Information Relevance for Informed Consent to Clinical Trials: Patients, Advisors, and Clinicians

This dissertation investigates patient and advisor information preferences regarding informed consent for clinical trials, and provider understanding of those preferences. The revised Common Rule requirements and their focus on identifying key information in consent make such investigation especially timely. This dissertation extends the literature on these topics by including, along with legal surrogates, advisors who lack legal decision making authority (“pure advisors”). Study 1 replicates and extends previous work by using patients’ and advisors’ choices of relevant information from a consent form to shorten the form. The results indicate that this produces a substantially shorter form that is broadly similar across groups, while also highlighting some ways in which surrogates’ preferences seem to diverge from those of patients and advisors, in that they choose less information from the original form and feel somewhat more negatively regarding trial-related decisions. Study 2 tests the shortened form against the original form, and finds that the revised form does not cause decreases in trial comprehension or engagement. However, participants, particularly surrogates, seem to feel less positively toward the shortened form. This result and some stakeholder group differences in decisions captured in this study point toward the importance of both the status quo and group membership to interpretation of informed consent and the clinical trial process. Study 3 evaluates medical providers’ ability to predict patient preferences for informed consent content, and finds that while they tend to overestimate patients’ desire for many types of information on a sentence level, they have a better understanding of the general issues patients find important in clinical research enrollment, though there is some evidence for systematic misunderstanding. Extensions and applications of these studies have the potential to improve the informed consent process for all stakeholder groups discussed.