Rationale, Purpose and Scope
The advancement and integration, as well as possibilities, of technology in the everyday life of Canadian citizen and residents calls for the movement of research ethics boards and regulatory agencies in recognizing the use of technology in the informed consent process. Technology may provide opportunities as well as new ideas. However, this also presents new questions and concerns. The term written informed consent is often viewed as synonymous with obtaining handwritten (‘wet ink’) signatures from a study participant or their legal representative on a paper informed consent document. However, the term written is not defined and can be interpreted differently. The Canadian legal system recognizes and qualifies an electronic signature, obtained & documented in compliance with the regulations set out in the Canadian Evidence Act and the Personal Information Protection and electronic documents Act (PIPEDA), as equal to a handwritten (‘wet ink’) signature of an individual.
This document outlines the policy of the CHEO REB regarding the use of electronic consent forms (eIC) and electronic signatures (eSIG) in the consent process for researchers.
The use of eIC & eSIG for consent processes will be limited to non-regulated research studies. Consultation with the regulatory authorities is an on-going venture.