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, 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 three steps: the feasibility questionnaire, the technical assessment, and applying for AIHW ethical approval.

Please begin both the Technical Assessment  and ethics approval process early. Leave plenty of time for these processes. The Ethics Secretariat and the DISC will make every effort to progress your project as quickly as possible, but we cannot guarantee that all applications submitted will be progressed to the next Committee meeting.

All applications submitted to the Ethics Secretariat will be subject to a quality assurance review and only applications that meet the requirements of this review will be allocated to a 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) or other ethics 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 or other HREC under the NMA scheme. HREC approval is required and the approval letter (and any amendment approval letters that may be relevant such as extension request approval or addition of personnel approval) must be provided before the Committee will assess the application. Institutional HREC approval must be maintained for the duration of the project specified in the EthOS form. 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) To meet NHMRC standards of research merit and 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 or other application form to your institutional HREC and others as relevant
• 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), 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 conditions 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) and upload it via the ‘Create Amendment’ function in the project record in EthOS
• ensure any new staff have signed the Undertaking of Confidentiality (s.29) for approved projects (45kB Doc) and include it as an attachment to your amendment
• For data linkage projects, all amendments require an updated Technical Assessment. All technical assessment forms must be provided in Microsoft Word format. All updates must be marked with track changes against the most recent technical assessment submitted to the AIHW Ethics Committee. If your project does not have a technical assessment, please contact DISC to discuss the requirements for your proposed amendments.

The Committee considers requests for amendments at each meeting. Amendments must be submitted to the requisite standard in order to be presented for consideration.

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 to the Ethics Committee, please contact the Ethics Secretariat.

Email [email protected]

Phone +61 2 6249 5004

For further information and guidance with lodging a Feasibility Questionnaire or Technical Assessment, please contact the AIHW Data Integration Services Centre team.

• 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)