Violations/Deviations

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:

  • The deviation has harmed or posed a significant or substantive risk of harm to a participant.
  • 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.).
  • 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.).
  • 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:

  • Missing pages of a completed consent form.
  • Missing signatures on a consent form.
  • Participant did not receive a copy of a signed consent form (but is later given one when this is discovered)
  • Study procedure conducted out of sequence.

Deviations must be reported to REC-H immediately after occurrence of the deviation.
 

Violations/Deviations report (for studies approved on MEOS - the Mandela Ethics Online System))

Violations/deviations for studies granted original ethics approval via MEOS must be submitted on MEOS.

  1. Refer to the MEOS Applicant User Guide (ver 1.5, updated 19 Jun '23) for details on creating a sub-form.
  2. Log into MEOS using your Nelson Mandela University username and password.
  3. Click on the project for which an extension is required.
  4. Click the [Create Sub Form] button in the left-hand panel.
  5. Select REC-H: Violations/Deviations Report and click [Create]. 
  6. Students are advised to share the form with their supervisors.
  7. Complete the form.
  8. Sign the form.
  9. Request the signature of the PRP (Primary Responsible Person).
  10. Once signed by all relevant parties, the form will be automatically submitted for review.

MEOS Applicant User Guides:

Violations/Deviations report (for studies approved using the current offline process)

  1. Download the RECH-004 (Study Progress Report) template.
  2. Complete the form in full.
  3. Attach, as appendix 2, a letter outlining the violation/deviation.
  4. The completed report and appendix, original signed approval letter and original approved application must be submitted to Mr Imtiaz Khan.