• The Journal of KAIRB
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• v.3 no.1
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• pp.1-10
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• 2021

In 2004, India began investing in the clinical trial industry; the country now boasts a 20% market share with the help of a valuable resource - the world's second largest population. The Contract Research Organization has been able to generate profits efficiently conducting clinical trials via a large pool of participants, skilled researchers, and reduced developmental costs. As the demand and sheer number of global clinical trials increased, the International Council of Harmonization-Good Clinical Practice was introduced, and the need for the Institutional Review Board increased. While the clinical trial industry in India boomed, it came at the expense of the participants' civil rights. The increased media attention regarding the ethical issues forced the Indian Supreme Court to take action. Consequently, India is the only country, by law, that specifically compensates participants suffering from injury directly resulting from participation in clinical trials. This research paper will describe and compare the relevant laws of India and Korea including compensation criteria. In addition, the ethical issues and aspects of indemnity in clinical trials will be discussed. While the clear advantage of the compensation is one of the protected rights of a clinical subject, the current system is not perfect. Furthermore, laws created to redeem ethical issues can have unintended, negative consequences.

• Korean Journal of Clinical Pharmacy
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• v.26 no.1
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• pp.77-83
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• 2016

Background: Oversight on the bioethical compliance of national R&D projects or research personnel is currently conducted exclusively by IRB (Institutional Review Board) within the relevant research institute. Considering current state of affairs in Korea, there is an imperative to establish a national oversight system for bioethical compliance, conduct comprehensive oversight on bioethical compliance of national R&D projects, and enhance subject protection system. Methods: We examined opinions from researchers and IRB personnels regarding ethical oversight system on R&D projects. Additionally, we looked at IRB assessment by KAIRB (Korea Association of Institutional Review Board) in order to identify status and problems with current IRB system in Korea. Assessment was also done for four other countries (US, UK, Germany, Singapore) through in-person visits as well as surveys in writing for a total of 6 months (2012.12.1~2013.5.31). The research comprised of two aspects: system management and R&D project audit. Based on this, we examined current status and problems of the existing system in Korea and made recommendations for improvement. Results: Regulatory objectives and backgrounds of biomedical researches are different from each country due to different characteristics of bioethical oversight system. This shows that each country sets up its own regulations and procedures to fit each situation. Bioethical compliance oversight system greatly varied between the countries. From this study, it can be seen that improvement of existing procedures and oversight system or establishment of new ones are essential in Korea. Conclusion: In terms of system management, a dedicated government organization need to be established for bioethical compliance, subject protection, IRB inspection, training, evaluation, and certification of systems, and also support for IRB e-system. Regarding R&D project oversight, it is essential to confirm IRB review results before start of a research, to conduct a review on ethical aspects of research plans, and to carry out continued oversight on bioethical compliance through interim reports.

• Obstetrics & gynecology science
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• v.61 no.6
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• pp.693-697
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• 2018

Aggressive angiomyxoma (AA) is a very rare mesenchymal tumor most commonly found in the pelvic and perineal regions. For the complete excision of retrorectal tumors, with extension through the levator muscle into the ischioanal space, open anterior and posterior approaches are typically required. Herein, we report our experience with robotic excision of a giant presacral AA with extralevator extension into the ischioanal space and extraction via Pfannenstiel incision, which we found to be technically feasible, efficacious, and safe to perform. Mayo Clinic Institutional Review Board exemption status was obtained for this study.

• Health Policy and Management
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• v.33 no.3
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• pp.241-242
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• 2023

As part of efforts to internally strengthen the research ethics capacity of the Korean Academy of Health Policy and Management, we have compiled research ethics issues that are frequently encountered in public health researches. Firstly, when reusing research reports or dissertations as papers, efforts should be made to avoid unfair duplicate publication. Compliance with the institutional review board exemption process is required, and additional efforts should be devoted during the text recycling process to prevent self-plagiarism or unjust duplicate publication.

• 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 Journal of Nuclear Medicine
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• v.38 no.2
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• pp.140-142
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• 2004

As a molecular imaging is the most up-to-date technology in Nuclear Medicine, it has complicate ethical and regulatory problems. For animal experiment, we have to follow institutional animal care committee. for clinical experiment, we have to get approval of Institutional Review Board according to Helsinki declaration. In addition, approval from Korea Food and Drug Administration (KFDA) is essential for manufacturing and commercialization. However, too much regulation would suppress development of new technology, which would result in the loss of national competitive power. In addition, most new radioactive ligands for molecular imaging are administered to human at sub-pharmacological and sub-toxicological level. In conclusion, a balanced regulation is essential for the safety of clinical application and development of new technology.

• The Journal of KAIRB
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• v.4 no.2
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• pp.30-35
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• 2022

The Human Research Protection Program (HRPP) includes all subject protection activities and entities involved in the process of planning, reviewing, and conducting clinical research and it ultimately aims that research can be conducted ethically and scientifically while protecting the rights and welfare of research subjects. At the beginning of its introduction in Korea, it was settled down by adopting the United States HRPP, especially the form of AAHRPP element and regulations. However, regulations and operating forms of HRPP have been changed according to the Korean domestic research environment. Actually, all the Korean institutions are adopted the Korean HRPP guidelines that have been officially announced by the Ministry of Food and Drug Safety in Korea. Recently, Korean domestic laws such as the "Advanced Regenerative Biology Act" or "In Vitro Diagnostic Medical Device Act" have been dramatically innovated and our research environment becomes to be more complicated. Therefore, the development of a suitable Korean HRPP model considering the Korean research environment is strongly demanded. For the early settle down of the Korean HRPP model, the positive incentive method should be applied, when the HRPP is operated and/ or properly operated. These improvements in the Korean HRPP environment will eventually lead to the appropriate protection of subjects who are participating in human clinical research and the quality improvement of clinical research.

• 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.

• 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.

• Korean Journal of Health Education and Promotion
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• v.28 no.3
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• pp.113-128
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• 2011

Objectives: The purpose of this study was to investigate the current state and trends of health-related research on foreign migrants living in Korea. Methods: Among 85 articles identified via PubMed and RISS and additional 7 articles by ancestry search, 28 were selected for the review. Two authors independently reviewed the articles using a literature review matrix and examined together the three aspects of the studies: research methods, research topics, and research results. Results: Most of the articles were published between 2005-2009, and only 3 studies used an interdisciplinary approach. Most were exploratory and there were 4 intervention studies: three of them examined the effect of an art therapy on acculturative stress and mental health among marriage migrant women. The lack of information on informed consent, approval of institutional review board, and the validity/reliability of the translated instruments were noted. Conclusions: Research is needed to examine migrants' health behaviors, the prevalence of chronic illness among migrants, and the influence of acculturation on the use of health resources, health behaviors, and health status. Researchers should be aware of ethnic issues when they work with foreign migrants.