(a) Research involving the procurement or use of human oocytes or the creation of human gametes may not commence without SCRO committee review and approval in writing. If research involves the procurement of human oocytes from a living donor a member of the committee with expertise in assisted reproduction shall be present. The designated SCRO committee may require that modification be made to proposed research or documentation of compliance with the requirements of subdivision (a)(3) of this regulation as a condition of granting its approval. At a minimum, the SCRO committee shall require the investigator to:

(b) Research involving procurement, creation or use of human blastocysts or embryos may not commence without SCRO committee review and approval in writing. The designated SCRO committee may require that modification be made to proposed research or documentation of compliance with the requirements of subdivision (b)(3) of this regulation as a condition of granting its approval. At a minimum, the SCRO committee shall require the investigator to:

(c) Human subjects research with the aim to create, from sources other than human gametes, blastocysts or embryos, a covered stem cell line may not commence without written notification of the SCRO committee. A statement from the designated institutional official (as defined in Title 17, California Code of Regulations section 100040, subdivision (b)(1)) may be provided in lieu of SCRO committee notification. The institutional official shall submit documentation of any required review of the proposed research by an IRB, IACUC, IBC or other mandated review. Research may include animal assays to evaluate pluripotency; however, subsequent introduction of derived covered stem cell lines in non-human animals shall be reviewed in accordance with subdivision (e) of this section. The designated SCRO committee may require the investigator to:

(d) Purely in vitro research with the aim to create or use a covered stem cell line from non-identifiable cells may not commence with out written notification of the SCRO committee. A statement from the designated institutional official pursuant to section 100040(a) may be provided in lieu of SCRO committee notification if human somatic cells conform to the requirements of section 100080(a)(3); or the covered stem cell line(s) are recognized by an authorized authority. At a minimum the statement shall certify the:

(e) The introduction of covered stem cells into nonhuman mammalian blastocysts or fetuses or introducing human neural progenitor cells into the brain of non-human animals at any state of embryonic, fetal, or postnatal development may not commence without SCRO committee review and approval in writing. Studies involving postnatal animals performed pursuant to a FDA Investigational New Drug (IND) or Investigational Device Exception (IDE) application are exempt from SCRO committee review and approval. The designated SCRO committee may require that modification be made to proposed research or documentation of compliance with the requirements of subdivision (e)(3) of this regulation as a condition of granting its approval. The SCRO committee may establish guidelines and procedures for expedited review of animal research so that review by the entire SCRO committee is not required. At a minimum, the SCRO committee shall require the investigator to:

(f) Research introducing cells from covered stem cell lines into a live born human may not commence without SCRO committee review and approval in writing. The designated SCRO committee may require that modification be made to proposed research or documentation of compliance with the requirements of subdivision (f)(4) of this regulation as a condition of granting its approval. At a minimum, the SCRO committee shall require the investigator to:

(g) In cases where SCRO committee approval is required, a SCRO committee shall notify investigators in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure SCRO committee approval of the research activity. If the SCRO committee decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

(h) SCRO committee approvals shall be reviewed no less frequently than once per year. The renewal review shall confirm compliance with all applicable rules and regulations. The SCRO committee may establish guidelines and procedures for expedited review of renewals so that review by the entire SCRO committee is not required.