Amended in Assembly April 2, 2013

Amended in Assembly February 27, 2013

California Legislature—2013–14 Regular Session

Assembly Bill No. 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 amended, 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 begin insert 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 end insert .

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 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.

begin insert

(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.

end insert begin insert

(8) Additional protections of the rights and welfare of the
subjects will be provided, including, but not limited to, all of the
following:

end insert begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(D) Establishment of an independent data monitoring committee
to exercise oversight of the research.

end insert

(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.