Decentralized Trials Resource Guide

Remote Consent

COVID-19 has made the in-person consenting process logistically challenging and potentially an activity of increased risk. Remote consent can allow the investigator/designee and potential participant to engage in the informed consent process similarly to how it would be conducted in-person, without the challenges of meeting in-person. These conversations may occur via telephone, conference call, video conferencing, or eConsent platform. Participants would still reference the informed consent document during the conversation, which can be sent to the participant prior to engaging in the informed consent conversation. Remote consent may be performed as a hybrid process (e.g., consent is documented on paper), or virtual (i.e., informed consent form is electronic and an electronic signature is used).

Ethics & Regulatory

  • Communication platforms and consent approaches must receive prior approval by REBs, privacy, and IT departments.
  • The Health Canada regulations note that the process for obtaining informed consent via electronic means should also be detailed in an SOP, including how the form will be explained and discussed with the clinical trial participant (will the participant have the option to sign a paper copy, bring a copy home or have access to an electronic signed copy, etc.)[C.05.012(4)].
  • Electronic signatures are considered acceptable, only if the electronic system is fully validated. The proper controls should be in place to ensure that the signature belongs to the user who applied it.
  • REB and Institutional considerations vary for remote consent. SOPs should support the procedures used in clinical trials.

Privacy & IT

  • Platforms used to host the virtual consultation must be safe and secure. Platforms must be approved by the institution prior to use in a study.
  • The use of eSignatures must be approved by both the institution and sponsor prior to implementation.

Stakeholder (sites/sponsors/CROs/other)

  • During COVID it can be challenging for research staff to find appropriate space in the clinic to have consent discussions. Remote consent can alleviate some of this burden while improving and facilitating consent discussion.
  • If a platform is used for eConsenting remotely, all considerations in eConsent also apply.
  • If the practitioner or research staff is also remote, participant privacy must also be maintained on the staff side.
  • Research teams must verify the identity of the trial participant.
  • If an interpreter is required, one may be brought onto the call.
  • If wet-ink signatures are still required by either by the sponsor or institution, paper documents have to be sent to the participant and back to the site.

Patient / Caregiver

  • Remote consent can reduce participant burden by reducing the travel and visits to the hospital.
  • Access to technology, technological understanding, and access to internet can be an issue for remote consultations for some participants.
  • Remote consent may increase opportunities for rural patients to participate in decentralized trials.
  • The quality of information and interaction must be consistent to that of in-person consent.
  • The identity of the participant must be confirmed to ensure consent of the participant (not the caregiver) is obtained.
  • It is important that the clinical trial participant understands that any electronic signature is equivalent as a handwritten signature on paper.

Current Strategies

  • Consent documents may be mailed to participants in advance of the call and the consult may be performed using a secure platform (e.g., MS Teams), or over the phone.
  • eSignatures may be used on traditional consent documents depending on institutional and sponsor policy.

Opportunity to improve access to/uptake of decentralized approaches

  • Standardize the CTO ICF template for remote consent and include privacy wording for remote consent.
  • Include questions in the CTO Stream application to support assessment of remote consent procedures from a privacy and security perspective.