Skip to content.

Home

Allens

National Framework for the Development of Ethical Principles in Gene Technology

In brief: Senior Associate Caroline Ryan overviews the Consultation Draft for the National Framework for the Development of Ethical Principles in Gene Technology.

Background

The Gene Technology Act 2000 (Cth) (the Act) established the Gene Technology Ethics Committee (GTEC) as one of three committees designed to provide advice to the Gene Technology Regulator (the Regulator).

The function of the GTEC is described in section 112 of the Act as providing advice on request to the Regulator on the ethical issues relating to gene technology, including the need for, and content of, policy principles and codes of practice in relation to ethics. As part of this role, the GTEC liaises with other relevant ethical advisory committees, such as the National Health and Medical Research Council's Australian Health Ethics Committee, for the purpose of establishing a consistent approach to the ethical issues associated with the national regulatory scheme for gene technology in Australia.

In this context, the GTEC has now issued for public comment a Consultation Draft for the National Framework for the Development of Ethical Principles in Gene Technology (the National Framework).

In developing the National Framework, the GTEC has recognised that while ethical thinking in the areas of medical and animal research are well developed, the ethics of gene technology is at an earlier stage of development. The National Framework seeks to redress this deficiency in the Australian context for not only scientists and research institutions, but the general community as a whole.

Return to top

Core Principles

The National Framework outlines 10 Core Principles for the ethical conduct of work relating to gene technology and genetically modified organisms (GMOs). The Core Principles cover research involving gene technology, the scientific issues and the consultation processes involved in preparing risk assessment and risk management plans that form the basis of licence decisions by the Regulator. The Core Principles also have relevance to members of Institutional Biosafety Committees and other animal care and ethics committees who consider applications that involve the genetic modification of animals.

Under the National Framework, researchers and all others involved in gene technology should:

  1. treat integrity as the guiding value in the search for knowledge and in their commitment to the obligations of, and intentions underlying, the national regulatory system and other relevant guidelines and regulations (Principle 1);
  2. take responsibility for ensuring that activities within their control do not cause damage to the Australian environment or in areas beyond the limits of the national jurisdiction; to achieve this, there must be a thorough assessment of the extended side effects of applications of gene technology (Principle 2);
  3. accurately assess and be respectful of the environment and health needs of both present and future generations (Principle 3);
  4. conduct research and related activities in a manner that integrates environmental and health protection into the research and development process, and not in isolation from it (Principle 4);
  5. demonstrate respect for persons (as individuals and group members) in all activities associated with gene technology, including obtaining appropriate consent (Principle 5);
  6. demonstrate respect for all living things, and the living environment on which they depend, in all activities associated with gene technology (Principle 6);
  7. minimise risks of harm or discomfort to persons and nonhuman animals likely to be adversely affected by gene technology (Principle 7);
  8. act compassionately and justly towards others and with regard to future generations (Principle 8);
  9. promote an equitable distribution of the benefits of gene technology, particularly in the global context and with regard to the developing regions, which may include promoting equal access to scientific developments, sharing knowledge and recognising the value of benefit sharing (Principle 9); and
  10. act according to the values and principles set out in this Framework in an informed and balanced way, without sacrificing one value or principle while attempting to realise another (Principle 10).

Return to top

Conclusion

The Core Principles are intended to assist scientists, research institutions and the community identify and follow ethically correct conduct in relation to gene technology, GMOs and associated GM products. At this stage, the Core Principles are provided for guidance only, and are not intended to be prescriptive. However, it is likely that the Core Principles will form the basis upon which future codes of practice or policy principles are developed.

The GTEC invites public comment on the National Framework until 28 October 2005. Comments or inquiries can be directed to the GTEC Secretariat as follows.

GTEC Secretariat
Office of the Gene Technology Regulator
MDP 54 PO Box 100
WODEN ACT 2606
Email: ogtr@health.gov.au
Telephone: 1800 181 030
Fax: + 61 2 6271 4202

For further information, please contact:

Return to top

Share with

What are these?