Clinical Research Question of the Month: February 2018

In collaboration with First Clinical Research, each month we share a new question and accompanying anonymous survey, designed to encourage critical thinking about questions in clinical research and highlight discussion generated by the prior month’s question.

This month’s question:

You are a member of an IRB reviewing a Phase 2 study for cardozamine, a new drug for treating stress. One of the exclusion criteria in the protocol is: “Educated or employed as an attorney.” The cover letter on the application explains that the study sponsor has been sued on three occasions by attorneys who were study subjects, and does not want it to happen again. You have no other information to make your decision and no clever way to dodge it.

Will you vote to approve the study with this exclusion criterion? What profession(s), if any, could rightfully be excluded from certain clinical studies? To answer these questions, take the survey here.

Last month’s question posed readers with a hypothetical situation in which they had to decide whether or not to approve a study of a vaccine for Zika2, which recently emerged in Florida. The only prior studies discussed as evidence in the Investigator’s Brochure were conducted in Brazil with no regulatory committee approval, on a vulnerable population, and without informed consent. Survey respondents were divided in their opinions about whether to approve the study; 33% voted for approval because the Zika2 outbreak is a public health emergency, but 25% said that they would not approve the study without legitimate studies as evidence. The full report examines the ethical implications of setting a precedent by approving a study based on the results of past unethical studies. You can find the full report here.

The Question of the Month also appears on the IRB Forum. The IRB Forum is a robust community of IRB professionals engaged in an ongoing discussion of the latest issues and questions that arise for human subjects protections professionals. An account is free, and gives you access to an invaluable resource—the insight of your peers.

PRIM&R thanks Norm Goldfarb of First Clinical Research for allowing us to share this feature with our community!