[Brian Mustanski, "Ethical and Regulatory Issues with Conducting Sexuality Research with LGBT Adolescents: A Call to Action for a Scientifically Informed Approach," Archives of Sexual Behavior, published online 29 April 2011.]
Mustanski is particularly conerned with research on lesbian, gay, bisexual, and transgender (LGBT) youth. Such youth, especially men who have sex with men (MSM), are at elevated risk of illness, especially HIV infection. But researchers have done relatively little to study interventions targeted at adolescent MSM. More generally, scholars' failure to study LGBT adolescents weakens "our basic understanding of diversity in the development of core aspects of sexuality, like sexual attractions and orientation, gender identity and expression, and romantic relationships."
Why this lack of research? Mustanski (a former IRB member himself) believes that IRBs are a big part of the problem. He cites studies showing that psychologists have modified or abandoned plans for fear of IRB rejection.
As he puts it,
It can be extremely frustrating to agonize over perfecting every detail of a protocol to only then have it repeatedly questioned by anonymous individuals who may not have the same subject matter expertise. The standard IRB approach of written correspondence with long delays can be exasperating and is not designed to facilitate a collaborative relationship between IRBs and investigators. Investigators may be disturbed by requirements to make protocol changes that they perceive as decreasing the quality of the science without apparent reduction in risks or increasing protections. Communication can sometimes be unclear and, if a board has limited experience with the LGBT community, questions may seem uninformed, insensitive, or even homophobic. Community partnerships may be strained by the need for investigators to comply with IRB mandates over the recommendations of community members with expertise in serving the target population.
Mustanski notes his own involvement on a project that was funded for two years; IRB approval ate ten of those twenty-four months. Among the problems:
- The IRB applauded portions of the application in one round, then found those same portions unsatisfactory in a following round.
- The IRB labeled LGBT people as a vulnerable population, despite the fact that federal regulations do not list them as such. Mustanski notes that the regulatory categories are based on groups' inability to make decisions based on cognitive disability or a lack of power. "I know of no evidence that demonstrates such decisional impairment" with LGBT people, he writes, "and I believe many LGBT individuals would be insulted to have it implied otherwise."
- The IRB required the consent process to include the warning that some questions "could make you feel uneasy or embarrassed" and that counseling services would be available. But 89 percent of those interviewed found the experience no more uncomfortable than "a typical visit to your physician, doctor, psychologist, or counselor."
To improve the chances of future research making it through the IRB with less difficulty, Mustanski offers a list of recommendations to investigators. Mostly he thinks that if investigators become expert in the empirical data about risks and benefits of their research as well as relevant federal and local laws and regulations, and offer to share that information in in-person meetings with IRB staff and the board itself, everything will be fine.
I do hope so, though I fear that these recommendations may overlook the power dynamic involved. I am reminded of the 2007 University of California Academic Council Report on Institutional Review Boards at UC:
The challenge of training faculty IRB members is exacerbated by the extreme time commitment of serving on the IRB. There is little time available to faculty to be trained on subject protection beyond the time committed to protocol review. Some campuses include training in the IRB meetings, devoting 5 to 15 minutes of meeting time to developments in subject protection. However, IRB staff report that when training is on the agenda of the IRB meeting, faculty members often skip that part of the meeting because they are so busy. Rarely is there funding to train faculty IRB members.Mustanski offers no mechanism by which IRBs would be required to deploy or even read the information he wants investigators to compile. For example, he could have endorsed the 1999 proposal of the Working Group of the Human Subjects Research Subcommittee of the National Science and Technology Council that:
In determining whether there might be a reasonable risk or damage related to divulging the sensitive information, etc., it is not enough that there be merely some hypothetical possible risk that can be construed. Rather, the risks resulting from disclosure must be readily appreciable and significant.Still, even a cynic can join a call for emprical data, which could be useful to researchers even if IRBs fail to do their homework. So my favorite recommendation is number three. Researchers should
help advance knowledge about the risks and benefits of participating in research by asking participants how they felt about their participation in your study. Publish the results so as to build a corpus of knowledge that will allow for evidence-based determinations about risks and benefits. As scientists, we are in a unique position to bring to bear our expertise in understanding how people respond in various situations and we should harness this expertise to help inform the IRB review process. Whenever possible, provide your IRB the empirical data about risks and benefits of sexuality research as they may be unfamiliar with this area.Whatever one's feelings about IRBs, empirical research on the risks and benefits of different types of research is good for everyone. In some cases, this will take the form of projects designed specifically to measure the risks and benefits of research; many articles in the Journal of Empirical Research on Human Research Ethics take this form. But Mustanski's experience suggests that researchers who do not set out primarily to advance knowledge of research ethics nonetheless can accumulate valuable data as a byproduct of their main endeavor, e.g., by asking a question or two about how participants felt about participating.
Gathering and publishing such information (even informally, as on a blog), could indeed contribute to Mustanski's goal of improving IRB review "by transforming it into an evidence-informed process." And even if it doesn't, researchers would be better able to make their own ethical decisions.
Mustanski ends his article with sample language that could be included in an IRB application for a study of under-18 youth where parental consent is not being sought. This follows Rena Lederman's call for IRB boilerplate. Of course, when someone actually tried Lederman's boilerplate for fieldwork, the IRB responded by insisting on its own standard procedures. Maybe it's the thought that counts.