California Health and Safety Code 24178 – (a) Except for this section and the requirements set forth in …
(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.
Terms Used In California Health and Safety Code 24178
- department: means State Department of Health Services. See California Health and Safety Code 20
- Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
- 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:
California Health and Safety Code 24173
- medical experiment: means :
California Health and Safety Code 24174
- Person: means any person, firm, association, organization, partnership, business trust, corporation, limited liability company, or company. See California Health and Safety Code 19
- Spouse: includes "registered domestic partner" as required by §. See California Health and Safety Code 12.2
(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 § 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 § 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.
(Amended by Stats. 2003, Ch. 397, Sec. 3. Effective January 1, 2004.)