Cal. Code Regs. tit. 17 § 100080

Current through Register 2024 Notice Reg. No. 43, October 25, 2024

Section 100080 - Acceptable Research Materials

All covered stem cell lines used in CIRM-funded research must be "acceptably derived."

(a) To be "acceptably derived," the covered stem cell line must meet one of the following three criteria:

(1) The covered stem cell line is recognized by an authorized authority. To be recognized by an authorized authority the stem cell line must:

(A) Be approved by the National Institutes of Health; or

(B) Be deposited in the United Kingdom Stem Cell Bank; or

(C) Be derived by, or approved for use by, a licensee of the United Kingdom Human Fertilization and Embryology Authority; or

(D) Be derived in accordance with the Canadian Institutes of Health Research Guidelines for Human Pluripotent Stem Cell Research under an application approved by the National Stem Cell Oversight Committee; or

(E) Be derived in accordance with the Japanese Guidelines for Derivation and Utilization of Human Embryonic Stem Cells; or

(F) Be derived under license of the Australian National Health and Medical Research Council; or

(G) Be derived in accordance with California Code of Regulations, title 17, section 100090.

(2) The covered stem cell line is derived under the following conditions:

(A) Donors of human gametes, embryos, somatic cells or tissue gave voluntary and informed consent; and

(B) Donors of human gametes or embryos did not receive valuable consideration. For embryos originally created using in vitro fertilization for reproductive purposes and are no longer needed for this purpose, "valuable consideration" does not include payments to original gamete donors in excess of "permissible expenses." Original gamete donors may receive reimbursement for permissible expenses as defined in California Code of Regulations, title 17, section 100020, subdivision (h); and

(C) Donation of human gametes, embryos, somatic cells or tissue was overseen by an IRB (or, in the case of foreign sources, an IRB-equivalent); and

(D) Individuals who consented to donate stored human gametes, embryos, somatic cells or tissue were not reimbursed for the cost of storage prior to donation.

(3) The covered stem cell line is derived from non-identifiable human somatic cells under the following conditions:

(A) The derivation did not result from the transfer of a somatic cell nucleus into a human oocyte (SCNT) or the creation or use of a human embryo; and

(B) The somatic cells have no associated codes or links maintained by anyone that would identify to the investigator(s) the donor of the specimens, or, if such codes or links exist, that the identity of the donor is not readily ascertainable because, for example:

(i) the key to decipher the code or link is destroyed before the research begins;

(ii) an agreement prohibits release of the key to the investigators under any circumstances;

(iii) IRB-approved written policies and operating procedures for a repository or data management center prohibit releasing the key under any circumstances; or

(iv) the release of the key to the investigators is forbidden by law.

(b) In addition to the requirements of subdivision (a) of this chapter, the following requirements apply to the derivation and use of all covered stem cell lines.

(1) Any covered stem cell line derived from any intact human embryo, any product of SCNT, parthenogenesis or androgenesis after 12 days in culture may not be used unless prior approval is obtained from the Independent Citizens Oversight Committee, constituted under Health & Safety Code, section 125290.15. Use of any covered stem cell line derived from any intact human embryo, any product of SCNT, parthenogenesis or androgenesis after 14 days or after the appearance of the primitive streak is prohibited. The 12-14 day limit does not include any time during which the cells have been frozen.

(2) Any payments for the purchase of covered stem cell lines, somatic cells, or human tissue to persons other than the original donors shall be limited to those costs identified in Health & Safety Code, section 125290.35, subdivision (b)(5). Any payment for gametes and embryos, to persons other than the original donors, shall be limited to necessary and reasonable costs directly incurred as a result of providing materials for research, which include but are not limited to expenditures associated with processing, quality control, storage, or transportation.

Cal. Code Regs. Tit. 17, § 100080

1. New section filed 10-10-2006; operative 11-22-2006 (Register 2006, No. 41).
2. Amendment filed 5-30-2008; operative 6-29-2008 (Register 2008, No. 22).
3. Amendment of subsections (a), (a)(1), (a)(2), (a)(2)(B) and (a)(3) filed 1-10-2011; operative 2-9-2011 (Register 2011, No. 2).
4. New subsection (a)(1)(F) and subsection relettering filed 3-28-2012; operative 4-27-2012 (Register 2012, No. 13).

Note: Authority cited: Article XXXV, California Constitution; and Section 125290.40(j), Health and Safety Code. Reference: Sections 125290.35, 125290.40, 125290.55 and 125300, Health and Safety Code.