Medical and Scientific Accountability Standards

(a) Medical Standards

In order to avoid duplication or conflicts in technical standards for scientific and medical research, with alternative state programs, the institute will develop its own scientific and medical standards to carry out the specific controls and intent of the act, notwithstanding Sections 125300, 125320, 125118, 125119, 125119.3, and 125119.5, or any other current or future state laws or regulations dealing with the study and research of pluripotent stem cells and/or progenitor cells, or other vital research opportunities, except Section 125315. The ICOC, its working committees, and its grantees shall be governed solely by the provisions of this act in the establishment of standards, the award of grants, and the conduct of grants awarded pursuant to this act.

(b) The ICOC shall establish standards as follows:

(1) Informed Consent

Standards for obtaining the informed consent of research donors, patients, or participants, which initially shall be generally based on the standards in place on January 1, 2003, for all research funded by the National Institutes of Health, with modifications to adapt to the mission and objectives of the institute.

(2) Controls on Research Involving Humans

Standards for the review of research involving human subjects which initially shall be generally based on the Institutional Review Board standards promulgated by the National Institutes of Health and in effect on January 1, 2003, with modifications to adapt to the mission and objectives of the institute.

(3) Prohibition on Compensation

Standards prohibiting compensation to research donors or participants, while permitting reimbursement of expenses.

(4) Permitted Reimbursement

Standards permitting reimbursement for expenses, including, but not limited to, medical expenses and lodging, meals, and travel expenses, for research participants and caregivers in order to ensure functional access to clinical trials. For purposes of this paragraph, “caregivers” includes family members, friends, and professional caregivers providing supportive care.

(5) Patient Privacy Laws

Standards to assure compliance with state and federal patient privacy laws.

(6) Limitations on Payments for Cells

Standards limiting payments for the purchase of stem cells or stem cell lines to reasonable payment for the removal, processing, disposal, preservation, quality control, storage, transplantation, or implantation or legal costs or other administrative costs associated with these medical procedures and specifically including any required payments for medical or scientific technologies, products, or processes for royalties, patent, or licensing fees or other costs for intellectual property.

(7) Time Limits for Obtaining Cells

Standards setting a limit on the time during which cells may be extracted from blastocysts, which shall initially be up to 12 days after cell division begins, not counting any time during which the blastocysts and/or cells have been stored frozen.

(8) Standards for Genetic Medical Treatments and Research

Standards for research involving genetic medical treatments that shall, in the ICOC’s discretion, generally be based on the standards adopted by the National Academy of Sciences.

(Amended November 3, 2020, by initiative Proposition 14, Sec. 11. Effective on December 16, 2020. Note: This section was added on Nov. 2, 2004, by initiative Prop. 71.)