Journal of medical ethics
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Journal of medical ethics · Apr 2004
ReviewEvidence based medicine guidelines: a solution to rationing or politics disguised as science?
"Evidence based medicine" (EBM) is often seen as a scientific tool for quality improvement, even though its application requires the combination of scientific facts with value judgments and the costing of different treatments. How this is done depends on whether we approach the problem from the perspective of individual patients, doctors, or public health administrators. Evidence based medicine exerts a fundamental influence on certain key aspects of medical professionalism. ⋯ This challenges traditional professionalism in much the same way as managed care has done in the US. Here we chart some of these major philosophical issues and show why simple solutions cannot be found. The profession needs to pay more attention to different uses of EBM in order to preserve the good aspects of professionalism.
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Journal of medical ethics · Apr 2004
ReviewEvidence-based medicine and ethics: a practical approach.
The clinical decision is supposed to be based on evidence. In fact, what counts as evidence is far from being established. ⋯ Evidence in medicine very often has fuzzy boundaries, and dichotomising fuzziness and uncertainty can have serious consequences. Physicians and patients should accept the irreducible fuzziness of many of the concepts they use when dealing with health and disease.
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Journal of medical ethics · Apr 2004
ReviewEthical problems arising in evidence based complementary and alternative medicine.
Complementary and alternative medicine has become an important section of healthcare. Its high level of acceptance among the general population represents a challenge to healthcare professionals of all disciplines and raises a host of ethical issues. This article is an attempt to explore some of the more obvious or practical ethical aspects of complementary and alternative medicine.
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Journal of medical ethics · Feb 2004
Potential research participants' views regarding researcher and institutional financial conflicts of interest.
Financial conflict of interest in clinical research is an area of active debate. While data exist on the perspectives and roles of academic institutions, investigators, industry sponsors, and scientific journals, little is known about the perspectives of potential research participants. ⋯ The prevailing practice of non-disclosure of financial conflicts of interest in clinical research appears contrary to the values of potential research participants.
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Clinical Study Agreements (CSAs) can have profound effects both on the protection of human subjects and on the independence of investigators to conduct research with scientific integrity. Sponsors, institutions, and even investigators may fail to give adequate attention to these issues in the negotiation of CSAs. Despite the key role of CSAs in structuring ethically important aspects of research, they remain largely unregulated and unreviewed for adherence to ethical norms. ⋯ The Olivieri experience, and that of other investigators, has brought freedom of publication issues into sharp focus. Clinical study agreements also raise a number of other ethical issues relating to human subjects and research integrity, however, including disclosures relating to patient safety, data analysis and reporting, budget, confidentiality, and premature termination of the study. This paper describes the ethical issues at stake in structuring such agreements and suggests ethical standards to guide institutional ethics review.