Applying for ethical (HREC) review

Data requests not requiring ethical approval

Access to some data is available without following the formal ethics process. You should first check to see if the data you require are already publicly available by reviewing Our data collections.

Our Data on Request Service may assist where data is not publicly available. If you are unsure, contact experts (data custodians) through the email address provided for in Our data collections  to determine if what you need, is available through them. They will also be able to advise if your data request requires data custodian and ethical approval. Only data requests requiring ethical approval are considered by the AIHW Ethics Committee.

Applications involving data linkage

Data linkage, is when data from more than one source, but relating to the same individual or institution, is brought together.

For ethics approval in relation to linkage requests, please read the information and resources on our Data Linkage page. Requests for data linkage involve two compulsory steps: 1. technical assessment and 2. ethics approval.

Please begin both the technical assessment and ethics approval process early Leave plenty of time for these processes. Although the Ethics Secretariat and the Data Integration Services Centre (DISC) will make every effort to progress your project as quickly as possible, we cannot guarantee that all projects will be assessed in time for submission to the following AIHW Ethics Committee meeting.

The AIHW Ethics Committee will only consider data linkage project applications that include a technical assessment that has been completed and approved by the DISC Unit using the prescribed Request for linkage of national data: Technical assessment form.

The Ethics Online System (EthOS) application form is to be used for projects requiring approval by the AIHW Ethics Committee.

EthOS allows researchers to:

• lodge applications for projects to be considered by the AIHW Ethics Committee
• lodge monitoring reports
• lodge requests for amendment
• track the progress of their application online.

Access to EthOS

• Existing account holders are required to sign in. 

• First time users will need to request an EthOS account from the Ethics Secretariat. Access to EthOS is not granted automatically. Once your request has been reviewed and approved by the Ethics Secretariat, you will receive system generated email advising that your account has been created and providing a link for you to set a password.

• If you have any difficulties, please contact the Ethics Secretariat by email [email protected] or phone +61 2 6249 5004.

When you are ready to submit your application, you should change the status of your project in EthOS from ‘draft’ to ‘quote requested’. The Ethics Secretariat will receive a notification when this occurs.

Your application will be assessed and a quote provided. The status of your project will change to ‘quoted’ and you will be notified of the fee payable. When you accept the fee and make payment, you may then lodge your application for consideration by the Committee.

You will not be able to lodge an application or amendment until this process is completed. Applications must still go through the lodgement process in EthOS even if no fee is payable under the Fee Schedule.

Any quote that has not been accepted will expire after six months, at which time your application or amendment will revert to ‘draft’ status.

Please read the following documents before lodging your application:

• AIHW Ethics Committee: Guidance for applicants regarding community expectations (115kB Doc)
• Peer review guidance for applicants document (55kB Doc)

Other information

• National Statement on Ethical Conduct in Human Research 2007 (Updated 2018), NHMRC
• Australian Code for the Responsible Conduct of Research 2018, NHMRC
• Privacy Act 1988 (Cth)
• Australian Privacy Principles Quick Reference Guide
• Guidelines under Section 95 of the Privacy Act 1988, NHMRC

Applications involving Aboriginal and Torres Strait Islander people

• Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities (2018), NHMRC
• Keeping research on track II (2018), NHMRC
• See also Chapter 4.7 National Statement on Ethical Conduct in Human Research 2007 (Updated 2018), NHMRC

All applications to the Ethics Committee are required to be submitted online through EthOS. However, where a researcher has submitted (and had approved) a Human Research Ethics Applications (HREA) application to another Human Research Ethics Committee (HREC), then it can be submitted in EthOS to support an application to the Committee.

Check that your application complies with all relevant documentation listed below.

As set out in the EthOS application form, you will be required to attach:

• Human Research Ethics Committee (HREC) approvals, i.e. approvals from home institution HREC. Clearance from the researcher’s home institutional ethics committee is required before the Committee will assess the application and must be maintained for the duration of the project. If the researcher’s institution does not have an ethics committee, then please discuss this issue with the Ethics Secretariat prior to submitting the application.
• independent Peer review report (50kB Doc) that assess the value and rigour of the scientific methodology of your research project. To NHMRC standards of research integrity, the Committee requires that all projects must be scientifically reviewed by peers independent of the research team and its supervisors prior to submitting an application. For further information please read Peer review guidance for applicants document (55kB Doc).
• other supporting documentation as appropriate to your application e.g. consent forms or research protocols.
• the Technical Assessment form that has been approved by the DISC, for data linkage projects.
• a HREA application if you have already submitted one.
• signed copies of the Undertaking of Confidentiality (s.29) for new applications (45kB Doc). Ensure the head of your institution (or a person senior to the Principal Investigator who has the authority to commit the organisation to complying with the assurances, such as the supervisor of the Principal Investigator), the Principal Investigator and all relevant staff members who may have access to the requested data have signed this.

Notification of Committee decisions occurs via email to the Principal Investigator.

Once the AIHW Ethics Committee approves a research project or data collection, any subsequent amendments (or changes) must be approved by the Committee before they are implemented. Failing to do so is a breach of the condition of approval and may result in, for example, possible withdrawal of access to AIHW supplied data.

To amend a project:

• Complete the Amendment request form (35kB Doc).
• Ensure any new staff have signed the Undertaking of Confidentiality (s.29) for approved projects (45kB Doc) and upload it via the ‘Create Amendment’ function in the project record in EthOS.

The Committee considers requests for amendments at each meeting. Amendments must be submitted to the requisite standard and by the due date in order to be considered at the next meeting.

Principal Investigators are required to submit monitoring reports on an annual basis until the project is completed. The AIHW Ethics Committee is required to monitor approved projects through to completion. Projects are considered complete when results have been disseminated and all AIHW-supplied data have been returned or destroyed at which time the Principal Investigator should submit a final report. The Principal Investigator is responsible for the security and, if required, the disposal of the data received from the Institute.

Annual monitoring reports

EthOS will automatically email requests for annual monitoring reports to Principal Investigator 6 weeks prior to each anniversary of project approval. When prompted, please complete the Annual monitoring form (35kB Doc) and submit it through EthOS.

Final reports

If a project has been completed, research results have been published and any AIHW-supplied data have been returned or destroyed consistent with the terms of approval, then complete a Final monitoring report form (35kB Doc) and submit it through EthOS.

It will be necessary to demonstrate compliance with any conditions advised in the Committee's letter of approval and/or approved amendments regarding publication of results and any data destruction or return requirements.

For further information and guidance with lodging an application, amendment request or monitoring report, please contact the Ethics Secretariat.

Email [email protected]

Phone +61 2 6249 5004

• Technical Assessment form (see Data Linkage webpage)
• Peer review report (50kB Doc)
• Undertaking of Confidentiality (s.29) for new applications (45kB Doc)
• Undertaking of Confidentiality (s.29) for approved projects (45kB Doc)
• Amendment request form (35kB Doc)
• Annual monitoring form (35kB Doc)
• Final monitoring report form (35kB Doc)