Isn’t everyone supposed to be using electronic informed consent (eConsent) by now? We have been agreeing electronically to pay for books (and then everything else) for over 20 years, and houses for 17 years. eConsent products, too, have been on the market for years (Quorum Review IRB reviewed its first eConsent-enabled study in 2011), and innovations such as Apple ResearchKit, a smart phone-based framework that can support informed consent, promised a rapid introduction of electronic tools to research.
So why are participants in so many research studies still signing paper consent forms? What is holding us back? An article in September’s CenterWatch Monthly reviewed industry interest in eConsent. This blog looks at how, even as many barriers to adoption of eConsent drop away, others remain in place.
Electronic Informed Consent, a Brief Look
Generally, “electronic informed consent” (and its abbreviations, eConsent or eIC) has come to mean any software program that electronically helps a study participant learn about and join (or decline to join) a clinical trial. (Kinetiq, the consulting and technology division of Quorum, recently published a comprehensive blog on the background of eIC.)
After more than two years, only 22 studies rely on apps from the Apple ResearchKit. At least five eConsent tools are available commercially, but researchers are accepting those tools more slowly than many expected. Why have less than two dozen studies tried ResearchKit? Why haven’t more researchers tried eConsent?
Is it Regulatory Uncertainty?
In a joint eIC guidance document from December 2016, the FDA and OHRP emphasized that requirements for eConsent should mirror those for paper processes. The same requirements for comprehension, documentation, and content apply. The guidance document detailed the security and confidentiality requirements for eConsent, including standards under Part 11, HIPAA, and HITECH. As Kinetiq VP of Regulatory Affairs Mitchell Parrish said in the CenterWatch article, “The biggest organizational resistance factors are mostly centered around compliance concerns and security and privacy concerns.”
While requirements for informed consent certainly are nothing new to clinical researchers or to the ethical boards (IRBs) that review research, the technical requirements may not be as familiar. But when an eConsent product can demonstrate that it meets security and privacy guidelines—such as through vendor audits or third party verification—confidence should follow.
Or a Lack of Confidence?
Over the past year-and-a-half we have been asking people in clinical research what they would anticipate from an eConsent solution. At a series of industry conferences, we asked attendees to rate their willingness to try eConsent in research, to identify perceived barriers to adoption, and to name expected benefits. A clear trend that interested us was that resistance to eConsent technology is dropping. Organizational resistance stood at 60% during the first half of 2016, but dropped in the second half of the year to 52% in. By the midpoint of 2017, perceived resistance to eConsent had dropped again, to 38%. As Tom Favillo, our chief operating officer and president, told CenterWatch Monthly, “We have people who are very excited about looking at the tool and sharing it with others in their company. But it’s hard for even them to identify who within their company has been identified as the person who could say yes.”
While resistance dropped, we found that the number of people willing to advocate for eConsent held steady. By mid-2017, 75% of the people taking our survey said they would recommend trying eConsent. Not only is the number of people opposed to trying eConsent dropping, the number of proponents remain significant.
Is It Instability in the Market?
As the regulatory framework around eConsent solidifies, and as confidence grows, many may worry that consolidation, technology sales to other entities, and takeovers within the eConsent market is slowing adoption. The earliest eConsent products have changed hands at least once, as evidenced here and here. Another large central IRB) had a widely publicized exclusive partnership with an eConsent vendor, but that relationship faded and the IRB recently announced the purchase of a new, untested eConsent product. Beyond these lateral movements, sponsors and contract research organizations (CROs) have been developing or purchasing eConsent products for their proprietary use—potentially causing pause for study sponsors to adopt. The last thing they want is to implement an eConsent solution only to have a competitor acquire it (and thus, start over).
Dude, Where’s My eConsent?
Why do we not have more eConsent studies underway? Regulatory agencies have expressed their expectations for eConsent tools; serious eConsent solutions are demonstrating compliance with technical, security, and confidentiality guidelines; and overall resistance to the new solution is dropping. We hope that adoption continues, that confidence continues to grow, and that a stabilized collection of available eConsent products demonstrates that the time for eConsent has arrived.
To that end, we are proud to say that, in addition to launching our own eConsent product back in April, Quorum is equipped to review any eConsent-enabled study. eConsent review has been a critical part of our IRB services for several years, ensuring that eConsent adoption can continue to spread.