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KMID : 1172020040050010025
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Journal of Korean Bioethics Association
2004 Volume.5 No. 1 p.25 ~ p.35
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Roles and functions of ethics committees in medical research on humans in Germany
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Ku In-Hoe
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Abstract
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In the field of medical research on humans, the ethics committees have an important role. They ensure the necessary protection of the subjects and contribute to quality assurance in medical research. Opinions of the Committee do not have the force and effect of law and may not be relied upon as an absolute defense to a charge of ethical misconduct. Originally established as an instrument of ethical self-guard in the medical profession, the ethics committee soon advanced to a statutory institution and is now on the way to becoming the body charged with judicial control in medical research. This
development implies the need for changes in both position and function of the ethics committee, but these have not been made with due consideration for all the developments there have been. The existing uncertainties are hampering medical research, which is in the interests of neither the public nor the actual medical research. Owing to the different and obscure
legal arguments used, it has not been possible to make any definitive decision on the legal standing of decisions made by ethics committees. It seems obvious that these problems cannot be solved unless the work of ethics committees can be based on a clear and reliable legal basis regulating the judicial nature of the committees’ decisions, the composition of the actual committees and the procedures they are to follow in reaching their decisions. With regard to the existing regulations, this might be best achieved by integrating the work of the ethics committees into the approval procedures of an administrative authority. When a committee member has a conflict of interest in relation to a project under review, or could be seen to have a conflict of interest, that member should withdraw from the meeting.
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KEYWORD
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Ethics committees, Medical research, ethical self-guard, Medical ethics
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