Clinical trials are closely monitored to ensure they are run in an ethical manner. Your rights and safety are protected through:
- Informed consent
- Careful review and approval of the clinical trial protocol by Health Canada, the hospital or clinic where the trial takes place, and the hospital or clinic’s research ethics board.
- Ongoing monitoring during the trial by Health Canada, the research ethics board and your research team
What is Informed Consent?
Informed consent is a process through which you learn the purpose, risks, and benefits of a clinical trial before deciding whether to join. It is a critical part of ensuring patient safety in research. During the informed consent process you learn important information about a clinical trial. This information can help you decide whether to join.
The research team, which is made up of doctors and nurses, first explains the trial to you. The team explains the trial's:
- Tests and procedures
- Risks and benefits
They will also discuss your rights, including your right to:
- Make a decision about participating
- Leave the study at any time
Before agreeing to take part in a trial, you have the right to:
- Learn about all your treatment options
- Learn all that is involved in the trial - including all details about treatment, tests, and possible risks and benefits
- Discuss the trial with the principal investigator and other members of the research team
- Both hear and read the information in language you can understand
After discussing all aspects of the study with you, the team gives you an informed consent form to read. The form includes written details about the information that was discussed and also describes the privacy of your records. If you agree to take part in the study, you sign the form.
You can leave the study at any time, even after you sign the consent form. If you decide to leave the study, your doctor will discuss other treatment options with you.
Study Approval and Ongoing Monitoring
All clinical trials involving a new treatment or a different way of using a current treatment must be approved and monitored by 3 different groups:
- Health Canada
- The hospital or clinic where the trial takes place
- The hospital or clinic’s
Research Ethics Board
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Adapted from National Cancer Institute