Tips before applying

Readability of the patient information statement and consent form

The Justice Health HREC wants to ensure that people who are participating in research fully understand what is involved. We are aware that it is difficult for authors to judge the level at which they are writing, particularly if they are used to writing for professional audiences. We are also aware of the research showing that much of the information produced for the public is hard to read for the intended audience.

When developing a participant information sheet, try to think clearly about who your audience is and their literacy levels. There is ample research available which will help guide your decision on this.

The Australian Government recommends that all information for the public be suitable for someone with an age 9 reading level, which is the age of someone in year 3 or year 4 at school. This will ensure that information is accessible to all people.

There are a number of ways to assess the readability of a piece of text. None are perfect and none guarantee that the final product is well written, but each can give a guide as to the level of difficulty of the text.

Below are some commonly used reading tests, and the scores a piece of text would need to achieve to be equivalent to an age 9 reading level.

Test

Desired score for someone with reading age 9

Flesch reading ease

100 or more

Flesch-Kincaid grade level

4 or below

Gunning FOG

4 or below

SMOG

4 or below

 

While these tests are not definitive, be aware that HREC will be using them as a guide. We request that you check the reading age of all information that will be provided to participants and work to ensure that it falls within Australian Government guidance.

If you would like some guidance on writing to an appropriate reading age, we recommend:

You can use our template for the participant information sheet and consent form. The HREC recommends that all Network-led research uses this template.

And here is an example of a participant information sheet that the HREC considers to be in appropriate language.

Consideration of Aboriginal and Torres Strait Islander participants in research

All research involving people in custody or in detention in NSW is considered to significantly involve Aboriginal and Torres Strait Islander people. As such, researchers must take into account the principles and practices described in Ethical conduct in research with Aboriginal and Torres Strait Islander peoples and communities: Guidelines for researchers and stakeholders.

These guidelines:

‘apply to all research with Aboriginal and Torres Strait Islander people and communities. The Guidelines should inform all steps in the research process including conception (the initial idea), design (planning the research), conduct (ways of doing the research), reporting (what happened), and dissemination of findings (circulation to relevant bodies). The Guidelines apply to all researchers, whether they are Aboriginal or Torres Strait Islander people, other Australians or international researchers’ (p. 13).

Researchers applying to the Justice Health HREC are advised to also consider Guidelines for ethical research in Australian Indigenous studies 2012, produced by the Australian Institute of Aboriginal and Torres Strait Islander Studies.

It is considered good practice to ensure ongoing oversight by an Aboriginal Advisory Group, which can be involved in the conception, design, conduct, reporting and dissemination of findings. It is best practice to develop this advisory group at the conception of the research, and it is best practice for members to be paid for their contribution from the research budget.

Researchers will also need approval, obtained separately to this process, from the NSW Aboriginal Health & Medical Research Ethics Committee.

Support inexperienced researchers

At times, the HREC receives submissions by inexperienced researchers who have not had the support required from more experienced researchers. This can delay approval due to the need for repeated requests for more information. We recommend that all ethics applications be reviewed by the lead researcher before submission.

Step 1: Research proposal review and Aboriginal stakeholder support (mandatory for Network-led research, optional for others)

1a. Research proposal review

Research proposals are reviewed by the Network’s research leads and executive team. This is mandatory for Network-led research, and optional for externally-led research. The review aims to:

  • ensure that your study is feasible at the Network
  • ensure that you have discussed your proposed research with relevant Network staff and have obtained their support
  • determine resource commitments for the Network.

We encourage you to ensure that your study is aligned with the Network’s Strategic plan 2018 – 2022.

Please complete the Research proposal form and submit it to JHFMHN-Ethics@health.nsw.gov.au

We will notify you of the outcome by within 3 weeks, with either:

  • a request for further information; or
  • approval and confirmation to progress to the next stage in the ethics and scientific review process.

Should the proposal review request further information, you will be asked to respond to the queries by email. If the research proposal is approved, you must then submit an application to the Justice Health (HREC) (step 2), and for site-specific assessment or access request review (step 5). All steps must be completed in order for you to start your research.

The research proposal submission process may occur concurrently with Aboriginal stakeholder endorsement of research mentioned below in part 1b.

1b. Aboriginal stakeholder support

The Network’s research involving Aboriginal participants needs the involvement and support of Aboriginal people.

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

Gaining Aboriginal support for the proposed research is mandatory for Network-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.

  • When you have completed the research proposal form, please consult the ASCU team for advice on the Aboriginal stakeholder endorsement process at JHFMHN-AboriginalSCU@health.nsw.gov.au or on +612 9700 3003.

Aboriginal stakeholder endorsement of research can be sought concurrently with research proposal review (part 1b).

Step 2: 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 3) 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 3: 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 2).

Step 4: 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 5: 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 2) and AH&MRC Ethics Committee approval (step 3).

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. See the Quick reference guides and use our SSA submission checklist. 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

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 the Network 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.

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.