Today's Law As Amended


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AB-2531 Reproductive health and research.(2015-2016)



As Amends the Law Today


SECTION 1.
 The Legislature finds and declares all of the following:
(a) The purpose of this act is to create protections for research subjects and it should not be construed to affect any other form of medical care.
(b) Scientific research can be most effectively achieved by establishing protocols to protect, respect, and promote human health, safety, dignity, autonomy, and rights in conducting research.
(c) This act seeks to support the requirements in law upholding the principle of voluntary and informed consent and to tailor them to this new area of pioneering research that utilizes human oocytes.
(d) For all research subjects, there is a concern for exploitation when subjects are asked to subject themselves to drugs, devices, or procedures they might not otherwise need to do for their own health but for the benefit of all. This can range from persons with terminal illnesses who might be so desperate for help they would subject themselves to a high-risk procedure with limited benefit, to otherwise healthy people who might be motivated primarily by a financial award. To address this concern of exploitation, and to recognize the need for people to participate in research, mechanisms were created to balance the need to reward research participants without creating undue inducement.
(e) In California, the mechanisms dedicated to judging this balance include human subject research panels, institutional review boards, and stem cell research organizations.
(f) Concerns that women will be exploited if compensated for providing human oocytes for research have not borne out in the states where compensation is allowed.
(g) The ban on compensation for women providing human oocytes for research was created due to concerns regarding the high volume of oocytes needed for embryonic stem cell research, but extends to all research. Without compensation, few women participate in research, creating barriers to reproductive research that could benefit all women. As an example, more research could be done on embryo quality so that women undergoing in vitro fertilization (IVF) can confidently choose to have a single embryo implanted with a high probability of achieving a successful pregnancy, instead of multiple embryos. Lowering the rate of multiple pregnancies in IVF is a high priority goal that benefits women, parents, the resulting children, and society. The best source of available embryos for research comes from embryos created for fertility using a compensated donor, as she is more likely to produce a higher volume of oocytes and excess viable embryos than the infertile woman. Due to the ban on compensation, oocytes and embryos not needed for fertility will be unsuitable for research and will likely be discarded.
(h) All patients, including those participating in research, are due a reasonable duty of care. In addition, all women undergoing ovarian stimulation and oocyte retrieval have another layer of regulation as all cycles are reported to the federal Centers for Disease Control and Prevention.
(i) Sufficient protections are in place to treat women providing human oocytes for research, similar to any other research subject, knowing women are competent and able to make decisions for themselves.
(j) This act repeals the ban on compensation for women providing human oocytes for research. Compensation amounts will be determined by human subject research panels and institutional review boards.

SEC. 2.

 Section 125341 of the Health and Safety Code is amended to read:

125341.
 An institutional review board (IRB) that reviews and approves medical and scientific research shall require all of the following of any research program or project that comes under its review that involves AOP or any alternative method of oocyte retrieval:
(a) That it include a written summary as required under Section 125335 that would include information on health risks and potential adverse consequences of the procedure and describe the manner in which the research participant  subject  will receive and review this written summary.
(b) That it inform the research participant  subject  that ongoing studies are necessary will continue  to assess the long-term health impacts of ovarian stimulation and oocyte retrieval.
(c) That it obtain a signed acknowledgment of the Research Participants Undergoing Oocyte Retrieval for Medical Research Purposes Bill of Rights and obtain  informed consent in compliance with the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20), including informed consent for information obtained pursuant to Section 125342.
(d) That it provide the research participant  subject  with an objective and accurate statement about the existing state of the research for which the research participant  subject  is providing oocytes.
(e) That it perform psychological and physical screening, in accordance with the appropriate standard of care, for all research participants  subjects  prior to the oocyte retrieval procedure.
(f) That it ensure that after conducting AOP or any alternative method of oocyte retrieval on a research participant the research participant  subject, the subject  be given a postprocedure medical examination at a time within the standard of care to determine if the research participant  subject  has experienced an adverse health effect that is a result of the procedure. The research participant  subject  shall be informed that they have she has  the right to a second opinion if they have she has  any medical concerns.
(g) That it ensure that the research participant  subject  has access to and coverage for medically appropriate medical care that is required as a direct result of the procedure for research purposes. The research program or project shall ensure that payment or coverage of resulting medical expenses be provided at no cost to the research participant  subject  and that a summary of the arrangements the procuring entity has made for coverage or payment for medical care related to AOP or any alternative method of oocyte retrieval is provided to the research participant  subject  prior to the procedure.
(h) That it provide a summary informing the research participant  subject  that oocytes may not be sold or transferred for valuable consideration except as set forth in Section 125350.
(i) That it provide disclosure if the physician and surgeon and their  his or her  immediate family members have any professional interest in the outcome of the research or of the oocyte retrieval procedure and, if so, that it provide disclosure that they carry  he or she carries  the interest of both the research participant  subject  and the success of the research.

SEC. 2.SEC. 3.

 Section 125355 of the Health and Safety Code is repealed.

125355.
 (a) Notwithstanding Section 125350, an individual providing human oocytes for research shall be compensated for their time, discomfort, and inconvenience in the same manner as other research participants. Payment pursuant to this section shall not be for the human oocytes themselves or predicated on the number of oocytes obtained, including if no human oocytes are obtained. Whether a proposed compensation amount is appropriate shall be determined by a human subject research panel or institutional review board.
(b) A research participant providing human oocytes for research shall be provided with a summary of health and consumer issues associated with AOP as required under Section 125335, informed consent requirements as described in Section 125340, an authorized consent form containing the research participant’s signature as required under Section 24173, and the Research Participants Undergoing Oocyte Retrieval for Medical Research Purposes Bill of Rights as required under Section 12531.
(c) A research program that offers compensation to research participants providing human oocytes for research pursuant to subdivision (a) is subject to the requirements of Sections 125341 and 125342, including, but not limited to, coverage for medically appropriate medical care that is required as a direct result of the procedure for research purposes, regardless of the level of compensation offered.
(d) (1) A research program that offers compensation to research participants providing human oocytes shall, on or before January 16, 2023, provide aggregated deidentified information to the Legislative Analyst regarding the research participants. The research program shall advise a research participant of the data collection as part of the informed consent process required by Section 125340.
(2) The aggregated deidentified information provided by a research program to the Legislative Analyst shall include all of the following:
(A) The total number of candidates expressing an interest in providing human oocytes for research.
(B) The total number of candidates giving written and oral informed consent for the procedure.
(C) The total number of participants providing human oocytes for research.
(D) Basic demographic information about the candidates and participants, including all of the following:
(i) Age.
(ii) Race and ethnicity.
(iii) Gender, including self-identifying gender, which may include female, male, and nonbinary.
(iv) Primary language, and all languages in which the research participant is proficient in both oral and written form.
(v) Childbearing history, including gravida and parity.
(vi) The number of times of previous oocyte donations for research and the number of times of previous oocyte donations for fertility.
(vii) Education level.
(viii) Income level and annual income.
(ix) Amount of compensation, including expenses, for the oocyte research donation.
(E) Clinical data for oocyte research candidates and participants, including all of the following:
(i) Median anti-Mullerian hormone levels.
(ii) Antral follicle count.
(iii) Days of stimulation.
(iv) Peak estradiol levels.
(v) Number of oocytes retrieved.
(vi) Complications, including interruption of cycles, postcycle complications, and procedure complications, and a discussion of how the complications were managed.
(vii) Notable medical conditions.
(viii) Summary of information obtained through followup surveys.
(e) (1) The Legislative Analyst shall compile the information received pursuant to subdivision (d) and shall, on or before March 17, 2023, prepare and submit a report to the Legislature containing the aggregated deidentified information. The report shall be submitted in compliance with Section 9795 of the Government Code.
(2) The Legislative Analyst’s report shall be reviewed by an institutional review board, prior to submission to the Legislature, to ensure the protection and privacy of research participants.
(f) This section shall remain in effect only until January 1, 2024, and as of that date is repealed.

SEC. 4.

 Section 125355 is added to the Health and Safety Code, to read:

125355.
 (a) Notwithstanding Section 125350, a woman providing human oocytes for research shall be compensated for her time, discomfort, and inconvenience in the same manner as other research subjects. Payment pursuant to this section shall not be for the human oocytes themselves or predicated on the number of oocytes obtained, including if no human oocytes are obtained. Whether a proposed compensation amount is appropriate shall be determined by a human subject research panel or institutional review board. In the event that a human subject research panel or institutional review board determines that a proposed compensation amount is inappropriate, the panel or board shall determine an appropriate compensation amount.
(b) A woman providing human oocytes for research shall be provided with a summary of health and consumer issues associated with AOP as required under Section 125335 and informed consent requirements, as described in Section 125340.
(c) Any research program that offers compensation to women providing human oocytes for research pursuant to subdivision (a) is subject to Sections 125341 and 125342, including, but not limited to, coverage for medically appropriate medical care that is required as a direct result of the procedure for research purposes, regardless of the level of compensation offered.

SEC. 5.

 Section 125356 is added to the Health and Safety Code, to read:

125356.
 If a woman providing human oocytes for the purposes of fertility is compensated, and any human oocytes or embryos in excess of those needed for fertility are offered for research, the institutional review board shall disregard the amount of compensation if all of the following conditions are met:
(a) The clinic performing oocyte retrieval is a member of the Society for Assisted Reproductive Technology.
(b) The procurement and disposition for research purposes of human oocytes initially provided for reproductive uses, either for use by the donor or another woman, shall not knowingly compromise the optimal reproductive success of the woman in the infertility treatment.
(c) The infertility treatment protocol is established prior to requesting or obtaining consent for donation for research purposes and the prospect of donation for research does not alter the timing, method, or procedures selected for clinical care.
(d) The woman in infertility treatment makes the determination that she does not want or need the oocytes for her own reproductive success.
(e) The donation of oocytes for research is done without valuable consideration as defined in Section 125350.