eConsent: Sites and Sponsors Tout Benefits, Confront Obstacles
As more sponsors and sites use the flexibility offered by eConsent and remote consent, they’re also dealing with some concerns attached to those approaches, especially the documentation that the FDA will ask for during inspections.
“When sites or sponsors contacted the IRB and they asked about remote consent, one of the biggest recommendations I gave was that they create forms on their remote consent process, either checklists or forms, so that their documentation was consistent, especially for audit purposes in the future,” Heather Kim, WCG IRB’s Quality Assurance Manager told the WCG FDAnews FDA Inspections vSummit.
“That way you wouldn’t have some remote consents with a witness and some without, or some that had the investigator sign the remote consent process and some that just noted their names.”
Kim added, for example, that a patient may be unable to send back the informed consent form (ICF) if they don’t have access to a printer, camera phone and/or email.
When patients don’t have access to a printer, Kim recommended that their verbal consent be obtained and documented with a witness present. Also, a subject could, after doing the consent discussion, be allowed to email that they consent and agree to sign the ICF when they next visit the site, if they have email access. Recordings of phone or video calls done to consent a patient can also be used as documentation, Kim said, and stamped return envelopes can be provided to patients alongside mailed ICFs so they can return the signed form easily. Importantly, these need to be documented and stored in a way that makes them easily accessible if they’re requested by an investigator.
For eConsent, the FDA has laid out specific expectations for sponsors and sites. For one, the identity of the patient must be verified prior to establishing or certifying their electronic signature. This includes, for each subject, official ID documentation (such as a driver’s license or passport), security questions to confirm identity and a username/password. eConsent also still requires one of the most pivotal elements of informed consent — giving subjects a suitable opportunity to ask questions. Additionally, a record of the eConsent must be given to the subject and all electronic records must be accessible when and if the FDA turns up for an inspection.
A number of eSignature tools have been used successfully for eConsent, including Adobe Sign, DocuSign, REDCap (Research Electronic Data Capture) and the FDA’s MyStudies App. When picking a tool, it’s integral for sites and sponsors to ensure that the system and signature process is fully compliant with the agency’s Part 11 regulations, which cover electronic records and signatures. This was especially important for Adobe Sign and DocuSign, which have both noncompliant and compliant versions.
“Even when a site receives or decides to implement an eSignature tool, they have responsibilities that the tools themselves might be Part 11 compliant, but there are elements of Part 11 that are on the sponsor and site,” she said. “For example, defining how the sponsor, monitors or inspectors will have access to eConsent documents — that should be outlined either in training or SOPs, and Part 11 does require documented training for staff on Part 11 systems before implementation. While the system itself may be Part 11 compliant, sites also need to remember that they have responsibilities under Part 11 as well.”
Suellen Bigaj, vice president/principal consultant for Pharma Compliance Partners, foresees that sponsors and sites will evaluate their approaches to signing informed consent in the next year and act accordingly to adjust them — but she believes remote methods are here to stay.
“Every site, every sponsor, everyone involved will make their assessments and then be able to look back and then make a better assessment of ‘OK, this can stay, this can go, this we can make better,’” she said. “I don’t see it moving forward any other way but as a hybrid.”
And Patty Mendoza, manager of regulatory affairs, compliance and clinical trial management at Houston Methodist Research Institute, predicts that eSignatures will “keep being a big deal” as we move into the future. For Mendoza, they’ve been highly effective.
“I told people, I’m a monster now. I use my electronic signatures, DocuSign, for training, reviewing newsletters. There were [principal investigators] I would literally have to stalk outside the bathroom to get a signature, and now they sign right away because the peer pressure, all the other investigators are listed on that same document,” she said. “I use them to adjudicate adverse events, serious adverse events, etc., so I think that’s going to be something.”
Thankfully, trials that move to implement remote consent or eConsent do not, by regulation, need to have their ICFs revised accordingly or approved by the FDA, which could take a significant amount of time. Instead, subjects can be sent ICF Addendums or “Dear Participant” letters to reflect new information, Kim said. But regulations do require IRBs to review and approve moves to remote consent or eConsent, and failure to document these reviews and approvals could result in an inspection finding.
The pandemic, still not yet over, has made these approaches indispensable options for patients hesitant to come onsite, and they’ve even shown to foster greater interaction during the consent process than the traditional way.
“Since some sites had implemented video and telephone conferencing to obtain consent, it was more face time than some subjects had experienced previously where they were just given the consent form, told to read it and [to] come back if they had questions,” Kim said. “That was an interesting observation.”
These remote tools also showed benefit in that they, in some cases, helped to ensure patients were seeing the most current version of the ICF and pointed out missing fields, including checkboxes, dates and signatures that weren’t filled out. These missing fields have been among the most frequent site monitoring findings, according to Kim.
But, as expected, challenges have been encountered, too. Remote and eConsent are not exempt from the potential cost and implementation burdens that are placed on sites when onboarding new approaches, Kim said, including the extra work of training staff and implementing SOPs.
The use of remote and eConsent has highlighted the issue of lengthy and complex ICFs and, with that, the importance of communicating key trial information to patients. When consenting patients, Kim said it’s critical that patients are presented with “information that would be most relevant in helping a subject decide whether or not to participate,” rather than inundating them with the entire consent form, which could span 30 pages of information to scroll through.