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Thursday, June 18 • 5:00pm - 6:00pm
#541 OD: ON DEMAND - Electronic Informed Consent: Global Perspectives

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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



Speakers
avatar for Jan Hewett

Jan Hewett

Regulatory Counsel for Policy, OSI, CDER, FDA
Jan Hewett is currently Regulatory Counsel (Policy) at the FDA (CDER – Office of Scientific Investigations). Before joining OSI, Jan served in various HRPP & IRB Director, Snr. Grants & Contracts and Clinical Research Nurse Coordinator roles at Yale University, University of Michigan... Read More →
avatar for Mika Lindroos

Mika Lindroos

Director, Product Management, eConsent, Signant Health
Mika Lindroos is the Director of Product Management and an eConsent expert at Signant Health, and he says he is most at home where technology meets humanity. With over 25 years of experience in software product management in the global environment, Mika’s breadth of experience spans... Read More →
avatar for Paula Walker

Paula Walker

Inspectorate Unit Manager, GCP/GPvP/ GLP and Lead Senior GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Paula Walker has been with the MHRA since 2009, joining as a GCP inspector, and subsequently moving to the role of Operations Manager for the GCP team in 2013. Paula is currently the Deputy Group Manager for the MHRA Inspectorate, and has been the Inspectorate Unit Manager since November... Read More →
avatar for Mika Lindroos

Mika Lindroos

Director, Product Management, Signant Health
Mika Lindroos is the Director of Product Management and an eConsent expert at Signant Health, and he says he is most at home where technology meets humanity. With over 25 years of experience in software product management in the global environment, Mika’s breadth of experience spans... Read More →


Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: R-D Quality-Compliance, Session |   03: Data-Data Standards, Session |   11: Statistics, Session