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6 Med., Health Care & Phil. 1 (2003)

handle is hein.journals/medhcph6 and id is 1 raw text is: Medicine, Health Care and Philosophy 6: 1-3, 2003. Editorial Research ethics Several contributions to this issue of the journal discuss current problems of research. Oduncu discusses stem cell research, especially the use of human embryonic stem cells in Germany. Gustafsson Stolt and colleagues describe genetic screening; they demonstrate how such controversial research, particu- larly with children, require examination of the ethical issues involved. Conradi and colleagues analyse empirical research in medical ethics itself; they argue that such research can benefit from a gendered perspective. Finally, Fangerau and colleagues point out that research collaboration across Europe at least requires a European database to facilitate bio-ethical information exchange. Research is one of the oldest topics in bio-ethics and philosophy of medicine. After a series of scandals (Tuskegee, thalidomide, DES) and classic publica- tions (Beecher; Pappworth), ethics and regulation of medical research was on top of the agenda for ethicists, philosophers, lawyers and politicians. An extensive system of review committees have developed in many countries. National legislation has been implemented. International codes, guidelines, declarations have been drafted and accepted. Since long, the general impres- sion was that this area was under control; it was also an excellent example of the positive interaction of ethics and health care. It is remarkable that since a number of years, the subject of research is a renewed topic of heated debates and controversies. One reason, of course, is the emergence of new technologies and innovations. In this issue, stem cell technology and genetic screening demonstrate how scientific progress illustrate that it is the hallmark of science that new issues and ques- tions will continue to arise and will give incentives for continuous ethical and philosophical reflection. However, a more fundamental reason is that the basic problem of research ethics continues to exist: the tension between the individual good of subjects and the social good of obtaining knowledge to improve health. Securing such knowledge is only possible with participation of subjects; but because these subjects at placed at risk for the good of others, there is always the potential for exploitation. Research subjects are used as means to obtain knowledge but they should not merely be used as means but treated with respect. This basic conflict is always there, regardless of the type of clinical research and the innovative aspects. As Oduncu shows, in the case of new bio-molecular technologies the debate centres on a similar query: the opposition between the therapeutic imperative and the principle of human dignity. Over the years, various approaches have been developed to strike the balance between the need to protect persons involved in trials, and the need to safeguard the advance of scientific research. Many countries nowadays have a system of review boards, and sometimes a national commission for research review. Most countries have legislation to protect the rights of research subjects. International organisations have drafted guidelines and consensus statements. It is also significant that apart from legislative regulation and committee review, the emphasis is on the responsi- bility of the scientific community itself. Scientific journals regularly have publications on research ethics. The framework for evaluating the ethics of clinical research studies apparently is generally accepted. Emanuel, Wendler and Grady (2000) have summarised this framework in 7 ethical requirements: (1) social or scientific value, (2) scientific validity, (3) fair subject selection, (4) favourable risk-benefit ratio, (5) independent review, (6) informed consent, and (7) respect for enrolled subjects. These requirements must be fulfilled in order to justify clinical research; they are necessary and sufficient conditions to make research ethical. They are also universal require- ments; they are supposed to apply everywhere and to anyone. However, as general statements of value, they need interpretation and sometimes adaptation to particular cultures, health conditions and economic settings. Recently, several controversial issues have re- emerged in the area of research ethics. One of these issues, the use of placebo controls, have partly gener- ated the revision of the Declaration of Helsinki. The earlier, 1996 edition of the Declaration requires that

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