Experimental Subject's Bill of Rights
Experimental Subject's Bill of Rights
As a research participant you have the following rights. These rights include but are not limited to the participant's 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 utilized;
- be given a description of any attendant discomforts and risks reasonably to be expected;
- be given an explanation of any benefits to the subject reasonably to be expected, if applicable;
- be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, 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 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- be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice;
- be given a copy of the signed and dated consent form; and
- 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
California Law, under Health & Safety Code (HSC) § 24172, requires that research participants who take part in a "medical experiment" receive a copy of the Experimental Subject's Bill of Rights in a language in which the participants are fluent. Translations can be found within the available Short Form Consent templates
"Medical experiment" is defined (CA HSC § 24174) as an experiment including one or more of the following activities:
- The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject.
- The investigational use of a drug or device as provided in Sections 111590 and 111595.
- Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject.