Section 50415 - Responsibilities of the IRB at State Hospitals(a) The IRB shall make available a copy of the regulations in this subchapter to any person inquiring about doing research covered by this subchapter.(b) The IRB shall meet and review all written research protocols within 31 days of receipt.(c) The IRB shall review the written research protocol and make a determination as to whether or not the research is exempt from these regulations as specified in 50403(d).(d) The IRB may request from the researcher any additional information necessary to complete its review, and may require modifications in the research activity or protocol before approval may be granted.(e) The IRB shall approve, disapprove or defer the research protocol in writing, giving reasons for the disapproval or deferment and any requested modifications, within 31 days of its review meeting.(f) The IRB shall give the researcher the opportunity to respond to these comments in writing or in person and shall re-review protocols which have been modified at the IRB's request. The IRB shall review resubmitted research protocols within 31 days of resubmission.(g) The IRB shall prepare and maintain adequate documentation of IRB activities, including (1) copies of all submitted protocols, consent documents and other attachments;(2) minutes of meetings including persons present and a summary of decisions and actions taken;(3) records of continuing review activities;(4) names, occupations, earned degrees, licenses, certifications and other pertinent information about members' qualifications; and(5) changes in committee membership. The IRB shall submit copies of meeting minutes, reports of continuing review activities, members' qualifications and changes in membership to the State IRB on an ongoing basis.
(h) The IRB shall review proposed research at convened meetings at which a majority of the members are present. In order for the research to be approved, it shall receive the approval of either three members present or a majority of those members present at the meeting, whichever is a larger number.Cal. Code Regs. Tit. 17, § 50415
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.
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).