A History of eConsent by Quorum Review IRB

October 15, 2015

Jim Gearhart is a member of the Board of Directors at Quorum Review IRB. He will be speaking at our next event on “The Road to eConsent” on Wednesday, November 18th at Onyx Pharmaceuticals, along with experts from the FDA, Genentech, and Parallel 6. We invite you to register at prcclinical.staging.wpengine.com/clinpulse to attend this event or receive the take-aways.

The current state of eConsents in medical research reminds me of where portable devices were ten years ago. At that time, visionaries and early adopters appreciated the potential of bringing together PDAs, Mp3 players, cellular telephones, and the Internet, but the products had not yet coalesced into the sleek instruments that many of us now consider indispensable.  I think that almost-but-not-quite-there status is where eConsents are now.

EConsents – shorthand for electronic informed consent forms — deliver information electronically to study volunteers. They present study information on a computer or portable device, and seek to improve a written consent form process that has been with us since the 1960s.

The ethical directive that participation in medical research must be voluntary and informed unfortunately has produced an elaborate process for delivering a study’s consent form. For the final decades of the 20^th century and the first few years of the 21^st, these requirements produced a cumbersome paper process of submit, review, revise, approve, distribute, discuss, initial and sign then file. Clearly, errors were likely; record-keeping could be problematic; and unexpected changes could create long delays. To make things worse, after all of these steps the final document did not always succeed at its original purpose: to help explain research to study volunteers.

EConsents aspire to change that. The programs offer the potential to present an interactive document to the participant; to collect valid digital signatures; and store the records away. The programs often produce more than a pdf version of the paper document. They can use animation to explain processes, offer inline definitions of unfamiliar terms, and present short quizzes to check or reinforce key information.

We have reviewed a number of eConsent studies at Quorum, and we find the potential for improving participant comprehension encouraging. A recent study compares paper consents with eConsents and suggests that participants get more out of eConsents than from paper. Researchers who use the current eConsent tools also admire how they improve document management, version control, and remote monitoring.

But eConsents are still in their early days. So far, most studies with eConsents have been late phase, observational, or aimed mainly to assess the feasibility of eConsents themselves. Significant barriers remain to wider adoption of eConsents, and we’ll need to overcome these obstacles before more researchers are ready to use them.

1. Regulatory Uncertainty: In March 2015 the FDA proposed guidelines for implementing eConsents. While the guidelines demonstrate a generally favorable approach to eConsent, the rules will not become final for at least a year to eighteen months.
2. Timelines: While an eConsent process could improve record-keeping and the consent process at the research site, using the program can delay study initiation. I attended a 2014 demonstration that suggested eConsent programming adds eight to twelve weeks to startup timelines. A Phase I researcher next to me shook his head and said, “That’s too long.”
3. Cost:  To make the benefits more appealing, prices will have to improve. At that same 2014 presentation, a university researcher who was otherwise enthusiastic about eConsent’s potential said that the tools were “too expensive for academics.”
4. Demand: Within our heavily regulated industry, many report a “If it ain’t broke, don’t fix it” response to eConsents. Despite the shortcomings of the paper consent processes, some prefer its staid familiarity over the risks of a new system.

I do not mean to sound pessimistic. EConsents are appearing in an arena that can be wary of change, and this feels like the start of something major. The barriers of uncertain regulations, extended startup times, and higher expenses seem high, but once they fall eConsents could become commonplace. As with the smart phones we carry, in a few years we may wonder how we ever got by without them.

Jim Gearhart | Board of Directors at Quorum Review IRB

Links & References:

• National Institute of Health Timeline of Protections of Human Subject Research: https://history.nih.gov/about/timelines_laws_human.html
• Study of eConsent vs. paper consents: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0058603]
• FDA Guidance on eConsents: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf
• ResearchKit vs. FDA Guidance (blog): http://www.quorumreview.com/blog/2015/04/09/econsent-mashup-fda-guidance-vs-researchkit/
• Pfizer mobile device study results: http://www.pmlive.com/pharma_news/pfizer_wont_abandon_social_media_trials_virtual_study_failed_408636
• CTTI Minutes on consent form improvement: http://www.ctti-clinicaltrials.org/files/Informed_Consent/IC-MeetingSummary_2015-03-10_Final.pdf

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