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:
- Participating in surveys, interviews, or focus groups.
- Undergoing psychological, physiological, or medical testing or treatment.
- Being observed by researchers.
- Researchers seek access to a participant's documents or other materials.
- 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;
- Access to a person's information (individually identifiable, re-identifiable or non-identifiable).
Ethical approval must be sought for research that involves human participants, their data, biological samples, or observations about them where:
- Information collected from or about human participants will be used to answer research aims or questions.
- Outcomes of investigations/exploration of research aims and questions will be presented or published for research purposes.
- Grant funding is provided to conduct research activities involving human participants.
- Quality Assurance or Improvement activities that trigger the requirement for ethical review.
Researchers must apply for human ethics approval in the UNSW iRECS portal. See the following to access the criteria for the different pathways for ethical review or notification of established approvals.
UNSW sponsors clinical trials within the remits of its Clinical Trials Governance Framework. If you are thinking about running a clinical trial with the appropriate levels of insurance, contractual frameworks, ethics and other Good Clinical Trial (GCP) obligations please visit our dedicated UNSW Clinical Trials Governance website.