Learning about a Clinical Trial - Informed Consent
Informed consent is a process through which you learn details about the trial before deciding whether to take part. This process includes learning about the trial’s purpose and possible risks and benefits. It is a critical part of ensuring patient safety in research.
During the informed consent process, the research team, which is made up of doctors and nurses, first explains the trial to you. The team explains the trial's:
- Purpose
- Procedures
- Risks and benefits
- They will also discuss your rights, including your right to:
- Make a decision about taking part
- 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 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 sign the form. But even after you sign the consent form, you can leave the study at any time. You can always ask questions. And, as new information becomes available, the research team will inform you.
Questions to Ask Your Care Team
Even after you've seen the information provided as part of the informed consent process, you can still ask your doctor and clinical providers any other questions you may have. Here are some questions you to consider with you care team.
Questions about the Trial
- What is the purpose of the trial?
- Why do the researchers believe that the treatment being studied may be better than the one being used now? Why may it not be better?
- How long will I be in the trial?
- What kinds of tests and treatments are involved?
- How will the doctor know if the treatment is working?
- How will I be told about the trial’s results?
- How long do I have to make up my mind about joining this trial?
- Who can I speak with about questions I have during and after the trial?
- Who will oversee my care?
- Is there someone I can talk to who has been in the trial?
- Questions about risks and benefits
- What are the possible side effects or risks of the new treatment?
- What are the possible benefits?
- How do the possible risks and benefits of this trial compare to those of the standard treatment?
Questions about Your Rights
- How will my health information be kept private?
- What happens if I decide to leave the trial?
- Questions about Costs
- Which costs do I have to pay if I take part in the trial?
- What costs will my health insurance cover?
- Who pays if I’m injured in the trial?
- Who can help answer questions from my insurance company?
- Who can I talk with about costs and payments?
Questions about Daily Life
- How could the trial affect my daily life?
- How often will I have to come to the hospital or clinic?
- Will I have to stay in the hospital during the clinical trial? If so, how often and for how long?
- How far will I need to travel to take part in the trial?
- Will I have check-ups after the trial?
Questions about Comparing Choices
- What are my other treatment choices, including standard treatments?
- How does the treatment I would receive in this trial compare with the other treatment choices?
- What will happen to my cancer without treatment?
Text adapted from the National Cancer Institute; images provided by Genentech. Reviewed on November 15, 2023.