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

ABSTRACT:

Background

Consent forms have become too long and often do little to help people understand the risk elements of their participation in research, instead focusing on risk reduction for research institutions. Under the auspices of the Canadian Institutes of Health Research and the Canadian Critical Care Trials Group, we identified a core set of elements for participant consent documents to be used in clinical research and present these as a template consent form.

Methods

Our guideline core team comprised experts in the legal and ethical aspects of research, and a clinical trialist-scientist. We conducted a directed review to compile a list of applicable regulatory, policy, and guidance requirements for the documentation of informed consent for research conducted with human pa

SUBMITTER: Longstaff H 

PROVIDER: S-EPMC12448764 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature