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New FDA draft guidance risks ‘Confused Consent’

Clinical trials require researchers to ensure that each participant is fully aware of the details of the trial before they take part. The FDA’s recently released draft guidance for Institutional Review Boards (IRBs), clinical investigators and sponsors on Informed Consent Information Sheets for clinical trials, if passed, suggests that informed consent could soon more accurately be called ‘confused consent’.

Although the initial period for submissions and comments closed on 15 September, a second period has just been announced by the FDA with a deadline of 27 October. Numerous submissions have been received to date, expressing concern over the complexity of language used in the agreements, the overwhelming detail presented to prospective clinical trial participants, as well as the role mobile technology including iPads, smartphones and apps play in the Informed Consent process, alongside other concerns.

Alternative treatments

Particularly of concern is the FDA suggested requirement of disclosing information on alternative treatments including a description of foreseeable risks and discomforts and potential benefits associated with these alternatives. For diseases where there are many options for treatment, this would necessitate many more pages of explanation than currently required.

The Informed Consent process is complex enough to begin with. Factors such as low literacy levels, language barriers, socio-economic and cultural factors make the process even more difficult.

Length and complexity of agreements

Adding further to the complexity of the Informed Consent process is the fact that clinical trial participants most often receive this information at an extraordinarily difficult time in their lives. Having received a life altering, if not life threatening, diagnosis, is it really ethical to present these people with Informed Consent documents that are as complicated as mortgage applications and the length of a short novel?

Information not complication

At the end of the day, it needs to be remembered that the entire process is about informing participants, be they patients or healthy volunteers, and obtaining their free-willed consent without deception or coercion. It is not about confusing potential participants or saturating them with so much information that their signature on the informed consent document just ends up representing a box ticked on the Good Clinical Practice checklist.

The guidance, when finalised, will supersede “A Guide to Informed Consent” issued September 1998 by the Office of Health Affairs, FDA.

By Ric De Garis, Senior Consultant, Clinical Development

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