The FDA and the OHRP announced the finalized version of the regulatory guidance document for electronic informed consent (eIC) “Use of Electronic Informed Consent—Questions and Answers” December 2016. The guidance document represents the current thinking of these regulatory agencies and are recommendations, but like this one, sometimes include requirements where applicable. It is of note that the FDA and OHRP combined their guidance together into one document to support ongoing efforts to harmonize between the agencies. This is great news for those that consent under FDA regulated trials and / or government sponsored research! This emphasizes the point that an eIC solution needs to be flexible to support very simple to complex projects, as well as from high-risk treatment to non-interventional studies.
This guidance is written in a user-friendly Frequently Asked Questions (FAQ) style. Besides some important updates, the final guidance added two more FAQs:
- What methods may be used to verify the identity of the subject who will be electronically signing an eIC for FDA-regulated clinical investigations? – This FAQ addresses compliance with the requirements in 21 CFR part 11 to verify the identity of the subject who will be signing the eIC.
- What eIC materials should the investigator submit to the IRB? – This question specifies what materials to submit and how to submit to the IRB for review as part of the eIC process; this is an opportunity to link the eIC to an interactive training on being a participant, and much more!
The following are some additional key take aways. The messages in the guidance support:
- Clarification that when a study is conducted or supported by HHS and involves an FDA-regulated product, the study is subject to both 45 and 21 CFR parts and where regulations differ, the regulations that offer the greater protection to human subjects must be followed!
- eIC as a compliment to paper not necessary implying eIC as always a replacement; eIC can be used strategically at certain times of the consent; this supports a Hybrid approach. Electronic is emphasized due to speed of info to participants remotely for consent amendments, or incomplicated studies start with eIC to support presenting complex info more interactively, etc.
- Continuous consent where a subject can get information sent to them between visits to better support being informed throughout the trial.
- eIC should support interactivity and facilitate the subject’s comprehension of the information presented during the eIC process.
- eIC should support rapid information communication between stakeholders (investigator and subjects, investigator and sponsor, etc.).
- FDA / OHRP should be able to audit the records and reports for eICs.
- The guidance addresses special considerations for the use of eIC for pediatric studies. This section reminds us that the ethics committees determine if assent can be done and what is the most appropriate method.
If you would like to learn more about eConsent solutions check out this video series in conjunction with CRF Health here. Additionally, feel free to contact us for more information and look for upcoming trainings.
-The Clinical Pathways team