eConsent can reduce barriers and improve the clinical trial experience for patients and sites. We sat down with Dr Caroline Forkin, senior director medical affairs of FIRECREST, ICON, to discuss this trend, its opportunities and challenges
What are some of the key considerations when implementing eConsent and how are security and privacy issues addressed specifically?
One of the main considerations prior to the roll-out of eConsent is the training of staff, both site and study teams, on how to use this technology solution. In some instances this may, understandably, be viewed as ‘yet another’ technology that the team have to get up to speed on and integrate into their normal procedures. Providing them with optimal training and on-going support during roll out is key to ensuring good uptake. Helpdesk support from the vendor during this early stage of adoption would also be advisable.
In my experience having a champion at site and in the study team in the early days of roll-out is also very important to ensuring continued buy-in and commitment to using eConsent as the first option, rather than defaulting to paper as the perceived ‘easier’ option. Reiterating the on-going benefits of eConsent (more informed patients, readily auditable tracking and monitoring system, reduction in the common errors in consenting, etc.) is central to this while sites and study teams familiarise themselves with eConsent.
From a regulatory standpoint, it is important that the system is in line with the parameters outlined by the FDA in their guidance of December 2016, as well as 21 CFR Part 11, and ICH GCP E6 R2.
In terms of security and privacy the eConsent system should be aligned to HIPAA and to the GDPR from an EU perspective. Access to the system by site and study staff should be done on a role-basis, ensuring that access rights reflect the user’s role (i.e site staff and CRAs have greater access levels that that of a study team member). From a security perspective, all information needs to be encrypted and stored on a server with robust back-up and disaster recovery plans to minimise risk.
What backup processes are in place if there are technology failures, and eConsent can’t be used?
If the technology fails or if there is an issue with the wifi network, the consent process can still proceed using a paper consent form as per the traditional consenting process. Thereafter the site can scan the signed consent form back into the portal with the other electronically signed ICFs allowing it to be stored and monitored centrally in the portal. The same approach would apply in the instance where a patient may prefer to sign on paper for their own reasons, i.e. this paper signed ICF can be scanned back in to be stored and monitored together with the electronically signed ICFs
Some sites may have changes to eConsent. How is this managed for approvals? What is the validation process if the consent document version changes during a trial?
It is a straightforward process and managed in a similar way to changes as today for the traditional consent process. If there is a change to the ICF, the electronic ICF would need to be updated and redeployed through the portal. A change in the eICF would generally be published in the portal within one to two days. If there are changes needed to the patient-facing material displayed in the patient information this could take longer, typically a few weeks.
Of note, in this instance a site could opt to consent patients to the updated ICF on paper if this was more efficient from a time perspective. The paper signed ICFs can then be scanned back into the portal and stored and monitored centrally there. A hybrid approach is fine if this is what works best in an individual instance.
What is the average cost of eConsent use in a study?
The cost of implementing eConsent varies depending on the size and specific requirements of the study. Generally a customised solution is required for each study and the final cost depends on whether both components are being used (patient information/education and signature capture application) and the size of the study in terms of numbers of sites, countries, IRB/EC submissions, languages.
Are there limitations or geographical considerations of where eConsent can be deployed?
The use of eConsent currently has some restrictions in certain jurisdictions such as Europe, specifically in relation to the signature capture component. However, in general there is broad support for the use of the interactive, multimedia approach to providing patients with more appropriate study information.
There are still some misperceptions about eConsent out in industry. The DrugDev Annual Investigator Survey responses to the question “Why have you not used eConsent on all clinical trials?” indicated that 77 percent of global sites said that they had not been asked by the study sponsor, whereas the material limitations were much less, for example:
- 12 percent said that their local IRB or ethics board did not approve the use
- 7 percent thought that the technology would be unacceptable to patients
- 6 percent thought it would be difficult to incorporate into their site workflow
The Transcelerate Landscape Assessment of 11 sponsors, 2 CROs and 3 eConsent vendors in 2016 showed that eConsent submissions have taken place in 29 countries and was used to consent patients in 12 countries to date. For full information see: Transclerate Landscape Assessment – Where is eConsent? Transcelerate eConsent Emerging Trends and Future Considerations
With the advent of virtual trials, what are your thoughts on remote eConsent, and can a patient be re-consented remotely?
Remote consent is becoming an important topic, with patients wanting to peruse information in the comfort of their own home, taking the time to digest and discuss with their family. The capture of an electronic signature remotely is more challenging. The FDA guidance of December 2016 does provide context for remote consenting as an option. It states that if any or all of the consent process takes place remotely and is not personally witnessed by study personnel, the electronic system must include a method to ensure that the person electronically signing the informed consent is the subject who will be participating in the research study or is the subject’s legal representative. The FDA does not mandate a specific method of verifying identification but does provide examples of what would be considered acceptable.
How is withdrawal of consent managed?
The flagging of a reason for withdrawal (including that of informed consent) is typically captured in EDC and/or IVRS/IWR as per the current process of documenting withdrawal from a study. All of the previously signed ICFs continue to be maintained in the eConsent system as part of the site file and as per regulations.
How is does eConsent improve the experience for the patient?
eConsent makes it possible for the patient to have more time to interact with the content, which was designed specifically for their study. The patient has the ability to ask questions, highlight text, etc. before submitting back to the investigator. The initial feedback we have received has been that patients come to the face-to-face discussion with their investigator with more focused questions about the study which are individual to them and central to their full understanding of the requirements and implications of partaking in the study. In other words, they are more empowered to make an informed decision and have more ownership over the face-to-face discussion prior to signing consent. Hopefully, this will result in more fully informed patients, better study compliance and enrollment.
Where do you see this technology heading in the future/next five years?
I think that is it inevitable that eConsent will ultimately replace the traditional paper-based consenting process. As the conversation develops, we need to acknowledge that an informed patient is more likely to stay engaged in a study, which will have a greater impact on engagement and retention.
With the EU Portal coming in 2019, what do sponsors need to do to prepare for this?
It would be advisable that transcripts of all eConsent content along with access to the portal is provided to Ethics Committee and regulatory authority submissions so that they are able to peruse the material in situ as viewable by the patient. It is also important to keep abreast of developments with respect to the portal requirements as they evolve, being cognisant of potential limitations for different types of content.
