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 the chairperson of an IRB overseeing a study comparing three diabetes drugs. Some of the study participants have been talking about the study on social media. The investigator believes their posts have affected study enrollment, adherence and retention.
How should the investigator deal with study participants who are sharing their study experiences online? To answer this question and others, take the survey here.
Last month’s question posed readers with a hypothetical situation involving reviewing a study on a new drug for the treatment of stress. One exclusion criteria in the study’s protocol is anyone who is “educated or employed as an attorney,” with explaining that the study sponsor had been sued several times before by attorneys who were study subjects. Respondents were overwhelmingly opposed to this exclusion criterion; 92% replied that they would not approve the study. Those who responded did point out that certain professions could be rightfully excluded from certain clinical studies, including health professionals with knowledge that may cause bias or people whose professions may leave them vulnerable to possible side effects. The full report further examines legitimate reasons for exclusion and the regulations and ethical guidelines surrounding exclusion criteria. You can read 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!
On Exclusion of Attorneys:
The Belmont Report states “An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly…” In the described study there is no known benefit to participants receiving the as yet unproven drug. Additionally, those exposed to the new drug could be harmed by such exposure. That’s what clinical trials are all about.
Therefore, the Belmont Principles, as defined, do not apply.