The use of electronic informed consent (eConsent) in clinical trials is on the rise. We have argued that widespread use of eConsent is an inevitable, natural progression away from paper-based informed consent forms, and from what we can see, its use is spreading. Not everyone agrees that the time is right, however, or that all eConsent programs offer the right solutions. Still, sponsors and sites are increasingly curious, and willing to give eConsent a try. As electronic alternatives to paper are taking over in other areas of medical research, such as electronic trial master files (eTMFs) and Electronic Health Records (EHRs), the progress of eConsent continues, too.
The expansion of eConsent can raise a question for sponsor and investigative sites alike: how can investigators be ready? What areas should a site concentrate on to prepare for an eConsent study? Based on our experience and on the 2016 FDA-OHRP guidance about eConsents (which the guidance calls eIC), here are five areas to investigate to determine whether your site is ready.
1. Informed Consent Procedures That Are Compatible with eConsent
The 2016 guidance on eConsents was clear: these computer programs cannot replace a complete informed consent discussion. The FDA has emphasized that informed consent is not only a document (or, in the case of eConsent, an electronic file), but a process. Introducing an eConsent process should enhance that process, not hinder it. Sites have reported that some eIC products can interfere with the existing informed consent processes, so successful implementation of eIC should accommodate a site’s preferred method of consent. (It’s important to add here that eConsents do hold the potential for remote consenting. Some studies, particularly minimal risk research, may allow for a completely remote consent process. Others, at a minimum, can provide a pre-appointment review of the consent document, saving sites time).
2. Hardware Requirements
Some eConsent products require that a site use specific brands or types of hardware in order to run the software. The need for particular hardware can inconvenience study staff, and may complicate innovations such as enabling subjects to preview informed consent documents remotely, or interfere with the consent process as noted above. The joint FDA-OHRP guidance on eConsent also said that sites should provide hard copies of eConsents whenever requested. A site that wants to join an eConsent study should understand what, if any, additional hardware expertise is needed.
3. 21 CFR Part 11 Compliance
FDA “Part 11” has long been the bogeyman of electronic systems for FDA-regulated research, but that does not have to be the case. While the FDA does require Part 11 compliance for how eConsents store data and verify signatures, the agency also allows investigators and sponsors to rely on a vendor’s certification about compliance. Sites and sponsors should ask any eIC product vendor to verify its Part 11 compliance.
4. Site Participant Profiles
Before embarking on a study with eConsent, a site should understand any particular requirements its population might present. Foreign language speakers still need consent forms in their native language. Children and caregivers/legally authorized representatives (LARs) create special requirements that an eIC program should be prepared to accommodate. Some patient populations may be less comfortable with electronic tools, and a site still will need to access or print hard copies of consent forms.
5. IRB Experience
Institutional review boards must approve any consent form used at a site, and eConsents are no exception. Since eConsents have been available for many years now, most IRBs should understand their responsibilities for review, and express their submission requirements clearly. For eICs that are not integrated with IRB review, or which require fully-approved text and displays before eConsent design can begin, it is important that an IRB approve the language and design of the program well ahead of time.