reglab/statecodes huggingface dataset:
California Code of Regulations › Title 17 - Public Health › Division 3 - Air Resources › Chapter 1 - Air Resources Board › Subchapter 10 - Climate Change › Article 5 - California Cap on Greenhouse Gas Emissions and Market-Based Compliance Mechanisms › Appendix D - CPP Glidepath Targets and Backstop Triggers from 2021 to 2031

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Year
Compliance
								Period
Annual CPP Glidepath
								Target#
								(MMTCO2e)
Full
								Compliance Period CPP Glidepath Target#
								(MMTCO2e)
CPP
								Backstop Trigger#
								(MMTCO2e)
2021
4
Not
								applicable
50.0
55.0
2022
50.0
2023
5
49.4
98.3
108.2
2024
48.9
2025
48.4
2026
6
47.8
143.4
157.8
2027
47.3
2028
7
46.7
92.9
102.2
2029
46.2
2030
8
45.6
91.3
100.4
2031
45.6
# For all two-year compliance periods after 2031, the CPP
						Glidepath Target is 91.3 MMTCO2e and the CPP Backstop
						Trigger is 100.4 MMTCO2e.
1. New
						Appendix D filed 9-18-2017; operative 10-1-2017 pursuant to Government Code
						section
						11343.4(b)(3)
						(Register 2017, No. 38).
California Code of Regulations › Title 17 - Public Health › Division 3.5 - Office of Environmental Health Hazard Assessment › Chapter 2 - Pesticide Program › Subchapter 1 - Pesticide-Related Illness and Injury › Article 1 - Reporting › Section 96100 - Local Health Officers' Report of Known or Suspected Pesticide-Related Illness. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
						division 3.5 (chapter 2, subchapter 1, article 1, section
						96100) and section filed 5-4-2007;
						operative 6-3-2007 (Register 2007, No. 18).
2. Change without
						regulatory effect renumbering former section
						96100 to new section
						98100 filed 9-5-2008 pursuant to
						section 100, title 1, California Code of
						Regulations (Register 2008, No. 36).
Note: Authority cited: Section
						  105200,
						  Health and Safety Code. Reference: Section
						  105200,
						  Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 3.5 - Office of Environmental Health Hazard Assessment › Chapter 2 - Pesticide Program › Subchapter 1 - Pesticide-Related Illness and Injury › Article 1 - Reporting › Section 98100 - Local Health Officers' Report of Known or Suspected Pesticide-Related Illness

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
					 Upon receipt of a report of a known or suspected pesticide-related illness or
					 injury from a licensed physician or other health care provider, as defined in
					 Title 17, California Code of Regulations, section
					 2500(a)(14), the
					 local health officer or designee shall report the following information to the
					 Director of the Office of Environmental Health Hazard Assessment, the Director
					 of Pesticide Regulation, and, for work-related illness or injury, the Director
					 of Industrial Relations:
(1) Patient
					 demographic information, including:
(A) First
					 and last name.
(B) Social security
					 number, if available.
(C) Birth
					 date.
(D) Residence address,
					 including street address, city, county, state, and zip code.
(E) Contact telephone number, including
					 residential, work, or cellular telephone.
(F) Gender.
(G) Ethnicity, if known.
(H) Race, if known.
California Code of Regulations › Title 17 - Public Health › Division 3.5 - Office of Environmental Health Hazard Assessment › Chapter 2 - Pesticide Program › Subchapter 2 - Medical Supervisors › Section 98201 - General

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Health and Safety Code 105206(f) allows the office to
					 establish reasonable requirements for the performance of medical
					 supervisors.
1. New
					 subchapter 2 (sections
					 98201-98203) and section filed
					 5-7-2018; operative 7-1-2018 (Register 2018, No.
					 19).
Note: Authority cited: Section
						105206,
						Health and Safety Code. Reference: Sections
						105205,
						105206
						and
						105200,
						Health and Safety Code; and Section
						6409, Labor
						Code.
California Code of Regulations › Title 17 - Public Health › Division 3.5 - Office of Environmental Health Hazard Assessment › Chapter 2 - Pesticide Program › Subchapter 2 - Medical Supervisors › Section 98202 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) "Office" refers
				  to the Office of Environmental Health Hazard Assessment within the California
				  Environmental Protection Agency.
(b) "Registration form" refers to the Medical
				  Supervisor Registration Form published by the office on October 30, 2017. The
				  office shall make the form available on its website and shall provide the form
				  to any person who requests it. The form is hereby incorporated by reference in
				  its entirety.
(c) "Medical
				  supervisor" is a physician who monitors the blood cholinesterase levels of
				  workers pursuant to Title 3 of the California Code of Regulations section
				  6728.
1. New
					 section filed 5-7-2018; operative 7-1-2018 (Register 2018, No.
					 19).
Note: Authority cited: Section
						105206,
						Health and Safety Code. Reference: Sections
						105205,
						105206
						and
						105200,
						Health and Safety Code; and Section
						6409, Labor
						Code.
California Code of Regulations › Title 17 - Public Health › Division 3.5 - Office of Environmental Health Hazard Assessment › Chapter 2 - Pesticide Program › Subchapter 2 - Medical Supervisors › Section 98203 - Registration of Medical Supervisors

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A medical supervisor who contracts with an employer to
					 monitor the cholinesterase levels of pesticide workers pursuant to Health and
					 Safety Code section
					 105206
					 must register with the office.
(a) A
				  medical supervisor shall register with the office by filling out the
				  registration form available from the office or on the office's website and
				  submitting it to the office electronically, by mail, or by facsimile as
				  provided on the form.
(b) Medical
				  supervisors must renew their registration between January 1 and March 1 of each
				  year following their initial registration by filling out the registration form
				  available from the office or on the office's website and sending a completed
				  copy to the office electronically, by mail, or by facsimile as provided on the
				  form.
(c) The office will maintain
				  on its website the list of registered medical supervisors.
(d) The office will remove from its list of
				  registered medical supervisors any medical supervisor who does not renew their
				  registration by March 1 of each year until such time as the medical supervisor
				  re-registers by completing the registration form and sending the completed copy
				  to the office.
(e) The medical
				  supervisor may not contract with an employer unless the medical supervisor has
				  a current registration with the office.
(f) If a medical supervisor no longer wishes
				  to participate in the medical supervision program, the medical supervisor may
				  request in writing that the medical supervisor's name and information be
				  removed from the office's list of registered medical supervisors posted on its
				  website.
(g) If a medical
				  supervisor does not renew their registration as specified in subsection (b) or
				  requests their name and information be removed from the office's list of
				  registered medical supervisors as specified in subsection (f), the medical
				  supervisor must inform all employers with whom they have a current contract to
				  perform medical supervision that they are no longer a registered medical
				  supervisor.
1. New
					 section filed 5-7-2018; operative 7-1-2018 (Register 2018, No.
					 19).
Note: Authority cited: Section
						105206,
						Health and Safety Code. Reference: Sections
						105205,
						105206
						and
						105200,
						Health and Safety Code; and Section
						6409, Labor
						Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Appendix A - California Institute for Regenerative Medicine Conflict of Interest Code

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Designated
						Positions
Disclosure
						Category
Independent Citizens' Oversight
						Committee
Chair
1
Vice Chair
1
Board Member
1
Senior Executive Assistant
3
Office of the President
President and CEO
1
Senior Science Officer
2
Senior Executive Assistant to the
						President
3
Legal
General Counsel
1
Associate General Counsel
1
Human Resources
Associate Director,
3
Human Resources Specialist
3
Grants Management
Director,
1
Associate Director,
2
Grants Management Specialist
2
Scientific Programs
Vice President
1
Associate Director
2
Senior Science Officer
2
CIRM Business Development
Director
1
Review and Portfolio
Vice President
1
Senior Science Officer
2
Project Manager
2
Therapeutics Development
Vice President
1
Director
2
Associate Director
2
Senior Officer
2
Senior Science Officer
2
Science Officer
2
Senior Program Manager
2
Program Manager
2
Administrative Assistant
3
Public Outreach and Board
						Governance
Vice President
1
Associate Director, Board Relations
2
Director of Patient Advocacy
1
Media Relations Director
1
Director, Marketing and Communications
1
Communications Team Coordinator
3
Information Technology
Information Technology Director
4
Senior Programmer
4
Software Engineer
4
Finance
Director
1
Finance Officer
3
Business Services Officer
3
Consultants/New
						Positions
*
__________
* With respect to consultants/new positions, the agency
				President may determine in writing that a particular consultant or new
				position, although a "designated position," is hired to perform a range of
				duties that is limited in scope and thus, is not required to comply fully with
				the disclosure requirements described in this section. Such determination shall
				include a description of the consultant's or new position's duties and, based
				upon that description, a statement of the extent of disclosure requirements.
				The agency President's determination is a public record and shall be retained
				for public inspection in the same manner and location as this
				conflict-of-interest code. (Government Code Section
				81008.)
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Appendix B

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Disclosure Categories
Category 1
An individual holding a designated position shall report
				any:
Investments, business positions in businesss entities, and
				income (including receipt of gifts, loans and travel payments) and all
				interests in real property located in the state of California.
Category 2
An individual holding a designated position shall report
				any:
Investments, business positions in business entities and income
				(including receipt of gifts, loans and travel payments) if the business entity
				or source of income is of the type to receive grants or other monies from or
				through CIRM;
Investments, business positions in business entities and income
				(including receipt of gifts, loans and travel payments) if the business entity
				or the source of income is of the type to offer or provide facilities,
				services, goods or products purchased or used, or contracted for, by CIRM, and
				is providing or planning to provide such facilities, services, goods or
				products; and Investments, business positions in business entities and income
				(including receipt of gifts, loans and travel payments) if the business entity
				or source of income is engaged in biomedical research or manufacturing
				biomedical pharmaceuticals.
Category 3
An individual holding a designated position shall report
				any:
Investments, business positions in business entities and
				income, (including receipt of gifts, loans and travel payments) if the business
				entity or source of income is engaged in biomedical research or manufacturing
				biomedical pharmaceuticals.
Investments, business positions in business entities and income
				(including receipt of gifts, loans and travel payments) if the business entity
				or the source of income is of the type to offer or provide facilities,
				services, goods or products purchased or used, or contracted for, by CIRM, and
				is providing or is planning to provide such facilities, services, goods or
				products.
Category 4
An individual holding a designated position shall report
				any:
Investments, business positions in business entities and income
				(including receipt of gifts, loans and travel payments) if the business entity
				or the source of income is of the type to offer or provide facilities,
				services, goods or products purchased or used, or contracted for, by CIRM, and
				is providing or planning to provide such facilities, services, goods or
				products.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Section 100001 - Definitions for Working Group Conflict of Interest Provisions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The following definitions apply to the conflict of interest
				regulations contained in this Chapter:
(a) "Applicant" includes investigators, the
			 project director(s) and the applicant entity or entities. Each campus of a
			 statewide university is considered to be a separate institution.
(b) "CIRM" is the California Institute for
			 Regenerative Medicine.
(c)
			 "Facilities Working Group" refers to the Scientific and Medical Facilities
			 Working Group.
(d) "Grant" means a
			 grant, loan or guarantee.
(e)
			 "Grantee" means a recipient of a grant from the institute. Each campus of a
			 statewide university shall be considered as a separate and individual grantee
			 institution.
(f) "Grants Review
			 Working Group" refers to the Scientific and Medical Research Funding Working
			 Group.
(g) "Member" is a non-ICOC
			 individual appointed to serve as a voting member on a working group.
(h) "Principal Investigator" is an individual
			 designated by the grantee to direct the project or activity being supported by
			 the grant.
(i) "Project Director"
			 is an individual designated by the grantee to direct the project or activity
			 being supported by the grant.
(j)
			 "Standards Working Group" refers to the Scientific and Medical Accountability
			 Standards Working Group
(k) .
			 "Working Group" means any of three advisory bodies to the Independent Citizens'
			 Oversight Committee ("ICOC"), the governing body of the CIRM.
1. New section
				filed 10-5-2006; operative 11-4-2006 (Register 2006, No.
				40).
Note: Authority cited: California Constitution, article XXXV;
				  and Section
				  125290.40(j),
				  Health and Safety Code. Reference: Sections
				  125290.50,
				  125290.55,
				  125290.60,
				  125290.65,
				  125292.10(i) and
				  (j), Health and Safety
				  Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Section 100002 - Conflicts of Interest - Non-ICOC Members of the Scientific and Medical Accountability Standards Working Group

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Prohibitions: Non-ICOC Members of the
			 Standards Working Group are precluded from deriving direct financial benefit
			 from the CIRM through grants, loans or contracts and from acting as a Principal
			 Investigator on any CIRM-funded grant. Senior academic officers (including, but
			 not limited to, chancellors, presidents of institutions, deans, chairs of
			 departments, executive officers of research institutions, and other similar
			 positions), who, as part of their responsibilities, oversee and advise
			 researchers in their institution or who sign off on grants, loans or contracts
			 shall not be deemed to have a conflict of interest under this
			 regulation.
(b) Disclosure: A
			 non-ICOC working group member has a financial interest in and must disclose
			 confidentially and under penalty of perjury the following:
(1) All California-based academic or
			 non-profit research institutions from which Standard Working Group members,
			 their spouses, or others with whom a member has a common financial interest,
			 receive current income of $5,000 or more;
(2) All biotechnology and pharmaceutical
			 companies from which members, their spouses, or others with whom a member has a
			 common financial interest, receive current income or other benefit or
			 investments of $5,000 or more; and
(3) All real property interests in California
			 of $5,000 or more (including real estate interests and interests in
			 intellectual property such as patents and copyrights) held by members, their
			 spouses, or others with whom a member has a common financial
			 interest.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Section 100003 - Conflicts of Interest - Non-ICOC Members of the Scientific and Medical Research Funding Working Group (the "Grants Working Group")

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Prohibition: Except as provided otherwise
			 in this regulation, a non-ICOC Grants Working Group member may not participate
			 in a decision of the working group in which the individual has a conflict of
			 interest. A conflict of interest exists when a non-ICOC Grants Working Group
			 member has a real or apparent interest in the outcome of an application such
			 that the member is in a position to gain financially, professionally or
			 personally from either a positive or negative evaluation of the grant
			 proposal.
(b) "Financial: Conflict
			 of Interest -- Defined: A non-ICOC member has a financial conflict of interest
			 if:
(1) The member or a member of his or her
			 Immediate Family is an employee of either the applicant organization, a
			 Subcontractor, or a Partner, or has received, or has been promised, income or
			 anything else of value, of $5,000 or more, or gifts worth $500 or more, in the
			 past year from the applicant institution, a Subcontractor, a Partner, or a
			 person listed in the application as Key Personnel.
(2) The member or a member of his or her
			 Immediate Family is under active consideration for employment at the applicant
			 organization, a Subcontractor, or a Partner.
(3) A member or a member of his or her
			 Immediate Family stands to receive a financial benefit of any amount from the
			 application under review.
(4) A
			 member or a member of his or her Immediate Family has a financial interest in
			 the organization, a Subcontractor, or a Partner of $5,000 or more. A "financial
			 interest" includes current stock holdings, equity interest, intellectual
			 property or real property interest, but does not include an interest held
			 through a diversified mutual fund.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Section 100004 - Conflicts of Interest - Non-ICOC Members of the Scientific and Medical Facilities Working Group

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
			 Prohibitions: Except as provided otherwise in this regulation, a Facilities
			 Working Group member may not participate in a decision of the working group in
			 which the individual has a conflict of interest. Non-ICOC members serving on
			 the Facilities Working Group may not receive compensation from any construction
			 or development entity providing specialized services for medical research
			 facilities. Non-ICOC members may not provide real estate facilities brokerage
			 services for any applicant for a facilities grant, or for any entity that
			 receives funding from the Facilities Working Group, and shall not receive
			 compensation from any recipient of CIRM funding grants.
(b) Conflict of Interest Protections: A
			 conflict of interest exists when a non-ICOC Working Group member has a real or
			 apparent interest in the outcome of an application such that the member is in a
			 position to gain financially or professionally from either a positive or
			 negative evaluation of the grant proposal.
(c) "Financial" Conflict of Interest --
			 Defined: A non-ICOC member has a financial conflict of interest if:
(1) The member, his or her spouse, or any
			 other person with whom the member has a common financial interest, is an
			 employee of any construction, real estate or development entity on an
			 application.
(2) The member, his or
			 her spouse, or any other person with whom the member has a common financial
			 interest, is under active consideration for employment at an applicant
			 entity.
(3) A member, his or her
			 spouse, or any other person with whom the member has a common financial
			 interest, stands to receive a financial benefit of any amount from an
			 application under review.
(4) A
			 member, his or her spouse, or any other person with whom the member has a
			 common financial interest, has received or could receive a financial benefit of
			 any type from an applicant institution or organization unrelated to the
			 proposal, of over $5,000 per year. This total includes honoraria, fees, stock
			 and other benefits. It also includes current stock holdings, equity interest,
			 intellectual property or real property interest, but does not include
			 diversified mutual funds.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Section 100005 - Conflicts of Interest-Members of Advisory Task Forces

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Prohibitions: Members of Advisory Task
			 Forces are precluded from deriving direct financial benefit from CIRM through
			 research grants or loans and from acting as a Principal Investigator on any
			 CIRM-funded award.
(b) Disclosure:
			 Before a meeting of an Advisory Task Force, members of the Advisory Task Force
			 shall disclose:
(1) All California-based
			 academic or non-profit research institutions from which the member or the
			 member's spouse has received income of $5,000 or more in the preceding 12
			 months;
(2) All public
			 biotechnology and pharmaceutical companies that are primarily focused on stem
			 cell or genetic research and therapy development in which the member or the
			 member's spouse has an investment of $5,000 or more. A public biotechnology
			 company or a public pharmaceutical company is considered to be primarily
			 focused on stem cell or genetic research and therapy development if it devotes
			 more than 50 percent of its annual research and development budget to stem cell
			 or genetic research and therapy development.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100010 - Scope of Chapter 2 - Stem Cell Research

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The standards set forth in this chapter apply to Awardees, as
				  defined in Title 17, California Code of Regulations, section
				  100020, performing research, as
				  defined in Title 17, California Code of Regulations, section
				  100020, funded by the California
				  Institute for Regenerative Medicine (CIRM) as authorized by Article XXXV of the
				  California Constitution.
1. New section
				  filed 10-10-2006; operative 11-22-2006 (Register 2006, No. 41).
2.
				  Amendment of chapter heading filed 9-18-2013; operative 9-18-2013 pursuant to
				  Government Code section
				  11343.4(b)(3)
				  (Register 2013, No. 38).
3. Amendment 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
					 and
					 125290.55,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100020 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100030 - Activities Not Eligible for CIRM Funding

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The following activities are not eligible for CIRM
				  funding:
(a) Human reproductive
				cloning, as defined in California Health and Safety Code Section
				125292.10.
				subdivision (k), or reproductive uses of SCNT prohibited by article XXXV,
				section 3, of the California
				Constitution.
(b) The culture in
				vitro of (i) any intact human embryo or (ii) any product of SCNT,
				parthenogenesis or androgenesis, after the appearance of the primitive streak
				or after 12 days whichever is earlier. The 12 day prohibition does not count
				any time during which the embryos and/or cells have been stored
				frozen.
(c) The introduction of
				stem cells from a covered stem cell line into nonhuman primate
				embryos.
(d) The introduction of
				any stem cells, whether human or nonhuman, into human embryos.
(e) Breeding any animal into which covered
				stem cells have been introduced such that they could contribute to the germ
				line.
(f) The transfer to a uterus
				of a genetically modified human embryo.
1. New section
				  filed 10-10-2006; operative 11-22-2006 (Register 2006, No. 41).
2.
				  Amendment of subsection (e) 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
					 and
					 125292.10,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100040 - Awardee Assurance of Compliance

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Awardees shall be responsible for
				providing written assurance satisfactory to CIRM that CIRM-funded research
				complies with the requirements set forth in this chapter.
Each Awardee shall ensure that the chancellor, chief
				  executive officer or person with plenary authority designates an institutional
				  official responsible for oversight of and documentation of
				  compliance.
(b) Awardees
				conducting human subjects research or research requiring SCRO committee review
				and approval under Title 17, California Code of Regulations section
				100070, shall:
(1) Designate one or more SCRO committee(s)
				established in accordance with the requirements of Code of California
				Regulations, title 17, section
				100060; and
(2) Designate one or more
				IRB(s).
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100050 - Compliance

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Grantees must report promptly to CIRM any failure to comply
				  with the terms and conditions of an award. Failure to comply with the
				  provisions of this chapter, as well as any other conditions of the award, are
				  set forth in the Grants Administration Policy that govern the
				  award.
1. New section
				  filed 10-10-2006; operative 11-22-2006 (Register 2006, No. 41).
2.
				  Amendment 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
					 and
					 125290.55,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100060 - SCRO Committee Membership and Function

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A SCRO committee shall be comprised of
				persons with expertise in, including but not limited to, developmental biology,
				stem cell research, molecular biology, assisted reproduction, and ethical
				issues in stem cell research. A SCRO committee shall include at least one
				non-scientist member of the public who is not employed by the relevant research
				institution and who is not part of the immediate family of a person who is
				affiliated with the institution. In addition, a SCRO committee shall include at
				least one patient advocate.
(b) Any
				member of a SCRO committee may be reimbursed for reasonable out-of-pocket
				expenses for attending the meeting, not including lost wages. No SCRO committee
				may have a member participate in the SCRO committee's initial or continuing
				review of any project in which the member has a conflicting interest, except to
				provide information to the SCRO committee.
(c) The designated SCRO committee shall
				provide scientific and ethical review of CIRM-funded research consistent with
				the requirements of Section
				100070 and other applicable CIRM
				requirements.
(d) The SCRO
				committee shall facilitate education of investigators with applicable
				requirements of this chapter.
(e) A
				SCRO committee may provide oversight for two or more funded research
				institutions, provided the SCRO committee has oversight authority consistent
				with the requirements of this chapter.
(f) A SCRO committee may be convened by an
				institution, a group of institutions, the CIRM or other state agency.
1. New section
				  filed 10-10-2006; operative 11-22-2006 (Register 2006, No. 41).
2.
				  Amendment of subsection (a) filed 10-30-2012; operative 11-29-2012 (Register
				  2012, No. 44).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j).
					 Reference: Sections
					 125290.35,
					 125290.40
					 and
					 125290.55,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100070 - SCRO Committee Review and Notification

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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:
(1) Provide an
				acceptable scientific rationale for the need to procure or use human oocytes or
				create human gametes. In the case of human oocyte procurement, a justification
				for the number needed. If SCNT is proposed a justification for SCNT shall be
				provided.
(2) Demonstrate
				experience, expertise or training in derivation or culture of human or nonhuman
				stem cell lines.
(3) Provide
				documentation of compliance with any required review of the proposed research
				by an IRB, Institutional Animal Care and Use Committee (IACUC), Institutional
				Bioethics Committee (IBC), or other mandated review.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100080 - Acceptable Research Materials

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100081 - Exemption Petition for Lines Derived Prior to November 22, 2006

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
For a covered stem cell line derived before November 22,
				  2006, the ICOC may find in public session that it is acceptably derived
				  pursuant to the following procedure:
(a) A person or entity seeking ICOC approval
				for a covered stem cell line not otherwise acceptably derived under Title 17,
				California Code of Regulations, section
				100080, shall submit a petition in
				a form as required by CIRM (see Appendix A to this regulation). That petition
				shall, at a minimum, provide the following information:
1. The name or designation of the covered
				stem cell line;
2. Information
				about the nature of the consents given by the donors of human gametes, embryos,
				somatic cells or tissue used to create the covered stem cell line, including
				copies of any such consents given;
3. Information about whether the donors of
				human gametes, embryos, somatic cells or tissue used to create the covered stem
				cell line received valuable consideration in exchange for their donation,
				including copies of any documents reflecting such exchanges;
4. Information about whether the donation of
				human gametes, embryos, somatic cells or tissue used to create the covered stem
				cell line was overseen by an IRB or equivalent, including copies of any
				documents reflecting such a review;
5. Information about whether the donors of
				human gametes, embryos, somatic cells or tissue used to create the covered stem
				cell line were reimbursed for the cost of storage prior to donation, including
				copies of any documentation reflecting such reimbursements;
6. Information regarding "best practices" at
				the time of donation of human gametes, embryos, somatic cells or tissue,
				including any documents substantiating those practices for each type of
				donation;
7. A statement describing
				the scientific and/or clinical necessity for granting the petition;
				and
8. Information submitted in
				connection with the petition that is of a confidential or proprietary nature as
				defined in H&S Code section
				125290.30, subdivisions (e)(B) or
				(C), or that is protected from disclosure pursuant to other federal or state
				law shall not be subject to disclosure pursuant to those
				laws.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Appendix A

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Petition to Designate a Covered Stem Cell Line as Acceptably
				  Derived
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California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100085 - Use of Fetal Tissue

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Fetal tissue shall be procured in accordance with 17 Cal.
				  Code of Regs. section
				  100080, subdivision (a)(2). In
				  addition, research involving human fetal tissue will adhere to the following
				  provisions:
(a) The woman who donates
				the fetal tissue must sign a statement declaring:
(1) That the donation is being made for
				research purposes, and
(2) The
				donation is made without any restriction regarding who may be the recipient(s)
				of materials derived from the tissue; and
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100090 - Special Considerations for CIRM-Funded Procurement, Derivation and Transplantation

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Where CIRM funds are to be used for
				research intended to derive a covered stem cell line, the SCRO committee must
				determine or the designated institutional official must certify the applicable
				requirements of Code of California Regulations, title 17, section
				100080, subdivision (a)(2) or
				(a)(3), have been met subject to the following:
(1) For embryos created before November 22,
				2006 consent exclusively from oocyte donors is sufficient provided the sperm
				donor cannot be identified and the donation was made in accordance with the
				legal requirements in force at the place and time of donation.
(2) For gametes or embryos, procured from
				human subjects, after November 22, 2006, the SCRO committee must confirm that
				donors provided voluntary and informed consent in accordance with Code of
				California Regulations, title 17, section
				100100, subdivision (b).
(3) For research involving the use of embryos
				originally created using in vitro fertilization for reproductive purposes, the
				physician performing oocyte retrieval or attending physician responsible for
				infertility treatment may not be the CIRM-funded Principal Investigator (as
				defined in title 17, California Code of Regulations, section
				100500) unless the SCRO committee
				has approved an exemption from this requirement.
(4) For human somatic cells, procured from
				human subjects after November 22, 2006, and the CIRM-funded research is
				designed to develop cells for transplantation into a live born human, the SCRO
				committee must confirm that donors provided voluntary and informed consent
				including the requirements of Code of California Regulations, title 17, section
				100100, subdivision
				(b)(1)(E).
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100095 - Additional Requirements for CIRM-Funded Research Involving Oocytes

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100110 - Fairness and Diversity in Research

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
CIRM grantees shall comply with the California Health
				  Research Fairness Act, California Health and Safety Code, sections
				  439.900-
				  439.906,
				  and Inclusion of Women and Minorities in Clinical Research Act, Health and
				  Safety Code, sections
				  100237-
				  100239.
1. New section
				  filed 10-10-2006; operative 11-22-2006 (Register 2006, No.
				  41).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 439.900-
					 439.906,
					 100237-
					 100239,
					 125290.40
					 and
					 125290.55,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100120 - Record Keeping

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) In
				addition to any other reporting or record retention obligations required by the
				CIRM, each grantee's institution shall also maintain records documenting:
(1) Review or notification requirements as
				described in Title 17, California Code of Regulations, section
				100070;
(2) The final disposition of gametes, embryos
				and, somatic cells donated for CIRM-funded research or products of SCNT. For
				donated materials used to derive a covered stem cell line this record must
				demonstrate compliance with section
				100080, subdivision
				(a).
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100140 - Scope of Chapter. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
				  division 4, chapter 2 (sections
				  100140-100150) and section filed
				  7-24-2006 as an emergency; operative 7-24-2006 (Register 2006, No. 30). A
				  Certificate of Compliance must be transmitted to OAL by 11-21-2006 or emergency
				  language will be repealed by operation of law on the following
				  day.
2. Repealed by operation of Government Code section
				  11346.1(g)
				  (Register 2006, No. 47).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.35(b)(1)
					 and
					 125290.55,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100141 - Categories of hES Cell Research. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 7-24-2006 as an emergency; operative 7-24-2006 (Register 2006, No. 30). A
				  Certificate of Compliance must be transmitted to OAL by 11-21-2006 or emergency
				  language will be repealed by operation of law on the following
				  day.
2. Repealed by operation of Government Code section
				  11346.1(g)
				  (Register 2006, No. 47).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.35(b)(1)
					 and
					 125290.55,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100142 - hES Cell Research Eligible for CIRM Funding. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 7-24-2006 as an emergency; operative 7-24-2006 (Register 2006, No. 30). A
				  Certificate of Compliance must be transmitted to OAL by 11-21-2006 or emergency
				  language will be repealed by operation of law on the following
				  day.
2. Repealed by operation of Government Code section
				  11346.1(g)
				  (Register 2006, No. 47).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.35(b)(1)
					 and
					 125290.55,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100143 - hES Cell Research Eligible for CIRM Funding After Additional ESCRO Review and Approval. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 7-24-2006 as an emergency; operative 7-24-2006 (Register 2006, No. 30). A
				  Certificate of Compliance must be transmitted to OAL by 11-21-2006 or emergency
				  language will be repealed by operation of law on the following
				  day.
2. Repealed by operation of Government Code section
				  11346.1(g)
				  (Register 2006, No. 47).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.35(b)(1)
					 and
					 125290.55,
					 Health and Safety Code.