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Ethical issues in biotechnology


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Ethical issues in biotechnology and related areas.

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Ethical issues in biotechnology

  2. 2. 2 ETHICAL ISSUES IN BIOTECHNOLOGY AND RELATED AREAS Chapter No. Contents Page No. 1 Introduction Ethics and Moral 3 2 Ethics in Biotechnology Research 17 3 Ethics in Medical Biotechnology Ethical Issues and Gene Therapy Ethics in Stem Cell Research Bioethics and Human Diagnostics 29 4 Ethics in Agriculture Biotechnology 52 5 Ethics in Gene Biotechnology Ethical Issues related to Cloning 61 6 Ethics in Animal Biotechnology 66 7 Ethics in Pharmaceutical, Biopharmaceutical & Biotech Industry, Clinical Trials Ethics in Pharmaceutical Companies Ethical Issues and Biotech Industry Ethical Issues and Clinical Trials 69 8 Ethics in Biotechnology related Area Ethical Issues and Synthetic Biology Ethics and Patenting 93 9 Resolving Ethical Issues To Resolve on Ethical Issues Regulatory on Ethical Issues related to Technology 104
  3. 3. 3 Chapter 1 Ethics and Morals "As our nation invests in science and innovation and pursues advances in biomedical research and health care, it's imperative that we do so in a responsible manner." - President Barack Obama. Morality-refers to the concept of human ethics which pertains to matters of good and evil—also referred to as "right or wrong", used within three contexts: individual conscience; systems of principles and judgments—sometimes called moral values—shared within a cultural, religious, secular, humanist or philosophical community; and codes of behavior or conduct. Personal morality defines and distinguishes among right and wrong intentions, motivations or actions, as these have been learned, engendered, or otherwise developed within each individual. ( Ethics-(from the Ancient Greek "ethikos", meaning "arising from habit"), a major branch of philosophy, is the study of value or quality. It covers the analysis and employment of concepts such as right, wrong, good, evil, and responsibility. It is divided into three primary areas: meta-ethics(the study of the concept of ethics), normative ethics(the study of how to determine ethical values), and applied ethics(the study of the use of ethical values). ( ) In classical Greek, the word ―ethics‖ entails the ―beliefs of the people‖ - the analyze of what is right and good in human conduct and the explanation of such claims. Values are rules, morals are how we judge others and ethics are professional standards. When your action affects somebody else it becomes ethical issue otherwise it‘s a question of moral. Anything that reflects of you is issue of moral, while anything that affects others is ethics. Morals Ethics 1 Define our character 1 Dictates the working of our social system. 2 2 Points towards application of morality. 3 3 Lays down set of codes. 4 Dependent on individuals choice or beliefs or religion 5 Means doing right or wrong things. 6 Tough to follow 6 Relatively easy to follow. 7 Morals are basic marker of behaviour 7 Ethics are Guidelines 8 Morals relates more to individuals 8 Ethics relates more to group, community or society. Ethics are collective. 9 Here dilemma is possible. 9 Here there is no dilemma. Values considered under Moral Values considered under Ethics 1 Honesty 1 Transparency
  4. 4. 4 2 Respect to others 2 Trust 3 To acknowledge others 3 Justice 4 Sincerity 4 Fairness 5 Modesty 5 Democracy 6 Responsibility 6 Respect to beliefs 7 Carefulness 7 Respect to community & others 8 Punctuality 8 No discrimination 9 Integrity 9 Importance of informing Ethics is a philosophy that questions morality, values and subsequent outcome; morality is a developed and adopted 'code of conduct'. The main objective of morality is to be able to highlight 'right' and 'wrong'. Abortion is legal and therefore medically ethical, while many people find it personally immoral. What is Morality? Morality refers to an adopted code of conduct within an environment and a set of agreed upon rules for what is 'right' and 'wrong'. Morals are backbone of modern society, religion and every individual's conscience. The conceptions changed in time and take on a new meaning. For example, 'murder is immoral', but 'on the battlefield murder is permissible'. In a way, morality is in sync with ethics. While one is abstract in understanding, the other is defined and in the form of written code. Morality addresses the ethical queries on the moral outcome of a specific situation. The code of conduct formulated probes prohibitions, controversial behavior, standards of belief systems and social conformity of morally 'right' behavior. Moral codes define 'appropriate' and 'expected' activity. Community morality is usually defined via commentaries and codes of authority. Morality is better understood as an assimilation of beliefs about the essentials to lead a 'good' life. It is not to be confused with religious or fanatic or political perception. Moral codes are based on value systems that have been tried and tested. The best examples of moral codes include the Eightfold Path of Buddhism and the Ten commandments. It is believed that all of us, throughout our lives, act from a developing moral core. The words morals and ethics are used to mean roughly the same thing, even though they do not. By morals we mean broadly accepted norms that govern practical behavior primarily toward our fellow humans, wherever and whenever they live. In its modern definition, morals include norms also with respect to nature. The discipline of ethics, on the other hand, is moral philosophy that is, describing the subject as well as comparing and critically reflecting different moralities. Personal values should not necessarily be imposed on others in the sense of prescriptive ethics. Values under moral are absolute while values under ethics are relative. Morals define personal character. Ethics stresses on social system in which those morals are applied. Ethics points to standards or codes of behavior expected by a group to which the individual belongs. If you take care of moral you will automatically take care of ethics. You have to teach moral to see that ethical issues will not arise. People who talk about ethics are unfortunately the most unethical people in the world. People talk things of convenience and normally do not bother about good-bad-ethical-unethical. When considering difference between ethics and morals example is often given of criminal defense lawyer. Though the lawyer‘s personal moral code likely finds murder immoral and reprehensible, ethics demand the accused client be defended as vigorously as possible, even when the lawyer knows the party is guilty and that a freed defendant would potentially lead to
  5. 5. 5 more crime. Legal ethics must override personal morals for the greater good of upholding a justice system in which the accused are given a fair trial and the prosecution must prove guilt beyond a reasonable doubt. The words morals and ethics are used to mean roughly the same thing, even though they do not. Morals – broadly accepted norms that govern practical behavior primarily toward our fellow humans. In its modern definition, morals includes norms also with respect to nature. Ethics – Moral philosophy – that is, describing the subject as well as comparing and critically reflecting different moralities. In general, ‗ethics‘ is defined as the ideals, values or standards that people use to determine whether their actions are good or bad. It is what society uses to judge whether an issue or thing is acceptable and justifiable and determines responsibility and justice. It answers the question ―Is an action right or wrong?‖ On one hand, ethics is a set of universal norms that are documented through legal or professional codes of practice, religious texts, literature and philosophy. On the other hand, ethics are values defined by a person or groups that are personal, introspective, and hence, difficult to manage for public discussion. Given the range of cultural diversity, it is expected that people would react in different ways to certain issues and concerns. There is another story of a thief and police – There was an encounter between the two and both became critical and needed medical attention – surgery. Police was relatively less critical while thief was more critical. They were taken to the nearby private hospital. There was only one operation theatre. Delay with any one of them could be fatal. The question is whom the doctor should operate first? Operating police first is morally correct but ethically wrong. Operating the thief first is ethically correct but morally wrong (Justice demands this). What is morality is the weight of the public opinion. As a student you need to know – (1) The technology that will affect your future and the ethical issues surrounding it. (2) The business environment and the places where you are going to work and the ethical issues existing there. Ideas of ethics change with time, with society and with stage of advancement of that society. Many a times people talk different things as seller and different things as customer. Social ethics includes issues of equity, justice, fairness and democracy. The Core Ethical Values "are intended to provide guidance to our industry where no legal requirements exist or where industry wishes to go beyond any legal requirement." Technology-transcending risks mostly materialize because a gap opens between human scientific technical ability and human willingness to shoulder moral and political responsibility. When Technological changes are bringing so much change in our living style and activities can we expect that our ideas of ethics and moral of 18th, 19th, 20th century or anything before will fit into it? In the field of research we have to think while setting up the goals of research by asking ourselves – We can but must we? ―If we can we inevitably will‖ Ethical Reasoning – What is and what ought to be. The Justice Approach – Treating equals equally and unequals unequally. The common Good – Creating set of conditions that are equally advantageous to all. Ethics is embedded in every aspect of our lives. Different ―definitions‖ of ethics are in use daily by the general public. (a) Ethics is adherence to the spirit and the letter of the law. People who claim that they ―have done nothing wrong‖ after they are caught in a legal but unsavory action often use this interpretation of ethics. (b) Ethics is
  6. 6. 6 adherence to a religious belief. (c) Ethics is adherence to ―community or cultural standards.‖ (d) Ethics is adherence to my ideas. In contrast, ethicists use definitions that are more complex and may contain elements of all these common notions about what is ethical and what is not. Ethics may be defined as a set of standards by which a particular group or community decides to regulate its behaviour – to distinguish what is legitimate or acceptable in pursuit of their aims from what is not. Ethics can be defined as: ―a method, procedure, or perspective, or norms of conduct that distinguishes between acceptable and unacceptable, right or wrong, behavior. More technically, ethics can also refer to a particular branch of philosophy which tries to analyze and clarify the arguments that are used when moral questions are discussed and to probe the justifications that are offered for moral claims. So ethics in this sense puts our moral beliefs under the spotlight for scrutiny. Ethics are integral part of social laws and politics. Ethics is best option choice when two choices are available. People may have moral concern about modern biotechnology but that does not mean that they have thought about ethical issues. Moral principles differ among cultures, and, within cultures, among individuals. Every individual has particular moral ideas about what is just and what is not. Moral judgment of individuals are not arbitrary but have its own reasoning or strong footing. In case of biotechnology people‘s major concern is to know how far we ought to go in the research in biotechnology since it involves intervention of basic life structures. In general, ‗ethics‘ is defined as the ideals, values or standards that people use to determine whether their actions are good or bad. It is what society uses to judge whether an issue or thing is acceptable and justifiable and determines responsibility and justice (Thompson, 2001). It answers the question ―Is an action right or wrong?‖ On one hand, ethics is a set of universal norms that are documented through legal or professional codes of practice, religious texts, literature and philosophy. On the other hand, ethics are values defined by a person or groups that are personal, introspective, and hence, difficult to manage for public discussion (Thompson, 2001). Given the range of cultural diversity, it is expected that people would react in different ways to certain issues and concerns. Types of Ethics There are several approaches towards ethics, which can broadly be divided into – (I) Normative Ethics - In the case of normative ethics, the notion behind what declares an action as 'right' or 'wrong' is derived and defined. (II) Non-normative Ethics - The non-normative approaches describe and analyze morality without taking moral positions. (III) Descriptive Ethics - One of the non-normative approaches is descriptive ethics, which is the factual description and explanation of moral behaviour and beliefs in a society, especially employed by anthropologists, sociologists and historians. This approach is reflected in the studies on consumer acceptance and public attitudes towards biotechnology. Descriptive ethics examines a situation as a choice made in
  7. 7. 7 the presence of the moral agents relevant. Here issues like preferred concepts of etiquette and aesthetics are considered. (IV) Metaethics - In meta-ethics, judgmental properties within a situation are investigated. Issues relating to the sensitivity of ontology, semantics and epistemology are explored in this stream of ethics. Metaethics examines the structure or logic of moral reasoning, including the justifications and inferences. This approach critically analyses whether positions in bioethical debates are in coherence with the principles on which they are said to be based and consistent with the way in which other comparable ethical dilemmas are dealt with. (V) Prescriptive ethics is a normative approach. Normative approaches in ethics involve taking moral positions. Prescriptive ethics attempts to formulate and defend basic principles and virtues governing moral life. In its applied form, prescriptive ethics are reflected in ethical regulation of modern biotechnology. (VI) Relational ethics – It relates to personal interactions and responsibilities. (VII) Applied ethics - This investigates the success or failure of the application of ethical theory to everyday situations. Moral concerns are felt about what it is right or wrong to do, while ethical concerns are about the reasons and justifications for judging those things to be right or wrong. Similar to Universal Declaration of Human Rights, the International Bioethics Committee of UNESCO is now developing an International Declaration on the Humane Genome and Human Rights, in order to preserve "the dignity of individuals and their rights and freedoms" in the context of the progress of molecular biology and genetics. The four fundamental principles of bioethics include: 1. Beneficence which refers to the practice of good deeds; 2. Non maleficence which emphasizes an obligation to not inflict harm; 3. Autonomy which recognizes the human capacity for self-determination and independency in decision-making; and 4. Justice which is based on the conception of fair treatment and equity through reasonable resolution of disputes. Does ethical debate have any practical importance in the real world? Questions and problems that are scientific, commercial, agricultural, medical should be left to the expert practitioners and be not discussed by others. Many people feel that science cannot be done in moral and ethical vacuum in a society that is healthy and civilized. A technology exists does not mean that it has to be employed. Legal and regulatory framework of society is based on the ethical base of that society. Worries are being increasingly expressed that the potential benefits of modern biotechnology may be lost if the new processes and products fail to gain ―consumer acceptance‖ because of moral concerns. Every technology has affected people in big way – be it machines, television, nuclear energy, computers or biotechnology. More powerful the technology and it will have more concerns with respect to morals and ethics, and have many environmental and health related questions. That is one of the reasons why there are big discussions with respect to developments of biotechnology. There are people who oppose genetic engineering for the fundamental reason that human beings should not do what they perceive as playing God. The argument on this can be - If God created humans as intelligent creatures, it should be compatible with God‘s intentions that they use their intelligence to improve living conditions. The ambivalence of technological progress and the fact that a technological innovation can be used for good as well as for ill is neither new nor confined to genetic engineering and biotechnology.
  8. 8. 8 So whether you see biotechnology as threat or blessing depends upon where you position the human being in the biosphere – as at the crown in form of intelligent species or brother and sister of other plants, animals. Bioethics The term bioethics refers to the branch of ethics which studies moral values in the field of medicine and biology. While some consider it as part of development process of science others have strong arguments against it. Right thing will be to identify the severity of these issues and take some steps to ensure that they don't affect the basic rights of the various life forms on the planet. The list of issues discussed under bioethics are – Abortion, animal rights, artificial insemination, biopiracy, body modifications, brain-computer interface, cloning, contraceptives, birth control, cryonics, eugenics, gene therapy, genetically modified food, nanomedicine, organ transplant, sperm donation, spiritual drug use, surrogacy, vaccination etc. Bioethics considers issues affecting all living organisms and the environment, from individual creature to the level of the biosphere in complexity. Bioethics has both descriptive nature as well as prescriptive approach, which means that it describes how we make decisions and also suggests a process to decide what are good and bad choices. Bioethics is not jast a word but it‘s a concept. Different people think differently on the issues of biotechnology. Their thinking and their reasoning has come out in various surveys. Such surveys throw light on the public acceptance. Recent surveys are not mere set of questions and are strategic. Such surveys are conducted in Australia, New Zealand, UK, Netherlands, India, Philippines, Hong Kong, Thailand, Singapore and Japan. These countries have different social, political and religion background and influences. Most of the surveys are done on agricultural biotechnology and medical genetics. In these surveys issues such as eugenic fears or environmental risk, are not the major concerns voiced by people in open questions. The more common concerns are interference with nature or general fear of a less concrete nature. Also the survey found that many people perceive both benefit and risk simultaneously, they are attempting to balance these; and also educated people show as much concern, in fact biology teachers considered there was more risk from genetic engineering than the ordinary public. Using one of the many methodological approaches for reaching an ethical decision, or at least a moral determination, we can ask the following questions:  What is the perception of the problem?  How do we analyze the situation?  What are the practical options?  What norms, qualities, and perspectives should we use?  Can we verify a binding applicability of our judgment or norms?  What is the result of our evaluation? Below are given the basic principles used for assessing the emerging technologies used by President’s commission with reference to synthetic biology. Basic Ethical Principles for Assessing Emerging Technologies To reach its recommendations, the Commission identified five ethical principles relevant to considering the social implications of emerging technologies: (1) Public beneficence The principles are intended to illuminate and guide public policy choices to ensure that new technologies, including synthetic biology, can be developed in an ethically responsible
  9. 9. 9 manner. The ideal of public beneficence is to act to maximize public benefits and minimize public harm. This principle encompasses the duty of a society and its government to promote individual activities and institutional practices, including scientific and biomedical research, that have great potential to improve the public‘s well-being. Public beneficence requires that when seeking the benefits of synthetic biology, the public and its representatives be vigilant about risks and harms, standing ready to revise policies that pursue potential benefits with insufficient caution. (2) Responsible stewardship The principle of responsible stewardship reflects a shared obligation among members of the domestic and global communities to act in ways that demonstrate concern for those who are not in a position to represent themselves (e.g., children and future generations) and for the environment in which future generations will flourish or suffer. Responsible stewardship recognizes the importance of citizens and their representatives thinking and acting collectively for the betterment of all. Importantly, it calls for prudent vigilance; establishing processes for assessing likely benefits along with assessing safety and security risks both before and after projects are undertaken. A responsible process will continue to assess safety and security as technologies develop and diffuse into public and private sectors. It will also include mechanisms for limiting their use when necessary. (3) Intellectual freedom and responsibility Democracies depend on intellectual freedom coupled with the responsibility of individuals and institutions to use their creative potential in morally accountable ways. Sustained and dedicated creative intellectual exploration begets much of our scientific and technological progress. While many emerging technologies raise ―dual use‖ concerns—when new technologies intended for good may be used to cause harm—these risks alone are generally insufficient to justify limits on intellectual freedom. As a corollary to the principle of intellectual freedom and responsibility, the Commission endorses a principle of regulatory parsimony, recommending only as much oversight as is truly necessary to ensure justice, fairness, security, and safety while pursuing the public good. This is particularly important in emerging technologies, which by their very definition are still in formation and are not well suited for sharply specified limitations. While clear guidelines to protect biosecurity and biosafety are imperative, undue restriction may not only inhibit the distribution of new benefits, but it also may be counterproductive to security and safety by preventing researchers from developing effective safeguards. (4) Democratic deliberation The principle of democratic deliberation reflects an approach to collaborative decision making that embraces respectful debate of opposing views and active participation by citizens. It calls for individuals and their representatives to work toward agreement whenever possible and to maintain mutual respect when it is not. Public discussion and debate with open interchange among all stakeholders can promote the perceived legitimacy of outcomes, even if those outcomes are unlikely to satisfy all interested parties. An inclusive process of deliberation, informed by relevant facts and sensitive to ethical concerns, promotes an atmosphere for debate and decision making that looks for common ground wherever possible and seeks to cultivate mutual respect where irreconcilable differences remain. It encourages participants to adopt a societal perspective over individual interests. (5) Justice and fairness
  10. 10. 10 The principle of justice and fairness relates to the distribution of benefits and burdens across society. Biotechnology and emerging technologies such as synthetic biology, for good or ill, affect all persons. Emerging technologies like synthetic biology will have global impacts. For this reason, every nation has a responsibility to champion fair and just systems to promote wide availability of information and fairly distribute the burdens and benefits of new technologies. Recommendations With these guiding principles in mind, the Commission considered the array of public policy issues surrounding the emerging science of synthetic biology and makes the following recommendations. In the cases of recommendations 1, 3, 5, 9, 11, 12, and 17, the Commission recommends ongoing review by the government, in consultation with the relevant scientific, academic, international, and public communities, with initial action completed within 18 months and made public. Some of these actions could easily be completed sooner, and the government is encouraged to do so and make its progress public. Promoting Public Beneficence Under the principle of public beneficence, the Commission recommends that the government review and make public findings regarding the scope of its research funding, especially for risk assessment and ethical and social issues raised by synthetic biology. This will promote public engagement and ensure needed transparency regarding federal efforts in the field of synthetic biology. Recommendation 1: Public Funding Review and Disclosure through a central body such as the Executive Office of the President, the federal government should undertake a coordinated evaluation of current public funding for synthetic biology activities, including funding for research on techniques for risk assessment and risk reduction, and for the study of ethical and social issues raised by synthetic biology. This review should be completed within 18 months and the results made public. Most potential products of synthetic biology are in very early stages of development. Therefore, basic research is critical to further expansion of this science and its effective translation into useful products. Necessary funding decisions should be made with the goal of advancing the public good, whether these decisions support synthetic biology research or other fields. The Commission does not offer an opinion on the relative merits of particular research directions, but recommends that such decisions receive ongoing evaluation as to the state of the science and its potential applications. Recommendation 2: Support for Promising Research Advancing the public good should be the primary determinant of relative public investment in synthetic biology versus other scientific activities. The National Institutes of Health, the Department of Energy, and other federal agencies should continue to evaluate research proposals through peer-review mechanisms and other deliberative processes created to ensure that the most promising scientific research is conducted on behalf of the public. Information sharing is a critical mechanism for promoting scientific progress and innovation. The principle of public beneficence requires researchers, inventors, patent holders, and others to work together to develop creative strategies to maximize opportunities for innovation. The government should consider best practices and other policy guidance, if needed, to ensure that access to basic research results and tasks is not unduly limited. Recommendation 3: Innovation Through Sharing Synthetic biology is at a very early stage of development, and innovation should be encouraged. The Executive Office of the President, as part of the coordinated approach urged in Recommendation 4, should lead an effort to determine whether current research licensing and sharing practices are sufficient to ensure that basic research results involving synthetic biology are available to promote innovation, and, if not, whether additional policies or best practices are needed. This review should be undertaken
  11. 11. 11 with input from the National Institutes of Health, other agencies funding synthetic biology research, such as the Department of Energy and the National Aeronautics and Space Administration, the U.S. Patent and Trademark Office, industry, academia, and public civil society groups. The review should be completed within 18 months and the results made public. Promoting Responsible Stewardship The Commission endorses neither a moratorium on synthetic biology until all risks are identified and mitigated, nor unfettered freedom for scientific exploration. Instead, the Commission believes that the field of synthetic biology can proceed responsibly by embracing a middle ground—an ongoing process of prudent vigilance that carefully monitors, identifies, and mitigates potential and realized harms over time. Responsible stewardship requires clarity, coordination, and accountability across the government. While new agencies, offices, or authorities are not necessary at this time, the Executive Office of the President should lead an interagency process to identify and clarify, if needed, existing oversight authorities and ensure that the government is informed on an ongoing basis about developments, risks, and opportunities as this field grows. This process must be undertaken by an office with sufficient authority to bring together all parts of the government with a stake in synthetic biology and be sufficiently authoritative to effectively engage or oversee engagement with foreign governments. Recommendation 4: Coordinated Approach to Synthetic Biology The Commission sees no need at this time to create additional agencies or oversight bodies focused specifically on synthetic biology. Rather, the Commission urges the Executive Office of the President, in consultation with relevant federal agencies, to develop a clear, defined, and coordinated approach to synthetic biology research and development across the government. A mechanism or body should be identified to: (1) leverage existing resources by providing ongoing and coordinated review of developments in synthetic biology, (2) ensure that regulatory requirements are consistent and non-contradictory, and (3) periodically and on a timely basis inform the public of its findings. Additional activities for this coordinating body or process are described in other recommendations. Because synthetic biology poses some unusual potential risks, as ―amateur‖ or ―do-it-yourself‖ (DIY) scientists and others outside of traditional research environments explore the field, these risks must be identified and anticipated, as they are for other emerging technologies, with systems and policies to assess and respond to them while supporting work toward potential benefits. Recommendation 5: Risk Assessment Review and Field Release Gap Analysis Because of the difficulty of risk analysis in the face of uncertainty—particularly for low-probability, potentially high-impact events in an emerging field—ongoing assessments will be needed as the field progresses. Regulatory processes should be evaluated and updated, as needed, to ensure that regulators have adequate information. As part of the coordinated approach urged in Recommendation 4, the Executive Office of the President should convene an interagency process to discuss risk assessment activities, including reasons for differences and strategies for greater harmonization across the government. It should also identify any gaps in current risk assessment practices related to field release of synthetic organisms. These reviews should be completed within 18 months and the results made public. Coordination and careful risk analysis are essential steps for responsible stewardship, but they are not sufficient. There are several additional approaches, which are known today and continue to evolve as our abilities in this field grow, to limit uncertain risks in synthetic biology. Technology can be harnessed to build in safeguards. A number of safety features can be incorporated into synthetic organisms to control their spread and life span. Surveillance or containment of synthetic organisms is a concrete way to embrace responsible stewardship. Recommendation 6: Monitoring, Containment, and Control At this early stage of development, the potential for harm through the inadvertent environmental release of organisms or other bioactive materials produced by synthetic biology requires safeguards and monitoring. As part
  12. 12. 12 of the coordinated approach urged in Recommendation 4, the Executive Office of the President should direct an ongoing review of the ability of synthetic organisms to multiply in the natural environment and identify, as needed, reliable containment and control mechanisms. For example, ―suicide genes‖ or other types of self-destruction triggers could be considered in order to place a limit on their life spans. Alternatively, engineered organisms could be made to depend on nutritional components absent outside the laboratory, such as novel amino acids, and thereby controlled in the event of release. The timing of deliberate release of synthesized organisms into the environment and the need to analyze risks prior to release raises special concern. We must proceed carefully, particularly when the probability or magnitude of risks are high or highly uncertain, because biological organisms may evolve or change after release. For any field release, there must be adequate consideration of risk. Recommendation 7: Risk Assessment Prior to Field Release Reasonable risk assessment should be carried out, under the National Environmental Policy Act or other applicable law, prior to field release of research organisms or commercial products involving synthetic biology technology. This assessment should include, as appropriate, plans for staging introduction or release from contained laboratory settings. Exceptions in limited cases could be considered, for example, in emergency circumstances or following a finding of substantial equivalence to approved products. The gap analysis described in Recommendation 5 should determine whether field release without any risk assessment is permissible and, if so, when. Synthetic biology is an international enterprise. Oversight and regulatory mechanisms should adopt an analogous approach, so that the United States is involved in regular discussions with other national and transnational organizations so they may seek coordination and consistency when possible. Recommendation 8: International Coordination and Dialogue Recognizing that international coordination is essential for safety and security, the government should act to ensure ongoing dialogue about emerging technologies such as synthetic biology. As part of the coordinated approach urged in Recommendation 4, the Executive Office of the President, through the Department of State and other relevant agencies such as the Department of Health and Human Services and the Department of Homeland Security, should continue and expand efforts to collaborate with international governments, the World Health Organization, and other appropriate parties, including international bioethics organizations, to promote ongoing dialogue about emerging technologies such as synthetic biology as the field progresses. Responsible conduct of synthetic biology research, like all areas of biological research, rests heavily on the behavior of individual scientists. Creating a culture of responsibility in the synthetic biology community could do more to promote responsible stewardship in synthetic biology than any other single strategy. There are actors in the world of synthetic biology, namely engineers, chemists, materials scientists, computer modelers, and others, who practice outside of conventional biological or medical research settings. These groups may not be familiar with the standards for ethics and responsible stewardship that are commonplace for those working in biomedical research. This poses a new challenge regarding the need to educate and inform synthetic biologists in all communities about their responsibilities and obligations, particularly with regard to biosafety and biosecurity. Recommendation 9: Ethics Education Because synthetic biology and related research cross traditional disciplinary boundaries, ethics education similar or superior to the training required today in the medical and clinical research communities should be developed and required for all researchers and student-investigators outside the medical setting, including in engineering and materials science. As part of the coordinated approach urged in Recommendation 4, the Executive Office of the President, in consultation with the National Academy of Sciences, the National Academy of Engineering, the scientific community, and the public, should convene a
  13. 13. 13 panel to consider appropriate and meaningful training requirements and models. This review should be completed within 18 months and the results made public. Additionally flowing from the principle of responsible stewardship, the Commission observed that careful and deliberate attention should be paid to discussions of potential moral objections as the field advances. Such moral objections include concerns that synthetic biology may conflict with essential conceptions of human agency and life; that its overall impact may be harmful to biodiversity, ecosystems, or food and energy supplies; and that it may fail to respect the proper relationship between humans and nature. The Commission devoted particular time and attention to discussing these possible moral objections during its deliberations. It heard relatively few objections from religious or secular ethicists concerning the present status of the field. Although the field currently is capable of significant but limited technical achievements, potential developments might raise further moral objections—for example, applications relying on the synthesis of genomes for higher order or complex species. Current objections to synthetic biology on moral grounds are often based on concerns regarding activities that the field is currently incapable of carrying out. However, continued evaluation and efforts to reach and maintain consensus will be needed as this field develops. Recommendation 10: Ongoing Evaluation of Objections Discussions of moral objections to synthetic biology should be revisited periodically as research in the field advances in novel directions. Reassessment of concerns regarding the implications of synthetic biology for humans, other species, nature, and the environment should track the ongoing development of the field. An iterative, deliberative process, as described in Recommendation 14, allows for the careful consideration of moral objections to synthetic biology, particularly if fundamental changes occur in the capabilities of this science and its applications. Promoting Intellectual Freedom and Responsibility The principle of intellectual freedom and responsibility asserts that restrictions on research, whether by self-regulation by scientists or by government intervention, should limit the free pursuit of knowledge only when the perceived risk is too great to proceed without limit. A moratorium at this time on synthetic biology research would inappropriately limit intellectual freedom. Instead, the scientific community—in academia, government and the private sector— should continue to work together to evaluate and respond to known and potential risks of synthetic biology as this science evolves. This effort may require the government to expand current oversight or engagement activities with non-institutional researchers. National Institutes of Health or the Department of Energy, for example, could be charged to sponsor education programs and workshops that bring together these groups. They could fund training grants or related programs to promote a culture of responsibility among this community. To exercise the appropriate level of oversight, the government will need to monitor the growth and capacity of researchers outside of institutional settings. Recommendation 11: Fostering Responsibility and Accountability The government should support a continued culture of individual and corporate responsibility and self-regulation by the research community, including institutional monitoring, enhanced watchfulness, and application of the National Institutes of Health Guidelines for Recombinant DNA Research. As part of the coordinated approach urged in Recommendation 4, the Executive Office of the President should evaluate, and re-evaluate periodically, the effectiveness of current research oversight mechanisms and determine what, if any, additional steps should be taken to foster accountability at the institutional level without unduly limiting intellectual freedom. Academic and private institutions, the public, the National Institutes of Health, and other federal funders of synthetic biology research should be engaged in this process. An initial assessment should be completed within 18 months and the results made public. The norms of safe and responsible conduct that have evolved over time for many researchers in institutional settings may not be understood or followed by those new to the field or outside of these settings. It is important to note that presently there appears to be no serious risk of
  14. 14. 14 completely novel organisms being constructed in non-institutional settings including in the DIY community. Scrutiny is required to ensure that DIY scientists have an adequate understanding of necessary constraints to protect public safety and security, but at present the Commission sees no need to impose unique limits on this group. Recommendation 12: Periodic Assessment of Security and Safety Risks Risks to security and safety can vary depending on the setting in which research occurs. Activities in institutional settings, may, though certainly do not always, pose lower risks than those in non-institutional settings. At this time, the risks posed by synthetic biology activities in both settings appear to be appropriately managed. As the field progresses, however, the government should continue to assess specific security and safety risks of synthetic biology research activities in both institutional and non-institutional settings including, but not limited to, the ―do-it-yourself‖ community. As part of the coordinated approach urged in Recommendation 4, the Executive Office of the President, working with the Department of Homeland Security, the Federal Bureau of Investigation and others, should undertake and periodically update this assessment. An initial review should be completed within 18 months and the results made public to the extent permitted by law. Certain risks—generally involving national security—often warrant additional protections. Completely free exchange of data and materials might endanger public safety, but unilateral action to limit exchange could damage American research efforts in synthetic biology if U.S. scientists and students are excluded from full collaboration with the international community. Several recent advisory groups have recommended ongoing discussions among research universities, industry, and government on this topic. The Commission agrees that scientists should be actively engaged in these debates. Recommendation 13: Oversight Controls If the reviews called for in Recommendation 12 identify significant unmanaged security or safety concerns, the government should consider making compliance with certain oversight or reporting measures mandatory for all researchers, including those in both institutional and non-institutional settings, regardless of funding sources. It may also consider revising the Department of Commerce‘s export controls. Any such change should be undertaken only after consultation with the scientific, academic, and research communities and relevant science and regulatory agencies such as the National Institutes of Health, the Department of Homeland Security, and the Environmental Protection Agency. Export controls should not unduly restrain the free exchange of information and materials among members of the international scientific community. Promoting Democratic Deliberation Through democratic deliberation, questions about synthetic biology can be explored and evaluated on an ongoing basis in a manner that welcomes the respectful exchange of opposing views. This principle yields several opportunities for government and non-government actors alike to work together to ensure that synthetic biology advances in ways that respect divergent views and that avoid some of the misunderstanding and confusion, which at times, have hampered other scientific endeavors. To enhance democratic deliberation and thereby ensure that the progress in synthetic biology is widely understood and policy choices are thoughtfully considered, the Commission makes the following recommendations. Recommendation 14: Scientific, Religious, and Civic Engagement Scientists, policy makers, and religious, secular, and civil society groups are encouraged to maintain an ongoing exchange regarding their views on synthetic biology and related emerging technologies, sharing their perspectives with the public and with policy makers. Scientists and policy makers in turn should respectfully take into account all perspectives relevant to synthetic biology. Recommendation 15: Information Accuracy When discussing synthetic biology, individuals and deliberative forums should strive to employ clear and accurate language. The use of sensationalist buzzwords and phrases such as ―creating life‖ or ―playing God‖ may initially increase attention to the underlying science and its implications for society, but ultimately such
  15. 15. 15 words impede ongoing understanding of both the scientific and ethical issues at the core of public debates on these topics. To further promote public education and discourse, a mechanism should be created, ideally overseen by a private organization, to fact-check the variety of claims relevant to advances in synthetic biology. This publicly accessible fact-check mechanism is among the most concrete ways by which public perception and acceptance of emerging technologies could be improved. Education also plays a key role in building public support for otherwise unfamiliar technologies. In light of our Nation‘s dependence on socially responsible scientific innovation for economic progress and individual well-being, the urgency of expanding effective science and ethics education cannot be exaggerated. Dialogue among individuals and public, private, and community groups demonstrates that science and its oversight do not belong exclusively to experts, highly trained professionals, or government officials. Science is a shared resource, affecting and belonging to all citizens. Recommendation 16: Public Education Educational activities related to synthetic biology should be expanded and directed to diverse populations of students at all levels, civil society organizations, communities, and other groups. These activities are most effective when encouraged and supported by various sources, not only government, but also private foundations and grassroots scientific and civic organizations. As part of the coordinated approach urged in Recommendation 4, the Executive Office of the President, with input from the scientific community, the public, and relevant private organizations, should identify and widely disseminate strategies to promote overall scientific and ethical literacy, particularly as related to synthetic biology, among all age groups. Promoting Justice and Fairness The principle of justice and fairness, at this very early stage of synthetic biology, yields two general recommendations that can be applied to both this technology and other emerging technologies. It directs those in government to consider rules for distribution of risks and benefits in research, and it directs those both in and outside of government to consider processes for just distribution of benefits and risks. Recommendation 17: Risks in Research Risks in research should not be unfairly or unnecessarily borne by certain individuals, subgroups, or populations. As part of the coordinated approach urged in Recommendation 4, the Executive Office of the President should lead an interagency evaluation of current requirements and alternative models to identify mechanisms that ensure that the risks of research in synthetic biology, including for human subjects and other affected parties, are not unfairly or unnecessarily distributed. Relevant scientific, academic, and research communities, including those in the private sector, should be consulted. This review should be completed within 18 months and the results made public. Recommendation 18: Risks and Benefits in Commercial Production and Distribution Risks to communities and the environment should not be unfairly distributed. Manufacturers and others seeking to use synthetic biology for commercial activities should ensure that risks and potential benefits to communities and the environment are assessed and managed so that the most serious risks, including long-term impacts, are not unfairly or unnecessarily borne by certain individuals, subgroups, or populations. These efforts should also aim to ensure that the important advances that may result from this research reach those individuals and populations who could most benefit from them. As part of the coordinated approach urged in Recommendation 4, the Executive Office of the President should evaluate current statutory mandates or regulatory requirements for distribution of risks and benefits and consider developing guidance materials and voluntary recommendations to assist manufacturers as appropriate. ( Ref. NEW DIRECTIONS - The Ethics of Synthetic Biology and Emerging Technologies, Presidential Commission for the Study of Bioethical Issues Dec. 2010, Washington D. C. )
  16. 16. 16 Ethical Concerns Ethics is a narrower concept than morality, and it can be used in several different, though related, senses. The most general of these: ―...suggests a set of standards by which a particular group or community decides to regulate its behaviour – to distinguish what is legitimate or acceptable in pursuit of their aims from what is not. Hence we talk of ‗business ethics‘ or ‗medical ethics.‘‖ More technically, ethics can also refer to a particular branch of philosophy which tries to analyse and clarify the arguments that are used when moral questions are discussed and to probe the justifications that are offered for moral claims. So ethics in this sense puts our moral beliefs under the spotlight for scrutiny. Idea of what is morally correct differs between different individuals, different cultures and in different periods of history. To call something a moral concern, then, does not necessarily mean that it is of much ethical significance. A number of surveys have shown that, if asked, people will express moral concern about modern biotechnology, but this does not tell us whether they have done any ethical thinking about the issues. According to this suggested distinction, then, moral concerns are felt about what it is right or wrong to do, while ethical concerns are about the reasons and justifications for judging those things to be right or wrong.  No new scientific or technological development can claim immunity against ethical scrutiny.  Science cannot be pursued in complete moral and ethical vacuum in civilized society.  In fact legal and regulatory system should be based upon ethical basis.  Moral and ethical concerns are of considerable importance in influencing ‗consumer acceptance‘ of science and technology. Basic categories of moral or ethical concerns regarding modern biotechnology fall into two classes: intrinsic and extrinsic (Comstock 2000; Hamid 2000). Extrinsic objection refers to the concerns regarding the application of the technologies such as the possible risks of different application of biotechnology, consumer ‘s right and patenting issues. All these issues need to be addressed as they have far-reaching consequences on the safety of human, environment and society.
  17. 17. 17 Chapter 2 Ethics in Biotechnology Research Research ethics Research ethics can be described in terms of ethics of the topics and findings (morality) and secondly as ethics of method and process (integrity). Institutions that practice research have adopted professional codes relating to research ethics that all include principles of honesty, objectivity, integrity, confidentiality, carefulness, openness, competence, and respect for intellectual property, responsible publication, responsible mentoring, and respect for colleagues, social responsibility, non-discrimination, legality and animal care. Objectivity in research gives researchers trustworthiness. This applies to both the a priori tasks of setting up the research and gathering the data and in the posteriori tasks of interpreting and publishing the results. The socialist Robert Merton published four norms of science in 1973 that are widely shared by scientists and non-scientists alike. These norms are:  Universalism that stipulates that scientific accomplishments must be judged by impersonal criteria;  Communism (as in communalism) that requires that scientific information is shared publicly;  Disinterestedness that cautions researchers to proceed objectively; and  Organized skepticism that requires that new findings are scrutinized through peer review, replication, and the testing of rival hypotheses. It is of growing concern how often research integrity is currently being challenged, and how common ―unprofessional‖ behaviour seems to be in research today. Research misconduct involves (i) fabrication, (ii) falsification, (iii) plagiarism and (iv) misappropriation. Researchers knowingly or intentionally ignore some of the most fundamental rules of research. Experimental designs and analyses are biased, results are reported inaccurately or incompletely or are fabricated, and improper credit is given to colleagues. Institutions take allegations of research misconduct seriously and have formal procedures to investigate such allegations. Potential misconduct is regarded with seriousness and requires in-depth investigation. Decisions are taken concerning the presence of misconduct and its severity, and appropriate corrective actions are taken, if needed. It is expected that both the person that reports possible misconduct, the whistleblower, and the person suspected of misconduct, the responder, are treated with "fairness and respect". In research that involves animals, adherence to a code of practice that ensures the ethical and humane care and use of animals used for scientific purposes is imperative. It is generally accepted in the scientific community that when animals are used, the principles of replacement, reduction and refinement (3Rs) should be taken into account:  Replacement requires that wherever possible, techniques that totally or partially replace the use of animals for scientific purposes must be sought;  Reduction requires that research projects must use no more than the minimum number of animals necessary to ensure scientific and statistical validity and should not be implemented at the expense of greater suffering of individual animals. The use of animals must not be repeated unless essential for the purpose or design of the project; and  Refinement requires that animals must be suitable for the scientific purpose and that their welfare should be of primary consideration in the provision of their care. Projects should be designed to avoid both pain and distress in animals. If this is not possible, pain or distress must be minimized.
  18. 18. 18 Ethics in Biotechnology People are able to give answer to the question as to whether computers and Information Technology, mobile phones, solar energy, space research, nuclear energy will cause benefits or harm or have no effects. But when asked about nanotechnology they have ignorance of it. And when asked about impact of biotechnology all seem to have awareness and education in all the countries and can balance between risks and benefits. That shows the ―Bioethical Maturity‖ of the society. ―Do not know‖ answer was given by 22% and 42% people for impact of Biotechnology and Nanotechnology in 2005 while 12% people clearly said that biotechnology will deteriorate things. Ethical issues, public debate, media coverage and public policy decisions played important role in development of biotechnology. Respect for biodiversity was considered as bioethical principle and was felt important by proponents as well as opponents of GM crops. Ethical objections are there for using agricultural produce for energy rather than for food. NGOs such as Friends of the Earth (FOE) have adhered to the view that biofuels triggered a "competition for food between cars and people". Concerns have also been expressed that the global support for biofuels, leading to rising food prices, would create temptations for farmers to cultivate once virgin lands. In developed countries, environmental associations deeply involved in the conservation and management of wetlands and set-aside lands, such as Ducks Unlimited in the United States and Canada, Birdlife International and WWF have deemed there was a high risk that set-aside lands, vital for many bird species and benefiting from specific protections in Europe and Northern America, could be used to grow biofuel crops. Moreover, within developing countries from Asia and South-America, this has led to massive action networks from international and local NGOs, all opposed to what they consider to be the gradual destruction of primitive forests and wilderness. Europe's consumption of biodiesel was causing deforestation and the destruction of natural habitats in Indonesia and Malaysia. Palm oil production for biofuel though seems to have marginal effect is not in right direction. In Brazil also it is claimed that the expansion of sugar cane crops to produce ethanol on lands once devoted to food production is causing food crop producers to move closer to Pantanal wetlands and Amazonian rainforest. The most important international NGOs, including Friends of the Earth, see first-generation biofuels, such as ethanol derived from corn or cane or biodiesel from rapeseed oil as environmentally and ethically unfriendly. Approaches in Ethical Thinking For practicing ethics first we have need thinking of ethics. Margaret R. McLean from Santa Clara University in USA has discussed framework of ‗Thinking Ethically about Human Biotechnology‘. Accordingly, the science of ethics asks us to justify our actions and account for our intentions. It is not enough just to intend the good or to do something to bring it about. We must give good reasons why we do what we do. In the area of biotechnology, our reasoning needs to address three main areas:  Incentives, or the ways that we encourage scientists to do particular kinds of research  Intentions, or the goals of that research  Actions, or the potential applications of research results Many of the biotechnologies have developed in unanticipated way and ethical framework did not exist to answer most of the questions which were raised suddenly. People need to be educated to understand these developments and hence methods, experimental results should be told to public in general and media in particular to avoid overreactions and wrong reactions. Giving results before publications is problematic and hence only responsible scientifically oriented scientists should be informed about it.
  19. 19. 19 1. Ethical Reasoning: Ethics deals with what ought to be. How do we responsibly move from what is to what ought to be? It is the job of philosophical ethics to provide standards that help us identify what ought to be done. 2. Utilitarianism: It is important to understand as to who will be affected and to what extent each stakeholder will be benefited or harmed. In the utilitarian view, an ethical action is the one that produces the greatest balance of good over harm or the greatest good for the greatest number of people. Regarding research in human molecular genetics, for example, the utilitarian might argue that the potential benefit of relieving human suffering outweighs the possible dangers of manipulating human genes and evolution through germ-line intervention. 3. Rights: What makes human beings more than mere things is our ability to choose freely what type of lives to lead and the right to have our choices respected. This view from rights describes an ethical action as that which protects people from being used in ways that they do not choose. Importantly, each human has a right not to be treated as means to another's end, even an undeniably good end. The right not to be used encompasses other rights: the right to be told the truth, the right to privacy, and the right not to be harmed are among those particularly relevant to biotech research and genetic medicine. For example, respecting rights may set limits on human subject research in molecular genetics by requiring adequate informed consent including an honest assessment of risks and benefits, or it may require that experimental gene transfer therapy be undertaken only as a last resort. In this view, actions that violate individual or human rights are wrong. 4. The justice approach to ethics is rooted in the principle of "treating equals equally and unequals unequally." Justice mandates fairness in that people must be treated the same way unless they differ in ethically relevant ways. For example, when two runners cross the finish line at the same time, it is unfair to award the blue ribbon to one and not to other unless, until someone has cheated. The primary form of justice in medicine and medical research is distributive justice, which is concerned with the fair distribution of benefits and burdens across society. Distributive justice seeks clarity regarding those aspects of individuals and society that may justify drawing distinctions in how benefits and burdens are allocated. That is, it seeks to identify under what conditions treating unequals unequally would be justified. Such material conditions could include distribution based on determinations of need, social worth, contribution, or effort. For example, the principle of need would support mechanisms for providing access to cutting-edge treatments to all who would tangibly benefit irrespective of their ability to pay for them. A principle of contribution might suggest that a family who sponsored research into an illness might have more influence on the direction of the research and greater access to its fruits than the rest of us. 5. The common good rests on a vision of society in which all people join in the pursuit of shared values and aims. Because individual good is inextricably woven into the good of the whole community, pursuing the common good includes creating a set of general conditions that are equally to everyone's advantage. Together with respecting individual rights and freedoms, the common good approach requires that common goals, such as human health and well being, be pursued through biotech innovation and a stable health care infrastructure. 6. A consideration of virtue assumes that certain ideals allow for the full development of our humanity. A person, who has inculcated these core ideals, or virtues, will do what is right when faced with an ethical choice. Virtues are dispositions that facilitate acting in ways that develop human potential and allow human flourishing. Virtues are good habits in that they are acquired through repetition and practice and, once acquired, they
  20. 20. 20 become characteristic of a person. Honesty, integrity, prudence, courage, wisdom, and compassion are examples of virtues. Once a person has developed a virtuous character, his or her inclination is to act in ways consistent with ethical principles. In much the same way as Barry Bonds is inclined to hit home runs, the virtuous person will be inclined to tell the truth and act with compassion and courage. Reasoning into Biotech Practice The above approaches suggest that biotech ethics should ask five questions.  What benefits and what harms can be predicted for biotech innovations in both the research and application phases, and which courses of action will result in the best consequences overall? It is important to remember that determining consequences is more or less a guessing game. In instances of profound uncertainty and sizable risk, it is best to err on the side of caution when calculating benefits and risks. Neither hopes nor fears should be over-sold.  Who are the ethically relevant stakeholders, and what rights do they have? Which course of action protects those rights? Is human dignity respected? The consideration of specific individual and group rights requires coming to grips with the right to health care—a right that Americans claim but which remains unfulfilled for many.  Which option treats everyone the same unless there is an ethically justified reason to treat them differently? Biotech justice might hold up "need" as a criterion for access to innovative treatments.  Which course of action seeks the common good? Certainly, the recent SARS epidemic has heightened concern for the health of the whole and for the creation of common conditions that maximize individual and communal well being.  Which option best develops virtues? And which virtues, such as trust and compassion, might be particularly relevant to biotech development and human health? Biotechnology‘s benefits are heavily advertised. Its risks are too little discussed. Although the techniques are too powerful and negative impacts are but natural side-effects, we cannot afford to be ignorant about ethical, social, economical, legal, and environmental and health impacts of this technology. In fact all these issues are closely associated and distinction is only for convenience. Questions arise specifically from nature of technology, commercial interests, uneven distribution of benefits, possible environmental risks and exploitation poor nations‘ genetic resources by rich nations. Some common questions are – (a) Who benefits from the technology? Who loses? (b) What have been the alternatives forgone? (c) To whose needs the biotechnology respond? (d) What are the social goals and ethical criteria that guide the research in biotechnology? Ethics in Biotech Research Deliberations should be there between scientists, layman on ethical issues associated with such scientific research. The science of ethics asks us to justify our actions and account for our intentions. It is not enough just to intend the good or to do something to bring it about. We must give good reasons why we do what we do. In the realm of biotechnology, our reasoning needs to address three main areas:  Incentives, or the ways that we encourage scientists to do particular kinds of research  Intentions, or the goals of that research  Actions, or the potential applications of research results
  21. 21. 21 Instead of over-reacting afterwards it will be appropriate to discuss the possible impacts in advance. Ethics is about questions: about who asks, what they ask for, and how we as individuals and communities respond. In reference to biotechnology, what questions should be posed? What aspects should be considered? For Biotechnology research we must try to see the personal, social impacts and also potential impacts on values, virtues, relationships, human rights. Are the benefits and burdens distributed fairly? Does biotechnology advance or impede the common good? What are the risks, burdens, and benefits? On whom do they fall? How are they distributed? What is an acceptable way to achieve a given benefit? May we do anything, as long as the outcome is good on balance? Or are there limits on what we do, even in the name of human health? And, what—or whom—have we not thought about? Get the facts. Many disagreements result from not grasping the facts of the matter. It is impossible to make sound judgments about the appropriate uses of genetic testing, for example, without understanding some genetic science and the nature of the information gathered through such testing. It is incumbent upon scientists and others working in biotechnology to educate the public in general, and the media in particular, about the scientific method and experimental results. The trend toward releasing experimental results to the press before publication in a peer-reviewed journal, which is problematic in and of itself, at least requires scientifically savvy journalists whose duty is, in turn, to provide an adequate set of facts to the public. Ethical Issues related to Medical Genetics 1. Informed Consent 2. Commercial Involvement and Conflict of Interests 3. New and Controversial research 4. Research involving human embryo 5. Fetal tissue transplant research 6. Researcher‘s relations with the media 1. All participation in research should be voluntary and should follow established procedures for informed consent. Participation or refusal of participation in research should not affect a person's health care in any way. If research involves children or fetuses, the parent or guardian should give consent with the knowledge and assent of the child if the child is able to understand. Individuals participating in genetic research projects may be required to provide a family history. This is different than that provided to family physician for treatment purpose. Whether relatives‘ consent is necessary is still an unsorted issue. 2. Prospective participants in research should also be informed of the sponsorship of research, so that they can be aware of the potential for conflicts of interest. If academic institutes are carrying out research in alliance with industry then there are possible conflicts of interest between researchers' scientific responsibilities and business interests (e.g., ownership or part ownership of a company developing a new product). 3. In human genetic disorders, the more knowledge of natural history and the specific genetic mechanisms that cause them, the greater the likelihood of developing diagnosis and therapy. Therapy will evolve both in terms of new drugs to ameliorate the expression of harmful genes and in terms of human gene therapy. Some disorders literally begin in the embryonic state or very early after implantation. Rational assessment should be done of the research with respect to fetus or embryo instead of categorical rejection based on fear. Rational approaches to fetal and embryo research are possible, even in
  22. 22. 22 societies with conservative moral traditions. Every society ought to support national research ethics commissions to debate and recommend guidelines to control possible abuses in fetal and embryo research, as well as to outline standards under which ethically acceptable research can be done. It will be incorrect to close the avenue of research instead of having rational ethical approach. 4. Both moral judgement and social judgement are important while discussing research on human embryos. (1) a moral judgment as to the status of human embryos prior to implantation and (2) a social judgment about the degree of protection in research that should be accorded to human embryos as a class. The embryo does not have the same moral status as infants or children, although it deserves respect and serious moral consideration as a developing form of human life. This judgment is based on three characteristics of pre-implantation embryos: absence of developmental individuation, no possibility of sentience, and a high rate of natural mortality at this stage. 5. Many sufferers from neurological disorders, such as Parkinson's disease, may stand to benefit from transplants of fetal cells. Fetal tissue may become beneficial in treatment of such widely varying conditions as Alzheimer disease, spinal column injuries, diabetes, and Hurler syndrome. Tissue from fetuses spontaneously aborted is not optimal for transplants, because it may be macerated, infected, or otherwise inadequate for therapy. Opponents of use of fetal tissue have argued that it will increase the number of social abortions. In reality, no woman has a social abortion primarily in order to donate tissue for research. Use of fetal tissue should be allowed, provided that (a) the woman consents; (b) the woman is not paid for the tissue; (c) the tissue will go to an anonymous recipient, not known to the woman who donates it; (d) the woman has decided upon the abortion before being asked to donate tissue; (e) the researcher is not the doctor who performed the abortion; (f) no third party is paid for the tissue; and, (g) the abortion is not delayed to recover more or better prepared material. Anonymity of the recipient is important, in order to prevent the possibility that a woman might conceive (or be coerced to conceive) a fetus for the purpose of donating tissue to a family member. 6. Researchers have a responsibility to make sure that the public is accurately informed about results without raising false hopes or expectations. Researchers should take care to avoid talking with journalists or reporters about preliminary findings. Sometimes the media report potentially promising research that subsequently cannot be validated. Sometimes the media report research on animals in such a way that the public thinks that the step to treatment for humans is an easy one. Retractions almost never appear in the popular press or on television. Therefore it is important to avoid premature reports. The best safeguard against inaccurate reporting is for the researcher to require, as a condition for talking with the media, that the reporter supply a full written or oral version of what will be reported, so that the researcher can make any necessary corrections. Ethical Issues are expressed in following areas related to biotechnology • Human cloning • Clinical Trials • Gene therapy • Genetic testing • Genetic engineering of crops • Genetically modified Foods • Transplantations • Patenting of genes, life forms
  23. 23. 23 (1) Should we alter the genetic structure of entire living kingdom in the name of utility and profit? Is there something sacred about life, or should life forms, including humans be viewed simply as commodities in the new biotechnological market? (2) Is the genetic makeup of all living things the common heritage of all, or it can be appropriated by the corporations and thus become property of few? Who has given rights to the individual companies the right to the monopoly over entire group of organisms? Is it possible to minimize ethical concerns and reduce environmental risks while keeping the benefits? (3) Do biotechnologists feel as masters of nature? Are we trying to play God? Should we become architects of life? Crossing taxonomic boundaries in genetic exchanges which has resulted into inserting of animal genes into human or human genes into animals and inserting plant genes into microorganisms and other species is not ethically correct. Is this an illusion constructed on scientific arrogance and conventional economics, blind to the complexity of ecological process? Do we have respect for life of other living forms? (4) How correct it is ethically to do patenting of genes or patenting of life forms? It‘s a common heritage. Owning something that is common heritage by few is an ugly idea. Patenting genetically engineered animals is equating it to the status of manufactured product. Will living things have no more intrinsic value than automobiles or garments or any other commodity? (5) Use of biotechnology in reproductive biology and genetic screening brings unique questions of discrimination, exploitation of women. (6) Transfer of genes from one species to another may be unethical for certain reason such as (i) transfer of human genes to food animals e.g. transfer into sheep of gene of factor IX (blood clotting factor) (ii) transfer of genes from animals whose flesh is forbidden for use as food by certain religious groups to animals that they normally eat (e.g. pig genes to sheep) would offend Jews and Muslims (iii) transfer of animal genes to plants can be of concern to vegetarians (iv) use of human genes in animal feed e.g. yeast modified to produce human proteins of pharmaceutical value and spent yeast then used as animal feed. Products from transgenic organisms containing copy of genes that are ethically unacceptable to some with dietary restrictions. (7) Can the definition of ―Human‖ be applied to altered species containing human genes? If we create a ‗being‘ that has ability to speak and perhaps even reason but looks like a dog or chimp, should that being be given all the rights and protection of human being? Some bioethicist argue that the definition of human being should be more expansive and protective rather than more restrictive. Others argue that definition which are expansive could be denigrating to humanity status and create a financial disincentive to patenting creations that could be of use to humanity. (8) Is it ethical to create altered animals that may suffer? The risks and benefits of experimental use of animals need to be discussed as well. Similarly by combining animal DNA, human DNA and plant DNA, do we run the risk of creating new diseases for which there is no treatment? The long-term risks to the environment are unknown. It is wrong to create ―monsters‖ or animals that would suffer as a result of genetic alteration (for example a pig with no legs) and that such experiment should be banned. (9) Is it possible that technology may be used to create slaves? Several bioethicists have called for a ban on species-altering technology that such ban would be enforced in international tribunal. Part of the rationale for ban is the concern that such technology may be used to create slave race, a race of sub-humans that would be exploited. In April 1998, scientists Jeremy Rifkin and Stuart Newman who are both opposed to GMOs applied for a patent for ―humanzee‖ part human and part chimpanzee to fuel the debate
  24. 24. 24 and draw attention to potential abuses on this issue. USPTO denied the patent on the grounds that it violated 13th amendment of US constitution, which prohibits slavery. (10) Genetic experiments and possible misuse – (i) Embryo with mixed gender developed during the experiment of transfer of embryo cells for getting rid of genetic defect. (ii) Aborted fetus of second trimester – ovary cells obtained – could become source of eggs. (11) Prenatal Diagnosis – As research to correlate genetic status with predisposition to disease has accelerated so has the concern that participation in such studies creates the risk of genetic discrimination and emotional distress. (12) Diagnostic procedures may neglect individual privacy, rights. Anybody‘s blood sample or few cells are enough to do the genetic fingerprinting. Information can be misused. Watson insisted on knowledge of a person and parents about such investigations and their proper consent. There is need to broaden disclosure during consent process to ensure that potential subjects understand these risks and other issues and to address them in consent form (marriage, insurance, employment etc.) (13) The development of individualized medicine (customized genotype based therapies) raise ethical concerns for the conduct of research with human subjects, particularly with respect to confidentiality, risk-benefit analysis, DNA banking, and pharmacological issues. (14) Ethical issues that surrounds the use of genotyping in clinical pharmacogenetics research are – The selection of ‗human‘ ‗research subjects‘ for clinical trials is of increasing concern to ethicists and research ethics committee and recent attention has focused on the eligibility criteria for such trials. One crucial question raised by the current and possible future uses of genotyping in clinical trials is whether it is justifiable to select specific group of individuals for research protocol based on their genotype. What will be the social implications? What will be the chances of discrimination? What about confidentiality? What about psychological effects on the subject? The principle of respect to the communities should be added in ethical considerations. Organ Transplants and Embryological Tissue Many lives are prolonged or saved every year through organ transplants. The National Organ Transplantation Act prohibits the sale of human tissue and organs for transplantation. This prohibition does not apply to non-transplantation purposes, including the sale of organs and other parts, such as embryological tissue, for research. There is disagreement on the issue of what constitutes a human person with all the moral rights appertaining to that status. Some believe that this status is established at the moment of conception. If that is the case then no manipulation of the early embryo, other than for its own direct benefit, could be ethically justified. Others, however, take a more developmental view of the way in which a human foetus grows into a person, with the dawning of sentience and eventually of mentality. This latter view forms the basis of the legal restriction in the UK on research using embryos to the 14-day period before the development of the primitive streak. Fetal organs and tissue are believed by some researchers to be essential to research that might lead to alleviation of Parkinson's disease, diabetes, and other serious illnesses. There are some good moral arguments in favor of germline genetic intervention, whose goal is to prevent or alleviate disease or disability. Such intervention is more efficient than repeating gene therapy generation after generation, and even in utero gene therapy is too late for some diseases. The one case that could justify nuclear transfer in the early embryonic stage, is that in which a woman is likely to pass on a mitochondrial disease to her offspring. In such a situation, after in vitro fertilization it would be justified at perhaps the four-cell stage to remove all the cells' nuclei and fuse them with enucleated egg cells from a donor. Because mitochondria are in the
  25. 25. 25 cytoplasm and would be derived from the donor, the resulting embryos would be free from mitochondrial disease. cell-nuclear-replacement (CNR) techniques (No decision on permission in UK.) This type of case would involve simultaneous germline intervention and cloning in the technical sense. The federal government banned federally funded human embryology research for 15 years, (1979 to 1994), although some research continued with private funding. President Clinton has ordered that no federal funds be spent on embryos created for research. However, the order did not specifically forbid support for research on human embryos. The National Institutes of Health convened an ad hoc Human Embryo Research Panel to examine the issue of embryo research. In 1994, the panel found that such research could make substantial contributions and agreed that pre-implantation embryos should receive serious moral consideration but not to the same degree as infants and children. The panel restricted its attention to research on pre-implantation embryos, or multi-cell clusters that are less than 14 days old and that are without a definite nerve system. The panel recommended an advisory process and contended that federal funding would help to establish consistent public review of the research. Researchers obtain fetal tissue from hospitals and clinics. Some clinics have developed an informed consent form for patients giving permission to use fetal tissue from an aborted fetus for research or organ transplant. It is observed that "there has been virtually no effective policing of fetal organ harvesting by the federal government or any state agency," and that such appears unlikely. On April 23, 2009, NIH published draft guidelines allowing funding for research on stem cells derived from donated embryos leftover from fertility treatments, provided that certain conditions be met, such as the voluntary informed consent of donors. NIH would continue to fund research on adult stem cells and induced pluripotent stem cells, which are adult cells that have been directed by scientists to take on properties of embryonic stem cells. However, it would not fund research on embryos created specifically for research or on stem cells derived by research cloning techniques or by parthenogenesis (a method that uses unfertilized egg cells) Ethics approval and Biotechnology Research In biotechnology research, the usual ethical principles applicable to health research involving animals and human participants must be observed and such research must be scientifically sound. Any research project should be subject to the review of Ethics Committee who must review the ethical and scientific rigor of the proposed research. The objects of Research Ethics Committees are to:  Maintain ethical standards of practice in research;  Protect research participants and investigators from harm or exploitation;  Preserve the research participant‘s rights which take preference over society‘s rights; &  Provide assurance to the public that research is conducted ethically. Guiding Principles This guideline addresses the ethics of research to ensure compliance with the basic ethical values of beneficence, non-maleficence, justice and respect for persons. Furthermore, the guideline aims to identify good, desirable and acceptable conduct in research which promotes the welfare and rights of research participants.
  26. 26. 26 Any research, including biotechnology research must conform to the following ethical principles and values: (1) Integrity Researchers must always act with honesty and respect for the truth. (2) Autonomy/Respect for persons Patients, participants and research subjects must be treated with respect for their individual autonomy, freedom of choice, dignity and human rights. Informed consent is a vital element to respecting the right to individual autonomy. (3) Beneficence Researchers must always act in the best interests of the patient/research participant and make efforts to secure their well-being. (4) Non-maleficence The ―do no harm‖ principle applies to biotechnology research and entails refraining from doing harm and attempting to maximize possible benefits and minimising possible harms. (5) Justice/Fairness In research endeavors, researchers must attempt to address past inequities, recognizing wider community interests beyond merely the interests of the individual, organization or corporation, providing redress for the vulnerable and promoting equitable access to resources. This principle can also be described as necessitating an equal distribution of the risks and benefits of research between communities. Only biotechnology activities which have the potential, to improve human health and quality of life, support for the environment and promotion of sustainable agriculture and industry must be pursued. Ethics and Medical Biotechnology Ethical guidelines have been developed with respect to research and practices of medical biotechnology. They are available as separate booklets on various concerned topics such as –  Seeking Patient‘s informed consent  Confidentiality While protecting and providing information)  Guidelines on Patients‘ records  Management of patients with HIV or Aids  Guidelines on reproductive health management  Canvassing of patients abroad  Guidelines on withholding and withdrawing treatment  Guidelines for making professional services known EuropaBio's Core Ethical Values The following elements are included in EuropaBio's Core Ethical Values:  No use of cloning to reproduce human beings;  Animal welfare needs to be respected and their use in research to be reduced;  No use of biotechnology for weapon production;  The privacy of medical information, including genetic information, has to be protected;  No alteration of genes of human sperm, eggs or germ line cells. No interventions on genes of human embryos until their consequences are publicly discussed and put into legislation;
  27. 27. 27  Clinical trials need to be based on prior informed consent. For individuals who are unable to give this consent, it may be obtained by the legal representative according to existing legislative requirements  Transparent product information is needed to promote informed consumer choice;  The conservation of genetic and biological diversity needs to be supported;  Transfer of technology between developed and developing countries, respecting their cultural heritages, needs to be stimulated. Source: website Ethical Issues in Developing Countries The European and US biotechnology organizations failed to consider how their ethical standards would be applicable to developing countries. Therefore, enterprises operating on a worldwide scale may see their own ethical values being challenged by ethical consideration arising from the use of biotechnology in developing countries. Even if an internationally operating company bases its activities on sound moral ground, it might become vulnerable to criticism if it applies either double standards or one single approach to the employment of biotechnologies. A European company which applies lower ethical standards in a developing country than at home is wrong in approach and would not be trustworthy. On the other hand, products that have been approved in the European context have to be reassessed using local ethical values before they are used in a developing country. At present, EuropaBio's effort to unify the biotechnology industry's views on ethical issues can be seen as an adjustment of marketing strategies rather than a first step towards a novel set of ethical guidelines. Moreover, to change the Core Ethical Values into a substantial commitment, EuropaBio would have to go beyond the existing regulation and make sure that its members apply these standards as minimal standards worldwide. In return, it could require that within Europe the same standards should be applied by nonmembers too. It can be assumed that in the long run the biotechnology industry's credibility will only increase if this first version of Core Ethical Values develops into a stronger ethical Code of Conduct, further specified to the needs of all the different societies that are influenced by the industry's activity. Suman Sahai, Convener of Gene Campaign of New Delhi thinks that ethical concerns are largely luxury of developed countries. Her thoughts are important for implementation of ethics in developing countries. They are - Bioethics is a western phenomenon. Developing countries just should not follow the moral dilemmas of North but should balance of ethics of biotechnology against ethics of poverty. According to her this bogus debate on bioethics which has started in India with its plagiarized metaphors (descriptions) and rhetoric (style) borrowed from the West is not Indian in context or substance, and far from relevant. The objections to biotechnology in Western societies might be logical for their context and economic situation. They even have to spend large sums of money to destroy the mountains of surpluses of fruits and vegetables. The expressed concerns and dilemmas around biotechnology in Europe might be right in Europe. However, in India we must discuss the ethical aspects of genetics or biotechnology rooted in our own philosophy and religion, reflecting our social and human needs, and resolving our own dilemmas and problems in the way that is right for India. There is little reason for people in food surplus countries to become excited about the biotechnology route to increase the yield of wheat or potato. But can ‗we‘ in India have the same perception? Is it more unethical to "interfere in God's work" than to allow hunger deaths when these can be prevented? If there is an outcry in the West against the recombinant bovine growth hormone rBST, which increases milk production in cows, it is understandable for a society that is afloat in an ocean of milk. However, is it logical in India, a country with severe milk shortages and many children who do not get minimal nutrition? Should India with its acute fodder shortage and an average milk production of 2 litres per cow per day, spurn on ethical grounds a technology that has the potential to improve this production level using the same amount of fodder? Is rBST an ethically
  28. 28. 28 acceptable product in India? With respect to the last question, there is no reason to anticipate any objection from the Hindu community to the use of rBST. Although the Hindus consider the cow as holy and do not slaughter it, experiments and research involving the cow are acceptable. During the 1970s, for example, the large scale artificial insemination programme using imported sperm was never an issue. The resistance in some sections of Western countries to the genetically engineered Flavr Savr, a tomato with a delayed postharvest softening process, is to be seen in the context of the huge piles of tasteless tomatoes produced in intensive cultivation systems in countries such as the Netherlands. In India, postharvest losses are considerable. Should 60 per cent of the fruit grown in India's economically weak hill regions be allowed to rot before reaching the market, or should we try to introduce fruit varieties in which the rotting process can be delayed? Should imported ethical arguments stop us from conducting biotechnological research on this characteristic in apple varieties, and so enhance earnings of hill farmers? Should we confine ourselves to borrowed ethical arguments when it comes to the critical areas of raising agricultural production? What should our ethical considerations be? Developing countries should harvest the power of science and technology to improve the living conditions of their people. As long as there is acute suffering, hunger, and starvation death, alleviating this should be our most important ethical drive. However, this should be done by adhering to high safety standards, which is in a way also an ethical matter. Genetic engineering has raised complex social issues as well as moral dilemmas. These issues need a sophisticated, reasoned response. It is much too simplistic and inadequate to rely on charged hyperboles and bans forbidding the use of science. The concerns and debates in each society must be specifically relevant to that society and rooted in its needs and in its culture. Ethical Issues in Drug Development Drug companies won‘t always agree with the U.S. Food and Drug Administration‘s processes for approving drugs, especially during clinical trials. When we‘re doing a survival trial, no one wants to be in the placebo group. One could question whether it‘s even ethical to have a placebo group or whether you should put everyone on the drug and compare it to historical standards, which of course is not as good of an experiment. Another dilemma that might present itself is the selection of which markets a drug should target. Frankly, we wouldn‘t try to make a drug for a third-world country disease because it‘s not profitable. Fortunately, there are groups and foundations that put money into efforts to bring new drugs to third-world countries, but big companies often just can‘t justify targeting those markets to investors. If it‘s a growth-driven business, I have to justify at the end that there‘s some return on the investment that I make. But that idea clashes with the way some drug companies distribute their products in the U.S., like companies that discount or subsidize insurance co-pays or actual costs of drugs for patients who can‘t afford them. ―We believe that at least in the western world where we operate, that everybody has access to our drugs, even if we just give it to them for free.‖ References Code of Ethical Practice for Medical Biotechnology Research in South Africa, Guidelines for Good Practice in the health care professions, General Ethical Guidelines for Biotechnology Research, Second Edition, Booklet 8, May 2007, Health Professions Council of South Africa Sahai, S. (1997), "The Bogus Debate on Bioethics." Biotechnology and Development Monitor, No. 30, p. 24.