Bioethics
Online ISSN : 2189-695X
Print ISSN : 1343-4063
ISSN-L : 1343-4063
Ethical consideration in epidemiological studies
Atsushi ASAIMotoki OHNISHI
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JOURNAL FREE ACCESS

2001 Volume 11 Issue 1 Pages 122-128

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Abstract
In this paper, we will discuss fundamental ethical norms required in epidemiological research. First, we will argue that the common argument that when no satisfactory informed consent can be obtained from individuals for epidemiological studies involving them consent from a community to which such individuals belong or permission from an ethical committee is acceptable, is not ethically plausible. Individual informed consent cannot be replaced by such alternatives. Second, it will be argued that automatic exemption of the need for informed consent in epidemiological research where anonymity of data or samples is guaranteed is also unacceptable. Even research which uses and stores data or samples without identifiers can harm individuals and even in situations where no harm is anticipated, ethically sound research is essential to avoid doing individuals wrong. Third, we will show that the common assumption that researchers can access patients' medical charts with permission provided by the patients' physicians or authorities at hospitals are not ethically defensible either. While it is essential to consider the ownership of medical information, it is clear that such information does not belong to medical professionals or researchers. Finally, we will argue that the institutional review boards and researchers should establish protocols and research procedures that cannot cause any moral harms or wrongs to individuals even if the research is conducted by a less than virtuous researcher. In conclusion, it is claimed that, taking into consideration the balance between the importance of medical and epidemiological research and respect for personal privacy, we have to set limits to the conduct of such research if we wish to create a morally superior societies. Informed consent from individuals for research involving them is essential even if obtaining it is costly and time-consuming.
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2001 Japan Association for Bioethics
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