Protocol Renewal
Expedited Review Protocols
Using the dates specified in the initial protocol application, the IRB will provide a period of time to conduct the approved protocol. In most, if not all expedited approvals, continuing review is not required. Investigators will be informed of a continuing review requirement if protocols meet certain criteria, including, but not limited to the following: inclusion of vulnerable populations, studies of criminal behavior, substance abuse and/or use of mental health data.
Studies reviewed and approved under the Expedited Review Process will be subject to post-approval monitoring by the ORPC to ensure that conduct of studies are in accordance with the IRB approved protocol.
Investigators are required to inform the IRB of any changes planned for previously approved research. These changes must be submitted to the ORPC at least two (2) weeks beforehand using the protocol amendment process.
Full Board Review Protocols
As stated above, the IRB is responsible for the continuing review of research to ensure that the rights and welfare of human participants are being protected. In cases of Full Board Review, at its discretion, the IRB may require continuing review of these protocols. If continuing review is required, access the Kuali Protocols Portal to submit the renewal report. The Kuali Protocol User Guide has a searchable table of contents to the specific sections of Guide to assist you in creating this report. The ORPC will provide investigators at the time of approval the appropriate continuation review documents.
Avoid Protocol Expiration
Kuali Protocols sends a courtesy reminder to investigators at least 30 days prior to the expiration date. Expedited renewals are reviewed on a rolling basis; full board renewals must be received no later than 30 days prior to a regularly scheduled IRB meeting.
Investigators must plan ahead to meet required continuing review dates. For both of the above categories, Federal regulations make no provision for any grace period extending the conduct of research beyond the expiration of IRB approval. Therefore, continuing review and re-approval of research must occur on or before the date when IRB approval expires. All of the research procedures must stop, including:
- Subject recruitment or enrollment
- Collection of data/information from or about living individuals
- All research-related interventions or interactions with currently enrolled subjects
- Data analyses involving subject identifiable data
Exemption Category Review Protocols
Investigators will receive an automated notice as expirations date are assigned by Kuali at the initial protocol approval. Renewals are not required for exemption determinations but information provided in the renewal process will help verify what research projects remain active at UMBC. Update the expiration date (as well as other changes) in the renewal request.
Have a Kuali technical issue or problems with access? Contact the ORPC on this online form and we’ll send your issue to VPR Research Administrative Systems