Submitting a Renewal (Renew & Amend) Application in KRP:

  • Per CDPH Guidelines for Human Stem Cell Research "SCRO Committee approvals shall be reviewed no less frequently than once per year. The renewal review shall confirm compliance with all applicable rules and regulations." As such, UCI hSCRO Approvals are issued for one year.
  • The Lead Researcher must submit a yearly Renew & Amend in KRP prior to protocol expiration.
    • It is recommended that renewals are submitted 8 weeks prior to expiration if the renewal will include amendments that require Full (Convened) hSCRO Committee review.
    • If the renewal does not include any amendments or the amendments are minor (e.g., personnel changes), then submission is recommended 4-6 weeks prior to expiration.
  • There is no grace period extending the conduct of the research beyond the expiration date of hSCRO approval period.
    • **If a protocol expires, all work with hSCRO approved stem cell lines must stop until hSCRO approval is granted!
  • All research approved by the hSCRO Full Committee qualifies for Expedited Continuing Review unless the research has had any instance of noncompliance or unanticipated problems during the previous year of approval.
  • Personnel updates (removal or addition of personnel, including lead researcher changes) are allowed at the time of Continuing review.
  • Addition of new stem cell lines is allowed at the time of continuing review (i.e. a modification will not be required to add each line) for protocols that include continuous generation of stem cells if the source material used to create new lines has been collected at UCI using an active UCI IRB-approved Consent or whose provenance documentation has already been reviewed for this protocol.
  • Once a protocol has been approved by the hSCRO, it is the LR’s responsibility to maintain hSCRO approval until all uses of gametes, blastocysts and cell lines have concluded.
  • A Continuing Application may be submitted along with a Full Committee Modification Request. At the time of the review both the Full Committee Modification Request and Continuation Application will be considered simultaneously.
  • See UCI hSCRO Policy for details

Submitting a Close Request in KRP

  • A Closing Report is submitted electronically by the LR through KRP.

  • Upon submission, the hSCRO Administrative Staff reviews the Closing Report and all attachments, checks the report for accuracy and completeness.

  • After administrative review, the hSCRO Chair review to verify that the protocol can be closed.

  • The official retention period for UCI's hSCRO records begins on the date a closing report is submitted to the hSCRO by the LR or 30 days after protocol expiration, whichever comes first.

Questions about Submitting to the UCI hSCRO

Feel free to contact if you have any questions about the hSCRO review process or how to complete the hSCRO application.