Biomedical research ethics updating international guidelines. Biomedical Research Ethics: Updating International Guidelines.

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Ethics in biomedical research



Biomedical research ethics updating international guidelines

The monocultural view, which has prevailed in the development and formulation of ethical norms and guidelines, carries the implicit assumption that Western culture has primacy over other cultures. An Appendix lists the items to be included in the research protocol to be submitted for scientific and ethical review and clearance. To overcome these deficiencies, we have for years employed some forms of content analysis of verbal behaviour, which has the advantage that both interviewer and interviewee come from the same linguistic background and tend to employ similar systems of meaning- inhabiting, so to speak, the same semantic space. Updating International Guidelines Research-based health care It is a privilege and a pleasure to offer my comments on transcultural aspects of informed consent presented in the paper of Patricia Marshall, whose contributions to health anthropology are both substantive and inspiring. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. As a process, a procedure or a product, informed consent must be documented in some form of permanent behavioural record such as a written signed statement, a thumbprint, a particular form of behaviour. 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. The Guidelines, first issued in and then revised in , are being updated and expanded to address a number of new and especially challenging ethical issues. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine AZT therapy to reduce perinatal transmission of HIV. Some research is designed to invent new concepts and organize information into knowledge of a generalizable nature. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. Ethical review does not simply mean complying with regulations: In research on human subjects, they are treated as carriers of traits of diseases that happen to be of interest. Other types of research are aimed at modifying existing practices or changing the state of previous knowledge. It means taking seriously the idea that dialogue is a true bioethical foundation of all research. Biomedical research ethics updating international guidelines

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Biomedical research ethics updating international guidelines



Biomedical research ethics updating international guidelines



Biomedical research ethics updating international guidelines



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  1. Language is probably the most important -the essential one -of these elements. It may serve for exchanging information, for partnership building, for a shared construction of reality, and for the development of affective meaning. We tend to forget that research-based medicine is a rather recent development in historical time.

  2. Language is probably the most important -the essential one -of these elements. 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. To request consent for an investigation in which subjects allow the investigator to draw a blood sample is quite different from asking them to engage in a series of confidential conversations about their inner lives or to respond to a survey.

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