Title page
Contents
THE NATIONAL STATEMENT: A USER GUIDE 4
PREAMBLE 6
PURPOSE, SCOPE AND LIMITS OF THIS DOCUMENT 8
Section 1. Values and principles of ethical conduct 11
Section 2. Themes in research ethics: risk and benefit, consent 14
Chapter 2.1. Risk and benefit 14
Chapter 2.2. General requirements for consent 18
Chapter 2.3. Qualifying or waiving conditions for consent 21
Section 3. Ethical considerations in the design, development, review and conduct of research 25
Chapter 3.1. The elements of research 27
Chapter 3.2. Human biospecimens in laboratory based research 44
Chapter 3.3. Genomic research 49
Chapter 3.4. Animal-to-human xenotransplantation 60
Section 4. Ethical considerations specific to participants 65
Chapter 4.1. Women who are pregnant and the human fetus 65
Chapter 4.2. Children and young people 69
Chapter 4.3. People in dependent or unequal relationships 72
Chapter 4.4. People highly dependent on medical care who may be unable to give consent 74
Chapter 4.5. People with cognitive impairment, an intellectual disability, or a mental illness 77
Chapter 4.6. People who may be involved in illegal activities 79
Chapter 4.7. Aboriginal and Torres Strait Islander Peoples 81
Chapter 4.8. People in other countries 84
Section 5. Research governance and ethics review 87
Chapter 5.1. Governance responsibilities of institutions 87
Chapter 5.2. Responsibilities of HRECs and other ethics review bodies 95
Chapter 5.3. Responsibilities of researchers 99
Chapter 5.4. Monitoring 101
Chapter 5.5. Minimising duplication of ethics review 105
Chapter 5.6. Disclosure of interests and management of conflicts of interest 107
Chapter 5.7. Complaints 109
Chapter 5.8. Accountability 110
TERMS USED IN THIS DOCUMENT 111
Figure 1. Risk profiles of research 14