Cal. Code Regs. tit. 17 § 50417

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

Section 50417 - Criteria for State Hospital IRB Approval of Research Protocols

In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:

(a) Risks to human subjects are minimized by using procedures, when possible, which are:

(1) Consistent with sound research design and which do not unnecessarily expose subjects to risk; and

(2) Already being performed on the subjects for diagnostic or treatment purposes.

(b) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and to the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB shall consider only those risks and benefits that may result from the research as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research. The IRB shall not consider possible long-range effects of applying knowledge gained in the research, such as the possible effects of the research on public policy as among those research risks that fall within the purview of its responsibility.

(c) Selection of subjects is appropriate and equitable. In making this assessment, the IRB shall take into account the purposes of the research and the setting in which the research will be conducted.

(d) The procedures described in the protocol for obtaining and documenting prior informed consent from each prospective subject or the subject's legally authorized representative are in accordance with these regulations.

(e) The material is to be used in obtaining informed consent are in accordance with these regulations.

(f) There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

(g) The researcher possesses professional qualifications, competence and integrity.

(h) If the state hospital does not have a separate entity to review the technical aspects of research protocols, the IRB also shall review the research for:

(1) scientific merit and relevance, including relevance to the missions of the state hospital, or facility; and

(2) adequacy of research design and appropriateness of research methodology.

Cal. Code Regs. Tit. 17, § 50417

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.