CPHS approval or determination of exemption must be obtained prior to any subject recruitment or data collection.

New study applications that are likely to need full Committee review (see below) must be submitted to OPHS no less than 8 weeks prior to the next regularly scheduled meeting of the appropriate Committee (see CPHS Meeting Schedule 2006-2007 for more information). OPHS reserves the right to determine when a study application is ready to be considered by the full Committee and will schedule it on the next appropriate meeting agenda accordingly.

Renewal/continuing study applications that need expedited or full Committee review (see below) must be submitted no less than 8 weeks prior to their expiration date and/or the date of the next appropriate full Committee meeting.

All applications are reviewed in chronological order of receipt, with the exception of protocols that require full Committee review at a convened meeting of the CPHS, and continuing studies that must be reviewed by their expiration date.

The CPHS panels meet monthly. The website provides upcoming meeting dates and related deadlines for submission of applications requiring full Committee review. (See CPHS Meeting Schedule 2006-2007).

All applications are given initial assessment after receipt in the OPHS to determine the type of review needed (see below). Depending on the result of this assessment, the review process may take at least 8 weeks to complete. Researchers are urged to submit applications in a timely manner to allow adequate time for review.

Researchers who are applying for a Federal grant are reminded that the Federal granting agency may require the CPHS to certify its approval of the research application for the grant. In such situations, researchers should submit their protocol for human subjects review at the same time that they apply for the grant.

Time allowance should also be made for projects that require additional review and approval from other IRBs or UCB regulatory programs, e.g., studies involving radiation or biological specimens (see CPHS website for further information).

Exempt Level Review
Applications for Determination of Exempt Status are reviewed by OPHS staff and the CPHS Chair. This review process may take up to 8 weeks. The research may be approved as Exempt, or it may be found to not qualify for Exempt Status and be re-assigned to a different level of review.

There are no deadlines for submission of Exemption requests. However, you should submit your Exempt Status application at least 8 weeks prior to the planned start date of your research.

Approved exemptions do not need annual review, provided there are no changes to the protocol. Any planned revisions to the project after an exemption has been granted must be submitted for CPHS review before the changes are implemented. (See "What to Submit - Amendment.")

Full Committee review takes places at the monthly CPHS meetings (see CPHS Meeting Schedule 2006-2007). Such applications should be submitted no less than 8 weeks prior to a scheduled meeting date.

Notification of the review decision is sent to the applicant as soon as possible following the meeting date, generally within a week. However, it may take up to 4 weeks before receiving a detailed letter regarding the Committee’s decisions.

Projects that have been approved and issued an expiration date must obtain renewed CPHS approval in order to continue beyond the time of expiration.

As a courtesy, a renewal notice with instructions will be emailed to all researchers approximately 8 weeks before the approval is due to expire. The deadline for submission will be included. However, please NOTE: It is the researchers’ responsibility to ensure that the application for renewal is submitted in a timely manner.  If a protocol expires prior to review and renewal (re-approval), the researcher must ‘cease and desist’ all human subjects research activities until the protocol is reapproved. This is the RULE per federal regulations. No exceptions!

The continuing review process may take up to 8 weeks before notification of decision is sent to the researcher. Continuing studies that require full Committee review will be considered at the next available CPHS monthly meeting. As with new studies requiring full Committee review, notification of the review decision is sent to the applicant as soon as possible following the meeting date, generally within a week. However, it may take up to 4 weeks before receiving a detailed letter regarding the Committee’s decisions.

Reminder: Research determined Exempt by CPHS is not subject to annual renewal.

Amendment applications must be submitted for all proposed revisions of:

• Currently approved protocols.
• Protocols being submitted for continuation approval which include major modification.
• Projects previously granted exempt status by CPHS.

The researcher must submit revised documents for review and approval prior to implementing the proposed changes to the study (See "What to Submit - Amendment"). In many cases, amendment requests can be reviewed and approved by the CPHS Chair or sub-committee. In situations where the changes might increase risks to subjects, full Committee review may be required.

Researchers will be notified of the review status generally within 4 weeks after submission of amendment requests.