Reproductive health and research: oocyte procurement.

Existing law prohibits human oocytes or embryos from being acquired, sold, offered for sale, received, or otherwise transferred for valuable consideration for medical research or development of medical therapies, and prohibits payment in excess of the amount of reimbursement of direct expenses to be made to any research subject to encourage an individual to produce human oocytes for the purposes of medical research. Before obtaining informed consent from a subject for assisted oocyte production (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, existing law requires a physician and surgeon to provide to the subject a standardized medically accurate written summary of health and consumer issues associated with AOP, as specified. Existing law also requires all oocyte extractions for research to be approved by an institutional review board, as defined. This bill, until January 1, 2024, would require individuals who provide human oocytes for research to be compensated for their time, discomfort, and inconvenience in the same manner as other research subjects, as prescribed and determined by a human subject research panel or institutional review board. The bill would establish the Research Participants Undergoing Oocyte Retrieval for Medical Research Purposes Bill of Rights and would require the bill of rights to contain specified information relating to the rights of a research participant providing human oocytes. The bill would require a physician and surgeon to obtain written and oral informed consent prior to providing a procedure for ovarian retrieval, including a signed acknowledgment of the bill of rights. The bill would require the institutional review board to disregard the amount of compensation paid to an individual providing human oocytes for fertility if certain requirements are met, including that the individual in fertility treatment does not want or need the oocytes for their own reproductive success. The bill would require an institutional review board to require any research program or project that comes under its review that involves AOP or any alternative method of oocyte retrieval to inform the research participant that ongoing studies are necessary to assess the long-term health impacts of ovarian stimulation and oocyte retrieval. The bill would require a research program that offers compensation to research participants providing human oocytes, on or before January 16, 2023, to provide aggregated deidentified information to the Legislative Analyst regarding the research participants, including, among other things, the number of candidates and participants in the program, and basic demographic information and clinical data about the candidates and participants. The bill would require the Legislative Analyst to compile the information received by the research programs and, on or before March 17, 2023, to prepare and submit a report to the Legislature containing the aggregated deidentified information. The bill would change references in existing law that refer to an individual who provides human oocytes for research as a "subject" to "research participant."