Cal. Code Regs. tit. 17 § 50427

Current through Register 2024 Notice Reg. No. 25, June 21, 2024

Section 50427 - Waiver of Requirement of Informed Consent at State Hospitals

A state hospital IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent or waive the requirements to obtain informed consent, provided the IRB finds and documents that:

(a) The research involves no more than minimal risk to the subjects and involves no procedures for which written consent is normally required;

(b) The waiver or alteration will not adversely affect the rights and welfare of the subjects;

(c) The research could not practicably be carried out without the waiver or alteration; and

(d) The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality;

(e) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Cal. Code Regs. Tit. 17, § 50427

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).
2. Amendment of section filed as an emergency 6-17-93; operative 6-17-93. Submitted to OAL for printing only pursuant to SB485 (Chapter 722, Statutes of 1992) Section 147(a) (Register 93, No. 26).
3. Certificate of Compliance as to 6-17-93 order transmitted to OAL 6-20-94 and filed 8-2-94 (Register 94, No. 31).

Note: Authority cited: Chapter 722, Statutes of 1992, Section 147; Sections 4514(e), 4791(i) and 5328(e), Welfare and Institutions Code. Reference: Sections 4514(e), 4791 and 5328(e), Welfare and Institutions Code.