Clinical Research Ethics Question of the Month: September 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 a physician at a Catholic hospital investigating a new treatment for a women’s health condition. This healthy volunteer study requires an unpleasant and somewhat risky procedure, so you do not expect to meet your enrollment target. The first five participants are nuns who say their primary motivation is altruism. What, if anything, should you do?

Would you promote altruism as a reason to enroll in the study? How much personal sacrifice (without personal benefit) should study participants be allowed to make? What, if anything, should you do? To answer this question and others, take the survey here.

Last month’s question posed readers with a hypothetical situation in which they the chief human research protections officer at a prestigious institution and discovered that two doctors were conducting a secret, highly unethical study on patients without their consent and some of them died. The study did lead to a medical breakthrough that would save lives. Majorities of the respondents agreed that the research misconduct would cause a great deal of harm to the institution and that the researchers should be dismissed and law enforcement should be contacted. Respondents made recommendations for how to handle the situation, which included issuing a public apology, reevaluating the HSP system, and reinforcing training programs. The full report delves into the nuances of this issue, including issues around publishing the groundbreaking study, notifying the research subjects, and more. You can read it 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!