How eConsent Optimizes Research – Webinar Q&A, Part 3

By Mitchell Parrish and Kay Neth

Quorum Review IRB recently aired a webinar on how eConsent optimizes research for sponsors and CROs, and what organizations should look for when evaluating electronic informed consent solutions. Viewers had a lot of great questions, and we’re here to answer them all. In Part 1 of this series, our expert presenters addressed questions around compliance, security, and accessibility. In Part 2, questions centered on researcher roles and responsibilities and the IRB review process for eConsent. In this final installment, Kay and Mitchell answer the balance of viewers’ questions.

 

Integration

Q: The presentation was compelling in support of eConsent. You spoke about the ability to track recruitment, and other important features, as well as a dashboard method to provide real-time information. That leads one to ask; shouldn’t this be an integrated part of a complete EDC solution, rather than a separate module added on to the base product?

A: Research stakeholders are increasingly seeking eClinical software systems (such as Electronic Data Capture, or EDC) to digitize and automate data collection and sharing in human subject research.

But there is no magic bullet. An eClinical system that promises comprehensive management of study data is typically costly, complex, and gives up depth for breadth: consent functionality within an expansive eClinical system will typically lack advantages that even a comparatively simple, cost-effective eConsent solution offers. Unlike EDC or similar software, eConsent emphasizes the user experience for both study staff, and participants. The right eConsent solution sets the stage for error-free consenting and participant engagement (leading to better participant recruitment and retention).

 

Implementation

Q: Two viewers had questions about who is and is not using eConsent and why, observing that they rarely see it implemented on industry studies.

A: During the last decade, eConsent has inspired more industry discussion than adoption. But that’s changing. A growing number of industry stakeholders are using, or anticipate the use of eConsent for a variety of research: from minimal-risk survey-based protocols with remote consenting, to drug and device studies with consenting conducted at the research site. Industry stakeholders that aren’t using eConsent today (or at least preparing to use it in the future) will be playing catch-up tomorrow.

Why the shift? The short answer: perceived barriers to eConsent are eroding, while awareness of eConsent and its advantages is growing.

In the past, two factors slowed the industry’s embrace of eConsent. The first was the perception that developing, implementing, and maintaining a complex eConsent solution was an expensive investment that would extend study start-up timelines and offer a limited ROI. The second area of concern was regulatory uncertainty, such as questions about validity of electronic signatures and security of cloud-based technology.

But concerns about costs and compliance (and complexity) have given way to a new understanding. Paper-based consenting won’t survive in the 21st century. A simple, low-cost eConsent solution can preserve budgets, timelines, and compliance while offering the key advantages of eConsent—error-free consenting and participant engagement (with improved recruitment and retention).

 

 

Why the shift? The short answer: perceived barriers to eConsent are eroding, while awareness of eConsent and its advantages is growing.

Using a cost-effective, well-conceptualized eConsent product—with the right features and the right vendor—will offer ROI and drive eConsent adoption forward in the industry.

An eConsent product’s features are the “right” ones if they advance the core advantages of eConsent—consenting compliance and participant engagement. For example, even a basic eConsent solution should offer “smart form” functionality that catches missed signature lines and other consenting errors. It should provide dashboard metrics that give sponsors and CROs insights into the success of recruitment efforts. And it should offer capabilities that support participants’ all-important relationship with research staff (such as the ability to send questions to staff through the eConsent application).

The “right vendor” is an IRB-integrated one, with processes that mesh well with the IRB’s. A vendor should also demonstrate in-depth knowledge of the international, federal, state, and local obligations IRBs must address in reviewing research and consent forms.

Finally, the right vendor is one with the regulatory bona fides to replace uncertainty with clarity. An eConsent vendor ideally has been externally audited for 21 CFR Part 11 compliance, and it should also be well-versed in other relevant standards, such as the December 2016 federal guidance Use of Electronic Informed Consent: Questions and Answers, jointly prepared by the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA).

Beyond growing understanding of the advantages of eConsent and the dismantling of perceived barriers, the ever-growing integration of digital technology into our day-to-day lives might be driving increased adoption of eConsent. We still appreciate the virtues and appeal of paper, but digital technology is so ubiquitous in our experiences at work, at home, and at play that we don’t routinely think about how it shapes our lives. We just expect it to be there. eConsent will follow the same trajectory as other digital technology. Today, eConsent is the future of consent. In a few years, it will be the norm.

 

 

Q: Who usually engages eConsent—Sponsor or Site?

A: Generally, eConsent is initiated at the study level by the study sponsors. Sponsors control the study budget and logistics, and they have incentives to use eConsent for the entire study (for example, eConsent offers advantages of providing the sponsor or CRO with real-time dashboard metric insights into recruitment). That said, a site on a multi-site study could leverage the advantages of eConsent and work directly with a vendor even if other sites conducting the study are not. (In doing so, the site should communicate its intent with the sponsor to manage budgets and other considerations.)

 

Security

Q: Are there established solutions for secure encryption of eConsent?

A: The short answer is no. Consequently, look for an eConsent solution that encrypts data both at rest and in motion and that satisfies HIPAA and HITECH requirements.

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