Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently reminds industry in a new guidance addressing increasingly complicated electronic IC (eIC) issues. Issued almost simultaneously with Apple’s new ResearchKit tool, which promises faster, cheaper access to potential trial participants, and unimagined data streams to boot, the guidance comes at an important time for the clinical trial world.

Never accused of being early adopters of technology, clinical trial folks need to heed the FDA’s new guidance. Used properly, it can serve as something of a road map as everyone veers into previously unchartered territory.

First, understand the FDA’s expectations as laid out in the new guidance. It expects subjects to receive enough information to allow for an informed decision, and an easy way to ask questions and receive jargon-free answers.

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