An important message from the UCI Office of Research

REMINDER: Limited IRB Submissions Accepted from 5PM, July 16 – September 6, 2021

As previously announced, UCI is transitioning to a new Institutional Review Board (IRB) submission and management system – Kuali Research (KR) Protocols. During the transition there will be a period of limited IRB submissions starting this Friday, July 16 at 5:00PM, through September 6, 2021.

IMPORTANT: All eligible draft IRB submissions that are not submitted prior to September 6, 2021 will be discarded. Drafts will NOT roll over into KR Protocols.

What does “limited IRB submissions” mean?

It means that the UCIs IRB will only allow certain human research protocols to be submitted for UCI IRB or Non-UCI IRB review during the transition period.

The following table illustrates this limited IRB submission period:

	Not Allowed During Limited Submission Period	Allowed During Limited Submission Period
New Applications for Non-Therapeutic Research Without External Sponsor Support
Modifications Not Required to Ensure Subject Safety or to Enable Subject Treatment¹
New Applications for Therapeutic Research ²
New Applications with External Sponsor Support ³
New Applications Required for a Dissertation or Thesis
Modifications Required to Ensure Subject Safety or to Enable Subject Treatment
Continuing Protocol Applications or Closings for IRB Approved Studies
Non-Human Subject Research Determinations in KR Protocols
Exempt Self Determination Forms

Why is this happening?

The data migration will take approximately 2 weeks. Prior to the merge, HRP needs time to clear the IRB review queue. In addition, HRP needs time to train and learn the new system.

Will there be exceptions?

If a protocol does not qualify for submission via the above table, contact Beverley Alberola or Jessica Sheldon in HRP to see if HRP can accommodate the review prior to the data migration. Exceptions will be made based on how closely the protocol meets the criteria as noted above.

How will I submit a study during this time?

Researchers who qualify under the above table will submit through the current process. To obtain the passcode needed for submission, contact Beverley Alberola or Jessica Sheldon in HRP.

1 Since the modification is not required for subject safety, do not submit a modification to the IRB. Do not implement the change without prospective IRB approval. Submit the modification in KR beginning on September 7, 2021. Once the modification is IRB approved, implement the change.

2. Allowed even if research has no external sponsor support (e.g., department funds). Also, will allow a pilot study if required for future therapeutic research.

3 Will allow a pilot study if required to support a proposal for external sponsor support.