임상시험 대상자의 개인정보 보호 및 제공에 관한 기관위원회 심사를 위한 검토

Before conducting a clinical trial, the principal investigator must obtain written informed consent, which is including "personal information protection" and "provision of personal information", from the subject. And prior to that the Institutional Review Board(IRB) must review the informed consent form, the subject information sheet, and any other written information provided to the subject. So, in order to share common concerns among the members of each Institutional Review Board(IRB) several matters will be reviewed, which are regarding the review of personal information protection and processing in this paper. First of all, Instances which is exempt obtaining informed consent from the subject for personal information processing include: "processing anonymous or pseudonymized information," "additional processing within a scope reasonably related to the original purpose of collection," "exemption of review of the Institutional Review Board(IRB) or exemption of obtaining written informed consent for the subject's research participation," and "fulfilling data retention obligations by researchers." Next, specific considerations regarding obtaining written informed consent from the clinical trial subject(or information subject) for clinical trial participation and personal information processing are as follows: Firstly, the review should be conducted under the assumption that the principal investigator of a sponsor-initiated clinical trial (SIT) is the personal information processor. Secondly, informed consent for sensitive or uniquely identifiable information must be obtained separately from other personal information. Thirdly, the retention and use period for personal information must be presented for a minimum period that allows the subject to anticipate the scope of the period. Fourthly, when personal information is transferred overseas, the destination country's level of personal information protection must be substantially equivalent to that of Korea. Fifthly, It should not be overlooked that informed consent must be obtained from the information subject to process personal information for purposes such as tracking the occurrence of adverse events and survival status. Sixthly, if the clinical trial subjects or their partner get to be pregnant during the clinical trial, informed consent must be obtained from the pregants to process personal information of the pregants or the fetus.