A study violation or deviation is an unplanned or unforeseen failure of the Principal Investigator or other members of the research team to follow the specified procedures approved by REC-H in the original application. It is usually a once-off occurrence that requires immediate decision-making in order to eliminate an immediate risk or inconvenience to the participant.
Protocol deviations differ from amendments because they usually apply to a single incident or participant and are not intended at the time to change the study.
Violations/Deviations can be classified as major or minor.
Major deviations are those which affect a participant's safety, condition or status; the integrity of the study data; pose a significant risk of harm and change the balance of risks and benefits and a participant's willingness to continue participation.
A deviation which meets any of the following criteria would be classified as major:
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The deviation has harmed or posed a significant or substantive risk of harm to a participant.
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The deviation compromises the scientific integrity of the study data (e.g. A participant was enrolled but does not meet the protocol’s eligibility criteria; Changing the study without REC-H approval; Inadvertent loss of data, etc.).
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The deviation is a willful or knowing breach of ethical or regulatory policies or guidelines (e.g. Failure to obtain informed consent; Performing tests or procedures beyond the investigator’s professional scope; etc.).
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The deviation involves serious or continuing non-compliance with institutional or regulatory policies (e.g. Working under an expired professional license; Repeated minor deviations, etc.).
Minor deviations are deviations which do not affect a participant’s safety, compromise the integrity of study data or affect a participant’s willingness to continue taking part in the study.
Minor deviations could include:
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Missing pages of a completed consent form.
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Missing signatures on a consent form.
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Participant did not receive a copy of a signed consent form (but is later given one when this is discovered)
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Study procedure conducted out of sequence.
Deviations must be reported to REC-H immediately after occurrence of the deviation.
Violations/deviations for studies granted original ethics approval via MEOS must be submitted on MEOS.
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Refer to the MEOS Applicant User Guide (ver 1.5, updated 19 Jun '23) for details on creating a sub-form.
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Log into MEOS using your Nelson Mandela University username and password.
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Click on the project for which an extension is required.
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Click the [Create Sub Form] button in the left-hand panel.
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Select REC-H: Violations/Deviations Report and click [Create].
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Students are advised to share the form with their supervisors.
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Complete the form.
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Sign the form.
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Request the signature of the PRP (Primary Responsible Person).
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Once signed by all relevant parties, the form will be automatically submitted for review.
MEOS Applicant User Guides:
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Download the RECH-004 (Study Progress Report) template.
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Complete the form in full.
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Attach, as appendix 2, a letter outlining the violation/deviation.
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The completed report and appendix, original signed approval letter and original approved application must be submitted to Mr Imtiaz Khan.