Full Board Review is required for research that is not eligible for exempt or expedited review. Research that involves more than minimal risk, or involves protected populations such as children, prisoners, or disabled individuals, must undergo a Full Board Review. Studies assigned to full board review are reviewed by members ahead of time, and then discussed at the meeting. The Committee then votes on whether or not to approve the study. Investigators are requested to attend the scheduled Board meeting to make a brief presentation about the protocol and answer any questions the Board may have.
The following are instructions for preparing an application for Full Board Review:
1) Complete the Collaborative Institutional Training Initiative (CITI) training program
2) Please access the Kuali Protocols Portal to create a Full Board 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. 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.
Full board protocols must be received no later than 30 days prior to a regularly scheduled IRB meeting. Investigators will be notified of the IRB’s decision of approval by the ORPC following the scheduled meeting.
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
The IRB will provide an approval period at intervals appropriate to the degree of risk. In cases of Full Board Review, at its discretion, the IRB may require continuing review of studies that meet certain criteria, including, but not limited to the following: inclusion of vulnerable populations, criminal behavior, substance abuse and/or mental health data. If continuing review is required, 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 a protocol.
Post Approval Monitoring
Studies reviewed and approved under the Full Board 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.
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 you in creating a protocol.
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.