Human research ethics
New Online Human Research Ethics Application and Review System
Important information for staff and students wishing to undertake a research project involving humans from March 2010 – please read:
All staff and students who wish to undertake a research project involving humans (including direct collection of data, accessing data from databases and/or collection of human tissues/samples etc) must apply for ethics approval from the University of South Australia's Human Research Ethics Committee using the Online Human Research Ethics Application and Review System (the Ethics System) from March 2010. Auditorium and computer training sessions information
All human interaction, including human research, has ethical dimensions. Responsibility for the ethical design, review and conduct of human research is exercised at many levels. While the processes of ethical review are important, individual researchers and the institutions within which they work hold primary responsibility for ensuring that their research is ethically acceptable.
UniSA's approach to human research ethics is guided by the Australian Code for the Responsible Conduct of Research (PDF 508kb, download Adobe Acrobat) and the National Statement on Ethical Conduct in Human Research 2007. The following information will assist you in meeting UniSA requirements.
- Introduction to human research ethics
- Application and approval process
- Approved protocols: what you must report and/or do
- Amending an approved protocol
- Insurance cover for your project
Special circumstances
Relevant links
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. 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.
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.
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Relevant University policies and
guidelines |
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Relevant Commonwealth Acts |
Feedback on your application
Both you (and your supervisor, if you are a student) will be notified via email of the UniSA HREC or DEC's decision within 10 working days of the HREC meeting date
If your protocol is approved, you may begin your research project.
If your protocol is approved subject to certain conditions, you will need to make the changes required and submit these to the ethics committee before you begin your research.. Please revise the ethics application as required by the ethics committee and submit a cover letter outlining your response to each of the ethics committee's requirements. Students should discuss the committee's concerns with their supervisor.
If your protocol is not approved you will need to resubmit your protocol to the UniSA HREC or DEC for reconsideration. Again, students should discuss the committee's concerns with their supervisor before preparing a revised protocol.
Approved protocols: what you must report and/or do
Human research ethics approval is always made on the basis of a number of conditions. It is important that you are familiar with, and abide by, these conditions and notify the appropriate person of the following.
- Any serious or unexpected adverse effects on research participants must be reported immediately to the Ethics and Compliance Officer
- Any unforseen events which might affect the continued ethical acceptability of the research project must be reported immediately to the Ethics and Compliance Officer
- The Ethics Committee (either UniSA HREC or DEC as applicable) must be notified of, and approve, any changes (eg to research design or methodology, research tools, research participants' recruitment method and membership of the research team) to the original protocol before implementation. See Amending an approved protocol
- In Australia there is a legal obligation for raw data arising from human research to be stored securely. The University requires that research data be retained for a period of five years. If your data are not stored by your school, the school must be aware of the location.
- Approval is for a period of twelve months only. Researchers must submit annual requests for extension to the Executive Officer UniSA HREC or Executive Officer DEC, using the 'Application for extension to ethics approval' - RTF and Word
- A project completion report must be made to the Ethics Committee which granted the original approval within three months of the project's completion, using the 'Project completion form' - RTF and Word
- Clinical trials: The National Statement on Ethical Conduct in Human Research 2007 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 (eg Australian New Zealand Clinical Trials Registry) as a condition of ethics approval.
These conditions enable the University to monitor ethics approvals as required by the Australian Health Ethics Committee (AHEC) as well as helping to protect all those involved in the research.
Amending an approved protocol
Types of changes that need approval
Ethics approval must be obtained from UniSA HREC or DEC if you wish to change an approved protocol. These changes include:
- conducting additional or fewer interviews/focus groups/questionnaires than originally approved (eg if your approved protocol was to conduct 10 focus groups but it was decided that only 8 were needed then approval must be sought to alter the process)
- altering the wording of any recruitment material. This includes recruitment flyers, information sheets, consent forms, letters sent to participants/potential participants and media advertisements/campaigns
- including new survey tools/questions or removing or changing survey tools/questions
- changing the inclusion/exclusion criteria for participants and/or participant groups
- recruiting from a new organisation not previously approved/or deciding not to use a previously approved organisation
- introducing, removing and/or altering the honorarium given to participants
- changes to the research team (ie new researchers, researchers who are no longer involved in the project etc)
- changes to the funding and/or contractual agreements.
Formal notification of approval from UniSA HREC or DEC must be received prior to administering the protocol change(s).
Approval process
In order to gain approval for a change you wish to administer, you must provide UniSA HREC or DEC with:
- the protocol number and/or title of the project to be amended
- details of the amendment(s) you wish to make
- the reason why the amendment is needed
- any relevant documents (ie recruitment material) affected by the amendment.
These are to be submitted to either the Executive Officer of the relevant DEC, or one of the following for UniSA HREC:
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Vicki Allen |
Alice Granger |
Once submitted, either the Executive Officer of the relevant DEC or Vicki Allen and Alice Granger will liaise with the Chair or Deputy Chair of UniSA HREC who will consider your request to amend your protocol. Feedback from the DEC/UniSA HREC should occur within 10 working days from the date you submitted your amendment request.
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.
Forms and guidelines
Guidelines for preparing ethics protocols - RTF (pc) and
Word (Mac)
Ethics application form - RTF
(pc) and Word (Mac)
Clinical
Drug Trials Notification Form (Therapeutic Goods Administration) (PDF file, 136kb)
Participant Information Sheet guidelines
Model Consent Form - RTF (pc)
and Word (Mac)
Model Consent Form for use when
taped materials, photographs or original works are to be retained -
RTF (pc) and
Word (Mac)
Application for extension to ethics
approval - RTF (pc) and
Word (Mac)
Project completion form - RTF (pc)
and Word (Mac)
Use of human tissue samples in subsequent
research - RTF (pc) and
Word (Mac)
Guidelines for evaluation activities (and in particular, Appendix 2 -
Guidelines for external publishing and/or presentation of evaluation data)
(Word doc, 676kb)
Statement of authorship and Location of data - RTF (pc)
and Word (Mac).
See Frequently asked questions
Useful links
UniSA
Human Research Ethics RES-2.2
Authorship Policy RES-12.0.
See Frequently asked questions
Managing
your information and data (Research degrees)
External
Australian Health Ethics Committee
(AHEC)
Australian Health Ethics Committee (AHEC)
Position Statement
(PDF file, 139kb)
Australian
Code for the Responsible Conduct of Research (NHMRC, ARC, Universities
Australia)
Australian
New Zealand Clinical Trials Registry
Challenging ethical issues in contemporary research on human beings
(AHEC, NHMRC)
Children's Protection Act 1993 (South Australia) (PDF file, 190kb)
Essentially
yours: the protection of human genetic information in Australia
(Australian Law Reform Commission Report 2003)
Ethical guidelines on the use of assisted reproductive technology in
clinical practice and research (NHMRC, revised 2007) (PDF file,
2.8mb)
Keeping
research on track: a guide for Aboriginal and Torres Strait Islander peoples
about health research ethics (NHMRC 2005)
National Health and
Medical Research Council (NHMRC)
National
Statement on Ethical Conduct in Human Research 2007 (NHMRC)
NHMRC
Guidelines approved under Section 95A of the Privacy Act 1988
NHMRC
Guidelines under section 95 of the Privacy Act 1988
South Australian State Act
Freedom of Information 1991
Statement
on Consumer and Community Participation in Health and Medical Research
(the Statement on Participation) (NHMRC 2002, 2005)
The Ethics Centre of South
Australia
Therapeutic Goods Administration
Universities Australia
(formerly Australian Vice-Chancellors
Committee)
Values and
ethics: guidelines for ethical conduct in Aboriginal and Torres Strait
Islander health research (NHMRC) (PDF file, 310kb)
World Medical
Association Declaration of Helsinki
Abbreviations
The following abbreviations are used in relation to human research ethics.
| AHEC | Australian Health Ethics Committee |
|---|---|
| ICER | Indigenous College of Education and Research |
| AVCC | Australian Vice-Chancellors Committee (now called Universities Australia) |
| DEC | DDivisional Ethics Committee |
| UniSA HREC | UniSA Human Research Ethics Committee |
| NHMRC | National Health and Medical Research Council |