California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100100 - Informed Consent Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) All CIRM-funded human subjects research
				shall be performed in accordance with Title 45 Code of Federal Regulations,
				Part 46 (Protection of Human Subjects), revised June 23, 2005, and California
				Health and Safety Code section
				24173.
				In accordance with existing law, California Health and Safety Code section
				24173
				does not apply to a person who is conducting research as an investigator within
				an institution that holds an assurance with the United States Department of
				Health and Human Services pursuant to Title 45 Code of Federal Regulations Part
				46, revised June 23, 2005, and who obtains informed consent in the method and
				manner required by those regulations.
(b) In addition to the requirements of Code
				of California Regulations, title 17, section
				100080, subdivision (a)(2), the
				following provisions apply when CIRM funded research involves donation of human
				gametes, embryos, somatic cells or tissue for derivation of new covered stem
				cell lines:
(1) CIRM-funds may not be used for
				research that violates the documented preferences of donors with regard to the
				use of donated materials. The SCRO committee or IRB must confirm that donors
				have given voluntary and informed consent in accordance with this section. To
				ensure that donors are fully informed of the potential uses of donated
				materials in addition to the general requirements for obtaining informed
				consent identified in subdivision (a) of this regulation, researchers shall
				disclose all of the following, unless a specific item has been determined by
				the SCRO committee or IRB to be inapplicable:
(A) Derived cells or cell products may be
				kept for many years.
(B) Whether or
				not the identity(ies) of the donor will be ascertainable by those who work with
				the resulting cells or cell products. If the identity of the donor is to remain
				associated with the cell or cell products, then the investigator must inform
				the donor of any plan for recontact whether for the purpose of providing
				information about research findings to donors, or for the purpose of requesting
				additional health information. After donation, an investigator may recontact a
				donor only if the donor consents at the time of donation.
(C) Cell lines may be used in future studies
				which are not now foreseeable.
(D)
				Derived cells or cell products may be used in research involving genetic
				manipulation.
(E) Derived cells or
				cell products may be transplanted into humans or animals.
(F) Derived cells or cell products are not
				intended to provide direct medical benefit to the donor, except in the case of
				autologous donation.
(G) The
				donation is being made without restriction on the recipient of transplanted
				cells, except in the case where donation is intended for autologous
				transplantion.
(H) Neither consent
				nor refusal to donate materials for research will affect the quality of any
				care provided to a potential donor.
(I) Although the results of research
				including donated materials may be patentable or have commercial value, the
				donor will have no legal or financial interest in any commercial development
				resulting from the research.