As used in this chapter, “informed consent” means the authorization given pursuant to Section 24175 to have a medical experiment performed after each of the following conditions have been satisfied:
(a) The subject or subject’s conservator or guardian, or other representative, as specified in Section 24175, is provided with a copy of the experimental subject’s bill of rights, prior to consenting to participate in any medical experiment, containing all the information required by Section 24172, and the copy is signed and dated by the subject or the subject’s conservator or guardian, or other representative, as specified in Section 24175.
(b) A written consent form is signed and dated by the subject or the subject’s conservator or guardian, or other representative, as specified in Section 24175.
(c) The subject or subject’s conservator or guardian, or other representative, as specified in Section 24175, is informed both verbally and within the written consent form, in nontechnical terms and in a language in which the subject or the subject’s conservator or guardian, or other representative, as specified in Section 24175, is fluent, of the following facts of the proposed medical experiment, which might influence the decision to undergo the experiment, including, but not limited to:
(1) An explanation of the procedures to be followed in the medical experiment and any drug or device to be utilized, including the purposes of the procedures, drugs, or devices. If a placebo is to be administered or dispensed to a portion of the subjects involved in a medical experiment, all subjects of the experiment shall be informed of that fact; however, they need not be informed as to whether they will actually be administered or dispensed a placebo.
(2) A description of any attendant discomfort and risks to the subject reasonably to be expected.
(3) An explanation of any benefits to the subject reasonably to be expected, if applicable.
(4) A disclosure of any appropriate alternative procedures, drugs, or devices that might be advantageous to the subject, and their relative risks and benefits.
(5) An estimate of the expected recovery time of the subject after the experiment.
(6) An offer to answer any inquiries concerning the experiment or the procedures involved.
(7) An instruction to the subject that he or she is free to withdraw his or her prior consent to the medical experiment and discontinue participation in the medical experiment at any time, without prejudice to the subject.
(8) The name, institutional affiliation, if any, and address of the person or persons actually performing and primarily responsible for the conduct of the experiment.
(9) The name of the sponsor or funding source, if any, or manufacturer if the experiment involves a drug or device, and the organization, if any, under whose general aegis the experiment is being conducted.
(10) The name, address, and phone number of an impartial third party, not associated with the experiment, to whom the subject may address complaints about the experiment.
(11) The material financial stake or interest, if any, that the investigator or research institution has in the outcome of the medical experiment. For purposes of this section, “material” means ten thousand dollars ($10,000) or more in securities or other assets valued at the date of disclosure, or in relevant cumulative salary or other income, regardless of when it is earned or expected to be earned.
(d) The written consent form is signed and dated by any person other than the subject or the conservator or guardian, or other representative of the subject, as specified in Section 24175, who can attest that the requirements for informed consent to the medical experiment have been satisfied.
(e) Consent is voluntary and freely given by the human subject or the conservator or guardian, or other representative, as specified by Section 24175, without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence.
(Amended by Stats. 2003, Ch. 397, Sec. 1. Effective January 1, 2004.)
Last modified: October 25, 2018