Section 24178 Of Chapter 1.3. Human Experimentation From California Health And Safety Code >> Division 20. >> Chapter 1.3.
24178
. (a) Except for this section and the requirements set forth
in Sections 24172 and 24176, this chapter shall not apply to any
person who is conducting a medical experiment as an investigator
within an institution that holds an assurance with the United States
Department of Health and Human Services pursuant to Part 46 of Title
45 of the Code of Federal Regulations and who obtains informed
consent in the method and manner required by those regulations.
(b) Subdivisions (c) and (e) shall apply only to medical
experiments that relate to the cognitive impairment, lack of
capacity, or serious or life-threatening diseases and conditions of
research participants.
(c) For purposes of obtaining informed consent required for
medical experiments in a nonemergency room environment, and pursuant
to subdivision (a), if a person is unable to consent and does not
express dissent or resistance to participation, surrogate informed
consent may be obtained from a surrogate decisionmaker with
reasonable knowledge of the subject, who shall include any of the
following persons, in the following descending order of priority:
(1) The person's agent pursuant to an advance health care
directive.
(2) The conservator or guardian of the person having the authority
to make health care decisions for the person.
(3) The spouse of the person.
(4) An individual as defined in Section 297 of the Family Code.
(5) An adult son or daughter of the person.
(6) A custodial parent of the person.
(7) Any adult brother or sister of the person.
(8) Any adult grandchild of the person.
(9) An available adult relative with the closest degree of kinship
to the person.
(d) (1) When there are two or more available persons who, pursuant
to subdivision (c), may give surrogate informed consent and who are
in the same order of priority, if any of those persons expresses
dissent as to the participation of the person in the medical
experiment, consent shall not be considered as having been given.
(2) When there are two or more available persons who are in
different orders of priority pursuant to subdivision (c), refusal to
consent by a person who is a higher priority surrogate shall not be
superseded by the consent of a person who is a lower priority
surrogate.
(e) For purposes of obtaining informed consent required for
medical experiments in an emergency room environment, and pursuant to
subdivision (a), if a person is unable to consent and does not
express dissent or resistance to participation, surrogate informed
consent may be obtained from a surrogate decisionmaker who is any of
the following persons:
(1) The person's agent pursuant to an advance health care
directive.
(2) The conservator or guardian of the person having the authority
to make health care decisions for the person.
(3) The spouse of the person.
(4) An individual defined in Section 297 of the Family Code.
(5) An adult son or daughter of the person.
(6) A custodial parent of the person.
(7) Any adult brother or sister of the person.
(f) When there are two or more available persons described in
subdivision (e), refusal to consent by one person shall not be
superseded by any other of those persons.
(g) Surrogate decisionmakers described in this section shall
exercise substituted judgment, and base decisions about participation
in accordance with the person's individual health care instructions,
if any, and other wishes, to the extent known to the surrogate
decisionmaker. Otherwise, the surrogate decisionmaker shall make the
decision in accordance with the person's best interests. In
determining the person's best interests, the decisionmaker shall
consider the person's personal values and his or her best estimation
of what the person would have chosen if he or she were capable of
making a decision.
(h) Research conducted pursuant to this section shall adhere to
federal regulations governing informed consent pursuant to Section
46.116 of Title 45 of the Code of Federal Regulations.
(i) Any person who provides surrogate consent pursuant to
subdivisions (c) and (e) may not receive financial compensation for
providing the consent.
(j) Subdivisions (c) and (e) do not apply to any of the following
persons, except as otherwise provided by law:
(1) Persons who lack the capacity to give informed consent and who
are involuntarily committed pursuant to Part 1 (commencing with
Section 5000) of Division 5 of the Welfare and Institutions Code.
(2) Persons who lack the capacity to give informed consent and who
have been voluntarily admitted or have been admitted upon the
request of a conservator pursuant to Chapter 1 (commencing with
Section 6000) of Part 1 of Division 6 of the Welfare and Institutions
Code.