Despite those arguments legislative and management policies
Despite those arguments, legislative and management policies relating to data collection, and the interpretations by individual organisations and by ethics committees, still often require informed consent, even for clinical registries using routine data. This may relate to failure to distinguish between observational work using routine data, which when done by healthcare management as part of routine administration proceeds with little comment, and intrusive research epitomised at the extreme by clinical trials . Traditional medical ethics has its background in the experimental therapies of individual patients, which have guided major ethical initiatives . Clinical trials are valid because the essential comparisons are internal, despite the fact that Malonyl Coenzyme A the subjects involved in a trial may not be representative of the source populations. With registries however, the loss of representativeness caused by a requirement for consent is critical, as a major function of the registries is to provide information on the management and outcome of all patients in a defined population.
It can be argued however that registration itself can be threatening and may be viewed as undesirable , in which case a specific consent policy may be appropriate. An opt-out system may be appropriate, as cast allows those who feel sensitive to such issues to decline, but in practice very few do, so the remaining database may be representative. Using an opt-out consent system, in Australia an Internet-based database for colorectal neoplasia has been operating with almost 100% completion ; and an opt-out system is used to achieve high recruitment for a detailed lung cancer registry . An opt-out system is used for a breast implant registry in the Netherlands, after previous attempts had produced only unreliable and incomplete information .
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