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§ 100095. Additional Requirements for CIRM-Funded Research Involving Oocytes.

17 CA ADC § 100095Barclays Official California Code of Regulations

Barclays California Code of Regulations
Title 17. Public Health
Division 4. California Institute for Regenerative Medicine
Chapter 2. Scientific and Medical Accountability Standards
17 CCR § 100095
§ 100095. Additional Requirements for CIRM-Funded Research Involving Oocytes.
When procurement of oocytes are required for CIRM-funded research, the SCRO committee must confirm the following conditions have been 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 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 infertility treatment. Pursuant to this requirement, the SCRO shall confirm the following:
(1) The infertility treatment protocol is established prior to requesting or obtaining consent for a donation for research purposes and that the prospect of donation for research does not alter the timing, method, or procedures selected for clinical care.
(2) The woman in infertility treatment makes the determination that she does not want or need the oocytes for her own reproductive success.
(3) The donation of oocytes for research is done without valuable consideration either directly or indirectly.
(4) If the procurement of oocytes involves a donor providing oocytes for another woman's reproductive use, then the donation to research must be expressly permitted by the original donor.
(5) If the procurement of oocytes involves use of materials donated for reproductive use by another woman and with valuable consideration in excess of reimbursement for permissible expenses for the oocyte donor, then oocytes may not be used for CIRM-funded research.
(c) The CIRM-funded institution shall develop procedures to ensure that an individual who donates oocytes for CIRM-funded research has access to medical care that is required as a direct and proximate result of that donation. Such care shall be provided at no cost to the donor. If a donor is medically insured, the donor shall not be required to claim any treatment costs through her own insurance policy.
(d) The physician attending to any donor and the principal investigator shall not be the same person unless exceptional circumstances exist and an IRB has approved an exemption from this requirement.
(e) The physician performing oocyte retrieval shall not have a financial interest in the outcome of the research.

Credits

Note: Authority cited: Article XXXV, California Constitution; and Section 125290.40(j), Health and Safety Code. Reference: Sections 125290.35, 125290.40 and 125290.55, Health and Safety Code.
History
1. New section filed 10-10-2006; operative 11-22-2006 (Register 2006, No. 41).
This database is current through 4/12/24 Register 2024, No. 15.
Cal. Admin. Code tit. 17, § 100095, 17 CA ADC § 100095
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