Biomedical research ethics updating international guidelines

In point of fact, the professionalization of research activity was modelled on the notion that the scientific method was such a powerful conceptual device that it precluded any spurious influence upon the products of research activities.Students were trained in the methods of their disciplines and in the intricacies of statistical analysis and data- reporting as though these methods and intricacies belonged to a universe of cosmopolitan, timeless and "objective" information.The ideal in the biological and experimental sciences was to have neutrality, objectivity and universality as guiding values in obtaining generalizable knowledge.Although it was recognized that several conditions affected this picture, among them economic and social contexts, the context of justification, as distinct from the context of discovery, emphasized the production of value-free, culturally neutral and context-insensitive data (2).This type of research necessarily demands other skills on the part of investigators, and the notion of objectivity and neutrality should at least be re-examined in the light of concurrent developments in the bioethical, legal and economic implications of research conducted in a multicultural setting, where researcher and research subjects belong to different cultures.It is probably necessary to reiterate that research is not a unitary activity. Some research is designed to invent new concepts and organize information into knowledge of a generalizable nature.

Technology breeds technology, and its associated research implies increasing the output of a given conceptual framework, whereas invention means the discovery of ways of increasing input to a body of knowledge.It could even be said that innovation always takes into consideration possible immediate benefits for those involved and may be related to the notion of "therapeutic" research, as formulated in the current text of the Declaration of Helsinki. The involvement of human subjects qualifies research in many ways - not only in terms of the new forms of encounter created between people different from other relationships, but also because, despite al formulations agreed upon by international bodies and accepted by governments and institutions, research can be conducted on human!subjects, with human subjects, and through human subjects.Nevertheless, I still think that international guidelines and regulations should consider the setting in which research activities art performed.This has to do also with the training required on the part of investigators and the prevention of harm or risks.

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