Informed consent should be obtained by investigators prior to beginning randomization and treatment protocols. This should include, at the least consent that is voluntary, informed, and ongoing. It is understood that consent from the participant may be withdrawn at any time. The voluntariness of consent implies that it is free of outside pressure, undue influence, or coercion. Information provided to the prospective participant, both verbal and written, should include: identity of the researcher(s), any conflict of interest, duration and nature of participation, expected duration, description of research procedures, any potential benefits, any reasonably foreseeable risks, strategies for dissemination of research results, and researcher contact information.

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans - TCPS 2 (2018)

There is a requirement that all clinical trials be registered in a publicly accessible registry prior to recruitment of the first trial participant. There currently exist greater than 20 trial registries worldwide.

Examples of registries include:

• Health Canada: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/health-canada-clinical-trials-database.html

• WHO International Clinical Trials Registration Platform or ICTRP) https://www.who.int/clinical-trials-registry-platform

This registration process increases transparency and accountability by providing a record of clinical trials by:

• Improving researcher awareness of similar studies to prevent

• Improving the researchers’ ability to identify potential collaborators and gaps in research that may lead to new avenues of inquiry

• To more easily identify when study findings have been withheld

• Trial registration ensures that all studies, not simply those with favourable results are reported.