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 principal investigator/owner at an independent clinical research site that is struggling financially. The first person you enrolled in a cardiology study had a serious stroke after one week in the study. The person had no history of strokes or related conditions. After unblinding, your SAE report to the very large CRO identified the study drug as causation. After a heated discussion, the CRO’s medical monitor says he will “overrule” your conclusion and report the SAE (on your behalf) to the IRB and FDA with unknown causation. To prevent further issues, the study will be closed at your site.
Should you tell somebody about the situation? You have no other information to make your decision and no clever way to dodge it. Read the full question and give us your answer.
Last month's question required you to choose a new IRB member from six qualified people. The "Community Leader" was the most popular choice, for the following reasons:
- Should be well-versed on community demographics, cultures, perspectives and priorities.
- Is likely loyal to the segment of the community he or she leads.
- Is likely to have a wide network of contacts from which to obtain input.
- Could help the community learn about clinical research.
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!