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Step 1: HREC review

How to apply

It is important to have a clear understanding of all aspects of the research project before applying for ethics review.

You will apply through REGIS, which is the NSW Health’s Research Ethics & Governance Information System. REGIS helps manage ethics and site governance approvals of human research projects in NSW and ACT public health organisations and local health districts. It replaces AU-RED and Online Forms. Please note that the Network has no control REGIS. For technical assistance with REGIS, please call 1300 073 447 or email support@f1solutions.com.au. The help desk is open Monday to Friday from 7 am to 7 pm (excluding public holidays).

We recommend you prepare your submission thoroughly before uploading it. We have prepared this ethics submission checklist to help. Please note that all documents you prepare, apart from standard tools, need page numbers, version numbers and version dates in the footer.

It is important that details of the application are consistent throughout the application. Any significant discrepancies will need to be corrected, and may delay approval.

Applications can be submitted at any time, but please note that deadlines are well in advance of the meeting date. These are available here. Please don’t wait until the last minute – rushed applications often contain errors.

You can seek AH&MRC approval (step 2) at the same time, using that organisation’s processes and forms. See https://www.ahmrc.org.au/ethics/

Approval process

Applications are reviewed at meetings held every 2 months – the dates are available here.

Some new applications are approved at the first meeting, but most require more information and are approved at a second meeting. Some take longer and need a number of review/response cycles.

We will notify you of the HREC’s decision within 2 weeks of the meeting. There are four possible outcomes:

  • ethical and scientific approval
  • ethical and scientific approval pending AH&MRC Ethics Committee approval
  • request for more information, to be reviewed by the Chair out of session
  • request for more information, to be reviewed by the HREC.

If we ask you for more information, we will do so in writing, and will ask you to respond in writing. We will be happy to discuss by phone or email as well.

If the request for more information is minor, and fully met, approval can be granted out of session.

If the request for more information is significant, approval can be granted only by the HREC.

In planning your research, you should allow 4-6 months from the time you start to prepare a submission, to gaining approval. Carefully prepared submissions, with a thoughtful consideration of the ethical considerations required, are more likely to be approved quickly.

If you disagree with the decision of the ethics committee 

If you disagree with either the decision of the HREC, or with the comments provided, please discuss this with the Research Governance & Ethics Officer. If this does not resolve the issue to your satisfaction, please escalate this to the HREC Chair.

We ask that you don’t speak directly with individual committee members, who are bound by confidentiality agreements and can only discuss an application outside of the meeting with the express permission of the committee.

 

Step 2: AH&MRC Ethics Committee review

Research involving Aboriginal people and communities will require review and approval by the Ethics Committee of the Aboriginal Health & Medical Research Council (AH&MRC), which is a properly constituted ethics committee registered with the National Health and Medical Research Council. Note that the Justice Health HREC considers that all research involving people in custody in NSW will involve at least some Aboriginal people.

The AH&MRC Ethics Committee seeks to ensure that research is conducted in an ethical and culturally appropriate manner. This means that there is community consultation at all levels, and that the project has been designed with the relevant Aboriginal community.

Please follow the link to the AH&MRC. That organisation uses its own forms and processes.

AH&MRC Ethics Committee approval can be sought concurrently with Justice Health HREC approval (Step 1).

 

Step 3: Assess whether other approvals or necessary

You will need to assess whether your research needs other approvals. In addition to Network's processes, research studies may also require review by other groups including:

Researchers are encouraged to seek advice from the relevant organisations regarding review and approval processes that apply to each study.

Applications may be reviewed concurrently via different processes. However, all required approvals must be obtained prior to site-specific authorisation, enabling the commencement of research at any Network sites.

 

Step 4: Site authorisation

All human research that takes place in NSW public health organisations, or that requires support from a NSW public health organisation in the form of access to participants, tissue or data, must be reviewed and authorised by that organisation’s Chief Executive.

You can’t start your research until this authorisation is granted, and site authorisation can’t be granted until you have obtained Justice Health HREC approval (step 1) and AH&MRC Ethics Committee approval (step 2).

There are 2 types of site authorisation:

  • a site-specific assessment (SSA) if the research involves using a NSW public health organisation in any way to:
    • direct contact with any potential participants into research, which includes screening for eligibility and gaining informed consent
    • carry out protocol-specific research procedures with or on participants
    • manage and analyse data, tissue, and responses from surveys and questionnaires collected at the public health organisation.
  • an access request review (ARR) if the research involves using a NSW public health organisation in any way to:
    • recruit participants through posters, leaflets, handouts, and letter of invitation
    • distribution of surveys and questionnaires through staff of the public health organisation
    • access to data or tissue held at the public health organisation.

In general, an ARR is sufficient if you have no plans to attend a site or speak to anybody on site. But please confirm this with the site/s in question.

How to apply

To seek SSA approval, go to REGIS and see the Quick reference guides. Note that you need support from the relevant Network Executive Officer.

To seek ARR approval, complete a NSW Health access request form and send it to the Research Governance & Ethics Officer at JHFMHN-Ethics@health.nsw.gov.au

Please use our site authorisation submission checklist to review what is required.

SSA and ARR applications can be completed and submitted while generating an ethics application in REGIS but cannot be authorised until ethics approval has been obtained.

Approval process

For research through Justice Health NSW or Corrective Services, the Research Governance & Ethics Officer will recommend approval or not to the Chief Executive, who makes the final decision. That decision will be made independent of HREC approval.

The Research Governance & Ethics Officer will notify you of the Chief Executive’s decision in writing.

 

After ethics approval

Changes to the research

If you change aspects of the research protocol after ethics approval, you need to inform the HREC and seek approval to continue the study.

Relevant changes include:

  • changes to the research team, whether that is adding or discontinuing a researcher
  • changes to the research protocol
  • changes to the recruitment procedure
  • changes to the sites nominated
  • changes to a data collection tool
  • changes to the use of the data.

The committee follows the guidelines set out by the National Statement to ensure that all approvals meet these ongoing ethical standards in which it sets. As research is a dynamic space and ever changing, it is incumbent on the committee to not rely on previous decisions, but require all approvals met the current standards. In light of this, and in accordance with item 5.1.3, 5.1.13 and 5.1.15 the committee reserves the right to

  • Request amendments or extensions require additional approvals, particularly that of the Aboriginal Health & Medical Research Council, if relevant to the project and/or request, despite not being required in the project’s original approval
  • Amendments or extensions may require further scrutiny than the original approval, in order to satisfy the committee’s ongoing scientific and ethical support
  • The committee will scientifically and ethically approve a project for a maximum of five years. After this time, a new application will be required, without the opportunity of extension. This is to ensure the project meets any changes to the National Statement, while creating greater ethical practice. This is a necessity to maintain the best interests of the participants by allowing the highest possible standard of research. Annual Statements will remain a requirement of approval. This will be in effect as of 31 December 2022.

You will need to generate an amendment form via REGIS, and you may need to upload supporting documents.

Please contact the Research Governance & Ethics Officer on +612 9700 3443 or at JHFMHN-Ethics@health.nsw.gov.au

Submitting annual progress reports and final reports

If you receive ethics approval, you must submit a progress report to the HREC each year, and a final report on completion.

If the study is a clinical trial, you must submit an annual safety report.

Please note that ethics approval can be withdrawn if these conditions are not met.

 

Aboriginal stakeholder support

Justice Health NSW’s research involving Aboriginal participants needs the involvement of Aboriginal people. It is important this engagement begins as early as possible, through the connection and support of an Aboriginal Reference Group. 

Justice Health NSW’s Aboriginal Strategy and Culture Unit (ASCU) supports Justice Health NSW-led research and aims to improve stakeholder engagement with the Aboriginal community controlled sector.

Gaining Aboriginal support for the proposed research is mandatory for Justice Health NSW-led research and not available to externally-led research. This applies to all research involving people in custody, and all workforce research with a focus on Aboriginal staff.