Human research ethics
It is important that research involving human participants is conducted in a way that protects all people involved in the research; the researcher, the participants (subjects) of the teaching or research, and the University.
- Human research guidelines
- Approval to access research participants and/or data and/or other information
- Use of human tissue
- Indigenous research (opens in a new page)
- Research outside Australia (opens in a new page)
- Research in the workplace (opens in a new page)
- Committees
- Forms and guidelines
- Useful links
- Abbreviations
Human research guidelines
Why seek ethics approval
All research which is carried out by University of South Australia staff or students and which involves human participants must be conducted in a manner consistent with University policy and relevant guidelines including the National Statement on Ethical Conduct in Human Research 2007 (PDF file, 777kb). Research involving human participants should also meet appropriate professional and cultural standards.
The University of South Australia has accepted the Australian Code for the Responsible Conduct of Research. The University's research policies are consistent with these guidelines, state and federal legislation, and the National Statement.
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. Approval of your ethics protocol by UniSA HREC or DEC automatically means that you are covered by the University's insurance policies in relation to your research project.
What requires ethics approval
Any research involving contact with human subjects requires ethics approval. This includes but is not limited to:
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, access to medical records or access to other records which are not publicly available and which identify individuals, and which contain intimate personal information also require ethics approval.
Steps to follow
Step 1
Determine whether your research project requires ethics approval. Any
research requiring contact with human participants (for example through
interview, questionnaires, clinical trials) 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.
Step 2
Complete the ethics coversheet
(RTF file) which records contact details and the title
of your project. This section also includes your (and your
supervisor's) signatures indicating that the application is complete and the
research will be undertaken in an ethical way. For student projects
the student should be listed as the researcher.
Step 3
Complete the ethics checklist
(RTF file).
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 coversheet (Section 1) (RTF file) and the checklist (Section 2) (RTF file) and include them in your submission to UniSA HREC or the DEC.
Step 4
Complete the proforma which provides the ethics committee with more detail
about your project and particularly your interaction with research
participants.
Guidelines on completion of this section of the ethics application can be
downloaded with the Ethics protocol proforma
(RTF file). Candidates should complete this section in
consultation with their supervisor.
Step 5
Submit your protocol to the UniSA HREC or appropriate DEC. (The section
on Divisional Ethics Committees details what projects can be considered by a
DEC and what must be submitted to UniSA HREC.)
Feedback on your ethics application
Both you and your supervisor (if you are a candidate) will be notified in writing of the DEC or UniSA HREC's decision.
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. You do not need to submit the whole protocol document; just the amendments and items requested by the committee. Candidates should discuss the committee's concerns with their supervisor.
If your protocol is not approved you will need to resubmit your protocol to the DEC or UniSA HREC for reconsideration. Again, candidates should discuss the committee's concerns with their supervisor before preparing a revised protocol.
After you have received approval for your research
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.
- 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) to the original protocol.
- The Ethics Committee must be notified of any changes in membership of the research team.
- 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 seven years. If your data are not stored by your school, the school must be aware of the location.
- Information for participants should include the name of the Executive Officer of the Human Research Ethics Committee as a person who is able to discuss any ethical concerns about the research or the rights of participants.
- 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, Divisional Ethics Committee, using the Application for extension form (RTF file)
- A project completion report must be made to the UniSA HREC or DEC (whichever granted the original approval) within three months of the project's completion, using the Project completion form (RTF file)
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.
Approval to access research participants and/or data and/or other 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.
Approval to access University of South Australia 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 should apply for ethics approval (through UniSA Human Research Ethics Committee or Divisional Ethics Committee) and approval to access research participants (through the appropriate University manager) simultaneously.
| 1 | Relevant University policies and guidelines Confidentiality of students' personal information (A-46.1) Acceptable Use of Information Technology (IT) Facilities (C-22.1) Guidelines on Electronic Communications with Students Guidelines for staff on use IT facilities including email and the Internet Guidelines for students on use of IT facilities including email and the Internet |
| Relevant Commonwealth Acts Privacy Act 1988 The Commonwealth Spam Act (2003) |
Forms and guidelines
Guidelines for preparing ethics
protocols - RTF (pc) and
Word (Mac)
Ethics protocol proforma - 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)
Useful links
UniSA
Authorship Policy RES-12.0
Managing
your information and data (Research degrees)
External
Australian Health Ethics Committee
(AHEC)
Australian
Code for the Responsible Conduct of Research (NHMRC, ARC, Universities
Australia)
Challenging ethical issues in contemporary research on human beings
(AHEC, NHMRC)
Children's Protection Act 1993 (South Australia) (PDF file, 190kb)
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) (PDF file,
777kb)
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 (PDF file, 102kb)
Abbreviations
The following abbreviations are used in relation to human research ethics. See also Useful links
| AHEC | Australian Health Ethics Committee |
|---|---|
| ICER | Indigenous College of Education and Research |
| AVCC | Australian Vice-Chancellors Committee (now called Universities Australia) |
| DEC | Divisional Ethics Committee |
| UniSA HREC | UniSA Human Research Ethics Committee |
| NHMRC | National Health and Medical Research Council |