Report of Noncompliance

							                                            UT Health Science Center San Antonio
                                                 Report of Noncompliance
IRB #     HSC20_____


                                                     REPORT OF NONCOMPLIANCE


Click here for Form Instructions.

1. IRB Protocol Number: HSC200                                                            Date:


2. Current Principal Investigator
Principal Investigator
(First name, Last name)
Dept/Division
Salutation/Degree
(e.g., MD, PhD, RN)
Work Phone/Pager/Fax                   Phone:                      Pager:                   Fax:
E-mail (if other than UT Outlook)

If contact person is the PI, delete this table
       Person to contact about this report
       Contact Name
       (Last, First)
       Phone/Pager/Fax                    Phone #:                 Pager:                   Fax:
       Email
       (if other than UT Outlook)


4. Guidance                                 [review the IRB Policy on Noncompliance]
A. When to use this form - Reporting Noncompliance
Type                      Description
                          Failure to conduct the study according to applicable regulations and local policies.
Failure to comply with
                          Examples include: accessing PHI without appropriate authorization/waiver; failure to obtain
applicable
                          informed consent prior to beginning research; failure to report unanticipated problems (UPIRSOs);
regulations or
                          conducting research without active IRB approval; making non-emergent changes to the protocol
policies
                          without IRB approval; failure to follow requirements of the VHA handbook for VA research
Failure to comply with    Failure to conduct the study as directed by the IRB
the requirements or       Examples include: allowing unapproved investigators to perform research procedures; conducting
determinations of the     research at unapproved study sites; using an unapproved or outdated consent form; using
IRB                       unapproved recruitment procedures




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                                            UT Health Science Center San Antonio
                                                 Report of Noncompliance
IRB #      HSC20_____

B. When not to use this form – Other deviations not considered Noncompliance
                     Minor or administrative protocol deviations are defined as those which do not affect the scientific
Minor or             soundness of the research or adversely affect the rights, safety, or welfare of human subjects. A minor or
administrative       administrative protocol deviation is limited to minor departures from the protocol for a single subject.
Protocol             Examples include: follow up visits that occurred outside the protocol required timeline or blood samples
Deviations           obtained at times close to but not precisely at the time points specified in the protocol.
                     Stop - Do not use this form to report minor or administrative protocol deviations.
                     When a deviation occurs in an emergency situation, such as when a departure from the protocol is
                     required to eliminate apparent immediate hazard to the subject.
                     Examples include: withholding study drug in response to a serious adverse event (actual harm) or to
Emergency
                     avoid a serious harm (risk of harm )
Deviations
                     Emergency deviations are always considered Unanticipated Problems Involving Risks to Subjects or
                     Others (UPIRSOs).
                     Stop - Do not use this form to report a UPIRSO – use the appropriate UPIRSO Report form.
                     A planned, major, non-emergent change in the protocol may not be initiated without IRB review and
Major, non-          approval.
emergent             Examples include: any changes to the study design or procedures or changes to study staff or sites)
Deviations           Stop - Do not use this form to request major, non-emergent protocol changes in the protocol – use the
                     Amendment Request form.


5. Did the noncompliance being reported also result in or contribute to an adverse event?
        No. Skip to Question 6
        Yes.
        If yes, was the adverse event serious or does it suggest a greater risk of harm to the subject?
               No.
               Yes. Promptly report this as a possible AE UPIRSO by attaching the appropriate report form.



6. Did the noncompliance being reported also result in or contribute to any other problems that were not adverse events
since the last IRB review?
        No. Go to Question 7
        Yes. If yes, were the non-AE problems of a nature that may have placed subjects (or others) at greater risk? (For
        example the loss of confidential data, dosing error with no detectable harm, etc.)
               No.
               Yes. Promptly report this as a possible Non-AE UPIRSO by attaching the appropriate report form.



                                             Summary of the Noncompliance

NOTE: Provide a description of the nature of the noncompliance. Include a summary of the events leading up to the
         failure to follow the regulations governing human research or the IRB’s determinations. Comment on how the
         noncompliance affected or may have affected the safety and welfare of the subject. [Note: noncompliance
         that results in an increased risk of harm should be promptly reported to the IRB as possible UPIRSOs.]
         Describe the subsequent action(s) taken to prevent future noncompliance of this nature.

7. Description of the noncompliance.       (Provide a description of the event and relate it to the regulation/policy or IRB
determination that was not followed)
Describe here 

Has this particular noncompliance issue occurred before with this study?                            Yes                   No
If yes, describe previous noncompliance here




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                                             UT Health Science Center San Antonio
                                                  Report of Noncompliance
IRB #         HSC20_____


8. Summary of the events leading up to or contributing to the noncompliance.
Describe here 




9. Description of how the noncompliance affected or may have affected the safety, rights or welfare of the subject(s).

Describe here 




10. Describe any subsequent actions taken to prevent future noncompliance of this nature.
Describe here 




11. Is this an externally sponsored study?
        No. Go to Question 7.
        Yes. If yes, select one below:
                The study sponsor has not been made aware of the noncompliance.
                The study sponsor is aware of the noncompliance.

                Give a brief description of how the sponsor
                was informed of the noncompliance



12. Do you need to change your protocol to prevent future noncompliance?
        No. Go to Question 8.
        Yes. The changes are detailed in the attached amendment form and revised documents as required. Submit
        appropriate number of copies if submitting for full Board review.



                                                      Special Populations
13. Did the event involve a subject from any of the categories of special populations?
        No.
        Yes. If yes, check the applicable vulnerable population(s) the subject(s) belongs to:
                                          Vulnerable Population
        Children
        Pregnant women/fetuses
        Non-viable neonates / neonates of uncertain viability
        Prisoners
        Cognitively impaired (adult surrogate consent)




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                                           UT Health Science Center San Antonio
                                                Report of Noncompliance
IRB #      HSC20_____


14. Which items are being attached to this Report? Check all that apply.
        Form A-1, Multipurpose Signature Assurance Sheet - Required
        Notification of Possible UPIRSO form (AE or Non-AE)
        Amendment Form with applicable attachments
        Sponsor reports or notifications
        Other: (describe)




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                                                 UT Health Science Center San Antonio
                                                      Report of Noncompliance
IRB #      HSC20_____

For IRB Office Use Only:
Administrative Review Determinations                                                                            Yes             No

Is there sufficient information to determine whether the event is noncompliance?

Is the noncompliance possibly serious or continuing? (If yes, refer to convened IRB)

Does the noncompliance also involve an Unanticipated Problem Involving Risk (UPIRSO)?

Is the PI’s plan for preventing future, similar noncompliance acceptable?

Does the PI’s plan include an amendment containing corrective changes to the protocol?

Are other actions necessary to address this noncompliance? (If yes, detail below)

Does the noncompliance possibly affect the integrity of the study? (If yes, refer to convened IRB)

Should the study be monitored to verify that no other material changes have been made to the study? (If
yes, detail below)

Does the study continue to meet the approval criteria at 45 CFR46.111?

Should other UTHSCSA Institutional Officials be notified? (If yes, detail below)

Should institutions other than UTHSCSA need to be notified? (If yes, detail below)
Details/Comments/Conditions:
__________________________________________________________________________ ___________________________________
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Administrative Reviewer: ________________________________ Date: ____________________                      Refer to convened IRB meeting




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