Prescriptive or formulaic approaches to writing an "information and Consent Document: is to be strongly avoided. Rather, investigators must draft these documents by considering the specific type and nature of the research and the population to be recruited. The “FRSQ Working Group for the Harmonization of the Information and Consent Document,” produced a working document that serves as an educational, informational and guidance resource. Although designed specifically for clinical trials, it is an excellent reflection tool to help with writing most types of Information and Consent Documents for human subjects research.
The translated English version of this template has been slightly modified from the original French. The most significant modification is the reduced literacy level of the “consent document text” (highlighted in yellow), which remains much higher in the French version. At the MUHC, the recommended literacy level for the information and consent document is Grade 8.
- For those conducting research on children, please contact the elizabeth [dot] craven [at] mail [dot] mcgill [dot] ca (Pediatric Research Ethics Board Coordinator) for consent and assent templates.
- English and French versions of the Information and Consent Document must be available to potential participants. This document can be submitted to for ethics review in either language. Once the document is approved by the REB, a translated version must be submitted and approved. The versions must be consistent with each other.