Nuffield Council on Bioethics.
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The possibility of using genetic analysis to predict response to medicines has led some to make the optimistic claim that personalized medicine--"the right medicine, for the right patient, at the right dose"--will only be a matter of time. Indeed, pharmacogenetic tests could be one of the earliest practical applications that information from the Human Genome Project will have on our lives. Many patients experience side effects from medicines, and the use of pharmacogenetics in the drug discovery process has the potential to improve efficacy and safety of some treatments. However, both the research and the clinical applications raise ethical, legal, social and regulatory issues that need to be addressed before targeted prescription becomes reality. The Nuffield Council on Bioethics has established a Working Party to consider these issues and has recently issued a consultation document on the subject.
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Concerns about bioethical issues raised by scientific developments in genetics are a common feature of both public and policy debates in the UK. This article sets out how one such body, the Nuffield Council on Bioethics, contributes to public and policy debates, and provides information about similar bodies in the UK and around the world.
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Inevitably a policy-oriented report on issues as complex and as rapidly changing as the medical and scientific uses of human tissue can achieve neither philosophical purity nor regulatory completeness. The council's strategy has been to begin with robust ethical principles, for which sound philosophical arguments can be given, which will (it is hoped) command widespread support. The council went on to argue for guidelines of sufficient, but not vapid, generality which could be of practical use to the various medical intermediaries, professional and regulatory bodies and research ethics committees which will carry out the tasks of detailed regulation and of making decisions that affect uses of human tissue. The council's hope is that the recommendations of the report can be absorbed into regulatory and professional practice, and where needed into government policy. If they can, the increasing diversity of uses of human tissues need lead neither to overt nor to covert 'commercialisation of the human body', but will also not put unnecessary restrictions on advances in research and medical practice.
OBJECTIVE: To compare opinion of surgical inpatients with the conclusions of the report of the Nuffield Council on Bioethics regarding the ownership and uses of human tissue. DESIGN: Survey of results of questionnaires completed by patients. SETTING: Large teaching hospital. SUBJECTS: 384 postoperative adult surgical patients. RESULTS: There was strong support among patients for the use of tissues in medical education, research, and science with the exception of those tissues which may transmit disease to others. Few patients (39; 10%) believed that they retained ownership of tissue removed at surgery. Most believed that the tissue belonged to the hospital (103; 27%), to nobody (103; 27%), or to the laboratory (77; 20%). Most patients had not been given any information about the possible uses of their tissues after removal. CONCLUSIONS: Surgical inpatients seem to endorse the conclusions of the Nuffield report regarding the ownership and uses of human tissue. The recommendations regarding patient information and consent procedures should be implemented at the earliest opportunity.
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The possibility of early diagnosis and intervention is radically changed by the advent of genetic testing. The recent report of the Nuffield Council on Bioethics is timely and helpful. I have suggested, that not only the severity of the disability indicated by genetic information, and the accuracy of the data, ought to govern the approach to the implementation of screening for genetic disorders. In addition, assessment of the value of the information to those involved should be considered. The efficacy of the available therapeutic measures, combined with the prognostic data are important indices of the value of the information. These measures fall into three categories and thus indicate that three different courses of intervention may be appropriate. Three approaches to diagnosis and intervention are then outlined, drawing on the experience of various clinical initiatives.
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