eConsent is an innovative consenting method that uses multimedia components (e.g., videos, interactive presentations) to further explain the risks and benefits of participating in a clinical trial. It may support a more interactive and engaging informed consent experience with flexibility for diverse learning styles (e.g., auditory, visual). eConsent may be performed in the clinic or it may be implemented remotely with the participant accessing the eConsent platform through a website.
eConsent technology exists, but detailed requirements of the institution (i.e., privacy and security) and REB remain opaque to the sponsor, contributing to study start-up delays. Sponsors indicate delays in approval of eConsent use in clinical trials are often due to REB and institutional concerns over movement of information and discomfort with 3rd party communication with the participants. Sites often update and customize their own consent forms, resulting in version control challenges that are difficult and resource intensive to manage.
- Strategies and Opportunities
Ethics and Regulatory:
- Health Canada – use of electronic ICFs is generally considered acceptable if all applicable regulatory/ICH requirements are met: including but not limited to: 1) the system must be properly validated (ICH E6, 5.5.3) with documented procedures and appropriate training, 2) all required elements (C.05.010(h); ICH E6, 4.8.10) must be present in the ICF, 3) the information must be stored for 25 years [C.05.012(4)].
- The regulations also note that the process for obtaining informed consent via electronic means should be detailed in a SOP, including how the form will be explained and discussed with the clinical trial participant (e.g., will the participant have the option to sign a paper copy, bring a copy home or have access to an electronic signed copy, etc.)
- 3rd party vendors can be used as long as they meet confidentiality and privacy requirements. A short list of approved vendors that ethics committees have accepted exists, however these vendors are often chosen by global sponsors rather than local affiliates.
- Electronic signatures are considered acceptable if the electronic system is fully validated. The proper controls should be in place to assure that the signature belongs to the user who applied it.
- In contrast to the FDA, there is a lack of guidance from Health Canada on eConsent standards.
Privacy and IT :
- Collection of personal health information (PHI) must follow federal and provincial guidelines on PHI; this differs between provinces.
- Institutional requirements and policies must also be followed.
- There is significant cost associated with some platforms and hospital may not have sufficient IT resources to support.
- REB and Institutional approval timelines for eConsent strategies must be competitive in order to implement this strategy more fully in Canada.
- Requirements for privacy and security should be shared proactively with global sponsors selecting vendors.
- The use of eSignatures must be approved by both the institution and sponsor prior to implementation.
Patient / Caregiver:
- It is important that the clinical trial participant understands that any electronic signature is equivalent as a handwritten signature on paper.
- Use of multimedia may better inform the participant’s decision to join a trial.
- Limited access to technology may be a limitation to inclusion; choice is important.
- eConsent supports a decentralized trial approach, creating more opportunity for rural individuals to participate in decentralized trials.
- eConsent may be a more accessible approach to the consent process for participants with vision impairments, etc.
- Guidance documents on the implementation of eConsent have been written by leading clinical trial organizations outlining benefits, challenges, and key considerations in the adopting of eConsent strategies (see resources tab). However, these typically have a US focus and need to be adapted to the Canadian/Ontario context.
- Some sites have developed their own platforms while others use commercially available ones such as RedCap.
Opportunity to improve access to/uptake of decentralized approaches:
- Develop and publish an intake form to equip researchers, sponsors, institutions and REBs to assess and implement eConsent in a transparent and harmonized fashion. Standards would include: privacy language and minimum privacy and security requirements for vendor selection.
- Standardize the CTO ICF template for eConsent and include privacy wording for eConsent.
- Include questions in the CTO Stream application to support assessment of eConsent procedures from a privacy and security perspective.