In March, 2015, FDA released a new draft guidance: Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.
FDA defines electronic informed consent (eIC) as using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive Web sites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent.
This guidance demonstrates FDA support of eIC and provides a framework for clinical trials to move in this direction. While this new medium represents a transformation of the current process, FDA is prudent in emphasizing the need for continued compliance with existing regulations (those pertaining to electronic records/signatures, informed consent, and IRBs as detailed in 21 CFR parts 11, 50, and 56, respectively).
FDA’s view of consent as a continuous process rather than a single exchange is highlighted in this guidance and eIC has the potential to further dispel the notion of informed consent as a single, signed and dated paper form. This technology could also increase the speed and efficiency of dissemination of new information to research subjects.
While this guidance is encouraging as a starting point, there are several issues that warrant further exploration:
- What will this process look like and what components will be included?
- Who will provide or pay for the technology required to conduct eIC?
- Who are the largest beneficiaries in eIC?
- What are the potential regulatory pitfalls of using this technology?
- How will eIC affect IRBs ability to protect subject rights and safety?
- How will eIC be presented at audits or regulatory inspections?
While the guidance does touch on several of these questions, it seems to be represent a theoretical illustration of how the regulations will operate within this new medium. It will be valuable to see how eIC is implemented in real-world clinical trials.
How do you think eIC will affect the informed consent process?
How quickly do you this will be implemented, if at all?
Please share any other thought on any of the questions above or this blogControl @ Avalon in Hollywood w/ Deorro via photopin (license)