As UCI transitions to KR Protocols, Researchers should be aware of the following:
- DATA TRANSFER
Prior to September 7, 2021, Electronic Research Administration (ERA) and the Office of Information Technology (OIT) will electronically transfer currently IRB approved or IRB submitted protocols into KR Protocols. For IRB submitted protocols, both those transactions under IRB review (e.g., new, continuing review and modifications (hereafter referred to as ‘amendments’)) and those not yet approved by the IRB will be transferred electronically.
- ERA SUPPORT REQUIRED
Beginning on September 7, 2021, Researchers will be able to submit new protocols in KR Protocols. For existing protocols that are approved by the IRB or under review by the IRB, there is a critical step which must occur first before the Researcher may submit their continuing review or amendment (protocols approved by the IRB) or response (protocols under review by the IRB). To initiate this step, Researchers must contact ERA prior to their first transaction.
- Why do Researchers need to contact ERA?At the time of data transfer, we are unable to electronically transfer all the data points from the IRB approved or under IRB review protocol into KR Protocols. Accordingly, ERA will manually update KR Protocols to ensure that it is completely aligned with the last IRB approved or under review protocol submission. ERA will do this manual update upon request by the Researcher or their study team. If the protocol has not been updated in KR Protocols, the Researcher will encounter a series of validation errors preventing them from submitting the transaction. In accordance with ERA’s Service Level Agreement, expect ERA to manually update the existing IRB approved or under IRB review protocol within 2 business days of the request. Once ERA completes this task, Researchers may then begin using KR by initiating and submitting a continuing review, amendment or response.
- 2018 COMMON RULE
All existing IRB approved protocols will be required to align with the 2018 Common Rule. This will allow for Researchers to complete a single version of the IRB Application in KR Protocols.
- What does “transition to the 2018 Common Rule” mean?
It means that at the first official protocol transaction in KR Protocols (after ERA has manually updated the protocol) the UCI HPR Staff will walk Researchers through the steps needed to transition to the 2018 Common Rule. This could mean that a few additional questions will need to be addressed. Further, it could mean that consent text is re-organized so that key information is provided at the beginning of the consent document (written consent only).
- Updated Full Committee Deadline for IRB A
To help facilitate the transition, the deadline for the IRB A full committee meeting has been revised from September 2nd to August 31st.
For more information on KR Protocols, see the original announcement. Any questions? Please contact Beverley Alberola or Jessica Sheldon for questions related to HRP or IRB submissions. Contact ERA for technical questions related to the use of KR Protocols.