FDA opens door to a multitude of trial e-consent approaches

The FDA has released draft guidance on electronic informed consent. And the scope is as broad as trial sponsors' imaginations, with the FDA opening the door to the use of podcasts, "biological recognition devices" and any other method that conveys adequate, understandable information and captures informed consent.

The overarching theme of the document is that the message takes priority over the medium when it comes to obtaining informed consent for clinical trials. Potential trial participants must have a clear understanding of what they are signing up for before they give consent and be kept informed of any changes as the study progresses. If an electronic format can fulfill these objectives, the FDA is open to seeing it used in clinical trials.

The FDA specifically mentions text, graphics, video, podcasts, interactive websites, biological recognition devices and card readers as tools and technologies sponsors can apply to the informed consent process. Sponsors using one of these formats must consider how its unique features affect the ability to present adequate, understandable information. For example, interactive websites should allow users to go forward or back at any time and be designed to cater for the visually impaired.

The draft guidance is open for comments for the next 60 days and is likely to be scrutinized closely by many companies, some of which began experimenting with e-consent several years ago. Shire ($SHPG) had a pilot project up and running in 2012 and others have taken an interest, in part because research into adult learning shows the text-heavy documents used in traditional, paper-based informed consent make it hard for people to understand and retain information.

The FDA cites research on the benefits of using video and interactive tools for informed consent in the draft guidance and is clearly supportive of the concepts. The attitude of institutional review boards (IRBs)--which are responsible for reviewing informed consent documents--remains a possible obstacle. The guidance should make them more comfortable with electronic approaches, but it will be harder for sponsors to implement changes they request if multimedia are being used instead of text.

- read the guidance (PDF)
- check out Regulatory Focus' take

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