Challenges Facing eInformed Consent

Applied Clinical Trials

An effective consent process in today’s clinical environment involves more than an informed consent form that meets basic regulatory requirements. As research and resulting clinical trials become more complex, the ability to deliver targeted information to participants grows more difficult. Lack of understanding by participants can lead to noncompliance, expensive delays, and potential legal disputes.

As a result, sponsors are beginning to employ multifaceted approaches to participant communication in an attempt to deliver relevant study information in a user-friendly manner. In addition to simplified consent forms, computer animation, videos, and electronic/online consent represent some of the emerging trends regarding participant consenting.

On Wednesday, June 16, 2010, from 10:30 a.m. to 12:00 p.m., a panel discussion will be held about electronic consent entitled “eInformed Consent: Putting the Pieces Together.” This session will explore making a decision to use eConsenting, the steps to electronic consent usage with an emphasis on FDA guidelines regarding consent, the interaction with Institutional Review Boards, and their relationship to electronic consenting.

“The purpose of the session is to provide an overview regarding alternatives to paper-based consent forms,” said Linda Coleman, JD, Director of Regulatory Affairs at Quorum Review IRB, and a member of the panel discussion. “I think anyone that does clinical research and has used or is thinking about using electronic consent forms will be interested in this session.”

Coleman will discuss issues related to the IRB Review, including the challenges and benefits of electronic/online consenting.

“IRB’s need to review all information that will be presented to the potential subject including any audio, graphics, video, and screen shots in order to determine if the electronic/online content is appropriate and in compliance with applicable regulations,” Coleman said.

Her presentation will discuss the issues to consider before submitting an electronic consent form for IRB approval and what the IRB considers when evaluating these types of forms.

Susan Brink, PhD, President and CEO of ConsentSolutions, will discuss the advantages for both research candidates and sponsors of utilizing electronic informed consent (elC) technology to improve, manage, and streamline the consenting process and give an overview of the steps to be taken in implementing an e-consenting process for a clinical trial.

Additional members of the panel include Melissa Mau, eConsent, MS, Director, Clinical Research Core, Oral Health Research Institute, Indiana School of Dentistry who will talk about “eConsent: The Perfect Solution?” and Jonathan S. Helgott, MS, Consumer Safety Officer, CDRH, FDA, who will discuss the, “FDA Point of View.”

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