What is informed consent?

What informed consent means in a clinical trial, what the consent form covers, your rights, and how you can withdraw at any time.

6 min read · Informational only, not medical advice.

An ongoing conversation

Informed consent is more than a signature. It is a process where the research team explains the study and answers your questions before and during the trial.

You should never feel rushed. You can take the form home, read it with family, and talk to your own doctor before signing.

What the consent form covers

Purpose, procedures, duration, foreseeable risks, potential benefits, alternatives, confidentiality and contacts for questions.

It also explains whether there is a placebo, what costs or payments are involved, and what happens if you're injured during the study.

Your rights

Participation is always voluntary. You may withdraw at any time without losing access to the care you would otherwise receive.

You have the right to ask questions at any point, to be told about new information that might change your mind, and to get a copy of the signed form.

Who reviews the form

An Institutional Review Board (IRB) reviews and approves the consent form before the study can use it. The IRB checks that the form is clear, complete and fair. The form lists a contact, often at the IRB, you can call if you have concerns that you'd rather not raise with the study team.

Consent can change during a study

If the researchers learn something important — such as a new side effect — they must tell you and may ask you to sign an updated form.

This is called re-consent. It gives you a fresh chance to decide whether you want to continue.

Consent for others

When a participant can't give consent on their own — such as a child or an adult with memory problems — a parent or legally authorized representative can give permission.

Children old enough to understand are usually asked to agree too; this is called assent.

Leaving a study

To withdraw, tell the study team you want to stop. They may suggest a final safety check, and they'll explain what happens to information already collected, but the decision is yours.

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Quick answers

What is informed consent in a clinical trial?: Informed consent is more than a signature. It is a process where the research team explains the study and answers your questions before and during the trial.
What does a consent form cover?: Purpose, procedures, duration, foreseeable risks, potential benefits, alternatives, confidentiality and contacts for questions.
Can I leave a clinical trial after signing consent?: Participation is always voluntary. You may withdraw at any time without losing access to the care you would otherwise receive.
Who approves the consent form?: An Institutional Review Board (IRB) reviews and approves the consent form before the study can use it.
Can the consent form change during the study?: If the researchers learn something important — such as a new side effect — they must tell you and may ask you to sign an updated form.

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