• Journal of the korean academy of Pediatric Dentistry
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• v.41 no.2
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• pp.187-192
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• 2014

Research ethics is the basic attitude for researchers. Thanks to our predecessors we are able to conduct systematic studies. The current trend of results and the amount of study-oriented assessments make the side effect that researchers conduct SCI (Science Citation Index) studies. Since the Declaration of Helsinki, the importance of the right, safety and welfare for human participants have improved. In the present study, I looked into other countries' standpoints concerning the subject of the responsibilities for research ethics and compared them with Korean's standpoint. Recently, the Ministry of Health and Welfare revised the laws for bioethics and safety. In the point of bioethics, I checked out the function, exemption and process of the Institutional Review Board for the future researcher. It is suggested to use the research note to verify a study procedure and protect oneself from research misconducts.

• 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.22 no.4
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• pp.37-55
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• 2021

On March 19, 2021, the Korean Bioethics Association and related academic circles published a joint statement criticizing the partial revision of Infectious Disease Control And Prevention Act. However, according to the Bioethics And Safety Act of Korea, research conducted by the state or local governments for public welfare is excluded from human subjects research project. In addition, since the Korean legal system is not based on the dichotomy between research and surveillance, the discussion of the US Common Rule cannot be directly applied to Korea. For the harmonious operation of the state's duty to manage infectious diseases and the Institutional Review Boards, institutional alternatives should be prepared in consideration of the following issues. First, the related academic community should first pay attention to the problems of the current laws in Korea. Second, it should be understood that the state is carrying out many tasks without the consent of the parties in order to fulfill its duty to manage infectious diseases. Third, when presenting institutional alternatives, it is necessary to consider the feasibility of implementation in Korea. An in-depth discussion of the institutional alternatives by the Medical Law Society and other related academic circles is necessary.

• Journal of Korean Society of Archives and Records Management
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• v.17 no.3
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• pp.1-21
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• 2017

Oral history research is carried out through collecting information about a living person. The data collected from an oral history project is not a mere fact or a mass of information but accounts of persons who reveal their own personalities. For this reason, oral history research and data collection and the use of such data must be based on rigorous ethical standards. The Bioethics and Safety Law shares a similar view on human subject research, and the Institutional Review Boards includes human subject research as a subject of review and management. However, the Bioethics and Safety Law's protection of personalities and human rights focuses on life sciences methodologies, which are not suitable for qualitative research, such as an oral history of a value oriented and critical approach to human beings. This study examines the details of the Bioethics and Safety Law related to human subject research and the problems that may arise when this law is applied to subjects in humanities and social sciences such as oral history. Through this study, alternative methodologies, which can be used for oral history research, while maintaining academic autonomy, are suggested.

• The Journal of KAIRB
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• v.6 no.1
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• pp.1-4
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• 2024

The strengthening of Institutional Review Board (IRB) and Human Research Protection Program (HRPP) for clinical research on advanced regenerative medicine reflecting the 3 Principles of the Belmont Report (Respect, Beneficence, Justice) is very important. The research institution IRB should naturally be in charge of managing the clinical research process. And it is crucial to reinforce HRPP for the protection of research subjects in institutions conducting advanced regeneration clinical research. So, it is needed to establish a Protection System for Advanced Regenerative Medical Research Subjects composed of clinical research management communication system for advanced regenerative medicine between KAIRB (Korean Association of IRB) of research institutes and National Management Agency for Advanced Regenerative Medical Research. In advanced regenerative medicine clinical research to verify safety and efficacy of the investigational drugs to the subjects with rare and incurable diseases rather than to treat the patients, it is hoped that a management system that guarantees the scientific characteristics of research and the rights of research subjects would be well organized and operated.

• Korean Journal of Childcare and Education
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• v.14 no.2
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• pp.1-17
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• 2018

Objective: The purpose of this paper is to understand the bioethics and the Institutional Review Board (IRB) in the social and behavioral research area through "The Bioethics and Safety Act" and to examine the IRB's present situation, roles, responsibilities, and tasks. Methods: This paper reviewed articles, materials for education, and "The Bioethics and Safety Act" related with the IRB. Results: Bioethics included all the research in the social and behavioral area, and "The Bioethics and Safety Act" has been enforced in every research projects targeting human subjects since February 2, 2013. Accoding to the law, the IRB must review the research proposals for human subjects and was introduced in social and behavioral research as a self-regulating system. At present, all the related institutions including universities must establish and run the IRB. This paper introduced the definition of bioethics, the IRB's roles and review types, the total number of registered IRB, and "The Bioethics and Safety Act". Conclusion/Implications: Both the central government and the local government have to make an effort for the establishment and settlement of the IRB system. This paper also presented some of the problems of the IRB.

• The Korean Society of Law and Medicine
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• v.12 no.1
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• pp.99-131
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• 2011

To strengthen the protection of human research subjects and human materials, the Korean Ministry of Health and welfare proposed the amendment bill of Bioethics and Safety Law(2010) to the Congress. It includes so many meaningful clauses. According to the bill, the scope that this act shall apply will be expended to the research involving human subjects and human materials. In the bill, there are the principles of this act; the protection of the life, health, and dignity of the human subjects, the obtaining of the adequate informed consent, the protection of the human subject's information confidentiality and the human subject's privacy, the assessment and minimizing of the risks involved and the guarantee of the safety for the human subjects, the preparation of the special protection program for the vulnerable human subjects, and so on. According to the bill, Institutional Bioethics Review Board(the same as Institutional Review Board) will be responsible for the auditing and monitoring on the research that was approved by IBRB, conducting the education program for the researchers, IBRB members and administrative staffs, preparing of the special protection program for the vulnerable human subjects, and forming the guidelines for the researchers as well as the review of the research protocols. And the State and local governments shall take necessary measures to support the expending of the social infrastructure. In addition to, IBRB will have to be assessed and to be gained the accreditation by the Korean Ministry of Health and welfare. So, if Bioethics and Safety Law is amended, it will contribute enormously to enhance the level of the human research subjects protection. Also, if this Law is amended, IBRB will play a major role for the conduct of the ethically, scientifically, and legally proper research. But now, as a matter of fact, the capability of IBRB members and IBRB office members is not enough to charge of this role because some people and some organizations does not know the importance of IBRB exactly. In spite of, IBRB shall be able to this role to protect the human subjects and to develop the level of the research On the international level. Therefore, the State, local governments and the Organization shall back up the administrative and financial terms of the IRB and IRB Office.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.17 no.3
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• pp.438-449
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• 2016

This study investigates the factors influencing nurses' turnover intentions after evaluation for certification at geriatric hospitals. Focus is centered on job stress and burnout. The study was approved by the KUIRB. Data were collected from April 1 to August 31, 2015, and analyzed using SPSS WIN 18.0 software. The participants were 205 nurses recruited from 15 long-term care hospitals in metropolitan city B in province G. The average scores for job stress, burnout, and turnover intention were 3.83, 2.92, and 3.12, respectively (range: 1-5). Nurses' turnover intention had positive relationships with job stress (r=.356, p<.001) and burnout (r=.729, p<.001). The major factor influencing turnover intention was burnout (${\beta}=.729$), which explained 53% of the intention. In conclusion, intervention programs should be developed to reduce burnout, the key influencing factor, for decreasing nurses' turnover intention.

• The Journal of KAIRB
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• v.4 no.2
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

• 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.