2010 California Code
Health and Safety Code
Chapter 1.3. Human Experimentation
Health and Safety Code
Chapter 1.3. Human Experimentation
HEALTH AND SAFETY CODE
SECTION 24170-24179.5
SECTION 24170-24179.5
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.
(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.
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.
(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.
24177.5. (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.
(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.
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