Application Considerations

Prior to commencing the research, screening assessments (including national criminal history checks) are required in these situations.

Details for Screening Assessments are here.

In addition, to conduct research in or with public schools in South Australia, you will also need approval from the state Department for Education.

Details for obtaining Department for Education Approval are here.

 

Details for undertaking research with or about Aboriginal Peoples are available here.

The National Statement on Ethical Conduct in Human Research defines a clinical trial as a form of human research designed to find out the effects of an intervention. Health-related interventions can include drugs, surgical procedures, devices, behavioural treatments, dietary interventions or process-of-care changes. If your project is a clinical trial, you are required to register it in a publicly accessible trials registry prior to enrolment of the first participant (for example, the Australian New Zealand Clinical Trials Registry) as a condition of ethics approval.

Clinical drug trials notification forms can be accessed via the Therapeutic Goods Administration website.

If you are using radiation (ionising or non-ionising) for research or technical purposes, you must refer to the University Radiation web pages.

Where participants in human research are exposed to ionising or non-ionising radiation, approval must be sought from the University Radiation Safety Committee as a condition of ethics approval.

If you are planning to work with human tissue or fluid samples, you will very likely require ethics approval. Please seek advice from a Research Ethics Advisor or the Ethics Office. Guidance for some situations of this kind is also available in Chapter 3.2 of the National Statement on Ethical Conduct in Human Research.

If you plan to take tissue or fluid samples from yourself, the following applies:

  • Blood and semen do require ethics approval
  • Saliva, urine, faeces, sweat, tears and exhaled breath do not require ethics approval

However, If any other person is involved in providing a sample, even a colleague or student, then ethics approval is required.

Please also investigate if biosafety approval is required for your project.

Researchers are required to obtain written permission from any organisation to access their employees or clients, data associated with these people or other organisational data for research purposes.

Ethics approval does not mean that permission to access staff, clients, students, data or other information is guaranteed. This permission is separate from the ethics approval process and is usually required from the Chief Executive Officer or another authorised person. The decision to grant researchers permission to access staff, clients, students, data or other information is entirely up to the authorised person in the organisation.

Please be advised that the onus of acquiring and maintaining the records of these requisite approvals and permissions solely lies on researchers. 

Relevant Commonwealth Acts

If your research project will use existing data, stored in a database or another source, this may or may not require ethics approval.

Please review the Exempt Criteria on the Research Ethics Risk Defintion page.  If your project fulfils one category of the criteria, your research is exempt from requiring ethics approval.

If your project does not fulfil either category of these criteria, then you will need to apply for ethics approval.

If you are collecting data online, e.g., from social media sites, you may or may not require ethics approval, depending on the specific details of your project – please seek advice from a Research Ethics Advisor or the Human Research Ethics Team in the UniSA Research Office.

Your project may be exempt from requiring ethics approval if: 

  • you are accessing publicly-available data; and
  • you will only publish or present these data in a non-identifiable way; and
  • your research does not pose any risks to those from whom the data are sourced.

You must also comply with the terms and conditions of any website or social media platform from which you are collecting data.

 

The UniSA HREC seeks to avoid the unnecessary duplication of ethical review. If your research protocol has already been approved by another NHMRC-registered Australian Human Research Ethics Committee, you may use this ethics approval as the basis for obtaining ethics approval from the UniSA HREC.  You are required to create a new application in the online ethics system. When completing your online ethics application, under the section “Non-UniSA HREC”, you should answer “yes” when asked whether another HREC has approved the protocol.  This will shorten the application.

NHMRC permits single ethics and scientific review of human research that is occurring at multiple institutions in Australia. The application for ratification purposes does not go through a full committee review because the primary HREC conducts the full committee level ethical review. The UniSA HREC Chair will review the application form and approval letter received from the non-UniSA HREC and ratify the decision of the primary HREC.

Please note that the approval from the other HREC must be current (i.e., not expired), and must cover the entire period of the project. If you need to extend the approval period you must do that with the original approving HREC.

You will also need to obtain confirmation of insurance cover from the UniSA Insurance Office.

If you plan to conduct research in a hospital or local health network, you will need to first seek ethics approval from the relevant local HREC, identified via this list.

You may use this ethics approval as the basis for obtaining ethics approval from the UniSA HREC. You are required to create a new application in the online ethics system. When completing your online ethics application, under the section “Non-UniSA HREC”, you should answer “yes” when asked whether another HREC has approved the protocol.  This will shorten the application.

You will need to attach copies of the following documents to your UniSA ethics application:

  • The full ethics application submitted to the external HREC
  • The approval letter from the external HREC
  • Other supporting documents as necessary - for example: recruitment materials (Participant Information Sheet(s), Consent Form(s), etc.) and research tools

The UniSA HREC Chair will review these documents, and if satisfied, will ratify the decision of the other committee.

Please note that the approval from the other HREC must be current (i.e., not expired), and must cover the entire period of the project. If you need to extend the approval period you must do that with the original approving HREC.

You will also need to obtain confirmation of insurance cover from the UniSA Insurance Office.

If you plan to conduct research with current defence personnel or veterans, you will need to first seek ethics approval from the Departments of Defence and Veterans’ Affairs Human Research Ethics Committee (DDVA HREC). DDVA HREC is the primary HREC for research conducted with defence personnel or veterans.

You may use this ethics approval as the basis for obtaining ethics ratification from the UniSA HREC. You are required to create a new application in the online ethics system. When completing your online ethics application, under the section “Non-UniSA HREC”, you should answer “yes” when asked whether another HREC has reviewed and approved the protocol. This will shorten the application form as an ethical review has already occurred from a non-UniSA HREC.

NHMRC permits single ethics and scientific review of human research that is occurring at multiple institutions in Australia. The application for ratification purposes does not go through a full committee review because the primary HREC conducts the full committee level ethical review. The UniSA HREC Chair will review the application form and approval letter received from the non-UniSA HREC and ratify the decision of the primary HREC - in this case, DDVA HREC.

Please note that the approval from the other HREC must be current (i.e., not expired), and must cover the entire period of the project. If you need to extend the approval period you must do that with the original approving HREC.

You will also need to obtain confirmation of insurance cover from the UniSA Insurance Office.

Research conducted in another country is defined as when you are travelling to that country, and not when you are simply collecting data from an online survey. Overseas research might have legal, social or cultural implications which would not be an issue if the research was carried out in Australia.

Researchers are responsible for ensuring that research conducted offshore is culturally appropriate and complies with the legal requirements of the other country, as well as complying with Australian ethical standards.

It is the responsibility of the researcher (and the research supervisor) to thoroughly investigate any legal, governmental, visa, ethical, cultural or research approval requirements when conducting research in another country. If applicable, final ethics approval may not be granted until written evidence of having met those requirements has been provided.

Overseas research might involve Indigenous people. As with research involving Australian Aboriginal and Torres Strait Islander people, you should ensure that your proposed research is culturally appropriate by consulting with representative bodies.

Approval of your research by UniSA HREC ensures that you will be appropriately covered by the University’s insurance policy for research that you conduct offshore. For research in the U.S. or Canada, please refer to the Insurance website for further information about insurance cover.

Please be advised that the onus of acquiring and maintaining the records of these requisite approvals and permissions solely lies on researchers. 

Will your research include collaboration or funding with researchers from outside UniSA or with industry?  It is the researcher's responsibility to ensure that, where required, an appropriate written agreement regarding ownership of data and intellectual property is in place.  Assistance from the the UniSA Research Office Contracts Establishment team (research.contracts@unisa.edu.au) is available.

You may also wish to consult the University's Intellectual Property Policy.

Legal advice is available via UniSA Legal

The Guidelines for evaluation activities involving UniSA students and staff (PDF) provides guidelines for evaluation activities involving students or staff at UniSA. For the purpose of these guidelines, 'evaluation activities' may include methods such as surveys or focus groups and are often related to teaching and learning or the student experience. They include corporate evaluation instruments used to evaluate courses, programs, teachers or University products or services.

Some evaluation and quality assurance activities require ethics approval and some do not. Those that do not must meet the criteria detailed here.

Details for recruiting UniSA staff and students, and accessing UniSA data, are available here.

If an Honours or Research Degree Student is involved, please review the information on the Research Degree Student Intellectual Property website.

You may also wish to consult the University's Intellectual Property Policy.

Legal advice is available via UniSA Legal

Your responses to selected ethics application questions will be assessed to determine whether your research activity is covered by the University's standard insurance cover or whether individual insurance assessment is required.

Where individual insurance assessment is required the ethics team will email you (following the submission of your application) to obtain any additional information not available from your ethics application.

Please refer to the Insurance Website for further information about insurance cover and for a full description of standard insurance conditions which cover all research projects.

The Trans Health Research Group (University of Melbourne) have developed guidelines to equip Australian researchers and Research Ethics Committees with information on how to accurately and meaningfully capture demographic data which includes trans people.

This includes:

  • Written guidelines
  • 3-minute guideline video
  • 30-minute webinar recording

To access these guidance documents and webinar, please visit the following website: https://www.transresearch.org.au/professionalresources

Please also refer to the ‘Information Library’ for further related articles and helpful information.