FDA Guidance Emphasizes Importance of Robust Informed Consent Program

eConsent

A new U.S. Food and Drug Administration (FDA) guidance hammers home the agency’s aggressive focus on proper informed consent programs that ensure patient safety, help subjects comprehend clinical trial specifics, and demonstrate data integrity.

The “Use of Electronic Informed Consent—Questions and Answers” guidance for institutional review boards (IRBs), investigators, and sponsors also reminds industry that the term “informed consent” carries broader implications beyond simply obtaining a signature on a piece of paper. “Informed consent must include a process that facilitates the subject’s comprehension of the information and allows adequate opportunity for the subject to ask questions and consider whether or not to participate,” the guidance notes.

FDA also reminds clinical trial practitioners that the informed consent process “continues beyond obtaining the subject’s initial consent at the time of enrollment and may involve providing additional information as the research proceeds or as the subject requires.”

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Whether or not this definition sounds obvious to sites and others, it’s clearly important to keep abreast of the FDA’s latest thinking, as presented in guidances or by FDA speakers at such events as ACRP’s recent webinars on increasing minority enrollment in clinical trials.

The new guidance addresses a number of other informed consent issues, including the increasing use of electronic communications and record-keeping as it pertains to keeping subjects abreast of a trials path. FDA stresses that it does not endorse a particular way to attain either goal. That said, it does make its expectations clear in terms of results. The guidance explains that the electronic informed consent (eIC) process should incorporate procedures to ensure edocuments can be archived appropriately, and that all verions of the IRB-approved eIC can be easily retrieved.

Author: Michael Causey