Statement of ethical principles for biotechnology in Victoria

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1 Statement of ethical principles for biotechnology in Victoria

2 Statement of ethical principles for biotechnology in Victoria

3 Acknowledgments Published by the Public Health Group, Rural & Regional Health & Aged Care Services Division, Department of Human Services, Melbourne Victoria January 2006 Copyright State of Victoria, Department of Human Services, 2006 This publication is copyright. No part may be reproduced by any process except in accordance with the provisions of the Copyright Act This document may also be downloaded from the Department of Human Services website at: Printed by Ego, Howleys Road, Notting Hill, Victoria 3168 ii

4 Contents 1. Preamble 1 2. What is an ethical principle? 3 3. What is biotechnology? 4 4. Ethical principles for biotechnology 6 5. Interpreting the ethical principles 7 6. Map of ethical controls and guidance impacting biotechnology in Victoria Definitions of terms used in the statement of ethical principles for biotechnology Acknowledgement 13 iii

5 iv

6 1. Preamble 1.1 This Statement of ethical principles for biotechnology in Victoria (the Statement) has been developed to guide the decision-making and activities of individuals and institutions involved in biotechnology developments in Victoria at any point along the continuum from research to commercial product. Its primary purpose is to achieve ethical decisions and actions, taking into account all relevant considerations, by those undertaking biotechnological activities. The Statement is designed to be comprehensive with broad application to the diverse applications of biotechnology in the fields of agriculture, environment and health. 1.2 Governments all over the world recognise there are potential benefits from using biotechnology, but alongside these benefits are risks that need to be managed. Governments have the responsibility to ensure that biotechnology developments are guided in such a way that benefits are available to society and potential adverse impacts are identified, eliminated or managed in a way that the adverse impact is minimised. 1.3 The Statement acknowledges the importance of ethics in emerging technologies and science. The Statement acknowledges the community s expectations of individual and institutional practice in the biotechnology sector and provides guidance to those involved in biotechnological activities. 1.4 The Statement may be used to inform and educate members of the public on ethical principles for biotechnology and the place of the ethical principles in guiding the activities of the biotechnology sector. 1.5 The biotechnology sector is regulated by law, codes and guidelines. The Map of ethical controls and guidance details the current wide range of legal and non-statutory controls in the field of biotechnology in Victoria. The ethical principles in this Statement do not replace or supersede any law or other control that regulates any aspect of biotechnology activities, nor the obligation on everyone to conduct their activities in compliance with the law. 1

7 1.6 The Statement includes (a) ethical principles for biotechnology set out in section 4; and (b) a series of questions set out in section 5 to guide understanding and application of the ethical principles. These questions should not be regarded as an exhaustive list. 1.7 The Statement is voluntary and not binding in law. The Statement does not prescribe specific rules for biotechnology activities. It is anticipated that biotechnology users may find these ethical principles useful in planning and undertaking their biotechnology activities. As a voluntary Statement, the way in which individuals and institutions measure or monitor adherence to the Statement will be developed outside of the Statement as such measures or monitoring must be relevant to their specific application of biotechnology. 1.8 It is intended the Statement will be reviewed to ensure it remains relevant. 2

8 2. What is an ethical principle? 2.1 In the context of the Statement, an ethical principle expresses an agreed value that guides actions to achieve the best possible ethical outcome in a given set of circumstances. 2.2 Ethical principles place one s own actions in a broader context: collectively, ethical principles provide a common analytical framework to consider the value of things other than one s own interests. For example, the value of persons other than ourselves who demand respect, irrespective of out attitude towards them or how they figure in our own preferred actions. 2.3 It is possible to find ethical principles described in other documents and publications that have a different focus and, in the wider study of ethics, ethical principles that follow a specific philosophical approach. In this Statement, the ethical principles consider human interests and relate to the specific human activity. 2.4 As individuals view the Statement, there may be disagreement about the meaning and weight that should be given to a particular principle on its own or relative to another. The Statement highlights fundamental ethical principles that should be taken into consideration by any person involved in biotechnology activities in order to guide those activities and to assess if those activities are ethical. 3

9 3. What is biotechnology? 3.1 We take what we know about living organisms and how they function and apply biotechnology to make new products, to alter properties of existing products and to develop new industrial processes. 3.2 Biotechnology as it has been practiced for centuries has provided the world with beer and wine through the use of yeasts for alcohol fermentation cheese through the use of cultures for cheese production; and improved characteristics of plants through planned breeding. 3.3 Modern industries that use biotechnology include: human and animal healthcare to produce pharmaceuticals, diagnostics tests and enhance and control fertility plant and animal breeders seeking improved characteristics for production pollution control, land bio-remediation, water treatment, minerals extraction and processing, species conservation and pest management food and beverage processors using starters, enzymes, and fermentation in the production of foodstuffs industries involved in the further processing of agricultural products, bio-processing and generation of industrial enzymes; and energy production using biofuels. 3.4 Today, a common meaning of biotechnology has developed that includes specific scientific methodologies: gene technology, cloning, genomics, proteomics, DNA sequencing, transgenics, bio-remediation amongst others. 4

10 3.5 Some of the techniques employed in modern biotechnology rely on an understanding of how living organisms function at the cellular level. The cells of all living things contain DNA (deoxyribonucleic acid), the chemical basis for the genetic code common to all living organisms. The DNA in all genes contains the instructions (code) for proteins that are produced during an organism s life. These proteins then impact the features and functions of that organism. 3.6 A more recent use of biotechnology is genetic engineering and genetic modification. These terms, used interchangeably or collectively described as gene technology, describe a set of scientific tools for manipulating genes; genes can be copied, added to, deleted from or altered and then transferred between organisms giving the recipient organism a new and desired feature. Researchers using gene technology have a greater ability to direct features and functions of organisms than would have been possible by other means, such as traditional breeding. 3.7 Examples of how gene technology is used includes placing genes from animal cells that produce insulin into bacteria, so the altered bacterial cells can generate large volumes of human insulin needed in treatment of diabetes. The genetically modified bacteria replace the need for animals as an insulin source and the insulin obtained in this manner is indistinguishable from human insulin. Another example is research placing genes from wild grapevines that are mould-resistant into commercial grapevines to prevent significant loss in yield or to the quality of the wine produced. Gene technology is also fundamental to biomedical research in investigating the genetic origins of diseases. 5

11 6 4. Ethical principles for biotechnology The following principles are agreed as fundamental to all activities in biotechnology: 4.1 Respect for Persons The recognition that persons have an inherent dignity and the welfare, rights, beliefs, perceptions, customs and cultural heritage of individuals should be taken into account. 4.2 Respect for Animals The recognition that animals have a value both in their being and in relation to human culture and the welfare and humane treatment of animals should be taken into account. 4.3 Respect for the Natural Environment The recognition that the natural environment is our common heritage and sustains all life and human culture. The natural environment is more than a means to satisfy human ends. The safeguarding of biodiversity, ecosystems and the beauty of the natural environment should be taken into account now and in the interest of future generations. 4.4 Respect for the Public Good The recognition that individual activities take place in a context of social and institutional relationships. The public good is a collective good that should be taken into account along with individual interests. 4.5 Benefit and Harm The recognition that human activities have impact and should promote good and avoid harm. Using risk assessments, as a tool to ensure health and well-being, should be taken into account. 4.6 Justice and Equity The recognition that benefits and burdens from biotechnology activities should be distributed equitably through society such that no particular group is inequitably advantaged or disadvantaged now or in the future. 4.7 Probity The recognition that activities should be conducted honestly, truthfully, lawfully, impartially, competently and with considered regard for transparency of process. 4.8 Accountability The recognition that persons and institutions are inherently responsible for their actions and the justification, purpose and consequences of any action should be taken into account when it is determined.

12 5. Interpreting the ethical principles The following questions are intended to assist in the interpretation of the ethical principles. 5.1 In relation to Respect for Persons a) Have persons likely to be affected by decisions been informed and consulted about the proposed biotechnology activity? b) Has this biotechnology activity been undertaken with regard for the safety, welfare, rights and beliefs of research staff, research participants and those impacted by the activity? c) Has individual autonomy been respected through the provision of accurate information presenting both the benefits and the risks likely to occur from undertaking the activity that will allow individuals to make informed decisions? d) Has the privacy of personal information been protected? e) Will genetic information arising from biotechnological activity potentially be used in a manner that may lead to discrimination? f) Does this biotechnology activity contribute to an identified need by improving human health or otherwise enhancing the quality of human life? g) Has a properly constituted Human Research Ethics Committee approved any biotechnology research proposal involving humans? 5.2 In relation to Respect for Animals a) Have alternatives to the use of animals in biotechnology research been sought wherever possible? b) Have the minimum possible number of research animals needed to produce valid results been used and a justification provided for the determined number? c) Has biotechnology research been designed with regard to the biological characteristics of research animals including their behaviour, species and genetic attributes and their nutritional and general health status such that potential pain and distress to the research animals is avoided or minimised? d) Has a properly constituted Animal Ethics Committee approved the biotechnology research proposal involving animals? e) Where the biotechnology activity may result in the creation of a transgenic or genetically modified animal, has regard been given to minimise any suffering of the animal including the deprivation of its natural expressions? 7

13 8 5.3 In relation to Respect for the Natural Environment a) Will the benefits from the application of biotechnology be achieved at the expense of damaging the natural environment for future generations? b) Has humanity s stewardship of the splendour and inherent value of the natural environment been taken into account through the biotechnology activities being neutral or beneficial in their impact? c) Does the biotechnology activity support environmental sustainability? d) Does the biotechnology activity preserve and foster biodiversity and avoid serious side effects to species present in the surrounding environment? e) Have suitably qualified persons undertaken an environmental impact assessment where there is uncertainty or lack of information regarding the effects of proposed biotechnology activities? f) Is environmental degradation reduced or avoided as a result of the biotechnology activity? 5.4 In relation to Respect for the Public Good a) Has balanced information been made available to the public so as to foster informed public discussion of biotechnology related issues and to allow for the expression of any public concerns about a particular development? b) Does the biotechnology activity lead to an overall benefit for the public with consideration given to the social and environmental benefits as well as expected economic benefits? c) Is the biotechnology activity consistent with accepted the ethical standards of professional practice? d) Is the proposed biotechnology research activity of sufficient scientific merit that it does not produce results of questionable validity or duplicate other research unnecessarily? e) Have the results of biotechnology research been published within a reasonable timeframe (given consideration of any commercial in confidence restrictions)? f) Has this biotechnology activity been carried out in a manner that recognises and protects the cultural heritage and rights of indigenous populations?

14 g) Is the biotechnology activity adequately secured so that it not be used or applied to destructive ends such as in biotechnological weaponry? h) Have research staff and research ethics committees undertaken training in ethics and research governance to ensure that biotechnology activities are conducted according to accepted ethical standards? i) Has a social impact study been undertaken for this biotechnology activity where appropriate? 5.5 In relation to Benefit and Harm a) Is the biotechnology research carried out by individuals who have the relevant technical knowledge and skills for such activities? b) Do risk assessments of the biotechnology activity identify the possible long-term effects so these may be taken into account in risk management strategies? c) Is the biotechnology activity undertaken in a way that causes harm to, or put at risk the safety of, persons, animals or the natural environment, where such harm or risk is disproportional to the expected benefits? d) Are there systems in place to ensure any biotechnology activity or genetically modified product that possibly has negative effects on human health, safety or the environment will cease or be recalled? 5.6 In relation to Justice and Equity a) Have the interests of those most likely to be affected by this biotechnology activity been taken into account? b) Have groups potentially disadvantaged by the biotechnology activity been identified? c) Have steps been taken to ensure that the biotechnology activity does not expose any particular group to a risk or burden disproportionate to the benefit or good that may be expected to flow to them? d) Will the biotechnology activity result in benefits being obtained for the present generation to the detriment of future generations? e) Will this biotechnology activity adversely impact efforts to foster a society where risks, burdens and benefits are distributed equitably? 9

15 In relation to Probity a) Are biotechnology activities undertaken with intellectual honesty and in accordance with professional standards? b) Have processes been put in place to identify and resolve actual or perceived users conflicts of interest relating to biotechnology product development? c) Are public statements made by biotechnology users or organisations tested to ensure they do not misrepresent the biotechnology product or the process of its development? d) Do biotechnology research results undergo peer review before being published? e) Are responses to requests for information from the community met promptly and accurately, subject to specific privacy or commercial-in-confidence restrictions? f) Have biotechnology users and institutions put in place processes to monitor their adherence to and compliance with the Statement of ethical principles for biotechnology in Victoria? g) Are there mechanisms in place for dealing with conflicts of interest as well as conflicting interests especially for persons responsible for public statements? 5.8 In relation to Accountability a) Is the biotechnology activity carried out in a transparent and open way with public scrutiny as far as is possible given the constraints of commercial-in-confidence requirements? b) Are the outcomes of publicly funded biotechnology research and development publicly reported? c) Will biotechnology users and institutions adopting the Statement of ethical principles for biotechnology in Victoria put in place transparent processes that report on compliance with the Statement? d) Where a biotechnology activity has inadvertently resulted in harm or loss to a third party, will the biotechnology user or organisation act to remediate the loss or harm? e) Has a properly constituted Institutional Biosafety Committee reviewed the biotechnology activity and established a monitoring process relative to the level of risk?

16 6. Map of ethical controls and guidance impacting biotechnology in Victoria The Map of ethical controls and guidance that impact on biotechnology in Victoria complements the fundamental ethical principles contained in the Statement of ethical principles for biotechnology in Victoria. The map may be used to assist individuals and institutions to identify the processes and procedures by which they may demonstrate their adherence to the principles. The Map may also assist individuals and institutions in identifying areas of activity that are outside of existing ethical guidance or controls so appropriate mechanisms to measure adherence may be adopted. The map will be updated to reflect changes in controls and guidance. The current version of the map will be available at: Map users should check the website periodically to ensure they are accessing the current version. 11

17 7. Definitions of terms used in the statement of ethical principles for biotechnology Benefit and harm equates to the terms beneficence and non-maleficence commonly used as principles underpinning ethical conduct of research involving humans. Biotechnology activity an activity that utilises technologies falling within the broader definition of modern biotechnology such as gene technology, cloning, genomics, proteomics, DNA sequencing, transgenics, bio-remediation amongst others play a part in research and laboratory procedures. Biotechnology user an individual carrying out a biotechnology activity; in the broader sense, an institutional setting where biotechnology activities occur. Consideration giving thoughts to the merits of a decsision or action against the ethical principle influencing how that decisison or action may occur; answering the question should I (we) proceed rather than can I (we) proceed? Equity exists when the outcome of a decision or process is fair, where one party or another is not advantaged or disadvantaged disproportionately. Justice used to describe the distribution of benefit and burden amongst those impacted by biotechnology activities. Natural environment the physical environment made up of air, land and water and the living organisms inhabiting that environment (animals, plants, micro-organisms) Properly constituted established according to the relevant guidance; typically a national or state level standard described in law. Public good giving consideration to the benefits available to a collective group; does not need to be a direct benefit for the individuals within the group, but may have indirect benefit such as acquiring knowledge. Risk assessment the process that combines hazard identification, evaluation of the outcome of an exposure to the identified hazard, the development and implementation of strategies to limit or eliminate the outcome of that exposure and the communication of the hazard identification and management strategies to interested parties. 12

18 8. Acknowledgement The Victorian Biotechnology Ethics Advisory Committee acknowledges the Statement of Ethical Principles for Biotechnology in Victoria was developed drawing on many sources of existing guidance, policy and theory. In particular, the input from members of the Victorian community and stakeholder groups was valued. Similarities between the Statement and other documents stand as evidence of the fundamental nature of ethical principles underpinning our human endeavour. 13

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