Why is it important?
"All human interaction, including the interaction involved in human research, has ethical dimensions. However, "ethical conduct" is more than simply doing the right thing. It involves acting in the right spirit, out of an abiding respect and concern for one's fellow creatures. This National Statement on "ethical conduct in human research" is therefore oriented to something more fundamental than ethical "do's" and "don'ts" namely, an ethos that should permeate the way those engaged in human research approach all that they do in their research." National Statement on Ethical Conduct in Human Research, NHMRC, 2007.
The protection of the rights and interests of subjects of research has been recognised internationally in
- The Nuremberg Code (1949), (developed following the revelation of unethical research practices during the Second World War)
- World Medical Assembly's Declaration of Helsinki (first printed 1965; last revised 2008).
In Australia a Statement on Human Experimentation, based on the Declaration of Helsinki, was produced initially by the National Health and Medical Research Council (NHMRC) in 1966, and has since undergone several revisions.
Refer to the National Statement on Ethical Conduct in Human Research (2013) for the conduct of ethical reserach in Australia.
Both of the Human Research Ethics Committees of the HREC (Tasmania) Network are constituted in accordance with the guidelines set out in the National Statement and the Australian Code for the Responsible Conduct of Research which establish basic principles and values for ethically good human research:
- Respect for Persons - Researchers must treat individuals as autonomous agents and protect persons with diminished autonomy.
- Research Merit and Integrity - Has the potential to make a contribution to knowledge and understanding, to improve social welfare and individual well being. Research must be designed appropriately and conducted by persons with suitable experience qualifications and competence.
- Beneficence - Maximise possible benefits and minimise possible harm (physical, psychological, emotional, economic or social).
- Justice - Distributive and procedural. Distributive justice: who bears the burden and who receives the benefits of the research? Procedural Justice: "Fair treatment" in the recruitment of participants and the review of research. The use of public funds may also raise questions of justice.
When is approval needed?
The National Statement on Ethical Conduct in Human Research (2007) defines human research as follows:
"Human research is conducted with or about people, or their data or tissue. Human participation in research is therefore to be understood broadly, to include the involvement of human beings through:
- taking part in surveys, interviews or focus groups;
- undergoing psychological, physiological or medical testing or treatment;
- being observed by researchers;
- researchers having access to their personal documents or other materials;
- the collection and use of their body organs, tissues or fluids (eg skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath;
- access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database."
It is important to note that this includes research that the participants themselves are not aware of.
The Australian Government Higher Education Research Data Collection Specifications (2012, DIISRTE) provides broadly accepted definitions of what does and what does not constitute research. Please refer to Section 1.3.10 (Page 7).
Almost all human research requires ethical review, although some research (for example, negligible risk research on existing collections of non-identifiable data) may be exempt. An understanding of the levels of risk defined by the National Statement will help you to assess if your proposal requires ethical approval.
All staff, students, visiting fellows and scholars, and persons holding discretionary titles of the University of Tasmania, who are involved in the conduct of research associated with the University are required to comply with the University of Tasmania Research Ethics Policy.
The Policy establishes a framework for research ethics to ensure that all University research activities are conducted ethically and conform to relevant legislation, guidelines and codes relating to ethical practices in research, including but not limited to:
- the National Statement on Ethical Conduct in Human Research (2007);
- the Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (2003);
- the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes (7th Edition, 2004);
- the Tasmanian Animal Welfare Act (1993);
- the Australian Code for the Responsible Conduct of Research (2007).
About the HREC (Tasmania) Network
The HREC (Tas) Network (the Network) is constituted by joint agreement between the University of Tasmania (UTAS) and the Department of Health and Human Services (DHHS).
The Network consists of two human research ethics committees (HRECs), and operates according to the following principles:
- The HRECs which make up the Network are decision-making bodies. Their decisions on the ethical aspects of projects are not subject to institutional ratification by either institution.
- The HREC system is available to anyone undertaking research under the auspices of UTAS or DHHS, and is available on a fee-paying basis to any person or group conducting human research in Tasmania.
- The Network aims to avoid duplication in the ethical review process and to provide a well-coordinated, systematic and consistent approach to the ethical assessment of human research.
Next: Assess the level of risk