Informed consent process

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  • A doctor or nurse explains the clinical trial in clear, plain language. Questions are encouraged at any time.
  • You receive a written form outlining the trial, including its purpose, procedures, possible risks and benefits, and participant responsibilities.
  • You take time to review the information and decide whether participation feels right.
  • You sign the form only if you fully understand and agree to take part. When signed, this form becomes a legal record showing the decision to participate was made voluntarily.
  • A copy of the signed form is provided to keep.

If new information becomes available during the trial, you are informed and can decide whether to continue.

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Who makes sure the process is appropriate?

An Institutional Review Board (IRB) reviews the informed consent materials before the clinical trial begins. The consent form includes an approval stamp showing when it was reviewed and how long the approval lasts. The IRB helps make sure:

  • Information is clear and accurate
  • Risks are explained clearly
  • The language is understandable
  • Participation is voluntary

Learn more about how the IRB plays a role in clinical trial safety.

What should I learn next?

What are the risks of clinical trials?

Understand the possible risks in clinical trials and how they’re managed.

How do I join a clinical trial?

Learn about enrolling in a clinical trial and how to ask for help with the process.

Find a clinical trial

Our TrialFinder site makes it easy to search for clinical trials based on your condition and location.

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Call us for help

Our CareLine case managers can answer your questions about clinical trials. Call:
1-855-329-5969

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Learn more about the services and programs offered by Patient Advocate Foundation to support patients.

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