Informed Consent

Informed Consent

The informed consent for a clinical trial is both a document and a process.

Informed consent is crucial to ensuring participant safety in research. The principle of informed consent is based on a 1914 U.S. Supreme Court decision which stated that every adult human being of sound mind has the right to determine what shall be done with their own person. Informed consent is an ongoing process during which potential participants learn important information about a clinical trial. This information helps them decide whether to participate.

The Document:

  • Summarizes the clinical trial — its purpose, treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.
  • Explains your rights as a participant.
  • Does not have to be signed immediately. You will be given a copy of the consent form.
  • A participant in a clinical trial can drop out at any time once the document is signed.

The Process:

Informed consent is an ongoing process of communication involving the patient, caregivers, and key members of the medical care team.

Participants can expect:

An initial meeting with the research team which could include physicians, nurses, social workers, and other patient representatives. They will answer questions and address concerns.  The team explains the trial’s:

  • Purpose
  • Procedures
  • Risks and benefits.

The research team also informs participants of their rights, including:

  • The availability of alternative treatment
  • The right to leave the trial at any time.

Tips for Participants:

  • Bring along a relative or friend when you meet with the research team. It’s important to have support during this process.
  • Write down questions in advance, so you don’t forget to ask them.  If there is anything you don’t understand, ask questions until you have all the information you need to make an informed decision about whether to begin or continue participating in a trial.
  • Don’t hesitate to ask questions — your health is at stake. Ask for clarification of confusing language in the document. Sometimes repeating the information in your own words can help you to understand.

The informed consent process does not end once the form is signed. If new benefits, risks, or side effects are discovered during a trial, the researchers must inform study participants. In addition, participants are encouraged to ask questions at any time during the trial. Thus, participants can make informed decisions about whether to continue participating.

Page last updated on Mar. 24, 2009