Panel VI: The Conceit of Consent—What Does it Do and What Should We Ask it to Do?

Informed consent is deeply entrenched in human subjects research from both ethical and regulatory perspectives. There are also persistent issues related to length and complexity of consent forms. However, there are deeper questions about whether informed consent can bear the weight it is asked to bear from a human subjects protections perspective and how consent intersects with other important considerations related to justice and representation in research. It has long been recognized that understanding is suboptimal among many individuals who enroll in research studies, yet research has not been halted. What does this mean, and what should change? There are prominent efforts to increase diversity among research subjects, but increasing engagement with populations who have low health literacy will predictably raise challenges with regard to informed consent. How should this be navigated? Power differentials can complicate consent processes, and lack of trust may be significant. However, factors that help to facilitate trust and enhance respect may threaten some conceptions of autonomy. How should we balance what appear to be competing goals? This panel will address these questions.