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KMID : 0986720110190010033
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Korean Journal of Medicine and Law
2011 Volume.19 No. 1 p.33 ~ p.60
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The Categorization of Obtaining Informed consent Procedure considering with level of consent in Clinical Trials
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Bae Hyun-Ah
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Abstract
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In obtaining and documenting informed consent, the investigator and IRB(institutional review board) should comply with the applicable regulatory requirements such as GCP. Under Korean law, there is no explicit regulatory requirements on exemption or waiver of obtaining and documenting informed consent. As FDA and OHRP in HHS regulations, it can be categorize into waiver of IRB approval, exemption of general requirement in informed consent, exemption of signing written consent form and expedited review process considering with risk. The IRB risk assessment process is highly unstructured and essentially each members is free to interpret the reasonable standard and assess a study"s risks and benefits as well as to ensure the adequacy of informed consent. Through this study, although relatively comprehensive Korean regulations, it can be helpful that IRB assesses the risk of a clinical trial and make more concrete interpretation on risk and decision on the informed consent procedure such as waiver of formal informed consent, expedited review procedures.
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KEYWORD
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IRB, 위험 평가, 정보 동의 절차, : IRB, risk assessment, informed consent procedure
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