Frequently asked questions on ethical research

Does my research project need ethical approval?

Human research that involves the following methodologies generally requires ethics approval by a properly constituted Human Research Ethics Committee (HREC):

• conducting surveys, interviews or focus groups
• performing psychological, physiological or medical testing or treatment
• observational studies
• accessing personal documents or other materials of research participants
• collection and use of body organs, tissues or fluids (for example skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or exhaled breath
• accessing personal information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.

If you are unsure of whether your project requires ethical review please contact the relevant Executive Officer associated with the Human Research Ethics Committee at the institution where you plan to undertake your research.

Do I need approvals to carry out my research in the SA public health system?

Yes. There are two main types of approval you will need to obtain:

1. Ethical approval
2. Research governance approval

What if my research is not carried out in the SA public health system?

If your research is not being undertaken within the public health system, you are not required to receive approval from a public health sector Human Research Ethics Committee (HREC).

You will need to refer your proposal to the relevant HREC at the site at which your research will be carried out. Please refer to the National Health and Medical Research Council (NHMRC) website for a full list of HRECs within South Australia (PDF 370KB).

How do I receive approval from a SA public health system HREC?

In order to obtain ethical approval you will need to apply to the relevant Human Research Ethics Committee (HREC) associated with the institution where the research is to be conducted. Researchers are encouraged to visit the HREC website for further information including submission requirements and meeting dates.

A list of the public health system HRECs and their website is available on the SA Health HRECs page.

For further information please contact the HREC you intend to seek ethical approval through.

How do I receive governance approval?

In order to obtain governance approval you need to submit a site specific assessment (SSA) form for each site/institution where the research will be undertaken. The SSA form can be completed online using Research GEMS.

The SSA form will be assessed by a Research Governance Officer (RGO) associated with the site/institution. Their assessment will be provided to an institutional authority (e.g. Chief Executive Officer or delegate) who will then authorise the project to commence. This process must be completed for all research projects taking place across the South Australian public health system.

What does it mean if I do not receive ethics approval?

If your project is not approved, it is recommended that you discuss the decision further with the Executive Officer of the Human Research Ethics Committee (HREC). This may assist you in responding to any issues raised by the HREC or in understanding their decision. A project cannot commence at a SA Health institution until ethics approval and research governance approval have been obtained.

Which HREC will approve my research project?

The research ethics applicant (Coordinating Principal Investigator) will select a lead Human Research Ethics Committee (HREC) to undertake a single ethical and scientific review from one of the SA public health system HRECs. Generally, this Committee will be the one located at the institution of the Coordinating Principal Investigator.

What if I only need to access to the database or registry at the site, do I still need approval?

As a general rule, ethics applications predominantly involving access to a database or data registry held by a site or institution should be submitted to the Human Research Ethics Committee (HREC) attached to the site or institution. If there are multiple sites involved, you only need to apply to one HREC.

Is the process different for research conducted on Aboriginal or Torres Strait Islanders?

Yes.  If your research involves any of the following, you are advised to discuss the proposal with the Aboriginal Health Research Ethics Committee (AHREC) in South Australia. 

• the experience of Aboriginal and Torres Strait Islander people is an explicit focus of all or part of the research
• data collection is explicitly directed at Aboriginal and Torres Strait Islander people
• where it is proposed to separately identify Aboriginal and Torres Strait Islander people in the results
• the information has an impact on one or more Aboriginal and Torres Strait Islander communities
• the geographic location of the research is such that a significant number of the population are likely to be of Aboriginal and Torres Strait Islander origin (based on 4.7.6 of the National Statement 2023)
• where terms such as ‘resilience’, ‘well-being’, ‘cultural safely’, ‘cultural health’ and ‘language and culture’ are used in the description and design of the project indicating that the project has important health implications
• Aboriginal and Torres Strait Islander health funds are a source of funding.

How will I be impacted by the SA Health Single Review Model?

Ethics applicants undertaking multi-site research across the SA public health system can apply for ethical and scientific approval from one SA Health Human Research Ethics Committee. This approval will be accepted by all other SA Health sites/institutions.

Does the single ethical review model apply for research being done outside the SA public health system?

No. If your research is being conducted outside the SA public health system, you should discuss your research with the institution where the research will be conducted. It is entirely up to that institution whether they wish to accept the ethical review undertaken by the SA public health system Human Research Ethics Committee (HREC), or require their own institutional HREC to conduct an additional ethical review.

What is a SSA?

A SSA is a site specific assessment, and is a separate process to the ethics submission and review process. The SSA is effectively a research governance assessment, and will consider whether there are adequate processes, resources and approvals in place to conduct the research at the respective site or institution.

Do I still need to complete a SSA form for each site even though I am using the single ethical review?

Yes. You are still required to submit a Site Specific Assessment (SSA) form to each institution or site across the South Australian public health system where your research will be undertaken for a research governance review.

Can I make an amendment or modify my research project?

Yes. To modify a project already approved by a SA Health Human Research Ethics Committee (HREC), please refer to the website of the HREC that approved the protocol for advice, or alternatively speak directly with the Executive Officer or ethics office associated with the HREC.

Where can I get further information or advice?

For information specific to your project, please contact the Human Research Ethics Committee that will be reviewing your application.

For general enquiries relating to the material contained on these pages, please refer to the relevant research office.