Clinical Research Ethics Question of the Month: October 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 member of an IRB reviewing a study with an unusual feature: Because the study population will be very diverse economically, the investigator wants to vary the stipend based on each study participant’s financial situation. Her reasoning is that a fixed stipend for everybody would exploit high-income people but unduly influence low-income people. For the purposes of this survey, the investigator knows everyone’s income.

Will you vote to approve this approach to stipends? What range of stipends would you find acceptable? Would you support varying stipends (not expense reimbursement) for any reason other than income? To answer this question and others, take the survey here.

Last month’s question posed readers with a hypothetical situation in which they were conducting a healthy volunteer study that requires an unpleasant and somewhat risky procedure. The first five participants were nuns who said that their primary motivation for being part of the study was altruism. Forty-six percent of survey respondents replied that they would promote altruism as a reason to enroll in the study and 54% would not. Most survey respondents would not attempt to determine the contribution of altruism to the potential study subjects’ motivation, with only 29% of them saying that they would make such an attempt. The full report discusses what altruism is and if it is something that should be encouraged in research participants, or if high levels of altruism are reasons that they should be protected. 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!