Guide
Informed consent and your rights
Before you join a study, the study team must explain it fully and get your agreement. This is called informed consent, and it doesn't end when you sign: you can ask questions or leave at any time.
What the consent form must tell you
U.S. federal rules (45 CFR 46.116) require the consent process to cover:
- That the study is research, and what it's for
- How long you'll take part and what happens at each visit
- Which parts are experimental
- The risks and discomforts you might reasonably expect
- Any possible benefits to you or others
- Other treatments that might be available to you instead
- How your personal information will be kept confidential
- For higher-risk studies, whether treatment or compensation is available if you're injured
- Who to contact with questions about the study or your rights
- That taking part is voluntary
Your rights
- You can say no. Refusing won't affect the care you're otherwise entitled to.
- You can leave at any time, without penalty or loss of benefits you'd otherwise have.
- You can take your time. Take the form home, read it and talk it over with family or your own doctor.
- You can ask questions before, during and after the study.
If you leave a study
Tell the study team you want to stop. They may ask you to come for a final safety check, but that's your choice. Information collected before you left is usually kept and used as the consent form describes, so check that section before you sign.
Children in studies
Children under 18 can't give legal consent. A parent or guardian gives permission, and the child is asked to agree too, in words they can understand.
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