IRBs rethinking approachto sexual abuse studies
Sensitive questions may do no harm
Some IRBs are beginning to change how they view the risks of asking sensitive questions of subjects in social-behavioral research studies. Just as the risk of biomedical studies is assessed according to previous studies and the literature, so should the risk of social-behavioral studies be based on evidence, they say.
"I think more and more people want to see empirical data about whether these studies are as risky as IRB members might think they are," says Grant Benham, PhD, IRB chair at the University of Texas Pan America (UTPA) in Edinburg, TX. Benham also is an associate professor in the department of psychology and anthropology at UTPA and the interim assistant dean in the College of Social and Behavioral Sciences.
"There's a general sense out there that it's retraumatizing victims of abuse to ask these questions," Benham says. "What does research show on the individual response to being asked such questions is it distressing to subjects?"
IRB members typically have relied on subjective factors when making decisions about risks posed by studies involving sensitive topics and questions.
"A lot of IRB members go into this with preconceived notions about how risky asking these questions can be," Benham says. "IRBs have a range of members with perspectives based on life experiences or hunches."
These same IRB members would rely on published studies and data when assessing risks in biomedical research, yet not hold their assessment of socio-behavioral research to the same standards, he notes.
"Everyone thinks they can provide input in socio-behavioral research, and that input might be based on hunches, not on empirical evidence," he says.
Socio-behavioral investigators contribute to this problem by failing to provide empirical evidence supporting their research approach.
For instance, one investigator submitted to the UTPA IRB a protocol that involved asking subjects questions on sensitive topics, such as prior trauma, Benham recalls.
"The researcher had not submitted data with the application on how risky the questions were," he says.
"As IRB chair, I wanted to know more about it myself, and I didn't want the IRB to rely on their personal subjective experience when reviewing this," he adds. "So I started looking at this in terms of what research was out there, and I came across articles that address this topic."
Benham then brought his findings to the IRB meeting and asked members to make decisions based on the data, as well as their own opinions.
Onus on the researcher
Although Benham did the legwork for that study, this is the type of literature search that investigators should do before submitting their protocols to the IRB.
"It really benefited the committee to see empirical data, and I've become a stronger advocate for the need to produce these data," Benham says. "The onus should be on the researcher to provide the information because, if nothing else, it helps his or her application."
Evidence is growing that studies that ask sensitive questions do not cause significant or lasting harm to subjects. For example, one study published in 2009 in the Journal of Child Sexual Abuse, found that research participants who had experienced childhood sexual abuse reported minimal discomfort with answering personal questions for research purposes.1
Investigators had included a warning at the beginning of the questionnaire, telling participants that the questions they are about to answer are very personal and they did not have to answer them, says Frederick A. Ernst, PhD, professor of psychology in the department of psychology and anthropology at the University of Texas Pan America. Ernst is the principal investigator of the aforementioned study.
"We looked at how they responded and whether they had opted out of answering the questions, and we found that they didn't opt out even when they showed significant discomfort to questions about how they felt about answering questions about sexual abuse," Ernst says.
Ernst and colleagues were investigators on a study that addressed the ethical implications of asking sensitive questions. Participants answered questions about past sexual abuse, fantasies about rape, homosexuality and AIDS, and suicide. Then they were asked about how distressful they found these questions.2
More than 50% of subjects said the questions did not cause them discomfort or distress, 44.9% said the questions caused some minor discomfort/distress, and 4.5% said they found a number of the questions quite distressing.
"We found that 6% of subjects said 'yes' that the questions caused them more distress than they'd experience in their regular lives," Benham says. "But what's important, and it can be confusing, is that none of the subjects who found the questions quite distressing found it more distressing than what they'd experience in their regular lives."
Risks and benefits
IRB members also should think about the risks and benefits ratio for this type of research.
"The idea is this is important research, and even though some subjects did respond to questions, saying they felt distress, most still felt the research was important and necessary, and they were glad to be a part of it," Benham says.
This is an important subtlety, he notes.
"Nobody is saying there isn't some stress to people being involved in the research, but they might still feel like it's a good thing to be doing, and they feel some value in it," Benham says. "In other words, they're not being used as some people fear."
Also, IRBs can help improve the body of literature on this issue by encouraging researchers to ask questions about distress at the end of their studies, Benham suggests.
"One researcher is about to do some work with prisoners, and we suggested to him that he collect data on how distressing this was for subjects and whether they felt coerced into participating," he says. "We don't make this a requirement for approval, but whenever I have the opportunity to recommend to researchers to collect empirical data on this issue, I certainly suggest this to them."
This approach increases the body of evidence on the risk of sensitive questions, and the field and IRBs benefit from their work, he adds.
For participants questioned about substance abuse, one issue might be their perceived confidentiality and privacy, Ernst says.
"The protection of privacy or confidentiality could be more of an issue than whether the person is traumatized by the question itself," he says.
Ernst and co-investigators addressed this concern in one study with a disclaimer that read: "While the survey includes some questions about illegal and taboo behaviors (such as drug use), none of your responses can be traced back to you."2
In another study, a researcher used electronic response pads where student participants punched in their answers to sensitive questions on a remote control device, comparing that data entry method with a traditional questionnaire, Benham describes.
"The goal was to see if people responded differently," he says. "Maybe they thought their responses would be more anonymous on the electronic device versus a questionnaire with their handwriting on it."
Investigators found no differences in how people responded, he notes.
"The more empirical data, the better judgments we can make," Benham says.
References
- Ernst FA, Salinas NI, Perez N. Brief report: attitudes about responding to survey questions concerning childhood sexual abuse by Hispanic female college students. J Child Sex Abuse. 2009;18:574-581.
- Benham G, Croyle K, Ernst F. Ethical implications of asking sensitive questions. Poster presented at PRIM&R's 2009 Advancing Ethical Research Conference, held Nov. 14-16, 2009, in Nashville, TN. Poster: 15.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content