Specify the type of submission:
Choose one that applies:
For more information, visit:
ATTENTION! Amendments are NOT required for the following determinations:
These amendments are to be tracked by the Lead Researcher independently. If the amendment changes the level of review to where IRB review is required, a new protocol must be submitted.
What type of changes are being proposed for this request?
Choose one that applies:
Current Status of Enrollments:
Choose one that applies:
Number of subjects currently receiving active research intervention or if on hold, the number of subjects who were receiving active intervention prior to the hold:
Specify whether the enrollment hold is sponsor, FDA or investigator initiated and provide the rationale:
Are there approved re-consent documents on file (e.g., re-consent cover memos, consent addendums, or tracked changes versions of the consent form)?
IMPORTANT! To verify, review the 'Approved' documents in the Attachments section.
Is the reconsenting of participants complete?
Choose one that applies:
REQUIRED! Review and review the Attachments section to remove all re-consent cover memos that are no longer being used.
Provide a timeline for reconsenting all applicable participants:
Is there significant new information that would warrant notification or reconsenting of participants?
Choose one that applies:
Select the plan for notifying or reconsenting participants:
Choose one that applies:
REQUIRED! Submit the corresponding notification document in the Attachments section. Include translated notifications, as applicable.
List all requested changes below and provide justification for the change, as applicable.
IMPORTANT! The list below must be complete / comprehensive of all changes as it will be reflected in the IRB Approval Letter. Failure to provide a complete list of changes will delay IRB approval.
Choose one that applies:
IMPORTANT! Failure to provide a complete list of changes will delay IRB approval.
Choose one that applies:
Provide the details and reason for the administrative change(s):
Provide the details and reason for the change in clinical items/services from UC Irvine Health:
Provide the details and reason for the change in Clinicaltrials.gov:
Provide the details and reason for the change in consent:
Is the use of a device already included in the approved protocol?
Choose one that applies:
REQUIRED!
REQUIRED! Review and revise the Medical Devices section.
Provide the details and reason for the device change:
Is the use of a drug/biologic already included in the approved protocol?
Choose one that applies:
REQUIRED!
REQUIRED! Review and revise the Investigational Drug or Biologic section.
Provide the details and reason for the drug change:
Provide the details and reason for the change in related financial disclosable interest:
Is funding/support from the Department of Defense (DoD) being added?
Choose one that applies:
REQUIRED! Submit a completed UCI IRB DoD Supplement Form in the Attachments section.
Provide the details and reason for the change in funding:
Provide the details and reason for the change in HIPAA process:
Provide the details and reason for the change in Investigator Brochure:
Provide the details and reason for the change in Master Protocol:
Provide the details and reason for the change in performances site(s):
Provide the details and reason for the recruitment change:
Provide the details and reason for the reliance change:
Provide the details and reason for the change in research procedures:
Would the proposed modifications change the risk of harm to the subjects?
Choose one that applies:
Provide the justification for the increase in risk of harm to the subjects:
Does the research pose a different level of risk to subjects than initially submitted?
Choose one that applies:
Provide the details and reason for the change in risk assessment:
Provide the details and reason for the change in Sponsor Consent:
Is there a change of the Lead Researcher?
Choose one that applies:
REQUIRED! The new LR must complete:
Investigator's Assurance
As Lead Researcher, I have ultimate responsibility for the performance of this study, the protection of the rights and welfare of the human subjects, and strict adherence by all co-investigators and research personnel to all Institutional Review Board (IRB) requirements, federal regulations, and state statutes for research involving human subjects.
I hereby assure the following:
I and all co-investigators and research personnel agree to comply with all applicable requirements for the protection of human subjects in research including, but not limited to, the following:
Select all that apply:
Investigators' Disclosure of Financial Interest
In order to inform research subjects of circumstances that may affect their decision to participate in this study, all researchers are required to disclose their financial interests with outside institutions.
The Lead Researcher of the protocol must ask the following question of all study team members:
?Do you, your spouse/registered domestic partner, and dependent children together have any disclosable financial interests (i) that would reasonably appear to be affected by the research; or (ii) in entities whose financial interests would reasonably appear to be affected by the research?"
A member of the study team who answers in the affirmative will be contacted by the Conflict of Interest Oversight Committee (COIOC) to obtain additional information regarding their specific financial interest(s).
IMPORTANT! If there has been a change in the financial disclosures of the LR or the study team, please also request a 'Change in Financial Interests'.
Select all that apply:
Provide a reason for the change in study team and specify who is being added or removed:
IRB of Record Notification and/or Approval of the Personnel Changes:
Select all that apply:
REQUIRED!
REQUIRED!
Select the proposed changes for subject populations (check all that apply):
Select all that apply:
Provide the details and reason for the change in subject population(s):
Are translated documents (e.g., consents, HIPAA authorization, recruitments) available?
Choose one that applies:
Provide the details and reason for the other change(s):
Sponsor Suspension of Clinical Trial Involving Investigational Radiopharmaceutical(s)
Specify why the Sponsor has suspended the trial:
Select the level of risk for your approved protocol:
Choose one that applies:
Exempt/Expedited (minimal risk) studies: The IRB will accept documents translated by an individual fluent (credentials, certifications, education, native language fluency, etc.) in a given language.
Full Committee (greater than minimal risk) studies: a professional or certified translation of the consent/assent form(s) is preferred, unless the IRB has granted a waiver of documentation of informed consent.
Is there a translation certification or a letter from the translator available as a separate attachment?
Choose one that applies:
Specify the qualifications of the translator below:
End of translation form!
IMPORTANT! Do not make any changes to the protocol. Any changes to the protocol must be submitted as 'minor' or 'major' revisions.
Description of Changes
Provide a brief description of the proposed modification:
Addition or Deletion of Stem Cell Lines/Materials
Check all appropriate boxes, navigate to the Cell Line Provenance Section and update the 'Cell Tracking Table'.
Select all that apply:
Methodology and/or Procedural Changes
Check all appropriate boxes below regarding modification to methods and/or procedures and navigate to the specific sections in the protocol to make the modifications.
Select all that apply:
List IACUC Protocol # here:
Study Team Changes
Will you be adding and/or removing study team members?
Select all that apply:
List the study team personnel to be added along with their primary responsibility(ies) related to handling hSCRO approved stem cell lines / materials:
List the study team personnel to be removed:
Other Changes
Describe all other changes that have not been documented on this form and navigate to the specific sections in the protocol to make the modifications.
Confirmation of Changes:
Select all that apply:
Confirmation of Changes:
Select all that apply:
Confirmation of Changes:
Select all that apply:
The IRB/hSCRO staff submitted this amendment to process the approval.
Upon approval of this amendment, the IRB/hSCRO approved documents can be found in the Attachments section.
End of amendment form!
Within five working days after the use of an investigational drug or biologic a signed version of this part of the form, summarizing the consent process (if applicable), the date and results of the emergency use must be submitted to the IRB. The report will be reviewed by the IRB at a convened meeting.
IRB review is not merely confirmation of the emergency use but is an assessment of the circumstances, the appropriateness of the emergency waiver, and the consent process employed.
Following the meeting, the physician will be provided confirmation of IRB review and any noted concerns or requests for additional information. This confirmation should be maintained with the physician's records for audit purposes.
Was informed consent obtained from the patient or the patient?s legally authorized representative?
Choose one that applies:
Explain why a consent form that was not reviewed by the IRB was utilized:
Explain the change in circumstance and why informed consent could no longer be obtained:
Date(s) test article administered/utilized:
Provide a brief description of the results of the emergency use:
Provide an evaluation of the likelihood for a similar need for emergency use of this test article:
REMINDER! Submit a 'Request Close' once the single patient has completed the entire treatment according to their treatment plan. An annual renewal is not required.