§ 100100. Informed Consent Requirements.
17 CA ADC § 100100Barclays Official California Code of Regulations
17 CCR § 100100
§ 100100. Informed Consent Requirements.
(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.
(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:
(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) Prospective donors shall be informed of their option to deliberate before deciding whether or not to give consent. If a deliberation period is chosen, the donor shall be informed of her right to determine the method of recontact. The donor must be informed that she has the option to initiate recontact. Investigators shall not initiate recontact unless the donor has consented, and this consent is documented in the research record.
Credits
Note: Authority cited: Article XXXV, California Constitution; and Section 125290.40(j), Health and Safety Code. Reference: Sections 24173, 125290.35, 125290.40, 125290.55 and 125315, Health and Safety Code.
History
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).
This database is current through 4/26/24 Register 2024, No. 17.
Cal. Admin. Code tit. 17, § 100100, 17 CA ADC § 100100
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