5.1 Ethical principles in gene technology
BackgroundGTECCC has developed the following ten principles to guide decisions on ethical matters relating to research on gene technology and genetically modified organisms (GMOs) in particular, and to inform the community. These principles help to ensure that the values identified in Section 5.2, shape policies and actions that arise when dealing with gene technology. Researchers, scientists and others are encouraged to apply the principles during the course of their work. They should attempt to apply individual principles without substantially compromising other principles. Researchers should provide evidence that they have considered these principles when seeking approval for their research projects.
Public trust is a critical component of the regulatory system. The maintenance of high ethical standards in the private or public sector is essential for public trust.
Principle 1 – Acting with integrityAct with integrity in the search for and application of knowledge and benefits in gene technology research, both in the design of the research and having appropriate scientific qualifications to undertake the work and follow relevant codes of best scientific practice.
Principle 2 – Avoiding conflicts of interestDeclare and properly manage any conflicts of interest under the terms of the Australian Code for the Responsible Conduct of Research or other relevant requirements.
Principle 3 – Maintaining records of scientific dataAccording to best scientific practices, maintain accurate and comprehensive records of all relevant facts and data in dealings with gene technology to the standards required by regulatory authorities, including records of all negative as well as positive results.
Principle 4 – Caring for the environment and sustainabilityConduct dealings with gene technology so as to protect the environment, including genetic diversity, organisms, species and natural ecosystems, and to promote improvements in human health and sustainable agriculture and industry.
Principle 5 – Avoiding harm to humans and animalsMinimise risks of harm or discomfort to humans and animals likely to be adversely affected by gene technology research by ensuring compliance with the gene technology legislation.
Principle 6 – Assessing long-term impactsConduct dealings with gene technology with regard to the impact on present and future generations, including assessment of the long-term side effects of applications of gene technology.
Principle 7 – Sharing knowledge and benefits3Respect intellectual property rights, endeavour to promote access to scientific developments and share knowledge, and ensure that the Australian community benefits from gene technology.
Principle 8 – Promoting benevolent purposesConduct dealings with gene technology that promote their benevolent application and discontinue dealings that involve risk outside the relevant authorisation requirements.
Principle 9 – Ensuring transparencyConduct dealings with gene technology in a manner that ensures transparency and public scrutiny of the processes and that allows community consultation with those with a direct or potential interest.
Principle 10 – Considering responsibility beyond national bordersEnsure that dealings with gene technology do not cause damage to the Australian environment or to the environment beyond the limits of the national jurisdiction.
5.2 Values underlying the ethical principles for gene technology
BackgroundThe value of public trust is implicit and recognised in Australian Biotechnology: A National Strategy (Biotechnology Australia 2000, the National Strategy, see Appendix 1), the gene technology regulatory framework established in the GT Act, and the corresponding state and territory legislation. The National Strategy encourages the development and application of research and scientific knowledge associated with gene technology for the benefit and wellbeing of the community.
The National Statement on Ethical Conduct in Research Involving Humans (NHMRC 2007) and the Australian Code for the Responsible Conduct of Research (NHMRC/ARC/UA 2007) require researchers to conduct research with integrity.
In developing the principles in this National Framework, GTECCC identified the values set out below as the most relevant for the ethics of gene technology. The values are derived from international documents, in particular the UNESCO Universal Declaration of Bioethics and Human Rights (2005) which includes a number of principles relevant with respect to the environment (see relevant sections in Appendix 3). Other relevant national and international documents are set out in Appendix 2. In addition, GTECCC took account of the general values of the Australian community and values that were expressed during public consultations and in parliamentary debates that informed the development of the Gene Technology Act 2000 (the GT Act). GTECCC notes that concerns for the environment are at the forefront of government agendas internationally in continuing debates about climate change and sustainability. Ethical issues are based on individual, group and societal answers to questions about what they value as good, or what they believe to be the right thing to do. Ethical decision-making about environmental issues should take these values into account.
Value 1 — IntegrityThe value of integrity recognises that individuals have an ethical responsibility for their own conduct to act rightly, avoid conflicts of interest and deal honestly and truthfully with others. The value of integrity applies also to corporations.
Value 2 — TrustPublic trust in institutions, public officials and the professions are critical to a democratic society. The accountability of corporations, institutions and scientists working in the development and use of gene technology is an important value for the success of these technologies.
Value 3 — Respect for the environmentThe environment is of great value, and humans have duties to protect, conserve and preserve organisms, species, natural ecosystems, natural and physical resources, and the qualities and characteristics of locations, places and areas, both on local and global levels.
Respect for the environment is associated with sustainable development and management, as well as protecting biodiversity and ecosystem integrity and showing respect for individual species. Decision making should consider the short- and long-term impact of genetically modified organisms (GMOs) on the environment for present and future generations.
Value 4 — Respect for personsIn making ethical decisions involving GMOs, people should ensure the fair and just treatment of all whose interests are, or are likely to be, affected.
Value 5 — Respect for animalsRespect for animals, is reflected in animal welfare legislation that is designed to prevent cruelty to animals. This legislation is in place in most countries, including Australia. Respecting animals used or generated for research involving genetic modification also requires consideration of the possible consequences associated with the welfare of genetically modified animals, as well as the possible effects on human and animal health and the environment.
Value 6 — Research and the application of knowledgeThe freedom to pursue ethical research to acquire new knowledge is an important value. The application and sharing of knowledge can also benefit human, animal and environmental wellbeing.
3 UNESCO Universal Declaration on Bioethics and Human Rights 2005 provides some guidance on benefit sharing. Examples of benefit sharing may include:
- Art 15(a) special and sustainable assistance and acknowledgment of the persons or groups that have taken part in the research
- Art 15(e) access to scientific and technological knowledge
- Art 15(f) capacity-building facilities for research purposes – see Appendix 3.