Our thanks once again to PRIM&R’s Ampersand blog and to First Clinical Research for sharing some thought-provoking Questions of the Month with the IRB community.
February’s question addresses the exclusion from a phase 2 drug trial of a certain class of people, specifically people “Educated or employed as an attorney.” The drug in question is being developed to treat stress. A cover letter submitted with the application indicates the sponsor has been sued three times by attorneys who were study subjects, and doesn’t want that situation to recur. You have no other information to guide your decision regarding this study’s approval and no clever way to dodge the issue.”
We at IRB Blog Central know how we would vote on a study that included such an exclusion criterion. Hint: We’d think about the approval criterion relating to the equitability of subject selection.
This link also describes the responses to the previous month’s research ethics question of the month, which involved an IRB submission a study of a vaccine for an imaginary something called the Zika2 virus, recently noticed in Florida. The only prior studies discussed in the test article’s investigator’s brochure were done in a foreign country with no regulatory oversight or approval. Is this adequate, in your mind, to approve the study? If we add that a Zika2 outbreak is considered a public health emergency, does that change anything?