UT Health Science Center San Antonio
Report of Noncompliance
Study Title:Report of noncompliance
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UT Health Science Center San Antonio
Report of Noncompliance
Study Title:1. IRB Protocol Number: HSC20 Date:
2. Current Principal InvestigatorPrincipal 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, skip this table
3. Person to contact about this reportContact Name
(Last, First)
Phone/Pager/Fax / Phone #: / Pager: / Fax:
(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 comply with applicable regulations or policies / Failure to conduct the study according to applicable regulations and local policies.
Examples include: accessing PHI without appropriate authorization/waiver; failure to obtain informed consent prior to beginning research; failure to report unanticipated problems (UPIRSOs); conducting research without active IRB approval; making non-emergent changes to the protocol without IRB approval; failure to follow requirements of the VHA handbook for VA research
Failure to comply with the requirements or determinations of the IRB / Failure to conduct the study as directed by the IRB
Examples include: allowing unapproved investigators to perform research procedures; conducting research at unapproved study sites; using an unapproved or outdated consent form; using unapproved recruitment procedures
B. When not to use this form – Other deviations not considered Noncompliance
Minor or administrative Protocol Deviations / Minor or administrative protocol deviations are defined as those which do not affect the scientific soundness of the research or adversely affect the rights, safety, or welfare of human subjects. A minor or administrative protocol deviation is limited to minor departures from the protocol for a single subject.
Examples include: follow up visits that occurred outside the protocol required timeline or blood samples 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.
Emergency 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 avoid a serious harm (risk of harm )
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.
Major, non-emergent Deviations / A planned, major, non-emergent change in the protocol may not be initiated without IRB review and approval.
Examples include: any changes to the study design or procedures or changes to study staff or sites)
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.
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.
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 à
Has this particular noncompliance issue occurred before with this study? / / Yes / / No
If yes, describe previous noncompliance hereà
8. Summary of the events leading up to or contributing to the noncompliance.
Describe here à
9. Description of how the noncompliance affected or may have affected the safety, rights or welfare of the subject(s).
Describe here à
10. Describe any subsequent actions taken to prevent future noncompliance of this nature.
Describe here à
11. Is this an externally sponsored study?
/ No. Go to Question 12.
/ 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 13.
/ 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) /
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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