CPHS-Related Links
- California Information Practices Act, Civil Code, Section 1798.24 (SB 13)
- FDA Regulations
- FDA Web Site
- HIPAA Privacy Rule
- Common Rule
- Office for Human Research Protections (OHRP)
- Public Responsibility in Medicine & Research and Applied Research Ethics National Association (Prim&R and ARENA)
Contact CPHS at:
400 R Street, Suite 369
Sacramento, CA 95811-6213
Phone: (916) 326-3660
Fax: (916) 322-2512
E-mail: cphs-mail@oshpd.ca.gov
Committee for the Protection of Human Subjects
Legal Authority
Legal Authority - The CPHS operates under the terms of Federalwide Assurance (FWA) 00000681 signed in June 2001 with the U.S. Department of Health and Human Services, and conducts business, as appropriate, in compliance with the:
- Common Rule (45 CFR Part 46 of the Code of Federal Regulations)
- Food and Drug Administration regulations (21 CFR, Parts 50 and 56)
- Privacy Rule of the Health Insurance Portability and Accountability Act, (45 CFR, Part 160)
- California Information Practices Act, Civil Code, Section 1798.24 (SB13)
Scope of Authority - In compliance with the Federalwide Assurance, the CPHS is obligated to review all research involving human subjects, regardless of funding source, meeting any of the following criteria:
- Research sponsored by the California Health and Human Services Agency (CHHSA) or any of its departments.
- Research conducted by or under the direction of any employee or agent of the CHHSA or any of its departments.
- Research using personally identifiable data held by the CHHSA or any of its departments.
- Research involving subjects for whom the CHHSA or any of its departments have direct responsibility, such as patients in State hospitals.
The California Information Practices Act (SB13) (effective January 1, 2006) requires CPHS review and approval before personal information (linkable to any individual) that is held by any state agency or department can be released for research purposes.
Reciprocity with Other Institutional Review Boards - The CPHS will engage in formal agreements to serve as the institution review board for other institutions in California with current Federalwide Assurances in place. Reciprocity arrangements to enable other institutional review boards to approve projects for the CPHS under the Federal Common rule will be considered on a case-by-case basis. The CPHS does not delegate reviews for compliance with the California Information Practices Act, Civil Code, Section 1798.24 (SB13) to other institutional review boards.