Committee for the Protection of Human Subjects (CPHS)
CPHS serves as the institutional review board (IRB) for CalHHS. The role of the CPHS (and other IRBs) is to ensure that research involving human subjects is conducted ethically and with minimal risk to participants.
Mission and Purpose
CPHS is committed to following the federal regulations to protect the rights and welfare of human subjects involved in research conducted under the offices of CalHHS.
Legal Authority and Scope
The CalHHS established the the CPHS in July 1976, to operate under the terms of FWA #00000681 to conduct business in compliance with the following:
- Common Rule (45 CFR Part 46 of the Code of Federal Regulations)
- Food and Drug Administration regulations (21 CFR, Part 50; 21 CFR, Part 56)
- Privacy Rule of the Health Insurance Portability and Accountability Act (45 CFR, Part 160)
- California Information Practices Act, Civil Code, Section 1798.24 (SB-13)
Scope of Authority
In compliance with the FWA, 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 CalHHS or any of its departments.
- Research conducted by or under the direction of any employee or agent of the CalHHS or any of its departments.
- Research using personally identifiable data held by the CalHHS or any of its departments.
- Research involving subjects for whom the CalHHS or any of its departments have direct responsibility, such as patients in State hospitals.
The California Information Practices Act, Civil Code, Section 1798.24 (SB-13) (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 IRBs
The CPHS will engage in formal agreements to serve as the IRB for other institutions in California with current Federalwide Assurances in place. Reciprocity arrangements to enable other IRBs 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 (SB-13) to other IRBs.
CPHS Handbook (22 pages)
The CPHS is guided by principles delineated in the Belmont Report, which was issued by the U.S. Department of Health, Education, and Welfare in April 1979. These principles include:
Respect for Persons
“Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.”
“Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.”
“The selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.”
- Juan Ruiz, M.D., Dr.PH., M.P.H. (Chair) – Chief, Communicable Disease Emergency Response Program, Division of Communicable Disease Control, California Department of Public Health
- Alicia Bazzano, M.D., Ph.D., M.P.H. – Chief Physician Consultant Westside Regional Center, Clinical Faculty, Pediatric Emergency Medicine, University of California, Los Angeles
- Larry L. Dickey, M.D., M.P.H., M.S.W. (Vice Chair) – Associate Professor, University of California, San Francisco
- Maria Cesaltina da Silveira Nunes Dinis, Ph.D., M.S.W. — Professor and Director of M.S.W. Admissions, Division of Social Work, California State University, Sacramento
- Catherine (Katie) Hess, Ph.D., M.Phil. – Research Scientist, Substance and Addiction Prevention Branch, California Department of Public Health
- Carrie M. Kurtural, J.D. — CHPC Assistant Chief Counsel, California Department of Developmental Services
- Laura Lund, M.A. — Research Scientist, Center for Health Statistics and Informatics, California Department of Public Health
- Philip T. Palacio, Ed.D, M.S.M. — California Correctional Health Care Services, Medical Contracts Unit, California Department of Corrections and Rehabilitation
- John Schaeuble, Ph.D. – Professor of Psychology Emeritus, California State University, Sacramento
- Millard Murphy, J.D. — Alternate Member, Retired from the University of California, Davis
Contact the Committee
CPHS Administrator (Interim)
California Health and Human Services Agency
Committee for the Protection of Human Subjects
1215 O Street, 11th Floor, Sacramento, CA 95814
Phone: (916) 651-5599
Juan Ruiz, MD, DrPH, MPH
Chief, Preparedness and Response Section
California Department of Public Health
Phone: (916) 651-5599