Research is changing IRB views about PTSD studies
Risks of harm may be less than previously believed
In the past, IRBs considering protocols that sought to survey or interview trauma victims had to essentially follow their gut when pondering the question: Would answering questions harm participants by causing them to relive their painful experiences?
In the past several years, many trauma researchers have honed in on the specific issue of trauma research participation, interviewing participants after the fact to see how the research affected them.1-3 The results could be illuminating for IRBs.
In general, their studies have shown that most participants did not feel they had been harmed by the experience. Even many who described themselves as being very upset during the study thought such research was valuable; only a small number reported regretting their participation. And in some cases, people reported feeling a personal benefit from having discussed a past trauma.
As more information becomes available about which trauma victims have more potential for harm, IRBs will have even more useful information with which to review such protocols, researchers say. It can help researchers draft more precise consent forms and underscore the benefit of strategies such as debriefings that may direct participants who need further help.
"Seven years ago, if I look back at my old consents, I think the language was much stronger, implying that people would feel upset," says Anne DePrince, PhD, an assistant professor of psychology at the University of Denver in Colorado. "And now, as we get a better handle on the literature, we can say, A minority of people may feel this way,’ or Some people feel X, some people feel Y.’ Empirically we’re starting to delineate that. I think it’s very exciting, the research that’s coming out, how it will help us down the road use really accurate and informative text in our consent forms."
Elana Newman, PhD, an associate professor of clinical psychology at the University of Tulsa in Oklahoma, says her work looking at the risks and benefits of participation in trauma-related research appears to be making in impact at the IRB level already.
"My stuff on research risk is probably the least cited and the most requested," she says with a laugh. "I get e-mails several times a month saying, Would you send me this information, I need to send it to my IRB’ or Help me — I’m trying to do this study and my IRB doesn’t understand.’ I think having evidence is compelling to many IRBs."
Distressing but useful
Some of the social-behavioral researchers who have focused on this area were prompted by their own difficulties getting IRB approval for projects involving trauma victims. For example, Newman says that a plan she proposed in the late 1990s to interview children who had been sexually abused was eventually turned down by her IRB.
"It became very clear to me in this engagement that people were making lots of faulty assumptions about what worked and what didn’t in the name of trying to protect adults and children," she says. "I came to it with this view that we really do need to protect people if they need protection but we don’t know anything."
Newman has written extensively on the subject, including a 2004 paper for the Journal of Traumatic Stress. The studies looked at trauma victims ranging from battered women to children hospitalized after traffic accidents to Vietnam veterans, Bosnian refugees and New York City residents in the aftermath of the Sept. 11, 2001, terrorist attacks.
Many participants in the various studies reported strong, even unexpectedly distressing feelings during their assessments. For example, a 2003 study of female survivors of domestic violence showed that 41% felt strong feelings during the assessment, and 2% were highly distressed while taking a paper and pencil questionnaire. Five percent of the total reported an unwillingness to be similarly assessed again.
But at the same time, many people reported (in surveys where the question was asked) that they saw usefulness to the questions and were glad they participated. Newman herself was one of the authors of such a study, which looked at more than 200 injured children and their parents. Using a Reactions to Research Participation Questionnaire (RRPQ) she and her colleagues developed for children and their parents, the authors found that 77.3% of children and 90% of parents interviewed felt "good about helping other people by being in this study." Fifty-two percent of children and 74% of their parents reported they were glad they had participated.
Jennifer Freyd, PhD, a professor of psychology at the University of Oregon in Eugene, studies victims’ memories of "betrayal trauma," such as childhood physical or sexual abuse. She says that victims of personal traumatic events such as those are more likely to experience distress in a research setting than victims of a large scale natural disaster or terrorist attack.
"For one thing, most people who experience shared events do have an opportunity to talk about it," she says. "And I think IRB members and researchers have a reasonable gut feeling that it’s not as big a deal to talk about it as it could potentially be to talk about something that you’ve never talked about before."
Freyd says that while it may not matter how long ago the trauma occurred, a person is less likely to be upset if they have already had a chance to talk about it, in therapy or some other forum.
"Something could have happened 30 years ago and really not been dealt with and so it can be a crisis for people," she says. "What’s interesting is that for a lot of people it’s a kind of welcome crisis, in a sense. If they hadn’t gotten the chance to talk about it and they get asked and they’re in a position where they’re strong enough, it often leads to positive change for people," she says. "They’re relieved to finally get to talk about it and they seek other people — whether it’s friends or therapists to continue to process it. It’s not necessarily unwelcome even to get agitated about it."
One study Freyd has done with college students suggests that questions about personal trauma weren’t seen as any more troublesome than other highly personal questions, such as a student’s GPA, SAT score or personal body image.
"The students didn’t find questions about say, sexual abuse, more problematic than those other kinds of questions," she says. "And furthermore, they said it was more important that we ask them."
In fact, Freyd and others say that not asking about traumas such as child abuse may carry its own costs, at a personal and societal level. "It communicates that material is not speakable or not important," she says. "It seems an awful lot like the general problem we have of silence around these events that seems to contribute to their occurrence."
Freyd says she’d like to see IRBs look at protocols with an eye toward what is not being asked, as well as what is. "If they’re working in domains where it might be natural [to ask trauma-related questions], then why is this being left out? And what impact is this having on the participants?"
IRB’s understanding changes
Juliana Kyrk, IRB program officer for the University of Oregon, says her IRB has benefited from a close working relationship with Freyd. She says that when Freyd and other researchers first began submitting proposals for post-traumatic stress research, the board always gave it full review.
"We looked at it like, Oh my goodness, think of what happened to these poor women, and we’re bringing up all these issues,’ so we always full-reviewed it," Kyrk says.
But as Freyd’s research progressed, and members began to deal with the related issues more often, they became more comfortable with them. "We ended up putting her on the committee and as a result, we started getting more interaction with her and her ideas," Kyrk says. "We benefited from that because she heard our concerns and we heard hers. She could hear what we were concerned about — we were very clear that these participants needed to be debriefed appropriately, and that they always leave these sessions feeling as good about themselves as when they came into them," she says.
Kyrk says that when the committee saw feedback from women about how they felt about the sensitivity of the questions, members began feeling comfortable giving studies like Freyd’s expedited review.
She says some issues still raise red flags that a study should have a full review. For example, studies that involve an intervention or manipulation of participants would go before the full board, as opposed to research where participants are simply filling out a survey. Studies that target a potentially vulnerable population would receive closer scrutiny as well, Kyrk says.
After her early difficulties getting her studies through an IRB, Newman went on to become a member of the board. Even before that, she says, she made a point of going to the IRB to educate them about her work. "We sort of collaborated," she says. "I sort of educated them some, and they educated me as well."
Kyrk describes a similar process. Kyrk says an IRB seeking to understand this issue better should invite researchers to sit in on the meetings where the board discusses their concerns. "You can understand the skills and the knowledge of the researcher and what they consider the risks to be," she says. "When the IRB may be totally naïve regarding that type of research, then at least it gives them some information that helps them understand how that works."
Kyrk notes that Freyd would give the members articles as new information came out about the risks of trauma research, and adjusted her own studies to gather more information about those risks to help address IRB concerns.
"In the end, it elevated her research in that regard because she presented both sides of the situation."
References
- Newman E, Kaloupek DG. The risks and benefits of participating in trauma-focused research studies. J Trauma Stress 2004; 17(5): 383-394.
- Kassam-Adams N, Newman E. Child and parent reactions to participation in clinical research. Gen Hosp Psychiatry 2005; 27(1):29-35.
- Becker-Bease KA, Freyd JJ. Research participants telling the truth about their lives: The ethics of asking and not asking about abuse. American Psychologist. Publication pending, April 2006.
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