Protocol Type
Are you submitting a renewal for an IRB, sIRB, or hSCRO protocol?
Choose one that applies:
Timing of Submission
Exempt and Expedited IRB protocols must submit a short version of the renewal every three (3) years unless determined otherwise by the IRB. Investigators should plan ahead and submit 60 days prior to the study's expiration date.
Full Committee IRB protocols must submit a renewal at least annually (not more than 365 days). Investigators should plan ahead to meet required continuing review dates. For full committee review protocols, please submit 90 days prior to the expiration date to guard against a lapse in IRB approval.
Amendments at the Time of Renewal
Please refrain from making major changes during the renewal as this could result in a lapse of IRB approval.
Protocol Closure
To close out an approved protocol at the time of renewal, the transaction must be submitted as Request Close. If this option was not initially selected and closure is required, please Abandon the draft and start again. For more information, visit Post-Review Responsibilities and select the Protocol Renewal Tab.
Renewal Screener
Does any of the following apply to the currently approved protocol:
Choose one that applies:
Timing of Submission
sIRB protocols must submit a renewal within 5 days of receipt of the Renewal Letter issued by the IRB of Record.
Protocol Closure
To close out an approved protocol at the time of renewal, the transaction must be submitted as Request Close. If this option was not initially selected and closure is required, please Abandon the draft and start again.
Protocol Expiration
Did the IRB of Record specify an expiration date for the protocol?
Choose one that applies:
Provide the protocol expiration date issued by the IRB of Record:
For more information and guidance on submitting a hSCRO renewal, visit the online user guide.
If you have any additional questions about completing the hSCRO renewal or about the hSCRO process in general, contact the hSCRO Administrator.
If you have any technical issues or questions, contact Electronic Research Administration (ERA).
Protocol Expiration
Has approval for this protocol expired or will it expire within 3 weeks?
Choose one that applies:
IMPORTANT! If the IRB has not approved a research study prior to the expiration date, all research activities must stop*. This includes:
*Exception: Research-related interventions or interactions with enrolled subjects may continue if the IRB determines that stopping the research would jeopardize the rights or welfare of current subjects. A request for such an exception must be submitted in the writing to the IRB by the Lead Researcher. The IRB will decide which subjects should continue receiving the intervention during the lapse in approval.
Research Cessation Confirmation:
Choose one that applies:
Did an IRB Chair grant an exception to continue research activities during the lapse of approval?
Choose one that applies:
Assess whether the noncompliance with research cessation is considered a Reportable Event (i.e. serious/ continuing noncompliance or an unanticipated problem) and take one of the following actions:
Choose one that applies:
Provide a corrective and preventative action plan to address to ensure that noncompliance does not re-occur:
Study Team
Review the Study Team Section and consider whether anyone should be removed at this time via an Amendment.
RP Heat Map
Are RP tracked outside the approved protocol, in accordance with the RP Heat Map?
Choose one that applies:
Explain why a study team tracking log is not being maintained:
Financial Interests
Review the Study Team section and specify below if there have been any changes in the study team's related financial disclosable interests.
See Conflict of Interest Oversight Committee (COIOC) for more details.
Choose one that applies:
Relying Non-UCI Entity (as applicable)
When UCI is the IRB of Record for a non-UCI entity (i.e., site or independent investigator), review the sIRB section and remove any non-UCI entities (site or independent investigator) that are no longer engaged in research via an Amendment.
ClinicalTrials.gov Registration
Does this research meet the definition of a clinical trial that requires adherence to Clinicaltrials.gov (CT.gov)?
Choose one that applies:
Confirm the accuracy of ClinicalTrials.gov section in the IRB protocol (select one):
Please review the ClinicalTrials.gov section in the IRB protocol to verify that the information is still accurate.
If any revisions are required, please submit an amendment to request a 'Change in Clinicaltrials.gov' and update the the protocol accordingly.
Select all that apply:
Specify who is responsible for registering, maintaining, and updating the CT.gov record:
Choose one that applies:
Confirm the accuracy of the information on the ClinicalTrials.gov Protocol Registration and Results System (PRS):
IMPORTANT! Per federal requirements (42 CFR 11.64(a)(1)(ii)), clinical trial registration information on PRS must be updated not less than once every 12 months.
Please review the information on PRS to verify that the following fields are accurate and up to date:
Select all that apply:
Accruals
Please mark the option that represents the current status of subject enrollments:
Choose one that applies:
Has there been an Amendment reviewed by the Full Committee (i.e., greater than minimal risk) during the last approval period?
Choose one that applies:
Please confirm the total number of subjects (i.e. individuals, specimens, records) approved by the UCI IRB in the Subject Populations section.
Indicate the number of new subjects enrolled since last IRB review:
Indicate the total number of subjects (including the number in the previous question) enrolled since initial UCI IRB approval:
Please provide an explanation on why subject enrollment has yet to begin:
Did the total number of subjects enrolled to date exceeds the total number approved by the IRB?
Choose one that applies:
Assess whether the over-enrollment is considered a Reportable Event (i.e. serious/ continuing noncompliance or an unanticipated problem) and take one of the following actions:
Choose one that applies:
Indicate the total number of subjects enrolled per group since initial IRB approval:
Man (total):
Woman (total):
Nonbinary (total):
Not Collected (total):
Adults (total):
Minor (total):
Multi-Center Studies: If known, indicate the total number of subjects enrolled at ALL sites to date:
Early Termination(s)
Did the Lead Researcher or a Co-Researcher remove any subject(s) from the study?
Choose one that applies:
Please provide the reason(s) here (e.g., failed to follow instructions, missed appointment, medical complications, subject safety issue):
Voluntary Withdrawal(s)
Did any subject(s) voluntarily withdraw from the study?
Choose one that applies:
Please describe the reason(s) here (e.g., relocation; dissatisfaction):
Reportable Events
Have there been any problems that required prompt reporting to the UCI IRB?
Choose one that applies:
Reportable Events
Have there been any problems that were reported to the IRB of Record, but were not reported to the UCI IRB?
Choose one that applies:
Please explain why the problem(s) has not been reported to the UCI IRB:
REQUIRED! Promptly submit a Reportable Event along with the renewal.
Complaints
Have there been any complaints from UCI participants or others that required reporting to the UCI IRB?
Choose one that applies:
Please explain the complaints that require reporting:
UCI Progress
Please provide a detailed description of the progress of the study, including a brief summary of any interim findings or trends, and plans for the next approval period:
Relying Entity Progress (as applicable)
If UCI is the IRB of Record for a non-UCI entity, provide a progress report for each relying entity (e.g., number of participants enrolled at the sub-site; data analysis performed, if any, etc):
Sponsor Multi-Center Progress (as applicable):
Is a multicenter progress report / newsletter is available from the Sponsor?
Choose one that applies:
REQUIRED! Upload the Sponsor's progress report/ newsletter in the Attachments section.
Provide any available information related to multi-center progress from the Sponsor:
Confirm that there is no new information that raises concerns about the circumstances under which informed consent is being obtained:
Choose one that applies:
Please explain why the new information raises concerns:
Confirm that any new findings that have developed since the last continuing review, have been provided to enrolled subjects, as appropriate:
Choose one that applies:
Please explain why new findings have not been provided to subjects:
Confirm that the research team is using the most recently approved version of the consent/assent document and that it contains the most accurate, up-to-date information about the research:
Choose one that applies:
Please explain why the research team is NOT using the most recently approved version of the consent document:
Confirm that all signed consent documents are on file and available for inspection:
Choose one that applies:
Please explain why all signed consent documents are NOT on file and available for inspection:
Specify if any subjects were enrolled using a non-English consent document, information sheet, or script:
Choose one that applies:
Please list the language(s) in which the subject(s) were consented:
Given that some research studies have multiple consent/assent forms, please indicate which approved consent/assent forms should be reviewed by the IRB:
Choose one that applies:
Specify consent/assent forms to be reviewed:
Re-Consent Status
Since the last IRB Approval, did any Amendments require subjects to be re-consented?
Choose one that applies:
Is the re-consenting of participants complete?
Choose one that applies:
REQUIRED! Review the Attachments section and remove all re-consent cover memos that are no longer being used.
Internal Audit(s)
Have any internal (UCI/UCI Health) audits occurred since last IRB review?
Choose one that applies:
Please explain any significant findings:
External Audit(s)
Have any external (FDA/OHRP/Sponsor) audits occurred since last IRB review?
Choose one that applies:
Please explain any significant findings:
Relevant Recent Literature
During the past year has there been anything in relevant literature that the IRB should consider when reviewing this application for continuing approval?
Choose one that applies:
Describe the literature, provide the citation(s), and explain its importance:
Current Risk/Benefit Assessment
Has there been a change in risk/benefit?
Take into account the information gathered during the past year such as interim results, reportable events/problems, changes in scientific knowledge, and/or relevant regulatory actions regarding study-wide safety and/or efficacy (e.g., product recall). This assessment should be sufficiently detailed to assist the IRB in determining whether continuation of IRB approval is appropriate.
Choose one that applies:
Explain any findings that relate to risk assessment:
Data Safety Monitoring Board (DSMB)
Has there been any new DSMB findings relating to subject safety?
Choose one that applies:
Please provide any DSMB findings relating to subject safety:
Investigator's Brochure (IB)
For FDA regulated drug studies, enter the current version number and date of the Investigator's Brochure in the Supplemental Documents section.
If you need to provide updated information related to review by other committees (IBC & IACUC), complete both the renewal and amendment form and revise the Other UCI Committee Reviews Section in the main protocol.
Confirm the stem cell types currently approved for use on this protocol, as well as their progress:
Select all that apply:
For each of the stem cell type(s) checked above, describe the study progress (e.g., has not yet begun, is ongoing, is complete, etc.):
Provide a description of the progress of the study:
Provide citations for any publications or presentations resulting from this study since the last hSCRO review. If no publications/presentations resulted, indicate 'none'.
End of renewal form!
IMPORTANT! Go to the next section to complete the amendment form.
End of renewal form!
IMPORTANT! Go to the next section to complete the amendment form.