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Laws, Regulations, Policies and Procedures

Laws and Regulations

Federalwide Assurance For The Protection of Human Subjects

The Federalwide Assurance is the formal agreement between the California Health and Human Services Agency (CHHSA) and the United States Department of Health and Human Services (DHHS) stipulating that all research conducted within the jurisdiction of the CHHSA will be reviewed by the Committee for the Protection of Human Subjects in accordance with the ethics and procedures designated in the Common Rule.

The CPHS operates under the terms of Federalwide Assurance (FWA) 00000681 (pdf) signed in October 2011 with the U.S. Department of Health and Human Services, and conducts business, as appropriate, in compliance with the:

  • 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 Committee for the Protection of Human Subjects 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.
  • 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 institutional review board, the Committee for the Protection of Human Subjects 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 Committee for the Protection of Human Subjects (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 (SB13), 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 the Committee for the Protection of Human Subjects.
  • 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.

Policies and Procedures

The California Health and Human Services Agency (CHHSA) established the Committee for the Protection of Human Subjects (CPHS), an institutional review board, in July 1976. The Health and Human Services Agency is bound by the terms of the Federalwide Assurance (FWA) 00000681 signed in June 2001 with the U.S. Department of Health and Human Services (DHHS), Office for Human Research Protections. The CPHS is the only Institutional Review Board (IRB) empowered by the California Health and Human Services Agency.

Legal Authority and Scope

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:

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.


This page was last updated on Wednesday, December 21, 2016.