Human Subjects Protocols
UMBC has an Institutional Review Board (IRB) whose responsibility is to protect the rights and ensuring the safety of human subjects participating in research. The IRB requires that all investigators who are affiliated with UMBC and who are engaged in research, regardless of funding, comply with both UMBC procedures and federal regulations regarding the protection of human subjects in protocol activities.
Animal Research Protocols
UMBC requires that an animal research protocol, regardless of funding source, be submitted for review and approval by the IACUC (Institutional Animal Care and Use Committee) before any investigator purchases, obtains and begins research involving vertebrate species. The IACUC will review all animal use carried out in university facilities, as well as fieldwork conducted by UMBC personnel. All projects are to be approved prior to the actual use of animals, whether it involves research/teaching or warm/cold blooded vertebrates.
Kuali is your one-stop shop for submitting protocols. Note: IRB and IACUC will now only accept protocols Via Kuali.
Have a current protocol in progress? Please review your current protocol into KUALI before annual reviews or protocol amendments are approved. The ORPC staff is ready to assist you with questions or one-on-one training. Contact ORPC via email to firstname.lastname@example.org.
To submit or update a protocol, click on https://umbc.kuali.co/protocols/portal/protocols
Short training videos are available to help get you started. See Kuali Training Videos
Kuali Quick Cards & Training Guides
IRB Existing (Legacy) Protocols User Guide
Amending or Renewing Your IACUC Protocol
Closing Out Your IACUC Protocol
Have training needs or questions? See KUALI website
For other training, see Kuali Training
I am a PI. Can I create and work on my own protocol in Kuali?
Answer: Yes! Anyone at UMBC can create or work on a protocol, including a faculty or student Principle Investigator (PI). However, the IRB and IACUC do not recognize students as PIs, so student led projects must be submitted under a faculty member’s name.
Do all the final documents need to be submitted before the protocol is submitted for signature approvals?
The short answer is YES. The PI may update attachments while the protocol is in routing for ORPC pre review and committee review. No new attachments can be added once the ORPC initiates final protocol approval.
What documents are required to be attached with a protocol?
Your protocol attachments are dependent on the compliance committee protocol submission process.
How do I close a protocol?
Protocols should be closed once research is complete or when an investigator is planning on leaving or graduating from the university. Follow these steps for a closure reports:
IRB – https://research.umbc.edu/closing-an-irb-protocol/
IACUC – https://research.umbc.edu/protocol-closures/
What do I need to do to submit a protocol renewal?
Continuing review of research to ensure that the rights and welfare of participants are being protected. Follow these steps:
IRB – https://research.umbc.edu/protocol-renewals/
IACUC – https://research.umbc.edu/post-approval-administration/
What happens when I receive an expiration reminder?
Submit a renewal ASAP! If you wait until the protocol ends, Kuali officially closes the protocol record. To continue the research, a new protocol is required. These will take time for review and approval.
What should you do about a Reportable Event (non-compliance, adverse event, protocol violation)?
Inform the ORPC within 5 days of the occurrence. The IRB and IACUC have specific processes to follow for the committees to review. Follow these steps and be timely about it!
IRB – https://research.umbc.edu/post-approval-administration-2/
IACUC – https://research.umbc.edu/adverse-events/