Recent empirical ethics work has elucidated how little prospective research participants rely on consent forms when they decide whether to enroll in research, but other elements of the recruitment and enrollment process lack the same degree of ethical scrutiny. A better understanding of how and when individuals make decisions about participating in research is needed to develop guidance for IRBs and investigators to ensure they are achieving the goals of the consent process. This session will examine empirical data about the timing of research decision-making, describe our growing understanding of how people process information and what they value in research relationships, and propose specific approaches to better support decision-making by refocusing ethical review outside of the consent form.
Describe empirical data demonstrating the relatively minimal role of consent forms in prospective participants' decisions about research enrollment
Examine our evolving understanding of how people make decisions and the implications for the role and relevance of consent forms
Identify potential approaches to demonstrating respect for persons and supporting decision-making throughout the research recruitment and enrollment process