January 23, 2019 | The eConsent field is challenging: on the one hand it represents a major improvement in the consenting process for clinical trial participants. On the other hand, it is fraught with regulatory uncertainties and industry ambiguity. Tearing apart this tangle will be necessary for eConsent to do what the technology is meant to do: inform trial participants and speed enrollment.

Thorsten Ruppert, Senior Manager, Research, Development and Innovation, Association of Research-Based Pharmaceutical Companies, believes time is running out on the untangling. Both patients and researchers, he says, will soon be demanding these tools. And the industry must be ready with standards and an interoperability plan that works.

eConsent has the potential to ensure operational efficiencies, minimize regulatory risk, and safeguard participant comprehension and satisfaction to deliver mid- to long-term cost savings, Ruppert says. Now is the time to make it happen.

Ruppert and several of his colleagues will be hosting a roundtable discussion to identify and overcome what’s standing in the way of eConsent adoption at the upcoming Summit for Clinical Ops Executives, SCOPE, in Orlando, February 18-21.

To get the conversation started, Ruppert shared his take with Clinical Research News on when eConsent is appropriate, the role of regulations, and what implementation should look like.

Clinical Research News: Is eConsent appropriate for every trial? If not, why not?

Thorsten Ruppert: The introduction of eConsent represents a major improvement in the overall participant consenting process in clinical trials for investigation sites, sponsors, and Ethics Committee. eConsent can make use of electronic media (video, podcasts, interactive Websites, applications for tablets and smart phones, etc.) to convey the information for patients. So basically, eConsent can be relevant for every trial.

We see a greater demand from patients not to stick with the “old-fashioned” paperwork and use state-of-the-art technologies as electronic media plays a greater role in our day-to-day life. Rightfully this wish from trial participants to make more use of eConsent is clear and understandable. But currently we see many obstacles for a broader use of eConsent worldwide. Some national laws recommend purely a “wet signature” or don’t allow electronic documents. Also the assessment of these tools by ethics committees are not fully clear. Only some countries have first basic guidance documents on the recommendations regarding eConsent, for example guidance documents from the Swiss Ethics Committees on research involving humans.

The field is evolving, but still we need to discuss more about the approach to fully utilize eConsent. In the current situation, eConsent will not be suitable for every trial or every trial location worldwide—but we are on the way. Patients (young and old) will demand it from us.

Because eConsent offers practical benefits, including the capability to mitigate regulatory risk, improve study participants’ comprehension, and provide a more efficient way of collecting consent, researchers will demand the use of eConsent from sponsors as well. Currently we see that industry often doubts the adoption of yet another new technology, due to the challenges and expected costs of integration in existing systems. But I expect a clear demand to industry to provide these tools for their trials, so broad discussion on eConsent—also on the side of the industry—is needed. Luckily TransCelerate, for example, has an initiative regrading eConsent that brings together different industry stakeholders to push this topic forward.

How do IRBs and regulatory feedback impact the eConsent process?

Ethics Committees must be satisfied that the informed consent process meets the regulatory requirements for content and also supports their review process. If not, this will slow down the research and approval process of eConsent approaches. Involving IRBs as early as possible in the process is pivotal. The investigator, project leader, or the sponsor of the research project should discuss plans for using an eConsent with the Ethics Committee prior to finalizing the development of the eConsent to ensure that the Ethics Committee agrees that the format may be used to convey the information the subjects and that all relevant information is available for the trial participants. Currently we see that an applicant who wishes to use eConsent must submit the same eConsent materials to the Ethics Committee that will be presented to the subjects to obtain their consent for participation in the clinical investigation: copies of all forms and informational materials in PDF format, with a link to the eConsent Web page to access videos and Web-based presentations. The applicant should also provide transcripts in PDF format of the eConsent audiovisual presentations. If eConsent is available as an Application (App) for smart phones or tablets, the applicant is asked to provide the link to the Web page for downloading the App or provide the Ethics Committee with the needed electronic tools.

We see great disparity in different countries, and currently no harmonization in this regard is given. To fully exploit the possibilities of eConsent we need international discussion on guidance, for example at the ICH-level.

How does eConsent technology integrate with other systems?

When adopting eConsent, we not only face the challenge of replacing previous paper-based consent systems with the new electronic process, but also of ensuring that the eConsent technology integrates with any existing platforms. So to fully exploit the benefits from eConsent technology intelligent integration with other systems should be considered. Also—at least for some time—there will be a side-by-side between eConsent and paper documents for the consent process. An integration of both approaches needs to be used for a transitional period.

Sponsors need to consider all different platforms and technology that they will be using throughout a study program and how they can integrate with each other to achieve the best possible outcomes—not only for eConsent but also in regard to other systems such as electronic Clinical Outcome Assessment (eCOA) or trial management solutions. This integration should be started as early as possible so study teams can gain all the benefits associated with eConsent, while removing the additional burden that would be inherent with the use of a separate system. This also provides considerable benefits to researchers and internally for industry by removing the need to purchase different systems—which could save time and costs associated with the integration of procedures and training on these systems.

Can you walk us through a typical implementation timeline and explain how it impacts all stakeholders?

The potential of eConsent to ensure operational efficiencies, minimize regulatory risk, and ensure participant comprehension and satisfaction will lead to mid- to long-term cost savings. But a “typical implementation timeline” will be hard to define. Clearly the implementation of an eConsent system only for one specific trial makes no sense. The more eConsent systems will be used, the smarter they get, with more data and trust between users, but with the needed harmonization efforts (e. g. tool box(es) from TransCelerate and others, harmonized regulatory approaches) we will see a positive mid- to long-term effect of eConsent. So it must be clear that only an overarching approach establishing eConsent systems across multiple trials is useful to result in a budgetary and operational impact.