INTRODUCED BY   Senator Strickland

                        FEBRUARY 18, 2010

   An act to amend Section 24177.5 of the Health and Safety Code,
relating to public health.


   SB 1187, as introduced, Strickland. Human experimentation.
   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. Existing law provides an exemption from the act, until
January 1, 2011, for any medical experimental treatment that benefits
a patient subject to a life-threatening emergency if prescribed
conditions are met.
   This bill would provide that this exemption shall remain in effect
until January 1, 2021.
   Vote: majority. Appropriation: no. Fiscal committee: no.
State-mandated local program: no.


  SECTION 1.  Section 24177.5 of the Health and Safety Code is
amended 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
   (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
  December 31, 2010  .
   (2)  The patient is in a life-threatening situation necessitating
urgent intervention and available treatments are unproven or
   (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,   2021,  and as of that date is
repealed, unless a later enacted statute, that is enacted before
January 1,  2011,   2021,  deletes or
extends that date.