AB 58, as amended, Wieckowski. Medical experiments: human subjects.
Existing law regulates the conduct of medical experiments on human subjects and requires informed consent prior to conducting medical experiments on human subjects. Existing law, until January 1, 2014, exempts from this requirement a medical experimental treatment that benefits a patient subject to a life-threatening emergency if specified conditions are met, including that the patient is in a life-threatening situation necessitating urgent intervention and available treatments are unproven or unsatisfactory and informed consent cannot be obtained before treatment must be administered.
This bill would continue the exemption for life-threatening emergencies indefinitely.
Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no.
The people of the State of California do enact as follows:
Section 24177.5 of the Health and Safety Code
2 is amended to read:
(a) This chapter does not apply to a medical
2experimental treatment that benefits a patient subject to a
3life-threatening emergency if all of the following conditions are
4met:
5(1) Care is provided in accordance with the procedures and the
6additional protections of the rights and welfare of the patient set
7forth in Part 50 of Title 21 of, and Part 46 of Title 45 of, the Code
8of Federal Regulations, in effect onbegin delete December 31, 2010end deletebegin insert April 1,
92012end insert.
10(2) The
patient is in a life-threatening emergency necessitating
11urgent intervention and available treatments are unproven or
12unsatisfactory.
13(3) The patient is unable to give informed consent as a result of
14the patient’s medical condition.
15(4) Obtaining informed consent from the patient’s legally
16authorized representatives is not feasible before the treatment must
17be administered. The proposed investigational plan shall define
18the length of time of the potential therapeutic window based on
19scientific evidence, and the investigator shall commit to attempting
20to contact a legally authorized representative for each subject
21within that length of time and, if feasible, to asking the legally
22authorized representative contacted for consent within that length
23of time rather than proceeding
without consent.
24(5) There is no reasonable way to prospectively identify the
25individuals likely to become eligible for participation in the clinical
26investigation.
27(6) Valid scientific studies have been conducted that support
28the potential for the intervention to provide a direct benefit to the
29patient. Risks associated with the investigation shall be reasonable
30in relation to what is known about the medical condition of the
31potential class of subjects, the risks and benefits of standard
32therapy, if any, and what is known about the risks and benefits of
33the proposed intervention or activity.
34(b) This section does not relieve any party of any other legal
35duty, including, but not limited to, the duty to act in a
nonnegligent
36manner.
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