Laws and Regulations

The CPHS operates under the terms of Federalwide Assurance (FWA) 00000681 signed in October 2011 with the U.S. Department of Health and Human Services (DHHS), which stipulates that all research conducted within the jurisdiction of CalHHS will be reviewed by the CPHS in compliance with the following:

• Common Rule — The Common Rule (45 CFR Part 46 of the Code of Federal Regulations), regulates ethics for research projects involving human subjects that are funded by the United States Department of Health and Human Services and many other federal departments. It also provides specific requirements for the form and function of institutional review boards (IRBs). The CPHS operates in compliance with the Common Rule in reviewing human subjects research regardless of the funding source and promotes the high ethical principles contained in the Common Rule.
• AB 172 (Chapter 696, October 10, 2021)
• Federal Food and Drug Administration — The Federal Food and Drug Administration (FDA) regulates clinical investigations involving food, drugs, medical devices, and biological products for human use. As a federally-chartered IRB, the CPHS reviews such research in accordance with FDA regulations 21 CFR Parts 50 and 56.
• HIPAA Privacy Rule — The Privacy Rule of the Health Insurance Portability and Accountability Act (45 CFR Part 160)protects personal health information by designating that it may not be released for research purposes unless the patient has signed an authorization or an institutional review board (or privacy board) has approved a waiver of a signed patient authorization. The CPHS reviews requests for waivers of patient authorization in accordance with the HIPAA Privacy Rule.
• California Civil Code — California Information Practices Act, Civil Code, Section 1798.24 (SB-13), 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.
• California Health and Safety Code
• Protection of Human Subjects in Medical Experimentation Act — Sections 24170-24179.5 delineate State law regarding the rights of human subjects participating in medical experiments. This includes: the “Experimental Subject’s Bill of Rights,” required elements of informed consent, and consent by surrogate decision makers.
• Birth Certificate Data — Sections 102425-102475 delineate state law regarding the collection and release of information on birth certificates, including the responsibilities of the State Registrar and CPHS.
• Death Certificate Data — Section 102231(a)(3) states that “Death data files for public release shall not contain the mother’s maiden name and social security number.” Section 102231(a)(5) states, “Death data files containing personal identifying information may be released to persons expressing a valid scientific interest, as determined by the appropriate committee constituted for the protection of human subjects that is approved by the United States Department of Health and Human Services an has a general assurance pursuant to Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.” The full text of these and related statutes are contained in Sections 102175-102249.
• Research Involving Prisoners
  • Section 3500 provides definitions of biomedical and behavioral research.
  • Sections 3501-3509.5 delineate general provisions and prohibitions for conducting research with prisoners.
  • Sections 3515-3520 delineate administrative requirements with regard to research with prisoners.
  • Sections 3521-3523 delineate prisoners’ rights when participating in research, including informed consent.
  • Section 3524 addresses prisoners’ legal remedies for injuries incurred while participating in research.