Human research ethics

• Introduction to human research ethics
• Application and approval process
  • What requires ethics approval?
  • How to complete a human ethics application
  • Additional approvals: organisational (including UniSA)
  • Feedback on your application
• Approved protocols: what you must report and/or do
• Amending an approved protocol
  • Types of changes that need approval
  • Approval process
• Insurance cover for your project

Special circumstances

• Use of human tissue
• Indigenous research
• Research outside Australia
• Research in the workplace

Relevant links

• Committees
• Forms and guidelines
• Useful links
• Abbreviations

Introduction to human research ethics

All research carried out by University of South Australia staff or students which involves human participants must be conducted in a manner consistent with University policy, codes and guidelines, and relevant national and state legislation and guidelines. Research involving human participants should also meet appropriate professional and cultural standards.

The University of South Australia is guided by the Australian Code for the Responsible Conduct of Research (PDF 508kb) and the National Statement on Ethical Conduct in Human Research 2007 (PDF file 777kb). The University's research policies are consistent with these guidelines and state and federal legislation.

Under national guidelines the University of South Australia Human Research Ethics Committee (UniSA HREC) or Divisional Ethics Committee (DEC) are obliged to gather certain information before ethics approval can be granted.

Research involving human participants must not proceed without ethics approval.

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Application and approval process

What requires ethics approval

Research and teaching involving contact with human participants requires ethics approval. This includes but is not limited to:

• clinical research
• action research projects
• research involving data collection by interviews, questionnaires, focus groups, observation
• use of human tissue

See Human projects that do not require ethics approval for more details about exclusions.

Informal, professional conversations with people about their area of professional or academic expertise do not normally require ethics approval. However, if such conversations are a means by which the researcher systematically collects research data, regardless of the informality of the situation or questions asked, ethics approval is required.

In addition to personal contact, ethics approval is also required for access to medical or other records which:

• are not publicly available
• identify individuals and
• contain intimate personal and/or health information.

How to complete a human ethics application

Step 1: Determine whether your research project requires ethics approval

Any research requiring contact with human participants (for example through interview, questionnaires, clinical trials) or using human tissue requires approval, as does research involving access to medical records or other records which are identifiable and contain intimate personal information and are not publicly available. See above and Human projects that do not require ethics approval

If you require approval:

• access the Ethics application form - RTF and Word
• use the Guidelines for preparing ethics protocols - RTF and Word - to help you complete the form
• use the Participant information sheet guidelines to help you draft the Participant Information Sheet
• use the Model Consent Form - RTF and Word - or the Model Consent Form for use when taped materials, photographs or original works are to be retained - RTF and Word - to help you draft the consent form(s).

Step 2: Complete the ethics coversheet (Section 1)

Complete the 'Ethics coversheet' section (see Section 1 of 'Guidelines for preparing ethics protocols') which records contact details and the title of your project. This section also includes your and (and your supervisor's, if you are a student) signature, indicating that the application is complete and the research will be conducted in an ethical way. For student projects the student should be listed as the researcher.

Step 3: Complete the ethics checklist (Section 2)

Complete the 'Ethics checklist' section (see Section 2 of of 'Guidelines for preparing ethics protocols'). If you require ethics approval from another organisation in addition to the University of South Australia, you may submit your application in that organisation's format. However, you should still complete the ethics coversheet (see Step 2) and the ethics checklist, and include them in your submission to UniSA HREC or the DEC. Also, ensure that all details requested by the UniSA HREC's 'Ethics protocol proforma' (see Step 4) are provided.

Step 4: Complete the ethics protocol proforma (Section 3)

Complete the 'Ethics protocol proforma' section (see Section 3 of 'Guidelines for preparing ethics protocols') which provides the relevant ethics committee with more detail about your project, and particularly your interaction with research participants. Students should complete this section in consultation with their supervisor.

Step 5: Submit the ethics application form

Submit your completed ethics application to the UniSA HREC or appropriate DEC. (Divisional Ethics Committees details what projects can be considered by a DEC and what must be submitted to UniSA HREC.)

Other considerations:

• If you are a staff member or PhD/Masters by Research/Professional Doctorate (excluding IGSB) student, you must submit your ethics application to UniSA HREC.
• If you are an undergraduate, honours, graduate certificate or graduate diploma, or masters by coursework student, and you have answered 'yes' to any question in Section 2 of the checklist, you must submit your application to UniSA HREC.
• If you are an undergraduate, honours, graduate certificate or graduate diploma, or masters by coursework student, and you have answered 'no' to all questions in Section 2, you must submit your application to the appropriate DEC. If DEC believes your research should be considered by UniSA HREC, they will forward your application to UniSA HREC and notify you of this.

UniSA HREC meeting and submission dates

If you are still unsure whether you need ethics approval or require assistance about how to apply for human ethics approval, please contact the Ethics and Compliance Officer, Vicki Allen: vicki.allen@unisa.edu.au or 8302 3118 or the Compliance Officer, Alice Granger: alice.granger@unsia.edu.au or 8302 3523.

Additional approvals: organisational (including UniSA)

Researchers are required to gain written approval from any organisation (including UniSA) to access the organisation's employees or clients (which includes students), data associated with these people or other organisational data. Ethics approval does not mean that approval/permission to access staff, clients, students, data or other information is guaranteed. 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.

Organisational approval: to access employees, clients, data and information

If you require assistance or agreement from another organisation to undertake your research, you will need to gain written organisational permission/approval to access staff members, clients or other information for research purposes. This approval is separate from the ethics approval process and is usually required from the Chief Executive Officer or another authorised person. Ethics approval does not mean that approval/permission to access staff, clients, students, data or other information is guaranteed. 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.

University of South Australia approval: to access staff, students or data

The University strives to preserve the privacy of its staff and students and maintain confidentiality of data and other information held by the University. The University aims to protect its staff and students from unsolicited emails and minimise staff and students being over-researched. The University therefore discourages the recruitment of its staff and students and the collection of data and other information for research purposes unless the nature of the research is beneficial to the University and/or staff and students. The University also discourages the use of email as the method of recruitment of its staff and students for research purposes¹.

Note that formal ethics approval for projects involving access to UniSA staff, students or data means only that there are no ethical objections to that project. It does not mean that the researcher has approval to access UniSA staff, students or data.

Approval to access University of South Australia staff, students or data for research purposes should be sought in the following ways.

• For access to staff or students in one school, approval should be sought from the Head of School.
• For access to staff or students in more than one school within the same Division, approval should be sought from the Pro Vice Chancellor and Vice President of that Division.
• For access to staff or students within different Divisions, staff within Units of the University, or if the University itself is the object of research, approval should be sought from the Deputy Vice Chancellor and Vice President: Research and Innovation.
• Approval to access information held in university databases should be sought from the Director: Student and Academic Services.

You must apply for ethics approval (through UniSA HREC or DEC) and approval to access research participants (through the appropriate University manager) simultaneously.

Insurance cover for your project

Approval of your ethics protocol by UniSA HREC or DEC normally means that you are covered by the University's insurance policies in relation to your research project.

However, you must complete the appropriate insurance form and submit it to the University's Insurance Officer if your research falls within one or more of the descriptions below:

• involves a 'professional service' for which UniSA staff or students have obtained qualifications
• poses a physical risk to researchers, students or participants (where injury appears possible or likely)
• involves treatment or testing on human/animal participants
• involves questionnaires/surveys/information gathering in relation to a psychological condition/trauma/illness or history of such, or collection of personal data
• is to be conducted in a hospital/clinic/consultancy/professional treatment area
• involves participation or sponsorship by a third party such as a hospital/clinic/consultancy/professional service provider/other researcher/University
• involves research in remote areas or outside of Australia
• involves Indigenous participants or Indigenous research.

The University's Insurance Officer will provide confirmation of insurance cover for your research project. To finalise ethics approval, you will then need to submit this confirmation to UniSA HREC or DEC.