Health Research Ethics
Forms & instructions: Amendment
Forms & instructions: Amendments and protocol deviations
» Protocol Amendment Application Form and Guidelines
Protocol deviation: A protocol deviation is a once-off instance when the protocol is not followed, either deliberately, or when a mistake is made. For example: 1) the protocol states that only participants over the age of 18 will be enrolled. However, a participant aged 17 years and 6 months meets all admission criteria and is deliberately enrolled in this study; 2) the wrong follow up date is given and thus follow up occurs outside of a specified time frame.
Minor protocol deviations
·Do not change the risk-benefit profile of the study
·Can be listed with the annual progress report
Significant protocol deviations
·Are likely to adversely affect participant well-being or data integrity
·Should be reported to the HREC within a maximum of 15 days
Amendment: An amendment, sub-study, or addendum is a planned change to a study protocol, made in advance. The HREC must be notified of ALL amendments. The final decision as to whether an amendment is minor or major and whether it requires expedited or full committee review rests with the HREC chairperson or a person delegated this authority by the HREC.
Minor amendments
·Do not change the risk-benefit profile of the study
·Can be submitted in letter format
·Examples include: Additional investigators or study sites; Small changes in the Informed Consent; Change in background information or update of literature review; Extension of period of study; Other changes that do not affect study design and will not affect study outcomes orresults; Administrative changes; Stricter inclusion or exclusion criteria
Major or substantive amendments
·Require change(s) to the study methodology or procedures that may change the risk-benefit profile of the study
·Should be submitted to the HREC as a requested study amendment using the application form for substantial/major amendments
·Should not be implemented prior to HREC approval*
·Examples include: Change in study aims, objectives or design; Resulting changes to consent documents; Additional study procedures; Easing of inclusion or exclusion criteria
