2010 California Code
Health and Safety Code
Chapter 1.3. Human Experimentation

24170.  This chapter shall be known and may be cited as the
Protection of Human Subjects in Medical Experimentation Act.



24171.  The Legislature hereby finds and declares that medical
experimentation on human subjects is vital for the benefit of
mankind, however such experimentation shall be undertaken with due
respect to the preciousness of human life and the right of
individuals to determine what is done to their own bodies.
   The Legislature further finds and declares that:
   (a) The Nuremberg Code of Ethics in Medical Research was developed
after the trial of Nazi war criminals for unethical use of persons
in medical experiments; subsequently, the Declaration of Helsinki
additionally established recommendations guiding doctors in
experimentation involving human subjects.
   (b) Neither the Nuremberg Code nor the Declaration of Helsinki are
codified under law and are, therefore, unenforceable.
   (c) It is necessary that medical experimentation be done in such a
way as to protect the rights of the human subjects involved.
   (d) There is, and will continue to be, a growing need for
protection for citizens of the state from unauthorized, needless,
hazardous, or negligently performed medical experiments on human
beings.
   It is, therefore, the intent of the Legislature, in the enacting
of this chapter, to provide minimum statutory protection for the
citizens of this state with regard to human experimentation and to
provide penalties for those who violate such provisions.



24172.  As used in the chapter, "experimental subject's bill of
rights," means a list of the rights of a subject in a medical
experiment, written in a language in which the subject is fluent.
Except as otherwise provided in Section 24175, this list shall
include, but not be limited to the subject's right to:
   (a) Be informed of the nature and purpose of the experiment.
   (b) Be given an explanation of the procedures to be followed in
the medical experiment, and any drug or device to be utilized.
   (c) Be given a description of any attendant discomforts and risks
reasonably to be expected from the experiment.
   (d) Be given an explanation of any benefits to the subject
reasonably to be expected from the experiment, if applicable.
   (e) Be given a disclosure of any appropriate alternative
procedures, drugs or devices that might be advantageous to the
subject, and their relative risks and benefits.
   (f) Be informed of the avenues of medical treatment, if any,
available to the subject after the experiment if complications should
arise.
   (g) Be given an opportunity to ask any questions concerning the
experiment or the procedures involved.
   (h) Be instructed that consent to participate in the medical
experiment may be withdrawn at any time and the subject may
discontinue participation in the medical experiment without
prejudice.
   (i) Be given a copy of the signed and dated written consent form
as provided for by Section 24173 or 24178.
   (j) Be given the opportunity to decide to consent or not to
consent to a medical experiment without the intervention of any
element of force, fraud, deceit, duress, coercion, or undue influence
on the subject's decision.



24173.  As used in this chapter, "informed consent" means the
authorization given pursuant to Section 24175 to have a medical
experiment performed after each of the following conditions have been
satisfied:
   (a) The subject or subject's conservator or guardian, or other
representative, as specified in Section 24175, is provided with a
copy of the experimental subject's bill of rights, prior to
consenting to participate in any medical experiment, containing all
the information required by Section 24172, and the copy is signed and
dated by the subject or the subject's conservator or guardian, or
other representative, as specified in Section 24175.
   (b) A written consent form is signed and dated by the subject or
the subject's conservator or guardian, or other representative, as
specified in Section 24175.
   (c) The subject or subject's conservator or guardian, or other
representative, as specified in Section 24175, is informed both
verbally and within the written consent form, in nontechnical terms
and in a language in which the subject or the subject's conservator
or guardian, or other representative, as specified in Section 24175,
is fluent, of the following facts of the proposed medical experiment,
which might influence the decision to undergo the experiment,
including, but not limited to:
   (1) An explanation of the procedures to be followed in the medical
experiment and any drug or device to be utilized, including the
purposes of the procedures, drugs, or devices. If a placebo is to be
administered or dispensed to a portion of the subjects involved in a
medical experiment, all subjects of the experiment shall be informed
of that fact; however, they need not be informed as to whether they
will actually be administered or dispensed a placebo.
   (2) A description of any attendant discomfort and risks to the
subject reasonably to be expected.
   (3) An explanation of any benefits to the subject reasonably to be
expected, if applicable.
   (4) A disclosure of any appropriate alternative procedures, drugs,
or devices that might be advantageous to the subject, and their
relative risks and benefits.
   (5) An estimate of the expected recovery time of the subject after
the experiment.
   (6) An offer to answer any inquiries concerning the experiment or
the procedures involved.
   (7) An instruction to the subject that he or she is free to
withdraw his or her prior consent to the medical experiment and
discontinue participation in the medical experiment at any time,
without prejudice to the subject.
   (8) The name, institutional affiliation, if any, and address of
the person or persons actually performing and primarily responsible
for the conduct of the experiment.
   (9) The name of the sponsor or funding source, if any, or
manufacturer if the experiment involves a drug or device, and the
organization, if any, under whose general aegis the experiment is
being conducted.
   (10) The name, address, and phone number of an impartial third
party, not associated with the experiment, to whom the subject may
address complaints about the experiment.
   (11) The material financial stake or interest, if any, that the
investigator or research institution has in the outcome of the
medical experiment. For purposes of this section, "material" means
ten thousand dollars ($10,000) or more in securities or other assets
valued at the date of disclosure, or in relevant cumulative salary or
other income, regardless of when it is earned or expected to be
earned.
   (d) The written consent form is signed and dated by any person
other than the subject or the conservator or guardian, or other
representative of the subject, as specified in Section 24175, who can
attest that the requirements for informed consent to the medical
experiment have been satisfied.
   (e) Consent is voluntary and freely given by the human subject or
the conservator or guardian, or other representative, as specified by
Section 24175, without the intervention of any element of force,
fraud, deceit, duress, coercion, or undue influence.



24174.  As used in this chapter, "medical experiment" means:
   (a) The severance or penetration or damaging of tissues of a human
subject or the use of a drug or device, as defined in Section 109920
or 109925, electromagnetic radiation, heat or cold, or a biological
substance or organism, in or upon a human subject in the practice or
research of medicine in a manner not reasonably related to
maintaining or improving the health of the subject or otherwise
directly benefiting the subject.
   (b) The investigational use of a drug or device as provided in
Sections 111590 and 111595.
   (c) Withholding medical treatment from a human subject for any
purpose other than maintenance or improvement of the health of the
subject.



24175.  (a) Except as otherwise provided in this section, no person
shall be subjected to any medical experiment unless the informed
consent of such person is obtained.
   (b) If a person is under a conservatorship of the person or of the
person and estate, pursuant to Division 4 (commencing with Section
1400) of the Probate Code, informed consent for a medical experiment
involving such person shall be obtained:
   (1) As provided in Section 2354 of the Probate Code if the person
has not been adjudicated to lack the capacity to give informed
consent for medical treatment.
   (2) As provided in Section 2355 of the Probate Code if the person
has been adjudicated to lack the capacity to give informed consent
for medical treatment.
   (c) If an adult person is gravely disabled, as defined in
subdivision (h) of Section 5008 of the Welfare and Institutions Code,
and is under a conservatorship of the person or of the person and
estate, pursuant to Chapter 3 (commencing with Section 5350) of Part
1 of Division 5 of the Welfare and Institutions Code, informed
consent for a medical experiment involving such person shall be
obtained from such person, unless the conservator of such person has
the right to consent to medical treatment on behalf of the
conservatee, pursuant to subdivisions (c) and (d) of Section 5357 and
Section 5358 of the Welfare and Institutions Code.
   (d) If an adult person is developmentally disabled, as defined in
subdivision (a) of Section 4512 of the Welfare and Institutions Code,
and has no conservator and is mentally incapable of giving informed
consent, informed consent shall be obtained for a medical experiment
involving such person, pursuant to subdivision (c) of Section 4655 of
the Welfare and Institutions Code.
   (e) Informed consent given by a person other than the human
subject pursuant to subdivisions (b) through (d), inclusive, of this
section shall only be for medical experiments related to maintaining
or improving the health of the human subject or related to obtaining
information about a pathological condition of the human subject.




24176.  (a) Any person who is primarily responsible for conduct of a
medical experiment and who negligently allows the experiment to be
conducted without a subject's informed consent, as provided in this
chapter, shall be liable to the subject in an amount not to exceed
ten thousand dollars ($10,000), as determined by the court. The
minimum amount of damages awarded shall be five hundred dollars
($500).
   (b) Any person who is primarily responsible for the conduct of a
medical experiment and who willfully fails to obtain the subject's
informed consent, as provided in this chapter, shall be liable to the
subject in an amount not to exceed twenty-five thousand dollars
($25,000) as determined by the court. The minimum amount of damages
awarded shall be one thousand dollars ($1,000).
   (c) Any person who is primarily responsible for the conduct of a
medical experiment and who willfully fails to obtain the subject's
informed consent, as provided in this chapter, and thereby exposes a
subject to a known substantial risk of serious injury, either bodily
harm or psychological harm, shall be guilty of a misdemeanor
punishable by imprisonment in the county jail for a period not to
exceed one year or a fine of fifty thousand dollars ($50,000), or
both.
   (d) Any representative or employee of a pharmaceutical company,
who is directly responsible for contracting with another person for
the conduct of a medical experiment, and who has knowledge of risks
or hazards with respect to the experiment, and who willfully
withholds information of the risks and hazards from the person
contracting for the conduct of the medical experiment, and thereby
exposes a subject to substantial risk of serious injury, either
bodily harm or psychological harm, shall be guilty of a misdemeanor
punishable by imprisonment in the county jail for a period not to
exceed one year or a fine of fifty thousand dollars ($50,000), or
both.
   (e) Each and every medical experiment performed in violation of
any provision of this chapter is a separate and actionable offense.
   (f) Any attempted or purported waiver of the rights guaranteed, or
requirements prescribed by this chapter, whether by a subject or by
a subject's conservator or guardian, or other representative, as
specified in Section 24175, is void.
   (g) Nothing in this section shall be construed to limit or expand
the right of an injured subject to recover damages under any other
applicable law.


24177.  This chapter shall not supersede, but shall be in addition
to, Article 4 (commencing with Section 111515) of Chapter 6 of Part 5
of Division 104 of this code and Title 2.1 (commencing with Section
3500) of Part 3 of the Penal Code.



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 December 31, 2010.
   (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,
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.


24178.  (a) Except for this section and the requirements set forth
in Sections 24172 and 24176, this chapter shall not apply to any
person who is conducting a medical experiment as an investigator
within an institution that holds an assurance with the United States
Department of Health and Human Services pursuant to Part 46 of Title
45 of the Code of Federal Regulations and who obtains informed
consent in the method and manner required by those regulations.
   (b) Subdivisions (c) and (e) shall apply only to medical
experiments that relate to the cognitive impairment, lack of
capacity, or serious or life-threatening diseases and conditions of
research participants.
   (c) For purposes of obtaining informed consent required for
medical experiments in a nonemergency room environment, and pursuant
to subdivision (a), if a person is unable to consent and does not
express dissent or resistance to participation, surrogate informed
consent may be obtained from a surrogate decisionmaker with
reasonable knowledge of the subject, who shall include any of the
following persons, in the following descending order of priority:
   (1) The person's agent pursuant to an advance health care
directive.
   (2) The conservator or guardian of the person having the authority
to make health care decisions for the person.
   (3) The spouse of the person.
   (4) An individual as defined in Section 297 of the Family Code.
   (5) An adult son or daughter of the person.
   (6) A custodial parent of the person.
   (7) Any adult brother or sister of the person.
   (8) Any adult grandchild of the person.
   (9) An available adult relative with the closest degree of kinship
to the person.
   (d) (1) When there are two or more available persons who, pursuant
to subdivision (c), may give surrogate informed consent and who are
in the same order of priority, if any of those persons expresses
dissent as to the participation of the person in the medical
experiment, consent shall not be considered as having been given.
   (2) When there are two or more available persons who are in
different orders of priority pursuant to subdivision (c), refusal to
consent by a person who is a higher priority surrogate shall not be
superseded by the consent of a person who is a lower priority
surrogate.
   (e) For purposes of obtaining informed consent required for
medical experiments in an emergency room environment, and pursuant to
subdivision (a), if a person is unable to consent and does not
express dissent or resistance to participation, surrogate informed
consent may be obtained from a surrogate decisionmaker who is any of
the following persons:
   (1) The person's agent pursuant to an advance health care
directive.
   (2) The conservator or guardian of the person having the authority
to make health care decisions for the person.
   (3) The spouse of the person.
   (4) An individual defined in Section 297 of the Family Code.
   (5) An adult son or daughter of the person.
   (6) A custodial parent of the person.
   (7) Any adult brother or sister of the person.
   (f) When there are two or more available persons described in
subdivision (e), refusal to consent by one person shall not be
superseded by any other of those persons.
   (g) Surrogate decisionmakers described in this section shall
exercise substituted judgment, and base decisions about participation
in accordance with the person's individual health care instructions,
if any, and other wishes, to the extent known to the surrogate
decisionmaker. Otherwise, the surrogate decisionmaker shall make the
decision in accordance with the person's best interests. In
determining the person's best interests, the decisionmaker shall
consider the person's personal values and his or her best estimation
of what the person would have chosen if he or she were capable of
making a decision.
   (h) Research conducted pursuant to this section shall adhere to
federal regulations governing informed consent pursuant to Section
46.116 of Title 45 of the Code of Federal Regulations.
   (i) Any person who provides surrogate consent pursuant to
subdivisions (c) and (e) may not receive financial compensation for
providing the consent.
   (j) Subdivisions (c) and (e) do not apply to any of the following
persons, except as otherwise provided by law:
   (1) Persons who lack the capacity to give informed consent and who
are involuntarily committed pursuant to Part 1 (commencing with
Section 5000) of Division 5 of the Welfare and Institutions Code.
   (2) Persons who lack the capacity to give informed consent and who
have been voluntarily admitted or have been admitted upon the
request of a conservator pursuant to Chapter 1 (commencing with
Section 6000) of Part 1 of Division 6 of the Welfare and Institutions
Code.


24179.  This chapter shall not apply to a pharmacist dispensing
drugs upon a prescription.



24179.5.  Notwithstanding any other provision of this chapter, this
chapter does not apply to an adult in a terminal condition who
executes a directive directing the withholding or withdrawal of
life-sustaining procedures pursuant to Section 7188. To the extent of
any conflict, Division 4.7 (commencing with Section 4600) of the
Probate Code prevails over the provisions of this chapter.