National Statement on Ethical Conduct in Human Research (2007) - Updated 2018, NHMRC Australia

Authors of this National Statement

This National Statement has been jointly developed by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia (UA). This joint undertaking reflects a widely shared conviction that there is a need for ethical guidelines that are genuinely applicable to all human research and it gives expression to the shared responsibility for ethically good research described above.

The National Health and Medical Research Council Act 1992 (NHMRC Act) establishes the NHMRC as a statutory body and sets out its functions, powers and obligations. Section 10(1) of the Act requires the Chief Executive Officer to issue human research guidelines precisely as developed by the Australian Health Ethics Committee (AHEC) and provided to the CEO by the Council. AHEC is established by the NHMRC Act as a Principal Committee of the NHMRC. All the guidelines in this National Statement that are applicable to the conduct of medical research involving humans are issued by the NHMRC in fulfilment of this statutory obligation.

The Australian Research Council Act 2001 (ARC Act) establishes the ARC to provide the responsible Minister with advice and recommendations about research, including which research programs should receive financial assistance. The functions of the ARC also include administering the regimes of financial assistance for research and providing for the funding of research programs.

Universities Australia (UA) is the peak body representing Australia's 39 comprehensive universities in the public interest, both nationally and internationally. Its primary role is to advocate for regulatory, policy and fiscal settings conducive to a world-class university system.

The National Statement is subject to rolling review. This means that parts of the National Statement will be updated as needed, rather than reviewing the entire document every 5 years.

Compliance with the National Statement is a prerequisite for receipt of NHMRC funding.

CONTENTS

• The National Statement: A User Guide

• Preamble

• Purpose, scope and limits of this document

• Section 1 Values and principles of ethical conduct

• Section 2 Themes in research ethics: risk and benefit, consent

  • Chapter 2.1: Risk and benefit
  • Chapter 2.2: General requirements for consent
  • Chapter 2.3: Qualifying or waiving conditions for consent

• Section 3 Ethical considerations in the design, development, review and conduct of research

  • Chapter 3.1: The elements of research
  • Chapter 3.2: Human biospecimens in laboratory based research 
  • Chapter 3.3: Genomic research
  • Chapter 3.4: Animal-to-human xenotransplantation

• Section 4 Ethical considerations specific to participants

  • Chapter 4.1: Women who are pregnant and the human fetus
  • Chapter 4.2: Children and young people
  • Chapter 4.3: People in dependent or unequal relationships
  • Chapter 4.4: People highly dependent on medical care who may be unable to give consent
  • Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness
  • Chapter 4.6: People who may be involved in illegal activities
  • Chapter 4.7: Aboriginal and Torres Strait Islander peoples
  • Chapter 4.8: People in other countries

• Section 5 Processes of research governance and ethical review

  • Chapter 5.1: Institutional responsibilities
  • Chapter 5.2: Responsibilities of HRECs, other ethical review bodies, and researchers
  • Chapter 5.3: Minimising duplication of ethical review
  • Chapter 5.4: Conflicts of interest
  • Chapter 5.5: Monitoring approved research
  • Chapter 5.6: Handling complaints 
  • Chapter 5.7: Accountability

• Glossary.

• Index.

Use of this National Statement

This National Statement must be used to inform the design, ethical review and conduct of human research that is funded by, or takes place under the auspices of, any of the bodies that have developed this National Statement (NHMRC, ARC, UA).

The National Statement is intended for use by:

• any institution or organisation, governments, industry, private individuals, organisations, or networks of organisations  conducting research with human participants,
• any member of an ethical review body reviewing that research,
• those involved in research governance,
• potential research participants.