Research consent differs from clinical consent in several fundamental ways, including the differing fiduciary responsibilities of the investigators, the comprehension necessary for subjects to make informed decisions, and the type of regulatory oversight. In addition, like clinical consent, research consent can take place in a variety of settings, some of which (e.g. high-stress settings, community settings, special populations) pose specific difficulties or challenges in terms of the aforementioned responsibilities, comprehension and oversight. This symposium will address quandaries in research consent where there are likely to be gaps in knowledge or controversies about the best approach. The topics that will address these gaps include new tools for research consent, methods to address consent comprehension, the unique aspects of consent in settings like special populations, high-risk settings, community participatory research and comparative effectiveness research, and the special challenges of training community partners to obtain consent and conduct research.
At the conclusion of this activity, participants should be able to:
- Identify novel or modified approaches to research consent appropriate to populations at high risk for poor comprehension
- Describe methods to measure consent comprehension among research subjects
- Design educational programs to help community partners conduct compliant research