1. (a) Before any research involving human subjects may be conducted at state hospitals, the research protocol shall be reviewed and approved by the following entities:

   1. (1) the IRB responsible for reviewing research for the particular persons who will be the subjects of the research;
   2. (2) the Executive Director of the state hospital with which the IRB is affiliated; and
   3. (3) the State IRB if required by federal laws or regulations.

2. (b) If the research protocol requires obtaining confidential information about clients of more than one state hospital, the requirement for IRB review shall be met by having the research protocol reviewed and approved by either:

   1. (1) each IRB individually, or
   2. (2) a joint IRB composed of one or more representatives from each IRB involved.
3. (c) If the research protocol involves a statewide sampling of subjects, or subjects from a regional center with no IRB, the requirement for IRB review shall be met by submitting the research protocol to the Department which shall create or designate the IRB to review the protocol.

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.

History

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).