Maintaining your human research ethics approval
To comply with your ethics approval and ensure ongoing approval of a research study, all existing applicants must submit annual reports, then a completion report when the research has finished. If your study has to be changed in any way you must submit an amendment request prior to implementing any changes, and you must report any events such as protocol deviations, serious adverse events or unanticipated problems as soon as possible after they occur.
Log into InfoEd to submit annual and completion reports, make changes to the project (through an amendment request) and submit information on reportable events.
You must submit an annual report every year on the anniversary of approval in accordance with the NH&MRC National Statement on Ethical Conduct in Human Research. Failure to submit an annual report means your project does not have current approval. Your project will approved for an additional 12 months once your annual report has been approved.
You must submit a completion report on completion of the project in accordance with the NH&MRC National Statement on Ethical Conduct in Human Research.
All ongoing projects which have human research ethics approval from Curtin may be audited in accordance with the NH&MRC National Statement on Ethical Conduct in Human Research.
Projects are audited to ensure research is conducted ethically, legally, safely and in compliance with the protocol and conditions approved by the Human Research Ethics Committee.
Projects are selected to be audited based on:
- Request by the Human Research Ethics Committee
- Random selection
- A complaint
If your project has been selected to be audited you will be contacted by the Clinical Research Monitor who will provide you with more details.
A reportable event is any event that must be reported to the Curtin Ethics Office. 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 it:
- 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.
An adverse event is any unforeseen or unexpected outcomes that have a negative impact on participants, researchers or Curtin’s reputation. Adverse events can apply to interventional studies using new drugs or devices, but also to research with interventions such as behavioural modifications. People participating in 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, but still needs to be reported immediately (rather than in the annual report) because it potentially changes the risk-benefit profile of the study, it should be reported as an unanticipated problem.
An unanticipated problem is any unforeseen issues that have arisen in your 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.
If your study has 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 and potentially alter the risk-benefit profile of the study. For example:
- 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. An example is administrative changes to the protocol (e.g. a change in contact details).