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 scenario:

You are on a committee tasked with advising the FDA on whether certain past actions unrelated to clinical research should disqualify a physician from conducting clinical studies.

How serious does a past action have to be before it should disqualify a physician from conducting clinical studies? To answer this question, take the survey here.

The last question posed readers with a hypothetical situation in which a study site has enrolled study participants who, because of inconsistent blood flow to their brains, have inconsistent cognitive ability. Sixty percent of survey respondents reported that they would have considerable concern about the situation. Fifty-eight percent of respondents recommended that the IRB require an authorized representative to be present for and approve any risky activities in the study, and another 58% recommended that the IRB require periodic reconsent when participants are known to be cognitively competent. The full report contains more analysis of the survey results and a discussion of whether and when intermittent cognitive incapacity interferes with subjects' abilities to protect themselves. It is available 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!

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