Talking With Your IRBs About Risk: Show Them the Data

Say you want to distribute a questionnaire to trauma survivors in order to study coping mechanisms. Your IRB says to you, in essence, “Hmm, writing about traumatic experiences will be too stressful for the participants.” “Why do you believe it will be stressful?” you ask. The reply: “It’s a gut feeling” or “It’s common sense” or “We just know.” And then you’re asked to make changes to your study. Grrr.

We often hear cries for data, data, and more data when it comes to IRBs – data on how IRBs function; on rates of full, expedited, and exempt review; on how IRB composition affects outcomes, and on a whole host of other things. Data will theoretically make it easier to assess how well an IRB is doing its job and how it compares to other institutions.

One thing in particular that both IRBs and the research community have been clamoring for are data on risk assessment, especially on research in the behavioral and social sciences. The studies are growing in number, and Lorna Hicks, Associate Director of the Office of Research Support at Duke University, and Simon Whitney, Assistant Professor of Family and Community Medicine at the Baylor College of Medicine, have compiled a list of references you and your IRB can use to scientifically estimate how risky a particular topic or method can be. It will be of no surprise to behavioral researchers that many things non-behavioral scientists think might be harmful, such as writing about stressful experiences, don’t have long-lasting negative consequences. And now there’s a comprehensive resource to back that up.

Of course, this is not to say that all psychological science methods are risk-free. There are considerable risks revolving around confidentiality, direct vs. indirect benefits, etc., and the small minority of those who do suffer adverse risks in studies. But for some research, risk can often be overblown in IRB review. That said, IRBs have very little data to go on, so it’s only natural to expect them to side with their “gut feelings.” Well, no more. Use these references to start providing sound science behind risk assessment, and collect similar data at the end of your study! The more we can share, the better IRB review for the behavioral and social sciences will be.

Assessing Risk in Research in the Social and Behavioral Sciences*

Using Sociometric Measures with Children
Iverson, A.M., Barton, B.A., & Iverson, G.L. (1997). Analysis of risk to children participating in a sociometric task. Developmental Psychology, 33, 104-112.
Bell-Dolan, D.J., Foster, S.L., & Sikora, D.M. (1989). Effects of sociometric testing on children’s behavior and loneliness in school. Developmental Psychology, 25, 306-311.
Hayvren, M., & Hymel, S. (1984). Ethical issues in sociometric testing: Impact of sociometric measures on interaction behavior. Developmental Psychology, 20, 844-849.

Asking Questions About Behavior Change
Williams, P., Block, L.G., & Fitzsimons, G.J. (2006). Simply asking questions about health behaviors increases both healthy and unhealthy behaviors. Social Influence, 1, 117-127.
Fitzsimons, G.J., Nunes, J., Williams, P. (2007). License to sin: The liberating role of reporting expectations. Journal of Consumer Research, 34, 22-37.

Asking About Abuse and Trauma
Becker-Blease, K.A., & Freyd, J. (2006). Research participants telling the truth about their lives: The ethics of asking and not asking about abuse. American Psychologist, 61, 218-226.
The following studies are discussed in this article:
Binder, A., Cromer, L.D., & Freyd, J. (2004, November). What’s the harm in asking? Participant reaction to trauma history questions compared with other personal questions. Poster session presented in the 20th Annual Meeting of the International Society for Traumatic Stress Studies, New Orleans, LA.
Elliot, D.M. (1997). Traumatic events: Prevalence and delayed recall in the general population. Journal of Consulting and Clinical Psychology, 65, 811-820.
DePrince, A.P., & Freyd, J.J. (2006). Costs and benefits of being asked about trauma history. Journal of Trauma Practice, 3, 23-25.
Brabin, P.J., & Breah, E.F. (1995). Dredging up past traumas: Harmful or helpful? Psychiatry, Psychology and Law, 2, 165-171.
Smith, L.B., Adler, N.E., & Tschann, J.M. (1999). Underreporting sensitive behaviors: The case of young women’s willingness to report abortion. Health Psychology, 18, 37-43.

Additional Research That Evaluates Research Subjects’ Experiences
Cook, A.S., & Bosley, B. (1995). The experience of participating in bereavement research: Stressful or therapeutic? Death Studies, 19, 157-170.
Walker, E.A., Newman, E., Koss, M., & Bernstein, D. (1997). Does the study of victimization revictimize the victim? General Hospital Psychiatry, 19, 403-410.
Also look up the work of James W. Pennebaker, University of Texas, Austin.

*Compiled by Lorna Hicks, Duke University, and Simon Whitney, Baylor College of Medicine.

Observer Vol.21, No.2 February, 2008

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