Informed consent process

What is informed consent?

Informed consent is the process that explains a clinical trial before someone agrees to take part. The informed consent process provides time to learn about the clinical trial, ask questions, and carefully decide whether participation feels right. It involves:

• Conversations with the clinical trial team
• Opportunities to ask questions
• Written information explaining the trial
• Time to consider the decision without pressure

What happens during the informed consent process?

• 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.