The Research Ethics Boards have agreed to adopt the World Health Organization (WHO) definition of a clinical trial and to apply this definition to all applications received for review: "A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes."
This will ensure all researchers at the University of Waterloo are working from the same definition.
If a research study is a clinical trial, the study must be registered in a publicly available registry such as clinicaltrials.gov.
In addition, all researchers who are conducting biomedical research, which involves both clinical studies and clinical trials, are to register their study in a publicly available registry even if their study does not perfectly fit the definition of a clinical trial. This is to:
- ensure researchers are aware of similar studies so that they may avoid unnecessary duplication and reduce the burden on participants,
- improves researchers’ ability to identify potential collaborators and/or gaps in research so that they may pursue new avenues of inquiry with potential benefits to participants and to society,
- avoids the danger that some researchers or sponsors may only report trials with favourable outcomes since failing to report the outcome of a trial or withholding negative findings is more difficult when all trials must be registered.