Diseases of the urinary system. Treatment of blood disorders in renal disease and renal failure.

medical associations initiating the revision of the 1964 Helsinki Declaration, accepted the revised declaration in November 1975. Since then it has been considered a norm for Danish doctors engaged in biomedical research. As a consequence several independent ethical committees have to be established, and such committees represent an innovation in Danish scientific life. A preparatory group was set up, representing such different institutions and organisations as universities, the National Health Service, hospital owners, general practitioners, the pharmaceutical industry, dental and pharmaceutical high schools, scientific societies, the Medical Association, etc. The preparatory group ended its work in March this year and summarised its recommendations in a report. Procedure The report suggests that all types of biomedical research in Denmark should be covered by the ethical committees. The investigators will have to add a "self-declaration" to the research protocol, stating that the project has been considered in the light of Helsinki Declaration II (stage 1). The protocol then has to be referred to a regional scientific-ethical committee (stage 2). Such committees will have to cover one or two counties (250 000-500 000 inhabitants) and include all research activities in the area. Scientists and citizen representatives will share the six (or 7) seats on an equal basis. If the investigator relies on his self-declaration, and thus does not ask for evaluation, the committee may still evaluate the protocol on its own initiative, but the investigator is free to start the project immediately , and to continue it if no committee comments have appeared within one month. If the investigator asks for evaluation or if evaluation is statutory-for instance, when informed consent is considered inappropriate-the committee again has to consider the protocol within one month. It is suggested that membership should be honorary and the members bound by secrecy. The lay members are to be elected by the county councils and the scientific members by the scientists of the region. A central scientific ethical committee (third stage), covering all Denmark, is planned to comprise 10 to 12 members, again with an equal number of lay and scientific members. The central committee will receive appeals from the regional committees or scientists, counsel regional committees or individual scientists, survey the field of scientific ethics, and serve ministries, courts, etc. In the near future all groups affected (already represented in the preparatory work) will start negotiations to implement the suggestions of the report. The first committee should …