Informed Consent – Beyond the Signature

While a fully executed and signed informed consent form (ICF) is an important component of the consent record, the signature alone does not demonstrate the consent process. Clinical trial teams must be able to demonstrate that participants received appropriate information, had the opportunity to ask questions of the investigator and/or delegate and consider participation, understood the information relevant to their decision, and made a voluntary decision before any trial-related procedures were performed.

With ICH E6(R3) fully adopted by Health Canada as of April 1, 2026, CCTG would like to reinforce expectations regarding the consent discussion process throughout our trials.

In advance of consenting participants, the investigator should have the REB’s documented approval/favourable opinion of the informed consent process and materials (2.8.1.(a)).

The source records should allow an independent reviewer to understand how consent was obtained and not just indicate that “ICF was reviewed and signed” without evidence of an actual discussion. With that said, what are the elements of a great consent discussion note?

• Trial and Participant Identification: trial title/protocol number, date, participant ID and method of participant identity verification (2.8.1.(e)).
• Consent materials: most recent REB-approved version and any supporting REB-approved participant materials provided or discussed.
• Who conducted the discussion: name and role of individual(s) who were conducting the informed consent discussion.
• Information discussed: while all required elements outlined in 2.8.10. must be presented and understood by the prospective participant, best practice may not require documentation of each item explicitly, as all required elements are documented within CCTG’s ICF. Documentation of the consent discussion should clearly illustrate that the entirety of the ICF content was discussed and understood. 
• Voluntariness and rights: confirm that participation is free and that no coercion or undue influence was used. Consent is an ongoing discussion throughout the life of a clinical trial and withdrawal of participation at any point is permitted without penalty or loss of entitled benefits.
• Questions and understanding: participant was given ample opportunity to read/review the information, documentation of questions raised and that they were answered to the participant’s satisfaction, and record any material points requiring clarification.
• Decision and documentation: document that participant agreed to participate, signed, and dated the REB-approved ICF before trial participation and received a copy of the fully executed ICF.
• Special circumstances: document if interpreter/impartial witness was used and method of discussion (in-person/remote).

The consent discussion process may be documented in a variety of ways, including but not limited to detailed progress/nursing notes, standardized institutional templates, checklists, or forms, standardized scripts, or trial-specific materials.

As informed consent is an ongoing process, these same principles apply when any new information and/or revised consent materials are subsequently communicated to participants. When re-consenting participants, the new information should be clearly identified in the revised informed consent materials (2.8.2.). CCTG will facilitate this process by providing an informed consent addendum that clearly identifies how the information has changed.

Please also remember that the consent process/discussion should comply with any additional requirements per applicable institutional SOPs, provincial/local policies, regulations and any additional trial-specific requirements. All additional requirements should all be applied together alongside ICH E6(R3).

CCTG appreciates your continued attention to participant protection and inspection readiness across our trials. If you have any questions, please send them to monitoring@ctg.queensu.ca.