Clinical Research Ethics Question of the Month: May 2019

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 reviewing a study of a marketed drug for treating depression. Previous studies of this drug have shown minimal side effects. They have also shown a very high, enduring placebo effect. In fact, the symptoms of most study participants improved, regardless of whether they received the study drug or the placebo. This study has a twist: The goal is not to assess the efficacy of the drug, but to assess the efficacy of participating in a study of the drug. In other words, the study itself is the treatment under investigation.

Leaving aside the study design, do you consider this a legitimate research objective? Would you vote to approve the study? To answer these questions and more, take the survey here.

The last question asked readers to imagine a scenario in which a pedestrian was hit by a car driven by a study subject who appeared to be asleep at the wheel at the time of the crash. More than half of the survey respondents consistently felt that the study subject was responsible for the pedestrian’s injuries, except for when presented with a scenario in which study personnel did not discuss the drowsiness side effect with the subject during the consent process. In that case, 60% of respondents held the study investigator most responsible for the pedestrian’s injuries. The full report contains more analysis of the survey results and a discussion of the differences and the overlap between ethics and law. 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!