Expedited Category Research

Expedited review is an IRB review mechanism which does not take place at a convened IRB meeting. Rather, protocols are assigned to one or more IRB reviewers. Once these reviewers agree upon and approve the final version of the protocol, an approval letter be issued.

To be considered for expedited review, a protocol’s activities must:

  • present no more than minimal risk to subjects. The regulatory definition of “minimal risk” is the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Anticipated risks include a breach of confidentiality, depression, worry, anxiety, embarrassment, emotional distress, rapid heart rate, exhaustion, etc.;


The expedited review process may not be used where potential risks prove to be greater than minimal, i.e. could potentially cause harm beyond that which would normally be encountered by the participant in everyday life.

The following are instructions for preparing an application for Expedited Review: 

1) Complete the Collaborative Institutional Training Initiative (CITI) training program 

2) Please access the Kuali Protocols Portal to create an Expedited Research protocol application. The Kuali Protocol User Guide has a searchable table of contents to the specific sections of Guide to assist you in creating a protocol.

Explanations of each selected review categories are found in Kuali protocols.  Choose carefully the expedited category under which your research applies. 

Review and approval of expedited protocols will take approximately four weeks. The length of time a protocol will take to be approved and an approval letter received depends on the type or level of review required. The ORPC staff, working in concert with the IRB, will make every effort to work with investigators to process proposals promptly. If additional changes are needed, it can take longer depending on reviewer questions or protocol load. 

3) Upload to the Kuali Protocols record the proposed questions and/or measures, recruitment scripts/fliers and applicable consent documents .  Please upload in the Attachments Section of the Kuali Protocols.

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 

IRB Application and Pre-review Consultation 

The ORPC staff is available to answer any questions regarding the IRB submission process and IRB review of research studies. We also provide pre-review consultation to discuss all aspects of IRB review, from preparing the submission to completion of the study. The ORPC will send comments to investigators within one week if there are revisions required. Final versions are then forwarded to the IRB for review. If you have any questions, please contact us at compliance@umbc.edu 

Continuing Review 

Using the dates specified in the initial protocol application, the IRB will provide a period of time to conduct the approved protocol. 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.

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

If you are notified, please access the Kuali Protocols Portal to create a 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 

Post Approval Monitoring 

Studies reviewed and approved under the Expedited Review will be subject to post-approval monitoring by the ORPC to ensure that conduct of studies are in accordance with the IRB approved protocol. 

Protocol Amendments 

Investigators are required to inform the IRB of any changes planned for previously approved research. Kuali IRB uses the term “amendment”, rather than “modification”.  Please access the Kuali Protocols Portal to create an amendment to a previously approved protocol. These changes must be submitted at least two (2) weeks beforehand. The Kuali Protocol User Guide has a searchable table of contents to the specific sections of Guide to assist creating this amendment 

Adverse Events or Deviations 

Investigators have the obligation to report, via Kuali IRB, certain events (such as adverse events, deviations) under expedited approvals within five (5) days of the occurrence. 

return to IRB procedures