13
Apr2018

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 chairperson of a central IRB overseeing a large phase 3 study. Based on an anonymous call, you determine that one of the investigators is not accepting homeless people who want to enroll in the study.

What should your policy be for participation by homeless people in clinical studies? What reasonable steps, if any, should the investigator make to accommodate homeless people? To answer this question and others, take the survey here.

Last month's question posed readers with a hypothetical situation in which participants in a study of three diabetes medications actively discuss the study on social media; the investigator believes that these social media posts impact enrollment, adherence, and retention in the study. Respondents were presented with a number of questions about how to respond to various social media behaviors by study participants. Overall, the most popular responses were to explain the issue with the problematic social media posts, monitor the posts, and ask participants to stop. The full report further delves into the complex issues involved when study participants discuss the study on social media and provides ideas for how to mitigate the impact of social media posts or to use social media to the benefit of the study. 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!

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