DIA 2020 Virtual Global Annual Meeting

Component Type: Session
Level: Intermediate

Obtaining a participant’s oral or written informed consent is only part of the overall informed consent process. Informed consent involves providing a potential research participant with adequate information about the research to allow them to make an informed decision about their voluntary participation, and it must include a process that facilitates the research participant’s comprehension of the information and allows adequate opportunity for the participant to ask questions and consider participation. As clinical trial designs have become increasingly complex, informed consent forms have likewise become increasingly complex, technical, and challenging to understand. The use of electronic informed consent (eConsent) may offer multiple advantages by using a multimedia approach to provide consistent and complete information about the clinical trial to potential participants, by permitting testing to ensure participants’ understanding, and by facilitating discussions between research participants and site staff. Additionally, use of eConsent may introduce efficiencies in the trial conduct by improving overall management of the consent process. An industry 2019 eConsent Survey will be presented and speakers will provide views on use of eConsent from regulatory, industry and research participants’ perspectives.

Learning Objectives

Describe different stakeholder’s experiences and perspectives on use of electronic informed consent (eConsent) in clinical trials; Discuss potential benefits that may be achieved in the consent process with use of eConsent.

Chair

Jan Hewett, BSN, JD

Speaker

Informed Consent and the Emergence of eConsent: Global Perspectives and Challenges
Mika Lindroos, MSc

MHRA Perspective
Paula Walker, MA