When human ethics approval is required:
Human research has a broad definition and includes research conducted with or about people, or their data or tissue.
Research ethics is the application of fundamental ethos and principles that promote responsible conduct of research and determine the way in which researchers engage in human research.
Human research ethics clearance is required if research includes the involvement of human beings. For full details see page 8 of the National Statement on Ethical Conduct in Human Research.
The types of research include, but are not restricted to:
- Gathering information about human beings (and organisations) through interviewing, surveying, questionnaires, focus groups, observation of human behaviour, audio/video taping, undergoing psychological, physiological or medical testing or treatment
- The collection and use of their body organs, tissues or fluids (e.g. skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath
- Clinical trials
- Access to personal documents or other materials
- Using archived data in which individuals are identifiable
- Study or research in illegal activities
- Access to their information (in individually identifiable or re-identifiable form) as part of an existing published or unpublished source of database.
The framework of the National Statement on Ethical Conduct in Human Research consists of:
- Risk and benefits of research
- General requirements for consent
- Qualifying or waiving conditions for consent
- Qualitative methods, databanks, interventions and therapies including clinical and non-clinical trials and innovations, tissue samples, human genetics and human stem cells
- Vulnerable groups of participants including pregnant women, human foetuses, children, young people, people in dependent or unequal relationships, people highly dependent on medical care who may not be able to give consent, people with cognitive impairment, an intellectual disability or a mental illness, people who may be involved in illegal activities, Aboriginal and Torres Strait Islander peoples and people in other countries
- Institutional responsibilities
- Conflicts of interest
- Monitoring of approved research