[Elizabeth Yeater, Geoffrey Miller, Jenny Rinehart, and Erica Nason. "Trauma and Sex Surveys Meet Minimal Risk Standards Implications for Institutional Review Boards." Psychological Science (Published online before print May 22, 2012), doi: 10.1177/0956797611435131. h/t Michelle Meyer.]
The authors, all affiliated with the University of New Mexico's Department of Psychology, found that their IRB's fears about such reactions was leading it to impede research:
The IRB at the University of New Mexico has expressed many concerns about the use of [college students] in research that is judged as exceeding minimal risk (e.g., trauma and sex surveys). The IRB's primary concern is that college students may experience extreme distress or be harmed as a result of participation. IRBs also have assumed that the risks involved in asking questions about such topics are greater than the risks for ostensibly more benign measures (e.g., cognitive test questions). Thus, such "sensitive" questions require special protection of participants and a full rather than expedited review. Such assumptions, though unsupported by data, have delayed and derailed research projects at the University of New Mexico and have dissuaded researchers from studying "sensitive" topics that allegedly present greater than minimal risk.
Though they could (and do) cite several studies showing that "participation in trauma research does not cause long-term harm," the authors could find few explicit comparisons between allegedly sensitive questions and other topics. So they administered questionnaires to 504 undergraduates and compared reactions to those concerning trauma and sex with those taking cognitive measures.
They report that
The standard definition of minimal-risk research is that the probability and magnitude of harm or discomfort anticipated in the research are not greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations. Our first three findings show that the trauma and sex surveys were no more distressing than the routine psychological tests used in the cognitive condition. Furthermore, even the handful of participants indicating some negative emotions were no more than mildly distressed, so these surveys could be considered as posing minimal risk by that criterion. Our fourth finding shows that participating in the trauma-sex condition was less distressing than many stressors experienced in daily life, so it could be considered as presenting minimal risk by that standard. Our fifth finding shows that the trauma-sex condition was reasonably benign even for sexually victimized women, who might be expected to be especially vulnerable.
They therefore conclude that "many IRB committees have systematically underestimated the maturity and resilience of 21st-century adult research participants, such as college students."
These findings are consonant with other findings that trauma-based research is less risky than imagined.
Missing from the article is an indication of whether the UNM IRB was already familiar with the previous literature on the issue. If so, will one more study, even one enrolling as large a population as this, make a difference? If not, what would it take to get IRBs to base their decisions on evidence?
Note: The article states that "participants were 504 undergraduate men and women recruited from the psychology subject pool at a large Southwestern U.S. university." Since all the researchers work at the University of New Mexico, and the article seems designed to rebut assertions by the UNM IRB, how seriously are we to take this anonymizing?