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Please note:

The Human Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans has been revoked. This information is kept here for archival purposes only. For the current guidelines, Human Research Ethics Committees should refer to the National Statement on Ethical Conduct in Human Research 2007.

Commentary on the National Statement

Contents

Preamble to the National Statement

1. Principles of Ethical Conduct

  • Integrity, respect for persons, beneficence and justice
  • Consent
  • Research merit and safety
  • Ethical review and conduct of research

2. Human Research Ethics Committees

  • 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 NHMRC

3. Multi-Centre Research

  • Review
  • Monitoring

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

  • 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
  • HREC 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

12. Clinical Trials

13. Innovative Therapy Or Intervention

14. Epidemiological Research

15. Use of Human Tissue Samples

  • Respect for persons
  • Institutional responsibility
  • Where consent would be required
  • Where the requirement for consent could be waived
  • Confidentiality

16. Human Genetic Research

  • 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

18. Privacy of Information

19. Intellectual Property

Footnotes for all page in this section

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