1. Submit completed protocol by email to irb@ochca.com
2. Review Steps*
2.a. IRB Office reviews the protocol/study for required items, then submits the protocol to the Service Area Director for review and approval.
• If the protocol is approved, research will move forward to the next steps.
• If modifications are required, the protocol is sent back for revisions.
• If disapproved, a notification is sent to the principal investigator (PI).
2.b. Office of Compliance Review: Protocol must be approved by this office. This office also determines if the protocol would need to be forwarded to Contracts Division for Data Use Agreement (DUA). (Forwarding to Contracts would entail another administrative step subject to an additional 2 week response time.)
2.c. IT Review (if applicable, simultaneous with Compliance Review): If the protocol involves use/storage of HCA PHI/PII on non-county IT systems (including equipment and internet), the protocol requires IT review and approval.
If you believe this applies to you, you may email irb@ochca.com to request the IT Questionnaire for Security Requirements worksheet in advance. This worksheet must be completed for IT to proceed with their review.
2.d. HR Review (if applicable, simultaneous with Compliance Review): If the protocol involves County staff as subjects of the research, Agency HR must review, followed by:
i. County Counsel
ii. Labor Relations
(Forwarding to each of these entities entails another administrative step subject to an additional 2 week response time.)
3. Protocol Completeness (final IRB Office review)
• IRB Office reviews protocol for final time before Chair review to ensure all Agency and regulatory components are present and protocol is ready for further evaluation.
4. IRB Chair Review
• The IRB Chair (or designee) determines if the protocol qualifies for exemption, expedited review, or requires full committee review.
o Exempt: If the Chair or designee determines the protocol meets the criteria for exemption, the PI will receive confirmation that the study can proceed.
o Expedited Review: If the Chair or designee determines the protocol meets the criteria for expedited review, the PI will receive confirmation that the IRB approves the study and the study can proceed.
o Full Committee Review: If a protocol does not meet the criteria for exempt or expedited review, the IRB Office will schedule the protocol for Committee Review – note that a protocol cannot be disapproved at this step. The protocol will be scheduled for the next closest meeting. If the submission is received 10 or more business days before the next scheduled meeting, it will be reviewed at that meeting. Otherwise, the protocol would be reviewed at the following meeting. (see Agency Approval Deadline table under “New Research Protocols”
5. Decision Outcomes:
• If the protocol is approved by the IRB, research can commence, and data may be released.
• If modifications are required, the protocol is sent back for revisions.
• If disapproved, a notification is sent to the PI.
• The committee has 5 days from the meeting to respond to the PI regarding protocol status.
*Note: Response can take up to 10 business days for each county office once protocol is referred to them, which may compound the timeline. A simple protocol not requiring IT and HR review may take an average of 4 weeks for review from both the Service Area Director and Office of Compliance. If, however, a protocol then needs to be reviewed by HR, and then County Counsel, it could take 6 to 8 weeks to get responses from all the required county offices. Furthermore, if additional information is requested from any of these offices, approval can be further delayed beyond the 10 business days response window from an office.
When planning a research project, please keep these circumstances in mind and plan for at least 60 days before a protocol would be scheduled on the HRSC agenda. If you have questions about planning in this time frame, please contact the HSRC/IRB office: irb@ochca.com