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


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-Chaptered.html
BILL NUMBER: AB 58	CHAPTERED
	BILL TEXT

	CHAPTER  547
	FILED WITH SECRETARY OF STATE  OCTOBER 4, 2013
	APPROVED BY GOVERNOR  OCTOBER 4, 2013
	PASSED THE SENATE  SEPTEMBER 3, 2013
	PASSED THE ASSEMBLY  APRIL 8, 2013
	AMENDED IN ASSEMBLY  APRIL 2, 2013
	AMENDED IN ASSEMBLY  FEBRUARY 27, 2013

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, 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 and would add conditions for the use of
medical experimental treatment, including that the institutional
review board has reviewed and approved the informed consent
procedures and these procedures are to be used with subjects or their
legally authorized representatives in situations where use of the
procedures and documents is feasible and that specified additional
protections of the rights and welfare of the subjects will be
provided.


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 does not apply to 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 April 1, 2012.
   (2) The patient is in a life-threatening 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 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.
   (7) The institutional review board has reviewed and approved the
informed consent procedures and these procedures are to be used with
subjects or their legally authorized representatives in situations
where use of the procedures and documents is feasible.
   (8) Additional protections of the rights and welfare of the
subjects will be provided, including, but not limited to, all of the
following:
   (A) Consultation, including, where appropriate, consultation
carried out by the institutional review board, with representatives
of the communities in which the research will be conducted and from
which the subjects will be drawn.
   (B) Public disclosure to the communities in which the research
will be conducted and from which the subjects will be drawn, prior to
the initiation of the research, of plans for the research and its
risks and expected benefits.
   (C) Public disclosure of sufficient information following the
completion of the research to apprise the community and researchers
of the study, including demographic characteristics of the research
population and the results of the study.
   (D) Establishment of an independent data monitoring committee to
exercise oversight of the research.
   (b) This section does not relieve any party of any other legal
duty, including, but not limited to, the duty to act in a
nonnegligent manner.
  
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