Register Now: Beyond EDC: Designing a Connected Data Strategy for Predictive Clinical Development
|Articles|April 22, 2014

Video Consent Proving an Obstacle in India Trials

In November 2013, India's Drug Controller General required that all clinical trials must record on video a participant's informed consent.

In November 2013, India's Drug Controller General required that all clinical trials must record on video a participant's informed consent, which according to a recent article, is driving recruitment rates down.

Physician investigators report the reasons patients are declining clinical trials because of the video recorded consent. Those reasons include, they believe the videos could be leaked; tampered with or misused. Also, social and religious reasons, as well as poor self image during a sickness. The physicians in the article report ranges between 10%-40% of patients declining to participate in the clinical trial after learning of the video consent requirement.

While some believe the video consent has a noble intent, the questions behind the ethics of not allowing participants the decision to opt-out of the video requirement, as well as the long-term effects on science are being debated.

Read the full story here.


Related to this article

What Needs to Happen Beyond the Clinical Trial Modernization Act
In this video interview, Kent Thoelke, CEO of Paradigm Health, calls for safe harbor protections, CMS reimbursement safeguards, and funding mechanisms modeled on EHR meaningful use to help community and rural institutions participate in research on par with academic centers.
Building AI Assistants Clinical Trial Teams Can Trust: Q&A with E.K. Koh, Suvoda
In this Q&A, E.K. Koh, chief product officer at Suvoda, discusses what separates a trustworthy AI assistant from one that adds risk, why curated clinical knowledge matters more than general-purpose flexibility, and what safeguards must be in place when assistants move from answering questions to taking actions in clinical trial systems.