Cal. Code Regs. tit. 17 § 100020

Current through Register 2024 Notice Reg. No. 50, December 13, 2024

Section 100020 - Definitions

As used in this chapter:

(a) "Acceptably derived" means derived in accordance with the requirements of Code of California Regulations, Title 17, sections 100080 and 100090.

(b) "Awardee" means an organization that is the recipient of an award from CIRM and that is legally responsible and accountable for their use of the funds provided and for the performance of the CIRM-funded project or activity. The Awardee is the entire legal entity even if a particular component is designated in the notice of award. Campuses of the University of California shall be considered as separate and individual Awardees.

(c) "CIRM" means the California Institute for Regenerative Medicine.

(d) "Covered stem cell line" means a culture-derived, human pluripotent stem cell population that is capable of:

1) sustained propagation in culture; and (2) self-renewal to produce daughter cells with equivalent developmental potential. This definition includes both embryonic and non-embryonic human stem cell lines regardless of the tissue of origin. "Pluripotent" means capable of differentiation into mesoderm, ectoderm, and endoderm.

(e) "Funded research" means research supported in whole or part by funds authorized by article XXXV of the California Constitution. For the purpose of this chapter, training activities supported by such funds shall be considered funded research.

(f) "Human subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains:

(1) Data through intervention or interaction with the individual, or

(2) Identifiable private information.

(g) "Human Subjects Research" is research defined by Title 45, Code of Federal Regulations, Part 46 (Protection of Human Subjects), revised June 23, 2005.

(h) "Institutional Review Board" ("IRB") is an entity established in accordance with Title 45, Code of Federal Regulations, section 46.107, revised June 23, 2005.

(i) "Permissible Expenses" means necessary and reasonable costs directly incurred as a result of donation or participation in research activities. Permissible expenses may include but are not limited to costs associated with travel, housing, child care, medical care, health insurance and actual lost wages.

(j) "Research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of these regulations, whether or not they are conducted or supported under a program which is considered research for other purposes.

(k) "Somatic Cell Nuclear Transfer" ("SCNT") means the transfer of a somatic cell nucleus into an oocyte.

(l) "Stem Cell Research Oversight Committee" ("SCRO" committee) means a committee established in accordance with Code of California Regulations, Title 17, section 100060.

Cal. Code Regs. Tit. 17, § 100020

1. New section filed 10-10-2006; operative 11-22-2006 (Register 2006, No. 41).
2. New subsections (b) and (g), repealer of subsection (f) and subsection relettering filed 8-21-2017; operative 10-1-2017 (Register 2017, No. 34).

Note: Authority cited: Article XXXV, California Constitution; and Section 125290.40(j), Health and Safety Code. Reference: Sections 125290.35, 125290.40, 125290.55, 125292.10(p) and (q), Health and Safety Code.