Clinical Research Ethics Question of the Month: August 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 scenario:

You are the chief human research protections officer at a prestigious academic medical center (AMC). You have just discovered that two doctors on your staff have been secretly conducting a clinical study on their patients. The doctors have broken every rule in the human subjects protection book. They did not even tell their patients they were in a clinical study, and some of them died. The president of the AMC has called a meeting this afternoon where you will have to explain the situation and make your recommendations. What a nightmare! To complicate things, it turns out that the study treatment is an astonishing medical breakthrough that can save thousands of lives. The doctors want to submit a paper to a major medical journal by the end of the week. A Nobel Prize could be in order.

Is it unethical to base future medical treatment on this work? Will you recommend contacting law enforcement authorities for prosecution? To answer this question and others, take the survey here.

Last month’s question posed readers with a hypothetical situation in which they were reviewing a study on the effectiveness of placebo “treatments.” According to the investigators’ protocol, the placebo pill will be presented as a “booster” to their current treatment — not a placebo. The results of the survey were mixed, with 43% of respondents voting to approve the study and 39% rejecting the study. The full report goes into more detail about the effects of placebos and the ethical concerns surrounding deception studies. 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!