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Jun2018

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 a member of an IRB that is reviewing a diagnostic study for a new viral disease, PVD, that, in exactly 50% of those infected, causes Polaiteir dementia. The PVD virus has infected the entire population. Dementia does not evidence itself until age 70. If detected before age 30, it can be treated successfully. The experimental test is believed to be 100% accurate in identifying who will get dementia. However, it has the unique “quantum” effect of flipping the medical condition of the person tested. A person who would not have gotten dementia will leave the test and later get dementia, and vice versa. In other words, the test itself will cure 50% of those tested, and give dementia to the other 50%. The test can be taken only once. In either case, study participants will learn whether they have the condition, and can then plan their lives accordingly. In addition, results from the study will tell the researchers how to end the quantum flipping effect.

Will you vote to approve this study? How would changing the characteristics of the study affect your answers?

Last month's question posed readers with a hypothetical situation in which study investigators were not accepting homeless people who wanted to enroll in the study. Survey respondents came up with a number of reasons that an investigator may exclude homeless people from a study and a number of ways to accommodate homeless participants. The full report further delves into the complex issues involved in working with this vulnerable population. 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!

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One thought on “Clinical Research Question of the Month: May 2018

  1. Mary Riedford

    For the general population, I would not approve. If the protocol was proposed for a population whose underlying risk of having PVD was high, the risk benefit ratio would be easier to justify.

    Reply