California Legislature—2013–14 Regular Session

Assembly BillNo. 58


Introduced by Assembly Member Wieckowski

January 7, 2013


An act to amend Section 24177.5 of the Health and Safety Code, relating to medical experiments.

LEGISLATIVE COUNSEL’S DIGEST

AB 58, as introduced, 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:

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SECTION 1.  

Section 24177.5 of the Health and Safety Code
2 is amended to read:

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24177.5.  

(a) This chapterbegin delete shallend deletebegin insert doesend insert not apply tobegin delete anyend deletebegin insert aend insert 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 on December 31, 2010.

9(2) The patient is in a life-threateningbegin delete situationend deletebegin insert emergencyend insert
10 necessitating urgent intervention and available treatments are
11unproven or unsatisfactory.

12(3) The patient is unable to give informed consent as a result of
13the patient’s medical condition.

14(4) Obtaining informed consent from the patient’s legally
15authorized representatives is not feasible before the treatment must
16be administered. The proposed investigational plan shall define
17the length of time of the potential therapeutic window based on
18scientific evidence, and the investigator shall commit to attempting
19to contact a legally authorized representative for each subject
20within that length of time and, if feasible, to asking the legally
21authorized representative contacted for consent within that length
22of time rather than proceeding without consent.

23(5) There is no reasonable way tobegin insert prospectivelyend insert identify
24begin delete prospectivelyend delete the individuals likely to become eligible for
25participation in the clinical investigation.

26(6) Valid scientific studies have been conducted that support
27the potential for the intervention to provide a direct benefit to the
28patient. Risks associated with the investigation shall be reasonable
29in relation to what is known about the medical condition of the
30potential class of subjects, the risks and benefits of standard
31therapy, if any, and what is known about the risks and benefits of
32the proposed intervention or activity.

33(b) begin deleteNothing in this end deletebegin insertThis end insertsectionbegin delete is intended toend deletebegin insert does notend insert relieve
34any party of any other legal duty, including, but not limited to, the
35duty to act in a nonnegligent manner.

begin delete

36(c) This section shall remain in effect only until January 1, 2014,
37and as of that date is repealed, unless a later enacted statute, that
38is enacted before January 1, 2014, deletes or extends that date.

end delete


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