§ 125341. — 125341. (Amended by Stats. 2019, Ch. 864, Sec. 5.)

California § 125341.

• Jurisdiction: California
• Code HSC: Health and Safety Code - HSC
• Div. 106.: DIVISION 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT)
• Part 5.5.: PART 5.5. USE OF HUMAN CELLS
• Ch. 2.: CHAPTER 2. Procuring of Oocytes for Research

Text

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 will receive and review this written summary.
(b)
That it inform the research participant that ongoing studies are necessary 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 with an objective and accurate statement about the existing state of the research for which the research participant is providing oocytes.
(e)
That it perform psychological and physical screening, in accordance with the appropriate standard of care, for all research participants 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 be given a postprocedure medical examination at a time within the standard of care to determine if the research participant has experienced an adverse health effect that is a result of the procedure. The research participant shall be informed that they have the right to a second opinion if they have any medical concerns.
(g)
That it ensure that the research participant 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 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 prior to the procedure.
(h)
That it provide a summary informing the research participant 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 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 the interest of both the research participant and the success of the research.

Legislative History

Amended by Stats. 2019, Ch. 864, Sec. 5. (AB 922) Effective January 1, 2020.