SESSION KEYWORDS: CIHR, Minimal Consent, Clinical Research

SESSION ABSTRACT

We return to CAREB to present the first draft of the Pan-Canadian Minimal Consent for Clinical Research, the core objective of the CIHR Pan-Canadian Minimal Consent project: the production of a template that outlines a list of minimal requirements for research consent that, along with the additional required elements for submission of a complete research package, can be used by TCPS-compliant Canadian research ethics boards (REBs) to document the informed consent process thus facilitating the harmonization of ethics review of clinical studies. We again seek CAREB input as this community of practice is instrumental to the project’s success. Clinical studies that involve multiple hospitals or research programs require ethics approval in each applicable jurisdiction. Requirements for ethics approval differ among institutional and provincial REBs, including requirements for informed consent, a key element of the ethics submission. The requests for changes in the materials are at times complex and cause delays, due to inconsistencies across REB requirements. Informed consent forms are getting longer but are not leading to increased awareness of risk on the part of the participant. Further, participants often report dissatisfaction with these documents and have called for simplification of informed consent forms where possible. The scope for this project is the informed consent requirements for clinical studies involving human participants (clinical trials and observational studies) that are not minimal risk. This project is co- lead by the Canadian Critical Care Trials Group and COVID-19 Network of Clinical Trials Networks and CIHR’s Ethics Office. It follows the methods of a previous successful project to create a core set of elements for documents used to obtain participant consent for human genomics research in Canada which is now published in CMAJ. The CIHR Pan-Canadian Minimal Consent Project is led by a small team (the authors of this presentation) that is guided by an Advisory Group of experts from across Canada including REB administrators, research ethics experts, researchers, and patients. The second project deliverable that we seek to present at CAREB is the first draft of the Minimal Consent. After conducting a gap analysis and discussing it in various fora, the team proceeded to identify, from a participant’s point of view, what requirements are necessary to help making a decision regarding the active participation on a research. Elements incidental to the protection of the participant were left out from the draft consent template and now are part of its companion, the research package. After incorporating CAREB’s input we will have a new meeting of the Advisory Committee and a series of consultations with patients and their representatives and other stakeholders. We expect to have a pre-final draft uploaded for public consultation later this year. After reflecting on all input, we intend to submit the template for publication by early 2025.