Mother Frances Hospital Tyler
Institutional Review Board
irb@tmfhc.org / (903) 606-2472
Continuing Review
Humanitarian Use Device
Physician Sponsor:
IRB # and Protocol title:
Protocol version and date:
Investigator brochure version and date:
Informed consent version and date:
Assent version and date:
Name of person completing this form:
Date:
Handwritten, copied or scanned versions of this form are not accepted. To prevent errors and
delays due to legibility problems, submit the original to irb@tmfhc.org. All questions must be
answered. Indicate NA for questions that are not applicable.
All modifications and/or changes that have not been reviewed and approved by the IRB must be
submitted using the appropriate form.
HUD staff
List all HUD staff, providers, physicians, protocol coordinator, inventory coordinator and others
who have substantive interaction with patients (recruiting, obtaining consent, evaluating
response). The Physician Sponsor and each person listed must complete and sign a Conflict of
Interest statement.
Description and current status
1. Brief summary of the device and its indication for use in the rare disease or condition it treats
/ diagnoses:
2. Current status:
Device has not been used to date
Device is currently being used
Device is no longer being used and follow-up of subjects continues
Design and procedures
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Humanitarian Use Device
Last revised
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1. Summary of device safety.
2. Summary of the reliability of the device for its intended use.
3. Summary of any problems with, or changes in, the use of the device since the last review.
Include details.
Patient recruiting:
Inclusion or exclusion criteria:
Informed consent:
Documentation of informed consent:
Privacy or confidentiality protections:
Safety monitoring:
None of the above
4. If any changes listed in the question above were not prospectively reviewed and approved by
the IRB prior to implementation, explain why.
Not applicable
List and explanation:
Device use
1. Indicate total number of patients with the device since IRB approval.
2. Indicate total number of patients with the device since the last continuing review. (If this is
the first continuing review, list the number since IRB approval).
3. If screening procedures are used to determine eligibility, how many patients were consented
and failed screening?
Not applicable. No screening procedures used.
Number:
4. Indicate number of patients still active (includes follow-up procedures).
5. Indicate number of patients that have completed follow up.
6. If any patients have withdrawn, provide a summary of withdrawals and the reasons for
withdrawal.
Not applicable. No patients have withdrawn.
Continuing Review
Humanitarian Use Device
Last revised 08/12/2014
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Number Reason
Discontinued early due to unanticipated problem
Withdrew consent
Lost to follow up
Terminated by the Physician Sponsor
Expired
Other:
Risks and benefits
Since the last review …
Yes
No
1. Has there been any relevant information regarding this device, especially
information about risks / benefits? If yes, describe and indicate date
provided to the IRB:
2. Has the expectation of adverse events (frequency, severity, specificity)
changed? If yes, provide a summary of the changes and indicate date
reported to the IRB:
3. Have there been any unanticipated problems involving risks to patients or
others? If yes, provide a summary of the problems and indicate date
reported to the IRB:
4. Have there been any complaints about the device from patients or others?
If yes, summarize the number and nature of the complaint(s) and indicate
date reported to the IRB:
5. Have patients experienced any unexpected benefits? If yes, summarize and
indicate date reported to the IRB:
6. In the opinion of the Physician Sponsor, have the risks or potential
benefits changed? If yes, describe:
7. Overall risk classification (select one):
Minimal. “The probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in
daily life or during the performance of routine physical or psychological
examinations or tests.”
Greater than minimal.
8. If continuation of the use of the device is NOT justified in light of the above information,
please explain.
Additional information
Summary of amendments since the initial review (add lines as necessary):
Date Description
Continuing Review
Humanitarian Use Device
Last revised 08/12/2014
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Attachments
Indicate items attached: (*=required)
*Conflict of Interest statements for all HUD staff
Copy of the latest IRB approved stamped:
informed consent form(s)
assent document(s)
oral script(s) / letter(s) information sheet(s)
translated and authenticated versions of the above consent(s), assent(s), oral
script(s), letter(s), information sheet(s), for likely non-English speakers
*Copies of the signed consent / assent for the last two patients to receive the device since
the last review
Publication(s) related to the device since the last review
Copies of any interim findings reported by the sponsor or investigator since the last
review
*Summary of Local Adverse Events since the last review (includes all adverse events)
Audit reports (Includes local IRB, U. S. Food and Drug Administration, Office for
Human Research Protections, sponsor, Contract Research Organization and any other
regulatory agencies) since the last review
Copies of monitoring reports since the last review
Continuing Review
Humanitarian Use Device
Last revised 08/12/2014
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