• The Korean Society of Law and Medicine
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• v.19 no.1
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• pp.165-206
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• 2018

Researchers, Institutional Bioethics Committee(IBC)/Institutional Review Board (IRB) members, Research Institutions that have multiple interests in relation to research should ensure that conflicts of interest(COI) do not arise in making professional judgments. In other words, according to the role that must be performed or the obligation to fulfill it, the primary interest, which must be considered or should be prioritized, should not be affected by the secondary interest. Therefore, standards and methods should be prepared so as to prevent and solve the problems of COI that have arisen, and the basic matters on standards and methods should be clearly defined in terms of the law and policy so that all parties such as Researchers can understand and follow them. In order to establish a more realistic legal policy, it is necessary to grasp the current situation. Therefore, I have reviewed results of the questionnaire survey and interview conducted for the administrative staff of IBC/IRB to confirm their opinions on legal policy problems related to COI and countermeasures for resolving them. Also, I have reviewed the main contents of issued by the US Department of Health and Human Services in order to assist in the preparation of domestic legal policy about conflicts of interest. Finally, I have analyzed the present state of domestic legal policy in relation to the Researcher's COI, the IBC/IRB member's COI, and Institutional COI and suggested way to improve it.

• The Korean Society of Law and Medicine
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• v.23 no.4
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• pp.29-74
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• 2022

As social disasters occur under the Disaster Management Act, which can damage the people's "life, body, and property" due to the rapid spread and spread of unexpected COVID-19 infectious diseases in 2020, information collected through inspection and reporting of infectious disease pathogens (Article 11), epidemiological investigation (Article 18), epidemiological investigation for vaccination (Article 29), artificial technology, and prevention policy Decision), (3) It was used as an important basis for decision-making in the context of an infectious disease crisis, such as promoting vaccination and understanding the current status of damage. In addition, medical policy decisions using infectious disease data contribute to quarantine policy decisions, information provision, drug development, and research technology development, and interest in the legal scope and limitations of using infectious disease data has increased worldwide. The use of infectious disease data can be classified for the purpose of spreading and blocking infectious diseases, prevention, management, and treatment of infectious diseases, and the use of information will be more widely made in the context of an infectious disease crisis. In particular, as the serious stage of the Disaster Management Act continues, the processing of personal identification information and sensitive information becomes an important issue. Information on "medical records, vaccination drugs, vaccination, underlying diseases, health rankings, long-term care recognition grades, pregnancy, etc." needs to be interpreted. In the case of "prevention, management, and treatment of infectious diseases", it is difficult to clearly define the concept of medical practicesThe types of actions are judged based on "legislative purposes, academic principles, expertise, and social norms," but the balance of legal interests should be based on the need for data use in quarantine policies and urgent judgment in public health crises. Specifically, the speed and degree of transmission of infectious diseases in a crisis, whether the purpose can be achieved without processing sensitive information, whether it unfairly violates the interests of third parties or information subjects, and the effectiveness of introducing quarantine policies through processing sensitive information can be used as major evaluation factors. On the other hand, the collection, provision, and use of infectious disease data for research purposes will be used through pseudonym processing under the Personal Information Protection Act, consent under the Bioethics Act and deliberation by the Institutional Bioethics Committee, and data provision deliberation committee. Therefore, the use of research purposes is recognized as long as procedural validity is secured as it is reviewed by the pseudonym processing and data review committee, the consent of the information subject, and the institutional bioethics review committee. However, the burden on research managers should be reduced by clarifying the pseudonymization or anonymization procedures, the introduction or consent procedures of the comprehensive consent system and the opt-out system should be clearly prepared, and the procedure for re-identifying or securing security that may arise from technological development should be clearly defined.