A new guide to consent to clinical research has been published in the Canadian Medical Association Journal (CMAJ). The aim is to put the needs of the study participants in the foreground and to simplify approval procedures. Developed by the Canadian Critical Care Trials Group in partnership with the Canadian Institutes of Health Research, the guide provides a consistent basis for informed consent across Canada.

The guide defines 75 core elements for informed consent forms that are intended to ensure transparency and comprehensibility for participants. These include sections such as information about participation, the course of the study, and possible risks and benefits. By providing a fillable template, the documentation of informed consent is standardized, which is particularly advantageous for multicenter research projects. The template meets the legal requirements for clinical trials in Canada and is available in various formats at www.ccctg.ca/core-consent.

Traditional consent forms are often overloaded with regulatory and institutional requirements, which makes it difficult for participants to understand and can affect their ability to make informed decisions. The new guide aims to solve these problems by providing clear and concise information. It also serves as an ethical tool for research ethics committees when evaluating studies with human participants.

The introduction of the guide is seen as a step towards a more uniform and participant-friendly practice in clinical research. The aim is to increase efficiency and improve the quality of consent by harmonizing approval processes in order to increase participants’ trust in scientific studies.

Original Paper:

Core elements of consent documentation for clinical research in Canada: guidance for policy | CMAJ

Editor: X-Press Journalistenbüro GbR

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