연구윤리심의 표준화 필요성에 관한 제고찰

다국어 초록 (Multilingual Abstract)

The Institutional Review Board for Human Research (IRB) has elected to implement a formalized quality assurance system to improve the Human Research process.
In the field of medical research on humans, the IRBs have an important role. They ensure the necessary protection of the subjects and contribute to quality assurance in medical research.
But opinions of the IRB 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.
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 IRBs.
In this article I discuss the ethical, regulatory and policy concerns with human subjects research. I strive to create a standard guideline for the operation of various IRBs.
As with the review of all recruitment materials, IRBs should pay particular attention to risk and potential benefit information to ensure it is presented in a balanced and fair manner. The information presented should not mislead, for example, by promising benefits or implying a benefit beyond that potentially provided by the research.
When a IRB 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.

참고문헌 (Reference)

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