Cal. Code Regs. tit. 17 § 50409

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

Section 50409 - Continuing Review of Research Activities at State Hospitals

(a) The IRB shall conduct continuing review of approved research at intervals appropriate to the degree of risk involved in the research but not less than annually.

(b) At any time the Executive Director of the state hospital or the IRB shall have authority to revoke approval of the research if it is determined that any of the following occur:

(1) The research as conducted involves greater risks to the human subjects than had been anticipated when the protocol was approved;

(2) There is a subsequently discovered violation of clients' rights;

(3) There is a violation of the oath of confidentiality by the researcher or his or her agents; or

(4) The protocol is not being applied as approved.

(c) Such revocation shall include a statement of the reason for the revocation.

Cal. Code Regs. Tit. 17, § 50409

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).
2. Amendment of section heading and NOTE 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.

1. New section filed 1-22-87; effective thirtieth day thereafter (Register 87, No. 4).
2. Amendment of section heading and Note 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).