The Cost of Ethical Review, Part III: Hindering HIV Prevention

Risk-averse IRBs are hindering potentially life-saving research, write Brian Mustanski and Celia Fisher. “Critical advances in HIV prevention among AMSM [adolescent men who have sex with men],” they note, “have been impeded by the failure of IRBs to apply federal regulations permitting adolescents to self-consent to research without parental involvement.”

[Mustanski, B., & Fisher, C. B. (2016). HIV Rates Are Increasing in Gay/Bisexual Teens: IRB Barriers to Research Must Be Resolved to Bend the Curve. American Journal of Preventive Medicine, In Press. doi:10.1016/j.amepre.2016.02.026.]

To understand how to stop HIV transmission among teens, Mustanski, Fisher, and other researchers need to be able to talk freely with those teens. And the teens are often willing to talk, so long as they don’t need parental permission to do so. But most won’t talk if the researchers must get permission from their parents, and the minority who are willing to involve their parents are not representative of the larger group, thus skewing any sample and reducing the effectiveness of any intervention.

The IRBs that demand parental consent are ignoring expert guidance. More than ten years ago, Mustanski and Fisher note, the Secretary’s Advisory Committee on Human Research Protections recommended that these kinds of studies be allowed to proceed without parental consultation. I wonder how many IRBs are even aware of such guidance; recall Klitzman’s findings that IRB fears may not be “realistic or reality-based.”

In any case, these IRBs are jeopardizing the health and even the lives of America’s youth. As Mustanski and Fisher conclude,

IRB barriers to self-consent deprive AMSM of their right to participate in trials that will protect them from receiving developmentally untested, inappropriate, and unsafe interventions and is a clear case of scientific inequity driving health inequities. It is also an instance of losing sight of the forest for the trees. Study-by-study IRBs have sought to minimize risk to the institution and to AMSM participants by disapproving waivers of parental permission; in doing so, those individual decisions add up to a systemic injustice.