Ethics and ethical principles extend to all spheres of human activity. They apply to our dealings with each other, with animals and the environment.

Welcome to the Southern Cross University human ethics web pages. This resource is maintained by the Division of Research in conjunction with the Southern Cross University Human Research Ethics Committee. Inside you will find information and resources about human research ethics at SCU.

You will find forms and links to assist you with the planning and design of ethics applications on human research, the process of applying for ethical clearance, and the ethical conduct of research.

At SCU, the conduct of research involving the participation of humans must comply with the provisions of the National Statement on Ethical Conduct in Human Research [http://www.nhmrc.gov.au/publications/synopses/e72syn.htm].

The National Statement has been developed jointly by the National Health and Medical Research Council, Australian Research Council and the Australian Vice-Chancellors' Committee.The National Health and Medical Research Council Act 1992 (NHMRC Act) establishes the NHMRC as a statutory body and sets out its functions, powers and obligations. Section 10 (1) of the Act requires the Chief Executive Officer to issue human research guidelines precisely as developed by the Australian Health Ethics Committee (AHEC) and provided to the CEO by the Council. AHEC is established by the NHMRC Act as a Principal Committee of the NHMRC.

What is human research?

Human research is conducted with or about people, or their data or tissue. Broadly, it involves human beings in:

• 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(in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.

Researchers are required to be familiar with the National Statement when designing and conducting their human research and when submitting ethics applications to the HREC for review and approval.

SCU is committed to the ethical conduct of research and ensures that its' researchers maintain the highest ethical standards in the conduct of research and teaching. [http://www.nhmrc.gov.au/publications/synopses/e72syn.htm]

Section 1: Values and Principles of Ethical Conduct

• Section 1.1 - 1.3 - Research Merit and Integrity
• Section 1.4 - 1.5 - Justice
• Section 1.6 - 1.9 - Beneficence
• Section 1.10 - 1.13 - Respect

Application of these values and principles
Research, like everyday life, often generates ethical dilemmas in which it may be impossible to find agreement on what is right or wrong. In such circumstances, it is important that all those involved in research and its review bring a heightened ethical awareness to their thinking and decision-making. The National Statement is intended to contribute to the development of such awareness

These ethical guidelines are not simply a set of rules. Their application should not be mechanical. It always requires, from each individual, deliberation on the values and principles, exercise of judgement, and an appreciation of context.

Two themes must always be considered in human research: the risks and benefits of research, and participants' consent.

Section 2: Themes in Research Ethics: Risk and Benefit, Consent

• 2.1 - Risk and Benefit
• 2.2 - General requirements for consent
• 2.3 - Qualifying or waiving conditions for consent

Section 3: Research Methods or Fields. The National Statement now includes new guidelines specific to:

• 3.1 - Qualitative Methods of Research
• 3.2 - Databanks
  
• 3.3 - Interventions and Therapies including Clinical and Non-Clinical Trials, and Innovations
• 3.4 to 3.6 - Other areas such as Human Tissue Samples, Human Genetics and Human Stem Cells are also discussed.

Section 4 : Ethical Considerations specific to Participants

• 4.1 - Women who are pregnant and the human foetus
• 4.2 - Children and young people
• 4.3 - People in dependent or unequal relationships
• 4.4 - People highly dependent on medical care who may be unable to give consent
• 4.5 - People with a cognitive impairment, an intellectual disability, or a mental illness
• 4.6 - People who may be involved in illegal activities
• 4.7 - Aboriginal and Torres Strait Islander Peoples
• 4.8 - People in other countries.

Section 5: Processes of Research Governance and Ethical Review

• 5.1 - Institutional responsibilities
• 5.2 - Responsibilities of HRECs, other ethical review bodies, and researchers
• 5.3 - Minimising duplication of ethical review
• 5.4 - Conflicts of interest
• 5.5 - Monitoring approved research
• 5.6 - Handling complaints
• 5.7 - Accountability.

Updated: 22 June 2010