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“…research on the human genome and the resulting applications open up vast prospects for progress in improving the health of individuals and of humankind as a whole…such research should fully respect human dignity, freedom and human rights, as well as the prohibition of all forms of discrimination based on genetic characteristics,” (UNESCO Declaration on the Human Genome and Human Rights, July 1997) The Human Genome Project (HGP) is a co-ordinated, international research programme, which aims to identify and locate all human genes by determining the entire sequence of the human genome by the year 2005. Although there are indisputable benefits of this research, it is fraught with difficult ethical, legal and social issues. The possible implications are therefore an essential part of our understanding of the project. The Human Genome Project´s main objective is to determine the complete ‘reference´ human genome that will be the basis for further studies. This is being achieved using both physical and genetic mapping. According to the Genome Data Base (GDB), over 7000 of an estimated 80 000 human genes have already been mapped to particular chromosomes. The goal of physical mapping is to produce a genome map consisting of approximately 30 000 markers separated by about 100 kilobases. Each marker will be a sequence-tagged site, a stretch of DNA with a unique and well-defined sequence. Sequencing, that is, the listing of the order of the approximately three billion base pairs that make up the human genome, is the final planned step of the project. Also key is the pursuit of advances in technology, including robotics, automation, and new methods of identifying and mapping genes, to allow large-scale sequencing. The storing and analysing of the vast amounts of data generated by the project are also a consideration, and requires the development of new database tools and software. The benefits of sequencing the human genome are expected to be enormous. We will have information that will vastly increase our knowledge of the structure and function of DNA in chromosomes. It is thought that this information will revolutionise future biological research, particularly in the fields of medicine, gene testing, gene cloning and biotechnology. Mapping the human genome will lead us to understand the underlying causes of genetic diseases such as cystic fibrosis, Huntington´s disease, sickle cell anaemia and many forms of cancer. This, together with new clinical technologies will alter medical practices, with the onus shifting from treatment to prevention. Development of new classes of cheaper, purer drugs are expected, along with the possible replacement of defective genes through gene therapy. Scientists will also be capable of preventing genetic disorders by determining an individual’s predisposition to a particular disease through gene testing. This information could then be used to help individuals to avoid environmental conditions that may act as triggers. Advances in research into DNA mutation are also expected, since researchers will be able to directly study the effects of mutagens on DNA. We will be better able to understand the genetics not only of ourselves, but also of animals. Gene cloning will allow us to produce healthier and more productive animals, potentially able to produce drugs and other useful products for human consumption. In the future, cloning technology may be used in humans to produce whole organs from single cells or to raise animals with organs suitable for human transplantation. Advances are also anticipated in the industries related to biotechnology, for example, agriculture, energy production and environmental cleanup. These raise controversial issues concerning animal rights and the safety of genetically engineered food for human consumption. Genetic engineering also provides the prospect of us being able to modify bacteria to produce therapeutic products. Although the potential benefits of sequencing the human genome are immense, and indeed there are likely to be additional benefits that have not yet been considered, there is also scope for misuse of information and a threat to personal privacy. In 1997, UNESCO published a Declaration on the Human Genome and Human Rights. Although the recommendations were general, it outlined some important principles. “Everyone has a right to respect for their dignity and for their human rights regardless of their genetic characteristics…that dignity makes it imperative not to reduce individuals to their genetic characteristics and to respect their uniqueness and diversity” [Article 2 a) and b)] The Declaration supports seeking informed consent of individuals, highlighting the importance of educating both the public and medical professionals on issues relating to the Human Genome Project. It entirely supports the right of an individual to decide whether or not to be informed of information relating to their genetic profile. It also states that any benefits from advances in genetic science should be made available to everyone. These principles represent what most people consider to be right, however, they paint a simplistic view of a complex problem. The US Department of Energy and the National Institutes of Health have so far allocated between 3% and 5% of their total budget for the Human Genome Project to the investigation of Ethical, Legal and Social Issues (ELSI). Studies are currently concentrated in two main areas: privacy and confidentiality of genetic information, and the development of education in genome science and ELSI. Other issues raised by the project include fairness in the use of genetic information, genetic testing, reproductive issues, clinical issues, commercialisation issues and finally, philosophical implications. These issues will be discussed in turn. Privacy and confidentiality issues are perhaps the primary concern of the Human Genome Project. Who owns genetic information and who should control it? Privacy can be defined as the right of an individual to decide what information others may have about him. But this is problematic since information cannot always be kept confidential. Who should have access to genetic information? If information is managed carelessly, it could lead to discrimination by employers, insurers, courts, schools, police and many other institutions. A US case was reported in Newsweek in December 1997 where information that a child had the genetic condition known as fragile X syndrome was passed on to his health insurance company. Insurance was cancelled for him and his siblings, despite the fact that his siblings had not been diagnosed with the condition and the fact that there is no available treatment for fragile X. Accuracy of information is also an issue here, what controls and checks should be in place to ensure that information held on databases is correct? Genetic testing is a minefield of ethical issues since it has a wide variety of applications including carrier screening, prenatal diagnostic screening, presymptomatic testing for assessing risk of adult-onset diseases such as Alzheimer´s disease, conformational diagnosis of a symptomatic individual and forensic testing. For an individual, knowledge of a defective gene will have possible benefits including preventative treatment, lifestyle changes to delay or reduce symptoms, or, if treatment is not available, the chance to plan the individuals life and prepare for the onset of disease or the deterioration of health. However, it may also have negative effects, for example, it may cause unnecessary stress and unwelcome changes in personal relationships. For example, if an individual knows that he or she will develop Huntington´s disease in later life, does their partner have a right to know now? There is a possibility that genetic testing and gene therapy will create false hope, since many genetic conditions are also contributed to by environmental factors. In addition to this, there are other questions to consider. For example, should testing be carried out where there is no treatment available? Screening can give people the chance to prepare for the disease, but is this really beneficial? Should treatment be available to individuals with genetic conditions that are non-life threatening, for example, albinism and dwarfism? If so, should the state have to pay for it? One fear is that by making treatment available for such conditions, society will become less tolerant of those who are genetically ‘different’. The argument is therefore that it would be more advantageous for us to devote resources to promoting acceptance instead. Genetic testing also raises reproductive issues concerning the use of genetic information in decision-making. As a society, we should consider the acceptability of testing unborn infants. Is abortion on the basis of genetic disorder acceptable? If so, how severe must the ‘disorder’ be in order to justify terminating the pregnancy? In some countries, sex discrimination in family planning already a problem, and it is possible that this practice may expand in the future to include unborn infants with ‘undesirable’ genes. If children with genes that may cause disease in adulthood are tested, at what age should they be told the results? In a survey of its members, the UK Genetic Interest Group (GIG) said that prenatal testing for late-onset conditions should not be carried out unless the mother agrees to terminate the pregnancy, since, if born, the infant has not given consent to be tested. Of increasing concern is the possibility that people fear genetic discrimination and therefore will refuse genetic testing, even if there is a risk to their health. Clinical issues include the problems of educating the public and health care professionals. Results of tests may not be easy to interpret, and individuals may need to have the implications explained to them. This is known as genetic counselling and is very important to maximise the effectiveness of genetic testing. This means that health care professionals need to be trained to provide the public with advice on treatments, preventative measures and, if necessary, counselling. It is likely that the advance of public and professional education will not keep pace with the increase in genetic testing. Another of the potential problems of genetic testing is that, since the production of the tests is a highly profitable industry, manufacturers are likely to market them not only to the medical professions but also to the general public. Demand for tests is likely to grow as technological improvements make them easier to administer, cheaper and more reliable. There is a risk that the public will not be able to fully understand test results without professional advice. Genetic testing has limitations in the form of laboratory errors due to sample misidentification, or sample contamination, and there is a danger that this may not be taken into consideration when the results are interpreted. Commercialisation issues are concerned with property rights and the accessibility of trade secrets. This could be a particular problem where genetic information is relevant to pharmaceutical or biotechnological firms, since preventing information from becoming widely available could generate considerable revenue. Finally conceptual and philosophical issues raise questions regarding human responsibility, as opposed to concepts of genetic ‘fates’ and beliefs concerning disease and death. Genetic engineering is particularly controversial. Does anyone have the right to ‘play God’? As researchers locate genes associated with cognitive abilities and behaviour, will we be tempted to ‘improve’ our children? Some people argue that genetic enhancement is simply another form of selective breeding, which is present in nature. However, human genetic engineering cannot be developed without some degree of experimentation on humans. The possibility of germ-line therapy, where changes are made to the genomes of future generations is especially debatable. This may in some respects be beneficial; for example, it will improve the success rate of gene therapy by allowing scientists to remove a defective gene by altering just one cell. However, this kind of treatment could have unpredictable effects that would change the lives of all subsequent generations. Since the individuals are unborn, their consent cannot be obtained. Theoretically, it would be possible to take control of our own evolution and create ‘superhumans´. According to some scientists, genetic enhancement is an irresistible reality that is only twenty years away. However, there is a risk of unforeseen, unpredictable problems, both scientifically and socially. The results of the Human Genome Project will affect us all, either directly or indirectly. One of the main threats is that it has the potential to provide us with consequences that have not yet been considered. Without time to think about what is ethically sound, this may lead to considerable difficulties. It is generally held that advances that will prevent human suffering are worthwhile, whereas those that will not are questionable. It can be argued that the advancement of our knowledge concerning the human genome is progressing faster than our ability to regulate its impact. It is clear that widespread education is needed, so that people can formulate and voice opinions on what is ethically and socially acceptable, and so that policy and legislation may be brought into place to govern practices that concern the human genome.

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