Section 50423 - Informed Consent(a) Before confidential records or information may be released or disclosed to a researcher, the researcher must obtain prior informed consent from the person about whom the records or information pertain, or the person's legally authorized representative, to the maximum degree possible as determined by the appropriate IRB.(b) The researcher shall seek such consent only after the appropriate IRB has approved the research protocol, and only in the manner prescribed by the IRB, which shall be under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether to participate, and that minimize the possibility of coercion or undue influence.(c) The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.(d) No informed consent, whether oral or written, may include any language through which the research subject or the representative waives or appears to waive any of the research subject's legal rights, or any language which releases or appears to release the researcher, the facility, or its agents or any other person or entity from liability for negligence.Cal. Code Regs. Tit. 17, § 50423
1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4). Note: Authority cited; Section 4514(e) and 5328(e), Welfare and Institutions Code. Reference: Sections 4514(e) and 5328(e), Welfare and Institutions Code.
1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).