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Informed consent and your rights

Informed consent is not just a signature. It is a conversation that is supposed to give you what you need to decide, and a decision that stays yours.

Key takeaways

  • Consent is a process: you read, ask, think it over, and only then decide.
  • You may take the document home and talk with family or your own doctor.
  • You can say no, and you can stop later, without losing your usual care.

01 What it is

Before anyone joins a study, the research team must explain it in language the person can understand and make sure the person is joining voluntarily. U.S. federal rules require this for studies they cover. The consent form is a written summary of that conversation, but the conversation is the point.

02 What the document should cover

  • The purpose of the study and how long it lasts
  • What will happen, including visits, tests, and any treatments
  • Possible risks and discomforts, and possible benefits (if any)
  • Other options you have outside the study
  • How your information will be kept private
  • Whether there are costs or payments, and what happens if you are hurt
  • That taking part is voluntary and you can stop at any time
  • Who to contact with questions or concerns

03 Your rights, in plain terms

  • Time. You do not have to decide on the spot.
  • Questions. Ask anything, as many times as you need.
  • A copy. You are entitled to a copy of what you signed.
  • An independent voice. You can bring a family member, a friend, or your own doctor into the decision.
  • The exit. You can leave the study at any time. Your decision should not affect your usual medical care.

04 Red flags worth a second look

  • Pressure to sign right away
  • Promises that a treatment will work or that there is no risk
  • A consent form that is rushed through, or that you are not allowed to take home
  • No clear way to reach the study team, or to reach an independent review board

If any of these appear, pause and ask questions. You can also ask the institutional review board listed on the form, which exists to protect participants.

05 Where Clintivo fits

We are not a study team, so we do not collect consent for any study and we never sign you up for one. The consent we collect on this site is only about our own messages, and it is optional and separate. This guide is general information, not legal or medical advice.

General information only. This guide is not medical, legal, or financial advice, and Clintivo is not a medical provider. Talk with your own doctor about your health.

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