Today and tomorrow, the National Academy of Sciences is hosting a workshop on revisions to the human-subjects regulations (the “Common Rule”), especially for rules on social and behavioral research. The workshop is being simulcast, and viewers can send in questions. Join us!
The most provocative presentation this morning, from my perch in the front row, was from Brian Mustanski, who studies adolescent health and risk behaviors–especially same-sex experiences. It’s an important topic to study because of the risk of HIV/AIDS transmission, among other things. But it’s tough for investigators to conduct studies on sex because the topic worries Institutional Review Boards (or researchers believe the topic will worry their IRBs). Sociologist Janice Irvine makes a similar argument in her survey of sex researchers.
Do IRBs need to be so worried? Mustanski and his colleagues asked the adolescents that they studied how comfortable the kids felt answering their sex survey. Around 70 percent felt either “comfortable” or “very comfortable” answering the sex questions–the implication being that it was silly for IRBs to think the questions posed more of a minimal risk. But his data also showed that 3 percent of the respondents felt “very uncomfortable.” He did not point out this finding, and so I asked Dr. Richard Campbell, another presenter, to weigh in on whether he would consider 3 percent to constitute a “large” or “likely” risk. Earlier Dr. Campbell had given a conceptual talk arguing that IRBs conflate the magnitude of risk with the likelihood of risk to participants. In answer to my question, Campbell said that making 2-4 precent of adolescents “very uncomfortable” would not constitute a large or likely risk, and so the research should go forward.
I imagine that IRB members of a more conservative bent would disagree–and this is the crux of the problem. In considering how to revise the human-subjects regulations, would it be more helpful to make the regulations more specific, for example by setting quantitative thresholds and standards that everyone would have to follow? Or would it be best to make the regulations more flexible? The regulations already give IRBs more discretion than they use. IRBs don’t use the flexibility in the regulations because they are always concerned about institutional liability. For IRBs, conversations about protecting human subjects from harm is simultaneously a conversation about protecting the institution from legal harm. IRBs would read surveys like Mustanski’s by seeing the few people who are uncomfortable rather than the majority of people who were entirely comfortable. Why? Because it only takes one lawsuit.
Is this regulatory contradiction too big for NAS? The debate in Washington continues.