24173
. 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.