Section 50411 - Composition of the IRB at State Hospitals(a) Each state hospital IRB shall have at least five members, including: (1) Persons with varying educational and professional backgrounds sufficient to ensure a complete and adequate review of research activities commonly conducted by or at the facility;(2) Persons with sufficient expertise and experience to promote respect for their advice and counsel in safeguarding the rights and welfare of human subjects;(3) Persons possessing both the professional competence to review specific research activities and the ability to ascertain the acceptability of proposed research in terms of facility commitments and regulations, applicable law, and standards of professional conduct and practice;(4) Both men and women with diversity of backgrounds, racial, and cultural characteristics, and with sensitivity to community attitudes;(5) at least one member whose primary concerns are in nonscientific areas and who are concerned with the rights or persons with developmental disabilities; for example, a lawyer, a member of the clergy, a clients' rights advocate; and(6) at least one member who is not affiliated with the facility and who is not part of the immediate family of a person who is affiliated with the facility.(b) Excluded from membership are the Executive Director of the state hospital and the clinical director of the state hospital by which the IRB was constituted.(c) Excluded from voting on specific projects are members who have been or are participants in , or associated with, the research proposal.(d) If the state hospital does not have a separate committee to review the technical research design aspects of a research protocol, at least three members of the IRB shall have sufficient experience and expertise in conducting and critiquing research methodology to ensure the adequacy of review of research design and method.(e) The IRB may call upon consultants as deemed necessary to render technical advice.Cal. Code Regs. Tit. 17, § 50411
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 174; 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).