Submitting hSCRO Renewals

IMPORTANT:

Steps to renew your protocol in Zot hSCRO:

  1. All active hSCRO protocols have transferred from KRP to Zot hSCRO.
  2. Navigate to your study in Zot hSCRO. Resources: hSCRO Researchers Guide ; Navigating ZOT hSCRO: The Basics
  3. Click “Create Amendment / CR”: see pages 8 – 10 of the hSCRO Researchers Guide
  4. Under #1 “Type of Submission” click "Amendment / CR"
  5. Under #2 “Amendment Type”:
    1. Click “Other parts of the protocol” to upload your protocol narrative (explained in step 8)
    2. Click “Protocol team member information” if there are any changes to the study team. For study team member addition, be sure to specify their specific the activities they will be responsible for as well as their training / expertise.
  6. Progress report: provide a few sentences / details about study progress since the last renewal.
  7. In the “Amendment” section, summarize all changes to the protocol and their rationale.
  8. Protocol Narrative Transcription: As part of the transcription to the Zot hSCRO platform from KRP, all hSCRO protocols must transcribe information from KRP (copy found under “supporting documents” as a pdf) to the hSCRO Protocol Narrative template: Protocol Narrative - hSCRO
  9. Once you have transcribed the KRP pdf to the Protocol Narrative, please upload this under “supporting documents”.
  10. Finally, click “finish” and “submit”.

Renewal Process

Once a protocol has been approved by hSCRO, it is the PI’s responsibility to maintain hSCRO approval until all hSCRO covered activities have concluded. 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.

hSCRO requires a continuing review of approved protocols to confirm compliance with all applicable rules and regulations. The PI must submit a renewal & amendment prior to protocol expiration.

  • Submit 8 weeks prior to expiration if the renewal will include amendments that require Full (convened) hSCRO Committee review.
  • Submit 4-6 weeks prior to expiration, if there are no major amendments.

Unless determined otherwise, hSCRO will grant a one year approval for research that:

  • uses human gametes
  • uses human embryos
  • uses human fetal tissue
  • uses or generates new human fetal stem cell lines
  • uses or generates brain organoids, iBlastoids
  • generates new human embryonic stem cell lines
  • transplants hSCRO covered materials into animals / humans

Three year approvals:

hSCRO will provide a three year approval for in-vitro research that:

  • uses or generates materials from non-identifiable cells, or
  • uses cell lines recognized by an “authorized authority” like NIH, or
  • uses cell lines in which the provenance is approved by the UCI hSCRO Committee

When a three year approval has been issued, should a planned amendment make the study ineligible for three year approval, a Renewal & Amendment must be submitted. The hSCRO will review the study's progress and reset the approval period to an annual review cycle.

Questions about Submitting to the UCI hSCRO?

Contact hSCRO@research.uci.edu if you have any questions about the hSCRO review process or how to complete the hSCRO application.