Consent, confidentiality key in PTSD research
Spell out what will be asked, and who will see it
While recent studies have shown that interviews with trauma victims may not cause serious harm, and in fact can be beneficial, there still are serious issues surrounding asking people about such sensitive, personal experiences.
Those who deal with this type of research say IRBs should pay close attention to key issues surrounding what participants are told about the research and its confidentiality:
• Detailed consent forms. Always prepare participants. Consent forms should spell out explicitly what types of questions will be asked so that participants aren’t confronted with anything unexpected.
"They have to be told that they’re going to be asked very sensitive and personal questions about their personal life," says Juliana Kyrk, IRB program officer for the University of Oregon in Eugene. She notes that questions about sexual trauma, such as rape or child sexual abuse, should specifically state that the questions will not only be personal, but of a sexual nature.
Many IRBs require language in the consent form stating that a participant may find the questions upsetting. Researchers say that as more information becomes available about participants’ reactions, they should strive to include more information in consent forms.
For example, in her research with victims of post-traumatic stress disorder, Elana Newman, PhD, an associate professor of clinical psychology at the University of Tulsa in Oklahoma, found that some participants were more distressed by the research than they had expected to be. So she often puts that in her consent forms: "We have found that many people underestimate how distressing this might be."
She still hesitates to suggest in consent forms that the participant might benefit personally from discussing his or her past trauma, but she says she talks to the participant about that possibility.
"After they read the consent, I say there are a couple of things that we know so far," Newman says. "We know that people who have post-traumatic stress disorder may underestimate how emotionally taxing this is. And that a lot of people find that talking about this stuff is very beneficial, but you need to make that decision."
• Confidentiality. Researchers say it’s vital that victims of trauma understand under what precise circumstances their information will be revealed.
In many states, researchers are bound by law to report to authorities when they learn of an instance of child abuse or other ongoing danger. This makes promises of confidentiality tricky. For example, if an adult describes past sexual abuse in a household where there is another child at risk, what does the researcher do?
What’s key, says Jennifer Freyd, PhD, a professor of psychology at the University of Oregon, is that the participant understands what will trigger a mandated report, and what won’t.
"You can err in either direction," she says. "You can lead participants to feel they have complete confidentiality and then turn around and tell somebody [or] participants can feel that they’re telling you something, and you are going to do something about it. You also have to make clear when you’re not going to tell somebody."
Freyd handles that issue in her debriefings, giving participants information about where they can go to report a crime or seek further help. She says this isn’t just an issue in trauma research. Many psychological studies employ a standard tool for assessing depression that asks about suicidality.
"Let’s say a participant writes down that they’re very suicidal. What’s the researcher then going to do? Are they going to break confidentiality or not?" Freyd says. "You can justify either one, but what you need to do is warn the participant before the fact which way it’s going to go."
• Staff training. Freyd says the graduate students who run most of the studies involving the University of Oregon’s psychology student pool get training through local community organizations that manage people in crisis, including a battered women’s shelter and a sexual assault services organization.
"They offer very good training," she says. "And our graduate students are often in the clinical psychology program, so they’re getting training in being therapists."
Freyd says she’s never had a research subject suffer a severe reaction during a study. "We have had some people who have hung around afterwards and clearly needed to talk to somebody, but we’ve never had a case where somebody just fell apart," she says.
Ironically, it has happened to her a number of times while teaching — a student has broken down while discussing the topic of trauma or viewing a film. In those cases, she says, she makes sure the student is physically walked to a counseling center to get help.
She says that the issue of staff training becomes even more important if the study involves any kind of feedback to a person talking about trauma.
“I do think if it’s an interview format, an IRB should look closely at this,” Freyd says. “You could really do some harm by giving negative feedback. If somebody says they were raped and the interviewer says, “Oh well, it was long ago, you should be over it by now,’ it obviously could do damage.”
• Debriefing to assess distress. At the University of Oregon, any study involving the student psychology pool must provide a debriefing afterward that asks students about their research participation and provides them with resources in case they need counseling or other follow-up help.
Newman, who also uses debriefings in her work, says she would hesitate to recommend that an IRB require it of all trauma studies. But she does note that there are certain subsets of participants who may be more likely to be highly distressed by research participation — very old and very young people, those with multiple traumas or special vulnerabilities.
“If there’s a real, founded concern about exceeding minimal risk, then that might be a good compromise to recommend as a way of assessing and facilitating research,” she says.
“I’m wary of saying they should require it. But I also see that as a good compromise when it’s unknown.”