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KMID : 1025620180210030262
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Korean Journal of Medical Ethics
2018 Volume.21 No. 3 p.262 ~ p.277
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Ethical Principles for Consent in Human Subject Research: A Focus on Research Involving Vulnerable People and the Disabled
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Choi Kyung-Suk
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Abstract
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Research involving human subjects is necessary in the biomedical sciences. One of the main ethical issues involved in this area is how research involving human subjects can be carried out without infringing upon human dignity. In this article I argue that respect for autonomy is not the only ethical principle for research on human subjects. I identify and explain the other ethical principles that are required for obtaining informed consent. For competent human subjects, respect for autonomy demands that informed consent be obtained, but in the case of substituted consent I argue that the principle of autonomy is insufficient and that a best-interest standard is required. However, this standard should be applied with some qualification. I claim that the only principle that can justify the waiver of informed consent is utilitarian in nature, but in this case the research should not involve more than minimal risk to the human subjects. In addition to describing the ordering and qualifications concerning the three core principles of autonomy, best-interest, and utilitarianism this article examines international codes for the protection of vulnerable people, substituted consent, and the waiver of informed consent.
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KEYWORD
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human subject research, respect for autonomy, best interest, surrogate decision making, substituted consent, utilitarianism
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