Subjects Rights

Experimental Subject’s Bill of Rights

Informed Consent Process (US FDA)

Any person who is requested to consent to participate as a subject in a research study involving a medical experiment, or who is requested to consent on behalf of another, has the right to:

  • Be informed of the nature and purpose of the experiment.
  • Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be used.
  • Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment.
  • Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable.
  • Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits.
  • Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise.
  • Be given an opportunity to ask any questions concerning the experiment or the procedures involved.
  • Be instructed that consent to participate in the medical experiment may be withdrawn at any time, and the subject may discontinue participation in the medical experiment without prejudice.
  • Be given a copy of a signed and dated written consent form when one is required.
  • Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject’s decision.