You are the chairperson of a central IRB. You have learned that one of the sites in a study you oversee is achieving subject recruiting and retention rates far superior to that of other sites. An investigation has found nothing unethical or unusual about the site’s activities — the subjects just find the investigator’s personality irresistible. Read more
Scientists have created entities using artificial intelligence technology. These “betas” appear to have human-like intelligence and emotions so they could, for example, serve as companions for people who are lonely. The scientists want to conduct psychological experiments on them to improve their performance and reliability. While betas are not protected by human subjects protection regulations, the scientists have asked your institutional review board to review the ethics of the experiments anyway. Read more
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. Read more
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? Read more
In July of this year, the National Academies of Science, Medicine, and Engineering (NASEM) released a report titled, “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm.” It’s a comprehensive report that raises many important considerations and proposes a number of thoughtful recommendations on this very timely topic. I won’t be able to do justice to all of its details and nuance here. Instead, I’ll share what I take to be some key themes and takeaways, including for IRBs. Read more
