Content
National Statement on Ethical Conduct in Research Involving Humans
TABLE OF CONTENTS
Abbreviations
- Preamble
-
Importance of ethics
Purpose of this Statement
Historical context
Statutory considerations
The meaning of ethics and of research
Structure and interpretation
- 1. Principles of Ethical Conduct
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Integrity, respect for persons, beneficence and justice
Consent
Research merit and safety
Ethical review and conduct of research
- 2. Human Research Ethics Committees
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Composition
Appointment of members
Procedures
Advocates and interpreters
Expedited review for minimal risk research
Recording of decisions
Monitoring
Complaints
Suspension or discontinuation of research
Compliance reports to the National Health and Medical Research Council
4. Research Involving Children and Young People
5. Research Involving Persons with an Intellectual or Mental Impairment
- 6. Research Involving Persons Highly Dependent on Medical Care
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Emergency care research
Intensive care research
Neonatal intensive care research
Terminal care research
Research involving persons with impaired capacity for communication
Research involving unconscious persons
Human Research Ethics Committee consideration of research proposals involving persons highly dependent on medical care
7. Research Involving Persons in Dependent or Unequal Relationships
8. Research Involving Collectivities
9. Research Involving Aboriginal and Torres Strait Islander Peoples
10. Research Involving Ionising Radiation
11. Research Involving Assisted Reproductive Technology
13. Innovative Therapy or Intervention
- 15. Use of Human Tissue Samples
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Respect for persons
Institutional responsibility
Where consent would be required
Where the requirement for consent could be waived
Confidentiality
- 16. Human Genetic Research
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Social significance and consequences of genetic research
Privacy and confidentiality
Consent
Where the requirement for consent could be waived
Genetic counselling
17. Research Involving Deception of Participants, Concealment or Covert Observation
- Appendix 1
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Relevant Publications
International Declarations and Conventions
International Guidelines and Codes
National Health and Medical Research
Council Publications
Other
Appendix 2 Information Privacy Principles
Appendix 3 Glossary of Definitions
PLEASE NOTE
This Statement entitled the National Statement on Ethical Conduct in Research Involving Humans ('the Statement') consists of a series of Guidelines made in accordance with the National Health and Medical Research Council Act 1992 ('the Act').
The Statement has revised the guidelines entitled the NHMRC Statement on Human Experimentation and Supplementary Notes in accordance with section 90 of the Act, with the exception of Supplementary Notes 5 and 7, which have not yet been revised. This Statement therefore replaces the NHMRC Statement on Human Experimentation and Supplementary Notes with the exception of Supplementary Notes 5 and 7 which remain in force from the date they were originally issued in October 1983 and November 1992 respectively.
In addition:
(1) Despite the changes to the guidelines affecting Institutional Ethics Committees, any committee established under Supplementary Note 1 of the NHMRC Statement on Human Experimentation and Supplementary Notes 1992 (the previous Statement) and in existence immediately before the commencement of this Statement shall continue in existence as if established under 2. Human Research Ethics Committees of this Statement, and any matter being undertaken by such a committee prior to commencement of this Statement may be continued by that committee.
(2) Persons who, immediately before commencement of this Statement, had been members of an Institutional Ethics Committee established under the previous Statement are to be taken, with effect from the commencement of this Statement, to have been duly appointed to a Human Research Ethics Committee under this Statement and to be entitled to continue in office as members of that committee until 31 December 1999. From 1 January 2000 all Human Research Ethics Committees must be constituted in accordance with this Statement.
[Preamble] [Part 1] [Part 2] [Part 3] [Part 4] [Part 5] [Part 6]
[Part 7] [Part 8] [Part 9] [Part 10] [Part 11] [Part 12] [Part 13]
[Part 14] [Part 15] [Part 16] [Part 17] [Part 18] [Part 19]
[Appendix 1] [Appendix 2] [Appendix 3]