(a) Prior to providing AOP or any alternative method of ovarian retrieval to a research participant 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 research participant. Informed consent for the purposes of this chapter shall include a signed acknowledgment of the rights contained in the Research Participants Undergoing Oocyte Retrieval for Medical Research Purposes Bill of Rights and 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 research participant constitutes unprofessional conduct within the meaning of Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code. This section does not relieve the physician and surgeon from other existing duties under the law, including, but not limited to, the duty to obtain a research participant’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 does 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) A 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 research participants 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 research participant orally in easy to understand and nontechnical terms.
(e) Research conducted pursuant to this chapter shall adhere to federal regulations governing informed consent pursuant to Section 46.116 of Title 45 of the Code of Federal Regulations.
(f) This section does not limit or expand the right of an injured research participant to recover damages under any applicable law.
(Amended by Stats. 2019, Ch. 864, Sec. 4. (AB 922) Effective January 1, 2020.)