In order to be compliant with ethics approval and ensure ongoing approval of a research study, all existing applications must:
- Submit an annual report on the anniversary of approval (your project will be approved for an additional 12 months)
- Submit a completion report on completion of the research
Log into InfoEd to submit annual and completion reports, make changes to the project (through an amendment request) and submit information on reportable events.
If your study is changed in any way you must submit an amendment request. Amendments to the protocol must not be acted on until approval has been given by the Human Research Office.
Protocol amendments may be defined as major or minor. Major amendments are defined as changes to the protocol which substantially changes the study design or analysis plan. Examples of major amendments are:
- Change in the primary hypothesis,
- Change to the design of the study,
- Additional outcomes or exposures,
- Use of additional linkages to other databases.
Minor amendments are defined as changes to the protocol that do not have an impact on the main aims and outcomes of the study. Examples of minor amendments are:
- Change in definition to the study population (e.g. numbers recruited, increased age range etc.),
- Additional analysis (statistical or biological) that are not part of the main findings.
A reportable event is any event that must be reported to the HREC. Reportable events may include protocol deviations, serious adverse event or an unanticipated problem.
A deviation is a departure from the HREC approval protocol procedures and/or regulatory guidelines.
A deviation is considered major if:
- Increases the risk or decreases the benefit,
- Affects the safety, rights or welfare,
- Affects the integrity of the study design or data, or
- Compromises the ethical acceptability of the study.
If this event does not meet one of these criteria report this event in your annual report.
Serious adverse event
An adverse event is any unforeseen or unexpected outcomes that have a negative impact on participants, researchers or the reputation of Curtin University. Adverse events can apply to interventional studies using new drugs or devices, but also to research with new interventions such as behavioural modifications. Qualitative research may also experience adverse events that meet the above definition.
Adverse events are considered serious if any of the following outcomes occur:
- Life threatening
- Requires inpatient hospitalisation or prolongation of existing hospitalisation
- Results in congenital anomaly/birth defect
- Results in persistent or significant disability or incapacity.
If the adverse event does not result in any of the above outcomes it is considered an unanticipated problem report.
An unanticipated problem is any unforeseen issues that have arisen in the research project. This may relate to an individual or multiple individuals.
An unanticipated event needs to meet the following three criteria:
- Increase the risk of harm,
- Is unexpected, and
- Is caused by, or related to, the study
If this event does not meet these three criteria report this event in your annual report.