Concurrent Plenary Sessions
Celia Fisher, PhD
Marie Ward Doty Endowed Chair in Ethics; Professor of Psychology; Director, Center for Ethics Education; Director, HIV and Drug Abuse Prevention Research Ethics Training Institute
The revised Common Rule includes several revisions to the requirements for informed consent, including the introduction of new terms, which focus on deciding whether or not to participate in research. The new provisions include the following: (1) “…information that a reasonable person would want to have in order to make an informed decision about whether to participate…” (.116(a)(4)); (2) “key information…to assist a prospective subject… in understanding the reasons why one might or might not want to participate in the research.” (.116(a)(5)(i)); and (3) “…information…organized in a way that…facilitates the…understanding of the reasons why one might or might not want to participate.” (.116(a)(5)(ii)). How will these provisions be operationalized? Does the informed consent form need to include every reason a person might use to make a decision? Are the reasons listed on the form what an average person would use to decide? Do research studies vary enough that a template approach won’t work? Some research institutions, and the Secretary’s Advisory Committee on Human Research Protections, have already begun to consider how to put these ideas into practice, and panelists will discuss their current thinking on this topic, and speculate about how the field may evolve.