Research Intranet - Research ethics and integrity

Managing your approved research ethics application

Obtaining ethics approval to commence a (human/animal) research project is the first step in meeting your obligations for the design and conduct of ethical research.

To comply with the National Statement and ensure that your ethics approval remains valid, you will need to manage your project at various stages through to completion.

Conducting research ethically means making ethical considerations throughout the project, not just during the ethics approval process. It may be necessary to seek further approval from the Ethics Committee in some circumstances.

This section includes information on:

• conditions of approval;
• requesting an extension of ethics approval;
• informing the Ethics Committee about changes to the project and requesting approval for them; and
• managing adverse or unforeseen events.

All applications are approved with standard conditions of approval. Some projects may also have further specific conditions of approval. For more information download the HREC Conditions of approval.

For managing an approved animal ethics application, please see the Managing your approved animal research ethics application web page.

Monitoring

All research projects are approved subject to compliance with monitoring procedures. Monitoring is the process of verifying that the conduct of research conforms to the approved ethics application.

Institutions are responsible for ensuring that research is reliably monitored and establishing that a research project is being, or has been, conducted in the manner approved by the Human Research Ethics Committee.

Monitoring involves completion of an annual progress report (if your project is longer than one year) and completion of a final report at the end of your project.

You will be notified when a report is due and will need to complete a report in one of two ways.

1. If your project was approved in REMS, please visit your REMS Portal and click on the report icon for the appropriate project and enter the online reporting system; or
2. If your project was approved in STREAM, please download and complete the Ethics Report Form.

The Human Research Ethics Committees also reserve the right to adopt any additional appropriate mechanism for monitoring approved research projects.

Conditions of ethics approval

All applications are approved with standard conditions of approval. Some projects may also have further specific conditions of approval which must be met and approved before research commences. If there are specific conditions of approval attached to your application, these will be outlined on your approval email. Please read this document carefully.

For more information download the HREC Conditions of approval.

Extension of ethics approval

All research projects are approved for a specified period of time – from the date of approval until the date of completion provided in the ethics application.

Ethics approval covers both the collection and use/analysis of data, information and/or samples. Researchers should ensure that the period of time requested for ethics approval is sufficient.

If an extension of the approval period is required, a request must be submitted to the Human Research Ethics Committee – before the original approval expires. To request an extension of ethics approval, please review the following:

1. If your project was approved in REMS, please visit your REMS Portal and click on the report icon for the appropriate project and enter the online reporting system and choose the 'Extensions' tab; or
2. If your project was approved in STREAM, please download and complete the Ethics Report Form (Section 1).

Amendments or changes to your project

The Ethics Committee understands that research designs do change, particularly for long-term projects. Amendments to the research design that may affect participants and/or that may have ethical implications, must be reviewed and approved by the Human Research Ethics Committee before commencement.

Any changes to documents and other material used in recruiting potential research participants, including advertisements, letters of invitation, questionnaires, information sheets and consent forms, should also be approved by the HREC.

To request approval for a change, please review the following:

1. If your project was approved in REMS, please visit your REMS Portal and click on the report icon for the appropriate project and enter the online reporting system and choose the 'Amendments' tab; or
2. If your project was approved in STREAM, please download and complete the Ethics Report Form (Section 4).

Adverse or unforeseen events

Definition of an adverse event  (please see Managing your approved animal research ethics application for definitions pertaining to animal research)

Adverse events are any unforeseen or unexpected outcomes that may alter the continued ethical acceptability of a project and/or have a negative impact on participants, researchers, or the reputation of the University.

Examples include:

• higher than expected incidence of risk factors associated with the research project
• more serious reactions or impacts on participants than were expected by researchers/investigators
• any event that might change the ethical acceptability of the project

The following questions can be useful in determining an adverse event:

• Is there an increased risk of harm to participants, researchers/investigators, or the University?
• Was the event unexpected? and
• Was the event caused by, or related to the study?

Required action

Researchers/investigators are required by the conditions of their ethics approval to immediately report to the Human Research Ethics Committee or Animal Ethics Committee any event that might warrant review of the ethical approval of the research project.

If the adverse event is of a serious nature, the researcher/investigator should immediately consider the temporary suspension of research activities while the event is reviewed by the Ethics Committee.

At the first available opportunity, the researcher/investigator must complete and submit an Adverse Event Report.

All human research adverse events need to be reported in the REMS Portal. Click on the report icon for the appropriate project and enter the online reporting system. Select ‘Adverse Event’, enter details, including a description of the event and any actions already taken, and submit.

All animal research unexpected adverse events need to be reported to the Research Ethics Team using the Adverse Event Report Form.

This Report needs to be completed as soon as practicable after the event occurs and should also form part of your project’s annual and final reporting.

If a serious adverse event has occurred, your project activity may immediately be suspended while the event is investigated by the relevant Ethics Committee. Historically most adverse events have been less serious in nature and only required minor amendments to rectify.

Should you require further guidance please contact the Research Ethics Team.

Please note: you may also be required to log the event in Riskware. To Log the event in the Incident/Hazard Module of RiskWare please use the Easy Login link via the Student / Staff Portal or via the OSH website.

Risks posed by a delay in reporting

Delays in reporting an adverse incident or event may result further impacts, such as:

1. Breach of National Statement obligations;
2. Breach of The Australian Code for responsible Conduct of Research responsibilities;
3. Breach of ECU’s Duty of Care to research participants and stakeholders; and
4. Breach ECU’s Duty of Disclosure obligations to its Insurers, requiring notification of any incidents that may give rise to a claim as soon as reasonably practicable.

Where there are long delays in reporting of adverse incidents, ECU (or the research participant) may have reduced or limited capacity to make a claim against an insurance policy, or cover may not be available.  If cover is not available due to a delay in reporting, it may result in the research budget being called upon to cover any costs associated with the adverse event.