanted to be told if her “daughter” became pregnant. But in their state, the law says the daughter is old enough to keep that information confidential.
“I was giving the investigator a hard time about it, but those are the kinds of things they have to think about when they’re consenting subjects,” Antisdel says.
IRB trainers also used the role-playing sessions to ask questions that reminded study coordinators of things they needed to mention during the consent process. For instance, maybe the study coordinator forgot during the role playing to tell the subject where to go for the study visit. The play-acting subject would then ask that question.
“Other things we do is act like we understood what’s going on when it was clear we did not,” Antisdel says. “We wanted to see if the study coordinator would realize we didn’t understand.”
They were able to trick the coordinators because one of the trainers has a different first language and would just nod her head when the coordinators were talking. “After a while, anyone could see that she wasn’t getting it,” Antisdel says.
The pretend subjects also asked whether they’d receive compensation for being in the study, asking this in such a way as to suggest that the compensation was more important to them than the study participation.
“The coordinators did pick up on that,” she says.
The consent consults were well-received by the research community. They resulted in some unanticipated positive outcomes. One was that study coordinators would return to investigators, saying the consent language was too complicated and they needed to make consent more clear for subjects. Going through the training session with the role-playing piece taught coordinators how important it was to understand the study — for both coordinators and study participants, Antisdel says.
“They don’t usually come back to us for another consult once they learn this,” she notes. “We have seen amendment requests come through to make the consent easier to read, and we’ve probably done this process with close to 100 people over a year.”