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Section 125340 Of Chapter 2. Procuring Of Oocytes For Research From California Health And Safety Code >> Division 106. >> Part 5.5. >> Chapter 2.
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. (a) Prior to providing AOP or any alternative method of
ovarian retrieval to a subject for the purposes of medical research
or development of medical therapies, a physician and surgeon shall
obtain written and oral informed consent for the procedure from the
subject. Informed consent for the purposes of this chapter shall
comply with the informed consent requirements of the Protection of
Human Subjects in Medical Experimentation Act (Chapter 1.3
(commencing with Section 24170) of Division 20).
(b) The failure to obtain written informed consent from the subject constitutes unprofessional conduct within the meaning of Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code. Nothing in this section shall be construed to relieve the physician and surgeon from other existing duties under the law, including, but not limited to, the duty to obtain a subject's informed consent after fully explaining the proposed procedure. The requirement that a physician and surgeon provide the standardized written summary pursuant to Section 125335 is in addition to, and does not supplant, other existing legal requirements regarding informed consent, including, but not limited to, compliance with the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20.
(c) This chapter shall not affect the suitability or availability of oocytes procured for research before January 1, 2007, if the oocytes were donated pursuant to protocols or standards that are generally recognized and accepted by national or international scientific bodies.
(d) Any written document required pursuant to this section shall adhere to simplified reading standards, including, but not limited to, those generally accepted and required for government publications, and in layperson's language. The document shall be made available in languages spoken by subjects in the study if their proficiency is largely in a language other than English. All information in the written informed consent document shall also be conveyed to the subject orally in easy to understand and nontechnical terms.
(b) The failure to obtain written informed consent from the subject constitutes unprofessional conduct within the meaning of Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code. Nothing in this section shall be construed to relieve the physician and surgeon from other existing duties under the law, including, but not limited to, the duty to obtain a subject's informed consent after fully explaining the proposed procedure. The requirement that a physician and surgeon provide the standardized written summary pursuant to Section 125335 is in addition to, and does not supplant, other existing legal requirements regarding informed consent, including, but not limited to, compliance with the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20.
(c) This chapter shall not affect the suitability or availability of oocytes procured for research before January 1, 2007, if the oocytes were donated pursuant to protocols or standards that are generally recognized and accepted by national or international scientific bodies.
(d) Any written document required pursuant to this section shall adhere to simplified reading standards, including, but not limited to, those generally accepted and required for government publications, and in layperson's language. The document shall be made available in languages spoken by subjects in the study if their proficiency is largely in a language other than English. All information in the written informed consent document shall also be conveyed to the subject orally in easy to understand and nontechnical terms.
