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Common Terms to Understand When Considering a Clinical Trial

The Informed Consent Form

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The informed consent form should include provisions to the effect that:

  • The study involves research, including a statement about the purpose of the research.
  • A description of the trial, including the length of time, the research procedures that will be used, and description of any procedure that are considered to be experimental.
  • A description of the possible risks and benefits to participants.
  • A description of your options for treating your condition if you do not participate in the trial.
  • An Institutional Review Board will oversee the study.
  • You will be warned of known potential risks and side effects.
  • You will be informed right away of any adverse findings that appear during the course of the trial that would cause a prudent person to consider discontinuing the trial.
  • You have a right to drop out of the study at any time, with no cost to you.
  • If you will receive compensation, a description of the amount and when you will be paid.
  • All information concerning you individually will be kept confidential.
  • Who pays for expenses if you are injured in a trial.
  • You do not give up a right to sue in the event of injury.
  • A description of your rights as a participant in the trial.
  • Contact information in case you have questions about the research, your rights and who to contact in the event of a research-related injury. 

If there are major changes to the trial, you will be given a new Informed Consent form to sign. Review it as carefully as the original.

Your copy of the Informed Consent Agreement should be stored in a safe place for future reference. 

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