What is informed consent?

Informed consent is the process that makes sure you understand a clinical trial before you agree to take part. It is a fundamental protection for research participants and is required by law and by research ethics guidelines around the world.

Before you join a study, the research team must explain its purpose, what you will be asked to do, how long it will last, the possible risks and benefits, any alternatives to taking part, and how your personal information will be protected. This information is also provided in writing, usually as a participant information sheet you can take home.

You should have as much time as you need to read the information, ask questions and talk to your doctor, family or friends. A good research team will never pressure you to sign quickly, and you can request explanations in plain language or through an interpreter if needed.

Signing the consent form is not the end of the process. Consent is ongoing: the team must keep you informed of any new information that might affect your willingness to continue, such as newly discovered side effects. If the study changes in an important way, you may be asked to consent again.

Crucially, consent can be withdrawn at any time. Agreeing to join a trial today does not oblige you to stay in it, and leaving will not affect your usual medical care.

If any part of a consent form or information sheet is unclear, ask. Understanding exactly what you are agreeing to is your right, and helping you understand is part of the research team's job.