Experimental Subject’s Bill of Rights Required for California Sites Only



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Experimental Subject’s Bill of Rights

Required for California Sites Only
The Protection of Human Subjects in Medical Experimentation Act (California Health and Safety Code 24170 – 24179.5) requires that a potential experimental subject (or subject’s conservator, guardian, or other representative) be provided with a list of the rights of a subject in a medical experiment. A copy of this Experimental Subject’s Bill of Rights should be provided to a subject prior to consenting to participate in any medical experiment.
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:

  1. Be informed of the nature and purpose of the experiment.

  2. Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized.

  3. Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment.

  4. Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable.

  5. 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.

  6. Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise.

  7. Be given an opportunity to ask any questions concerning the experiment or other procedures involved.

  8. Be instructed that consent to participate in the medical experiment may be withdrawn at any time, and the subject may discontinue participation in the medical experiment without prejudice.

  9. Be given a copy of a signed and dated written consent form as provided for by California law.

  10. 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.

________________________________________________________

Signature of Subject (Conservator, Guardian, or Other Representative)

___________________



Date

F-026.01, Experimental Subject’s Bill of Rights Revised 1/07



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