Trial Participants: Informed Consent, GCP, Patient Involvement

4. Patients Can Get Information From Their Healthcare Professionals

4.2. What is Informed Consent?

There are several procedural safeguards built into the clinical trial process that continue throughout the study to protect the participant.

Informed consent is one of the ways that participants are protected during enrolment into a clinical trial and continues throughout the trial. During this process, potential participants learn the purpose and the potential burdens, risks and benefits of a trial before deciding whether or not they wish to participate.

Informed consent explains the trial to potential participants in understandable language including:
  • Purpose.
  • Procedures.
  • Risks and potential benefits.
  • Participant rights including the right to:
    • Make an independent decision about participating.
    • Leave the study at any time without jeopardising future treatment.
Sponsors are encouraged to have patient organisations read the informed consent documentation for content and language prior to submitting the CTA.