California Health and Human Services

Link to California State Web Portal
Link to the California Web State Portal

IRBManager

Submit research projects for review to IRBManager

Current Meetings

Find meetings, meeting dates, and project submission deadlines

Past Meetings

View meetings that have already passed


IRBManager

Committee for the Protection of Human Subjects (CPHS) has migrated to an online submission system, IRBManager, and is accepting submission for all new and continuing projects.

Forms and Bulletins

Forms

These forms may be printed and filled in by hand and submitted with original signatures or the Word documents may be filled in electronically, printed and submitted with original signatures.

Examples/Samples

Bulletins

IMPORTANT – ADVERSE EVENT/UNANTICIPATED PROBLEMS REPORTING REQUIREMENTS:
Adverse Events, Unanticipated Problems, Data Security Breaches, and Protocol Deviations are submitted via a Report Form on IRBmanager. Report Forms can only be accessed on IRBManager. For additional information, please see the  CPHS IRBManager Manual for Researchers on how to submit an Adverse Event/Unanticipated Problems Form or call the CPHS main line at (916) 651-5599 for assistance.

Meetings and Deadlines

Deadline Schedule 2021

Meeting Date | Protocol Submission Due Date
 
  • February 5, 2021 | December 31, 2020 – Agenda
  • April 2, 2021 | March 5, 2021 – Agenda
  • June 4, 2021 | May 7, 2021 – Agenda
  • August 6, 2021 | July 2, 2021 – Agenda
  • October 1, 2021 | September 3, 2021 – Agenda
  • December 3, 2021 | November 5, 2021 – Agenda
Committee Members

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

Darci Delgado, Psy.D., M.S. – Psychologist, Analytics and Research Team
California Department of State Hospitals

Larry L. Dickey, M.D., M.P.H., M.S.W. – Medical Director
Office of Health Information Technology – California Department of Health Care Services

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

Lois Lowe, Ph.D. (Retired)
California Department of Corrections – California Department of Alcohol and Drug Programs

Laura Lund, M.A. Research Scientist
Center for Health Statistics and Informatics – California Department of Public Health

Fred Molitor, Ph.D. Adjunct Faculty
California State University, Sacramento

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

Alternate Member – Millard Murphy, J.D., Retired from the University of California, Davis

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.
  • 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.

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:

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.

Resources
CPHS Handbook (22 pages)

About Us

CPHS serves as the institutional review board (IRB) for the CalHHS. The role of the CPHS and other IRBs is to assure 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.

ETHICAL PRINCIPALS

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.”

Beneficence

“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.”

Justice

“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.”

PROGRAM INFORMATION

CPHS Purview

CPHS is the institutional review board (IRB) for all of the departments under the CalHHS. See Instructions, page 8 for a list of departments under CalHHS. CPHS is also the IRB required to review all research-related requests for state personal information to the University of California and non-profit educational institutions. CPHS must also approve research requests for Death Data from the California Department of Public Health.

CPHS Protocol Submissions

CPHS has transitioned to a new electronic protocol submission and approval system, IRBManager. See the CPHS IRBManager Manual for Researchers for technical information and screen shots about registering for and utilizing this system.

CPHS Review Process

Depending on the type of research being executed, review may be conducted at a convened meeting of CPHS or completed on an expedited basis. Expedited reviews may have one to three reviewers. Most projects that have any contact with human subjects, such as a survey or collection of specimens, must be initially approved at a convened meeting. If they are deemed to be minimal risk, all subsequent reviews may be done on an expedited basis. All data-only projects are approved on an expedited basis.

CPHS Meetings

CPHS meetings are held on the first Friday of even-numbered months (February, April, June, August, October, and December) starting at 8:30 AM. Meetings are held in Sacramento at 1215 O Street, 11th Floor, Sacramento, CA 95814. The schedule and location of upcoming meetings and the agendas for those meetings are available on Upcoming Public Meetings page. Researchers are encouraged to appear in person, but may attend by telephone if arrangements are made in advance with the CPHS Administrator. All meetings are open to the public and conducted in compliance with the Bagley-Keene Open Meeting Act.

CPHS Members

The 13 CPHS members are volunteers who are appointed by the Secretary of CalHHS. Members are chosen for their expertise in differing fields of research and abilities to represent and understand the needs of diverse research subjects, particularly those who may be vulnerable due to factors such as age, socio-economic status, ethnicity, or medical conditions. Detailed information about current CPHS members is available in the CPHS Members section.

CONTACT INFORMATION

CPHS Administrator
Maria Salazar-Islas, MPA

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

CPHS Assistant Administrator
Olivia Harrell-Nash

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

CPHS Chair
Juan Ruiz, MD, DrPH, MPH

Chief, Preparedness and Response Section
California Department of Public Health
Phone: (916) 651-5599

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