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California Laws | Health and Safety Code
DIVISION 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT)
PART 5.5. USE OF HUMAN CELLS

125320. (a) A person may not knowingly, for valuable consideration, purchase or sell embryonic or cadaveric fetal tissue for research purposes pursuant to this chapter. (68325)

(b) For purposes of this section, "valuable consideration" does not include reasonable payment for the removal, processing, disposal, preservation, quality control, storage, transplantation, or implantation of a part. (68326)

(c) Embryonic or cadaveric fetal tissue may be donated for research purposes pursuant to this chapter. (68327)

CHAPTER 1.5. OOCYTE RETRIEVAL FOR FERTILITY TREATMENT (125325-125325.15) (68328)(Text)

125325. (a) The person or entity posting an advertisement seeking oocyte donation associated with the delivery of fertility treatment that includes assisted oocyte production and a financial payment or compensation of any kind, shall include the following notice in a clear and conspicuous manner: (68329)

"Egg donation involves a screening process. Not all potential egg donors are selected. Not all selected egg donors receive the monetary amounts or compensation advertised. As with any medical procedure, there may be risks associated with human egg donation. Before an egg donor agrees to begin the egg donation process, and signs a legally binding contract, she is required to receive specific information on the known risks of egg donation. Consultation with your doctor prior to entering into a donor contract is advised." (68330)

(b) A summary pertaining to oocyte donation procedures, shall be provided, as required pursuant to Section 125335, to all potential egg donors before signing a legally binding contract to become an egg donor, or beginning any egg donation procedures, as part of compliance with the informed consent requirements. (68331)

(c) Persons or entities that certify compliance with the American Society for Reproductive Medicine (ASRM) guidelines by registering with ASRM are exempt from the notice requirements set forth in subdivision (a). Use of the exemption when the guidelines are violated shall constitute false advertising. (68332)

(d) Donors recruited through the advertisement shall undergo the same disclosure, counseling, and informed consent process, as required pursuant to Section 125335, as donors recruited by those exempt from subdivision (a). (68333)

125325.15. The following definitions shall apply to this chapter: (68334)

(a) "Assisted oocyte production" or "AOP" means surgical extraction of oocytes following pharmaceutically induced manipulation of oocyte production through the use of ovarian stimulation for the purposes of fertility treatment. (68335)

(b) "Oocyte" means a female egg or egg cell of a human female. (68336)

CHAPTER 2. PROCURING OF OOCYTES FOR RESEARCH (125330-125355) (68337)(Text)

125330. The following definitions shall apply to this chapter: (68338)

(a) "Assisted oocyte production" or "AOP" means surgical extraction of oocytes following pharmaceutically induced manipulation of oocyte production through the use of ovarian stimulation. (68339)

(b) "Oocyte" means a female egg or egg cell of a human female. (68340)

(c) "Subject" means any person undergoing AOP or any alternative method of ovarian retrieval for research or for the development of medical therapies, including those who would not meet the definition of "subject" under 45 C.F.R. 46.102. (68341)

(d) "Alternate method of oocyte retrieval" means a method of oocyte retrieval that does not involve the pharmaceutically induced manipulation of oocyte production. (68342)

(e) "Institutional review board" means a body established in accordance with federal regulations, including Part 46 (commencing with Section 46.101) of Subchapter A of Subtitle A of Title 45 of the Code of Federal Regulations. (68343)

125335. (a) Prior to obtaining informed consent from a subject for AOP or any alternative method of ovarian retrieval on a subject for the purpose of procuring oocytes for research or the development of medical therapies, a physician and surgeon shall provide to the subject a standardized medically accurate written summary of health and consumer issues associated with AOP and any alternative methods of oocyte retrieval. The failure to provide to a subject this standardized medically accurate written summary constitutes unprofessional conduct within the meaning of Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code. (68344)

(b) The summary shall include, but not be limited to, medically accurate disclosures concerning the potential risks of AOP or any alternative method of oocyte retrieval, including the risks associated with the surgical procedure and with using the drugs, medications, and hormones prescribed for ovarian stimulation during the AOP process or any alternative method of oocyte retrieval. (68345)

(c) For purposes of subdivision (a), "written summary of health and consumer issues" means the guide published and updated by the American Society for Reproductive Medicine entitled, "Assisted Reproductive Technology: A Guide for Patients" or an alternative written medically accurate document prepared by a recognized authority on oocyte retrieval for medical research that also meets the criteria included in this section. This alternative document may be one that has been approved and recommended by the State Department of Public Health pursuant to Section 125118 and shall include all of the following: (68346)

(1) The document shall adhere to simplified reading standards, including, but not limited to, those generally accepted and required for government publications. The document shall be written in layperson's language and 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 document shall be conveyed to the subject orally in easy to understand and nontechnical terms. (68347)

(2) The document shall include additional resources for, or list additional sources of, medical information on health and safety issues surrounding oocyte retrieval. (68348)

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