Continuing review of an approved (non-exempt) protocol that was approved by a convened irb:

This page provides information about the different types of CPHS/OPHS submissions and review processes. If you are not sure whether or not a project requires review, please see What Needs Review.

Questions? Call OPHS at 510-642-7461.

New Exempt

There are seven categories of research activities involving human subjects that are eligible for Exempt Status. Applications for Determination of Exempt Status are generally reviewed by OPHS staff. Research that is found to be Exempt need not receive Full Committee or Expedited Review. Exempt determinations are good for ten years. Any intended changes to the project after an Exempt application has been approved must be submitted for CPHS/OPHS review before the changes are implemented.

Note: If the research does not qualify for Exempt Status, a New Non-Exempt application will need to be submitted. Contact OPHS if you are not sure about whether to submit an Exempt or Non-Exempt application.

• CPHS Guidelines on Exempt Research
  This explains the exemption categories and provides examples of exempt research.
• Policies and Procedures: Exempt Research

There are no deadlines for submission;these applications are reviewed in the order in which they are received. The Exempt review process usually takes 3-4 weeks, but this may vary depending on OPHS workload volume, quality of the submission, timeliness of investigators’ responses to review comments, etc.

Investigators should allow extra time for projects that require additional review from other IRBs or UCB regulatory programs (e.g., Laser Safety Committee, Conflict of Interest Committee, etc.).

How to Submit:

Exempt applications must be submitted online using Berkeley eProtocol.

For step-by-step instructions on how to submit a new application, see the eProtocol Quick Guide: Create a New Protocol.

New Non-Exempt

There are two possible modes of review for Non-Exempt research: Full Committee Review and Expedited Review.

Expedited Review is review by a subcommittee of IRB members, the IRB Chair, or an IRB member who has been designated by the Chair to conduct such reviews. To be eligible for Expedited Review, the research must include only activities that (1) present no more than minimal risk to human subjects, and (2) fit within the expedited review categories specified by federal regulations. Eligibility for Expedited Review is determined by the OPHS staff, in consultation with the IRB Chair as necessary.

• Policies and Procedures: Expedited Review
  This document includes the list of expedited categories.

Applications that qualify for Expedited Review are reviewed in the order in which they are received. The Expedited review process usually takes 6-8 weeks, but this may vary depending on OPHS workload volume, quality of the submission, timeliness of investigators’ responses to review comments, etc.

Investigators should allow extra time for projects that require additional review from other UCB regulatory programs (e.g., Laser Safety Committee, Conflict of Interest Committee, etc.).

Full Committee Review is review by a quorum of IRB members at a convened meeting. Full Committee review is required for all protocols that do not qualify for expedited review. Full Committee review takes place at the monthly meetings of two committees:

CPHS-1 reviews Optometry, School of Public Health, Biomedical, and Social-Behavioral protocols as needed.

CPHS-2 reviews Psychology, Information Technology, Education, Business, most other Social-Behavioral/Humanities protocols, and Biomedical protocols as needed.

• Policies and Procedures: Initial Review

Applications that are likely to require Full Committee review must be submitted by the submission deadline for a scheduled meeting date of the appropriate committee (see Committees and Meeting Schedules). Notification of the review outcome only (i.e., Approval, Conditional Approval, Deferral, or Disapproval) is sent to the applicant as soon as possible following the meeting, generally within 1 working day. However, as stated in the vote outcome notification, it usually takes up to 2 weeks (or possibly more) before detailed comments regarding the Committee’s decisions are posted. The entire Full Committee review process usually takes 6-8 weeks, but this may vary depending on quality of the submission, timeliness of investigators’ responses to review comments, etc.

Investigators should allow extra time for projects that require additional review from other UCB regulatory programs (e.g., Laser Safety Committee, Conflict of Interest Committee, etc.).

How to Submit:

New Non-Exempt applications must be submitted online using Berkeley eProtocol.

For step-by-step instructions on how to submit a new application, see the eProtocol Quick Guide: Create a New Protocol.

Amendment (Modification)

Amendment applications must be submitted for all proposed modifications/changes to exempt and currently approved protocols.

Amendment applications for minor changes to Non-Exempt research can receive Expedited Review. Minor changes are defined as changes that (if considered independently from the overall research) involve no significant alteration in research design or fall into one or more of the exempt or expedited review categories, and involve no more than minimal risk to participants. Amendment applications that do not qualify for Expedited Review must be reviewed by the Full Committee. The level of review is determined by OPHS staff in consultation with the IRB Chair as needed.

• Policies and Procedures: Amendment Review

Amendment applications that are likely to require Full Committee review must be submitted by the submission deadline for a scheduled meeting date of the appropriate committee (see Committee Directories and Meeting Calendars). All other applications are reviewed in the order in which they are received. Investigators should allow extra time for projects that require additional review from other UCB regulatory programs (e.g., Laser Safety Committee, Conflict of Interest Committee, etc.).

How to Submit:

Amendment applications must be submitted online using Berkeley eProtocol.

For step-by-step instructions on how to submit an amendment application, see the eProtocol Quick Guide: Amend/Modify an Approved Protocol.

Continuing Review (Renewal)

All previously approved Non-Exempt research protocols are required to be re-reviewed before the expiration of the current approval if any of the following activities are ongoing:

• research-related interactions or interventions with human subjects
• obtaining of identifiable private information
• analysis of identifiable private information

Once all of these activities as described in the IRB-approved research plan are finished, CPHS/OPHS should be notified of the study’s completion (see Study Closure).

Important Reminder: For protocols given a ten-year approval period, a continuing review application must be submitted if changes make the protocol ineligible for a ten-year approval (e.g.. FDA oversight, industry-sponsored, greater than minimal risk, etc.). For more information, see Ten-Year Approvals.

• Policies and Procedures: Continuing Review

Continuing Review applications must be submitted 8 weeks prior to their expiration date. If the protocol requires review by the Full Committee, the Continuing Review application must be submitted prior to the expiration date and the submission deadline for the next appropriate committee meeting (see Committees and Meeting Schedules). Investigators should allow extra time for projects that require additional review from other UCB regulatory programs (e.g., Laser Safety Committee, Conflict of Interest Committee, etc.).

Automated renewal notices will be emailed to all researchers 60 days, 30 days, and 15 days before the current approval is due to expire. However, it is the researchers’ responsibility (regardless of whether the renewal notice is received) to ensure that the application for renewal is submitted in a timely manner. If a protocol expires prior to re-approval, all human subjects research activities must stop until the protocol is re-approved.

How to Submit:

Continuing Review applications must be submitted online using Berkeley eProtocol.

For step-by-step instructions on how to submit a renewal/continuation application, see the eProtocol Quick Guide: Renew (Continue) an Approved Protocol.

Study Closure

All previously approved Non-Exempt research protocols are required to be re-reviewed unless all of the following activities, as described in the IRB-approved research plan, have been completed: (i) research-related interactions or interventions with human subjects; (ii) obtaining of identifiable private information; and (iii) analysis of identifiable private information. Once all of these activities are finished,the protocol may be closed by either submitting a “Close Protocol Request” or simply allowing the protocol to expire. Protocols that are allowed to expire will be automatically closed out 6 months following the expiration date.

How to Submit:

Close Protocol Requests should be submitted online using Berkeley eProtocol.

For step-by-step instructions on how to submit a Study Closure Request, see the eProtocol Quick Guide: Close an Approved Protocol.

Protocol Deviation

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.

• Policies and Procedures: Noncompliance

How to Submit:

Protocol Deviation Reports should be submitted online using Berkeley eProtocol.

For step-by-step instructions on how to submit a Protocol Deviation Report, see the eProtocol Quick Guide: Report a Protocol Deviation or Noncompliance.

Unanticipated Problem/ Adverse Event

Unanticipated problems or adverse events must be reported to CPHS/OPHS if they are: 1) unexpected; 2) related or possibly related to participation in the study; and 3) suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized. The IRB will review the report to assess whether any corrective actions or substantive changes are needed in order to protect the safety, welfare, and rights of subjects or others.

An initial report should be made by mail/delivery, phone, or email to the Director, Research Subject Protection as soon as possible, but within no more than one week (7 calendar days) of the Principal Investigator learning of the incident. The initial report must be followed by a formal written report within no more than two weeks (14 calendar days) of the Principal Investigator learning of the incident.

Note: Other reporting requirements/deadlines may apply for certain research, e.g., involving the FDA.

• Policies and Procedures: Unanticipated Problems and Adverse Events

How to Submit:

Formal Incident Reports should be submitted online using Berkeley eProtocol.

For step-by-step instructions on how to submit an Incident Report, see the eProtocol Quick Guide: Report an Incident (Adverse Event or Unanticipated Problem).

What is IRB Continuing review and when should it occur?

How often is IRB Continuing review?

Can IRB suspend or terminate an approved protocol?

How long is IRB approval good for?