• 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.

• 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.

• Journal of Yeungnam Medical Science
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• v.35 no.1
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• pp.36-39
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• 2018

In the personalized medicine era, utilizing paraffin blocks in pathology archives for investigating human diseases has come into the limelight. This archived material with clinical data will reduce the research time and could prevent new patient recruitment to obtain tissue for research. However, the clause indicating the necessity of consent from human material providers in the Korean Bioethics and Safety Act has made the Institutional Review Board (IRB) deny permission to use paraffin blocks for research without consent, and alternatively to get the same before starting an experiment. Written consent may be waived off in studies using paraffin blocks with anonymous status or conditions not linked to personal information by applying the paragraph 3, article 16 of the current Bioethics and Safety Act. Also, the IRB should recommend researchers to preserve the blocks as medical records of patients in long-term archives.

• 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 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.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.

• Journal of Korean society of Dental Hygiene
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• v.14 no.2
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• pp.241-250
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• 2014

Objectives : The purpose of the study was to examine the ethical requirements for the protection of human subjects in the publication guidelines of dental health journals. Methods : The guidelines of 27 dental health journals were reviewed to determine ethical standards alone, with Helsinki Declaration, by an institutional review board (IRB), informed consent, protection of subject privacy and confidentiality, and no conflicts of interest. Results : 1. Dentistry journals listed on National Research Foundation of Korea had a conflict of interest disclosure provisions of the contribution(76.9%) and the IRB approval(61.5%). 2. Half of the dental health journals were not listed on National Research Foundation of Korea Society but they agreed the advance posting provisions. 3. Dental hygiene journals provide 100% of ethics alone and receive 75% of IRB in the papers. 4. Dental health and dental hygiene journals have conflicts of interest disclosure regulations(59.2%) and IRB approval(51.8%). 5. There existed statistically significant differences between the dental health journals whether they were listed on the human subjects and ethical standards for protection in National Research Foundation of Korea or not. Conclusions : While the publication guidelines of dental health journals have followed to a greater extent in recent years, there is still a need for further instructions to ensure that the authors satisfy all ethical requirements in conducting research on human subjects. IRB approval for dental journals must be standardized and reinforced reflecting the characteristics of each journals. The researchers should obey the code of ethics suitable for education and the editors must review the paper continuously.