Tri-Council Policy Statement (TCPS) 2 Core Practice Exam

When harm or concerns arise in research, the focus is on formal, recognized channels that protect participants. The primary route is to raise the issue with the Research Ethics Board (REB) or the institution’s research ethics office. This independent body reviews what happened, checks whether the informed consent process and participant protections were adequate, and determines steps to remedy the situation. Remediation can include a range of actions, such as revising consent materials or the consent process to ensure future participants are better informed, stopping or modifying the study procedures, and offering appropriate supports to the harmed participant—like medical care, counseling, or other services. Institutions may also have policies that outline compensation or other remedies if harm occurred, aligned with legal and policy requirements. The key point is that redress is pursued through established ethical-review channels that are designed to protect participants and uphold research integrity, rather than immediate legal action or other ad hoc options. Other options aren’t the standard first routes. Leaving the study doesn’t address the harm, and financial compensation from a sponsor is not guaranteed or universally available. Pursuing court action as the initial step bypasses the ethical oversight process that exists to safeguard participants and ensure appropriate remedies.