BILL NUMBER: SB 1188	CHAPTERED  07/30/01

	CHAPTER  122
	FILED WITH SECRETARY OF STATE  JULY 30, 2001
	APPROVED BY GOVERNOR  JULY 28, 2001
	PASSED THE ASSEMBLY  JULY 14, 2001
	PASSED THE SENATE  MAY 14, 2001
	AMENDED IN SENATE  MAY 7, 2001
	AMENDED IN SENATE  APRIL 4, 2001

INTRODUCED BY   Committee on Health and Human Services (Senators
Ortiz (Chair), Chesbro, Escutia, Figueroa, Kuehl, Morrow, Polanco,
Vasconcellos, and Vincent)

                        MARCH 7, 2001

   An act to add and repeal Section 24177.5 of the Health and Safety
Code, relating to medical experiments, and declaring the urgency
thereof, to take effect immediately.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1188, Committee on Health and Human Services.  Exemption from
Medical Experimentation Act.
   Existing law, the Protection of Human Subjects in Medical
Experimentation Act, prohibits any person from being subjected to any
medical experiment unless the informed consent of the person is
obtained.
   This bill, until January 1, 2011, would provide an exemption from
the act for any medical experimental treatment that benefits a
patient subject to a life-threatening emergency that is conducted in
accordance with prescribed requirements even if the patient is unable
to give informed consent because of the medical condition.
  This bill would declare that it is to take effect immediately as an
urgency statute.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:


  SECTION 1.  Section 24177.5 is added to the Health and Safety Code,
to read:
   24177.5.  (a) This chapter shall not apply to any 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 January 1, 1997.
   (2) The patient is in a life-threatening situation 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 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 section is intended to 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,
2011, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2011, deletes or extends
that date.
  SEC. 2.  This act is an urgency statute necessary for the immediate
preservation of the public peace, health, or safety within the
meaning of Article IV of the Constitution and shall go into immediate
effect.  The facts constituting the necessity are:
   California law must be amended to comply with federal regulations
that allow the use of a new drug or device where the patient is
unable to consent due to a life-threatening emergency in order to
improve medical intervention and patient outcomes.  In order to save
as many lives as possible of people who are in life-threatening
emergency medical situations, it is necessary that this act take
effect immediately.