Bill Text: CA AB58 | 2013-2014 | Regular Session | Introduced

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Medical experiments: human subjects.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Passed) 2013-10-04 - Chaptered by Secretary of State - Chapter 547, Statutes of 2013. [AB58 Detail]

Download: California-2013-AB58-Introduced.html

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BILL NUMBER: AB 58	INTRODUCED
	BILL TEXT


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:

  SECTION 1.  Section 24177.5 of the Health and Safety Code is
amended to read:
   24177.5.  (a) This chapter  shall   does
 not apply to  any   a  medical
experimental treatment that benefits a patient subject to a
life-threatening emergency if all of the following conditions are
met:
   (1) Care is provided in accordance with the procedures and the
additional protections of the rights and welfare of the patient set
forth in Part 50 of Title 21 of, and Part 46 of Title 45 of, the Code
of Federal Regulations, in effect on December 31, 2010.
   (2) The patient is in a life-threatening  situation
  emergency  necessitating urgent intervention and
available treatments are unproven or unsatisfactory.
   (3) The patient is unable to give informed consent as a result of
the patient's medical condition.
   (4) Obtaining informed consent from the patient's legally
authorized representatives is not feasible before the treatment must
be administered. The proposed investigational plan shall define the
length of time of the potential therapeutic window based on
scientific evidence, and the investigator shall commit to attempting
to contact a legally authorized representative for each subject
within that length of time and, if feasible, to asking the legally
authorized representative contacted for consent within that length of
time rather than proceeding without consent.
   (5) There is no reasonable way to  prospectively 
identify  prospectively  the individuals likely to
become eligible for participation in the clinical investigation.
   (6) Valid scientific studies have been conducted that support the
potential for the intervention to provide a direct benefit to the
patient. Risks associated with the investigation shall be reasonable
in relation to what is known about the medical condition of the
potential class of subjects, the risks and benefits of standard
therapy, if any, and what is known about the risks and benefits of
the proposed intervention or activity.
   (b)  Nothing in this   This  section
 is intended to   does not  relieve any
party of any other legal duty, including, but not limited to, the
duty to act in a nonnegligent manner. 
   (c) This section shall remain in effect only until January 1,
2014, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2014, deletes or extends
that date.