Cal. Code Regs. tit. 17 § 50405

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

Section 50405 - Institutional Review Boards (IRBs)

(a) An IRB shall review all research protocols pertaining to research involving human subjects who are served by state hospitals or regional centers.

(b) Each state hospital shall establish an IRB to review and approve or disapprove research protocols and to assure that the protocols meet the requirements of this subchapter.

(c) Each regional center may establish an IRB and procedures to review and approve or disapprove research protocols and to assure that such protocols meet the requirements of Section 4514 of the Welfare and Institutions Code. The regional center's IRB shall review and approve or disapprove the research protocols that involve their clients except those residing in a state hospital in accordance with the procedures established by the regional center pursuant to this section.

(d) If a regional center does not choose to establish an IRB, the regional center shall submit the research protocol directly to the Department. The Department shall create or designate the IRB that shall review and approve or disapprove the research protocol, pursuant to Sections 50407 through 50429.

Cal. Code Regs. Tit. 17, § 50405

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.