Frequently Asked Questions (FAQs)

Who are the members of the CDPH IRB?

The CDPH IRB is constituted in a manner that follows federal regulations and includes CDPH employees and non-employees; including, but not limited to, individuals with medical, scientific, and public health backgrounds.  


What type of project requires CDPH IRB review?

Any research project that involves human participants requires IRB review. As a general rule, if you are interacting/intervening with an individual or have access/using identifiable private information or biospecimens in any way, you need to submit your protocol to the IRB. 

Some research involving "minimal risk" may be eligible for expedited review, and some forms of research such as certain secondary data analyses, certain surveys and interventions may be exempt from IRB review. Additionally, there are some circumstances where written consent can be waived by the IRB. The CDPH IRB determines whether these criteria are met for any given project. PLEASE NOTE:  On January 17, 2018, HHS announced changes to the Common Rule that govern human subjects research that became effective on January 21, 2019.   All studies approved on or after January 21, 2019 will be governed by the new rule.  The major changes to the Common Rule involve 1) informed consent, 2) exemptions, and 3) continuing review for certain studies. More information and the updated regulations can be found on the U.S. Department of Health & Human Services' (HHS) website


Who may conduct research under CDPH auspices?

To conduct a research project under CDPH auspices, one must be a qualified research investigator who has received training in protection of human subjects. In addition, all individuals listed as “key personnel” on a research project must submit evidence of current human subjects and research protections certification.  Key personnel include all individuals responsible for the design and conduct of the study. CDPH investigators should submit their certificates to the IRB email: ( Our Staff Assistant will maintain these records for the CDPH IRB. While the research investigators for many projects conducted at CDPH are affiliated with other institutions, every research project must have a CDPH sponsor who serves as a liaison and takes responsibility for the conduct of the research within the CDPH environment. In addition, awareness and approval of all research in a given CDPH program or site must be signed off by Division leadership.


How do I submit a protocol for CDPH IRB review? (Guided Linked)

Follow our requirements as listed in document and be sure including a protocol version number and date in the title page of the protocol. Please submit your protocol and all required submission forms to the IRB email: (


What do I do if the CDPH IRB has questions about my submission?

If the CDPH IRB has any questions or points of clarification after reviewing your protocol, you should respond by submitting

1) a cover letter addressing each comment from the IRB, including where any changes were made in the original protocol

2) a clean copy and

3) tracked changes copy of your revised protocol. 

Be sure to update the version number and date of the revised protocol, in either the title page of the revised protocol or in a footer.  These documents should be submitted to the IRB email: (


How do I write a Protocol? (Guide Linked)

Investigators have responsibilities to provide complete and accurate information for reviewers to make informed decisions on the requirements for IRB review/approval.  All supporting documents, such as approvals by other IRBs, letters of support, data collection forms, study tools, and informed consent documents should be submitted with the protocol for review.


How long does it take for CDPH IRB to review a project?

Please allow at least 6-8 weeks for CDPH IRB review and approval.

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