Informed consent is when you learn details about the trial before deciding whether to take part in it. You will learn about the trial’s purpose and possible risks and benefits. This is a critical part of ensuring patient safety in research.
Informed Consent Process
During the informed consent process, the research team – made up of doctors and research coordinators – will first explain the trial to you, describing in detail its:
- Risks and benefits
They will also discuss your rights 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 treatments, tests, and possible risks and benefits
- Discuss the trial with the study doctor and other members of the research team
- Hear and read the information in a language you can understand
After discussing the study with you, the research team will give you an informed consent form to read. The form includes written details about the information that was discussed with you and describes the privacy of your medical records.
If you agree to take part in the study, you must sign the form. But even after you sign the consent form, you can leave the study at any time. You can always ask the research team questions. As new information becomes available, the research team will inform you.