Guide to the IRB Review Process
This guide page is meant as a resource for students, faculty, staff, and others who are new to the process of submitting an application to the Committee for Protection of Human Subjects (CPHS), UC Berkeley’s Institutional Review Board (IRB). It provides key information and associated content links to other areas of the CPHS website. The Office for Protection of Human Subjects (OPHS) is the administrative office that supports the CPHS.
The guidance is organized into four parts:
- Part 1 focuses on when CPHS review is needed (not all projects constitute human subjects research as defined by the federal regulations).
- Part 2 addresses pre-submission steps and planning.
- Part 3 covers submitting an application to CPHS and the CPHS review cycle.
- Part 4 provides post-approval tips for maintaining a CPHS-compliant protocol.
Start the process early! If your project needs CPHS review, you should submit your application at least eight weeks in advance of when you plan to begin the research. We receive a high volume of applications, and most need adjustments before they may be considered review-ready. Please plan accordingly.
Part 1: Determine if you need to submit an application to CPHS
Go to What Needs Review for general guidance and helpful examples of activities that may or may not trigger the requirement to submit an application for CPHS approval. You may also complete the following questionnaire to determine whether or not you are conducting human subjects research: Am I Conducting Human Subjects Research? (If you’re unsure about the questionnaire results, please contact OPHS for guidance.)
If it appears that you need to submit a CPHS application, go to Types of Review and read the descriptions for new Exempt and new Non-Exempt applications. This information will help you determine which type of application is appropriate for your research.
Incoming Faculty: IRB approval from another institution does not automatically transfer to UCB. In your role as a UCB affiliate, you must obtain CPHS approval prior to engaging in or resuming any human subjects research activities (including data analysis). Contact OPHS for further guidance.
After reviewing the descriptions, if you are still unsure whether to submit or which type of application to submit, email OPHS, or call us at 510-642-7461. Our phone consultation hours are 1 – 4:30 pm, Monday through Friday.
Part 2: Pre-submission steps and planning
1. In order to submit an application to CPHS, you need to work with a Principal Investigator (PI). Student or Postdoctoral Investigators are not considered eligible to be a PI on any research project unless granted exceptional PI status.
2. Human subjects training requirement. UCB faculty (with some exceptions), staff, and students engaged in human subjects research must complete the online Human Subjects Curriculum CITI course (UCB-course sequence).
- When you register online, be sure to select “Log In Through My Organization” and “University of California, Berkeley.” Then enter your CalNet ID and password.
Depending upon your research activity, select one of the following
- Group 1: Biomedical Research Investigators OR
- Group 2: Social and Behavioral Research Investigators.
- Save a PDF of your CITI completion report.
The courses noted above are specific to UCB and required by CPHS. Researchers who have completed a CITI Human Research course at another institution should contact CITI to transfer modules in common and then finish the UCB course by completing any outstanding modules as applicable.
Note: The CITI Responsible Conduct of Research (RCR) curriculum is not required for the CPHS approval process. However, ALL students, postdocs, faculty and other senior personnel supported by NSF funds must complete the RCR training course before any funding can be awarded. Please see Responsible Conduct of Research for additional information.
3. CPHS Guidance on specific topics. Before you start the CPHS application, review the guidance topics listed, many of which will be helpful to first-time researchers (e.g., engagement, exempt research, recruitment, informed consent, parental permission and child assent, data security, secondary analysis of existing data). The guidance documents will provide you with a framework for what to include in the application.
- If your research is non-exempt, review the Informed Consent Guidelines, then the consent document templates and samples, and locate the one(s) most suitable for your research. If you plan to submit an Exempt application, consent documents are not needed for review. However, you should follow consent guidance outlined in Informed Consent in Exempt Level Research and in Section F, Respect for Persons and Informed Consent, of the CPHS guidance on Exempt Research.
4. Research collaborations involving an external institution, or another UC. Research involving external collaborations will require additional planning and coordination. If your external colleagues are engaged in the research, this may also involve IRB review at the other institution, or a process whereby one IRB relies upon the review of another IRB. If external collaborators intend to rely on UCB’s IRB review, be sure to include a UCB Request to Review Research for Another Institution/Individual form with your protocol application.
Part 3: Submitting a protocol to CPHS / the CPHS review cycle
1. eProtocol is the CPHS online application system. Before you begin the application, review the instructions and FAQ pages.
- When you are ready to start, go to the Quick Guides tab and select the Create a Protocol document. It includes helpful screenshots to orient you to the eProtocol system.
- Be sure to select the most appropriate application type for your research, as they cannot be converted to a different type once created. If in doubt, contact OPHS for assistance.
- Fill in the various sections of the application according to the prompts, and click Save periodically to ensure that your work is not lost if the system times out.
- The Quick Guide Submit a Protocol Application explains how to submit the completed application for review.
2. The Review Cycle. Submitted eProtocol applications are assigned to an appropriate review panel (i.e., exempt, non-exempt expedited, or full CPHS Committee). Exempt and non-exempt expedited protocols are reviewed on a rolling basis, and in the order received. Protocols that require full Committee review are assigned to the appropriate panel for review at the next available meeting.
- You will receive an eProtocol-generated email informing you of the name of the panel manager. Your protocol will be held in the review queue and pre-reviewed by staff as soon as possible. Protocols are reviewed in the order in which they are received.
- Exempt review applications. The panel manager/assigned staff reviewer will send comments in eProtocol (the system will issue an email to let you know when comments are available). Respond to comments in eProtocol as soon as possible. Sometimes response clarifications generate more questions, and therefore more rounds of eProtocol comments/responses; it is all part of the process. Once the review is complete, you will be informed of the outcome (i.e., exempt determination; not human subjects research as defined by the federal regulations; does not fit exempt criteria/submit non-exempt application).
- Non-exempt expedited review applications. The panel manager/assigned staff reviewer will send comments in eProtocol (see information for Exempt, above). Once the pre-review process is complete, the protocol will be submitted to the CPHS reviewer(s). Unless a CPHS reviewer has additional concerns, this last step in the approval process is typically completed within one week.
- Full Board review applications. The panel manager/assigned staff reviewer will pre-review the application (see information for Exempt, above). If there are any missing documents (e.g., consent forms) necessary for the review, the panel manager/staff will either submit eProtocol comments or contact you outside of the system, as appropriate to the situation/ timeline. Following the meeting, you will be notified of the vote outcome (e.g., full approval, conditional approval, deferral to another convened meeting). Post-meeting comments are sent in eProtocol to you and the Principal Investigator as soon as possible, usually within two weeks of the meeting date.
See Types of Review for the general time frame needed to review and approve each of the various application types.
Part 4: Post-approval tips for maintaining a CPHS-compliant protocol
Once you have your CPHS approval (congratulations!), be sure to review the following information so that you remain alert to your ongoing responsibilities as a UCB Investigator. Communicate regularly with your PI/research team throughout the implementation of the study. Contact OPHS at any time if you have any questions or concerns.
Approval Period. The CPHS approval letter will include an effective date and an expiration date. Be sure to make a note of the expiration date. Additionally, review the Study Renewal/Continuation section below.
- Study Renewal/Continuation. At UCB, most protocols are assigned either a ten-year or
a one-year approval period. (In some circumstances, CPHS may
designate a different approval period.)
- Ten-year approval period. To qualify, the research must:
- One-year approval period. Unless a protocol qualifies
for a ten-year approval period, in most circumstances it is
given a one-year approval period.
Several months before the expiration date of a non-exempt
protocol, you will start to receive eProtocol-generated courtesy
reminders. Applications for continuation review should be
submitted eight weeks prior to the expiration date to allow
sufficient time for the renewal process. It is a Principal
Investigator/Student Investigator responsibility to submit for
renewed approval in a timely manner. If approval expires, all human subjects research
activities—including data analysis—must cease until
re-approval from CPHS is received.
Note that all exempt protocols receive a ten-year
determination period. If the study lasts beyond ten years, the
exempt application will need to be cloned and resubmitted as
“new” for an updated exempt determination.
- Amendments/Modifications. eProtocol amendment applications must be submitted to and
approved by CPHS prior to implementation. This
requirement pertains to all proposed modifications/changes to exempt and non-exempt
currently approved protocols. Amendments include (but are not limited to): Requests to increase the approved
total subject sample size; changes or additions to subject contact
materials/consent documents; consent document translations; study personnel
changes; changes in funding sources; study design modifications; new
- Unanticipated Problems and Adverse Events. Discuss any issue promptly with the protocol PI. Together, you
will need to determine if it triggers the need for a prompt report
- Any unanticipated problem involving risks to subjects or others, and/or a serious adverse event, must be reported promptly to CPHS within no more than one week (7 calendar days), by phone, email, or mail/delivery.
A written report (via eProtocol) must be sent within two weeks (14 calendar days), of
the Principal Investigator becoming aware of the event.
- Protocol Deviations (includes noncompliances). Any deviation from an approved Non-Exempt protocol or Exempt protocol must be reported to CPHS/OPHS promptly. The IRB will review the report to determine whether the incident was a serious or a minor noncompliance and assess whether any corrective actions or substantive changes are needed in order to protect the safety, welfare, and rights of subjects or others.