Clinical Research Ethics Question of the Month: April 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 on a jury in a courtroom trial. The plaintiff is suing “everyone” for serious injuries received when she was hit by a car driven by the subject. The subject was in a clinical study of a medication that might cause drowsiness. A witness has testified that the subject appeared to be asleep at the time of the crash.

Who, if anyone, are most responsible for the plaintiff’s injuries? If you learned only that the plaintiff was jaywalking at the time of the crash, who, if anyone, are most responsible for the plaintiff’s injuries? To answer these questions and more, take the survey here.

The last question asked whether certain past actions unrelated to clinical research should disqualify a physician from conducting clinical studies. Respondents answered that child abuse, sexual misconduct, racist statement(s), and a business relationship with an unsavory government are the most serious offenses. On average, respondents believe that investment in a business that harms the environment, statements that an alien invasion is underway, and an investment in a business that treats workers unfairly are the least serious offenses. The full report contains more analysis of the survey results and a discussion as to whether professional achievements should be considered separately from a person’s personal failings; 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!