Research & Ethics Unit

 Protocol deviation/violation
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Definitions

There is no official definition of a protocol deviation or violation, but the following may serve as a guide:

  • A protocol violation is a failure to comply with the study protocol as approved by the Ethics Committee. A violation is a serious non-compliance with the protocol that can result in the exclusion of a patient or their results in the study and in some cases a charge of research misconduct;

  • A protocol deviation is a less serious non-compliance with the approved study protocol. A protocol deviation presented in advance of the event may be considered acceptable by the sponsor (if any) and the Ethics Committee.

Reporting Protocol Deviations/Violations to the Ethics Committee

Researchers should provide written details to the Ethics Committee of protocol violations or deviations when:

  • There are safety or ethical implications for the participant(s)
  • The scientific integrity of the study is affected (normally the sponsor will advise this)
  • The protocol methodology causes the protocol deviation/violation to occur (eg. exclusion criteria too strict)
  • The conduct of the study causes the protocol deviation/violation to occur (eg. rotating staff not detailing consent procedures in patient notes).

Researchers should provide the following details to the Ethics Committee using the Protocol Deviations/Violations Form:

  • Project number and name
  • Name and signature of the principal researcher
  • Details of the deviation/violation
  • The impact of the deviation/violation on patient safety and/or scientific integrity
  • Evidence of acceptance of the deviation by the sponsor, if relevant
  • What steps have/are to be taken to avoid a recurrence

Please email the completed form to research@alfred.org.au. An acknowledgement receipt will be sent by return email. 

Please note

  • If any changes to the project/protocol are required, an amendment should be submitted to the Ethics Committee.
  • The Ethics Committee is under no obligation to approve a protocol deviation presented in advance.

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This page was last modified on 09/02/12


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