• Neonatal Medicine
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• v.15 no.2
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• pp.119-122
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• 2008

Clinical research is a necessity, not an option, for developing better and new medicines and therapeutic modalities. But in the course of clinical research, there are rules and guidelines that should be followed to ensure the due respect for persons, beneficence, and justice for persons who voluntarily participate in the research as described in the Belmont Report. Good Clinical Practice (GCP) is an "international scientific and ethical quality standard for designing, conducting, recording, and reporting" clinical trials. The main purposes of GCP would be to protect rights, safety, and well-being of trial subjects, in compliance with the principles of Declaration of Helsinki, and to assure that the data obtained from clinical trials are credible. In order to achieve these, investigators must be fully aware of the meanings as well as actual procedures involved in the research and should make the best effort to comply with GCP. For those individuals who belong to vulnerable populations, such as neonates, in addition to the general principles of GCP, further measures to ensure added protection should be implemented. It is our duty to develop and provide better care through clinical research even for neonates. But in doing so, we have to make sure that the importance of protecting the rights, safety, and well-being of the subjects supersede the interests of science and society.

• 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.

• The Journal of KAIRB
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• v.4 no.1
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• pp.16-22
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• 2022

Purpose: The traditional ethical study only suggests a blurred insight on the research using medical big data, especially in this rapid-changing and demanding environment which is called "4th Industry Revolution." Current institutional/ethical issues in big data research need to approach with the thoughtful insight of past ethical study reflecting the understanding of present conditions of this study. This study aims to examine the ethical issues that are emerging in recent health care big data research. So, this study aims to survey the public perceptions on of health care big data as part of the process of public discourse and the acceptance of the utility and provision of big data research as a subject of health care information. In addition, the emerging ethical challenges and how to comply with ethical principles in accordance with principles of the Belmont report will be discussed. Methods: Survey was conducted from June 3th August to 6th September 2020. The online survey was conducted through voluntary participation through Internet users. A total of 319 people who completed the survey (±5.49%P [95% confidence level] were analyzed. Results: In the area of the public's perspective, the survey showed that the medical information is useful for new medical development, but it is also necessary to obtain consents from subjects in order to use that medical information for various research purposes. In addition, many people were more concerned about the possibility of re-identifying personal information in medical big data. Therefore, they mentioned the necessity of transparency and privacy protection in the use of medical information. Conclusion: Big data on medical care is a core resource for the development of medicine directly related to human life, and it is necessary to open up medical data in order to realize the public good. But the ethical principles should not be overlooked. The right to self-determination must be guaranteed by means of clear, diverse consent or withdrawal of subjects, and processed in a lawful, fair and transparent manner in the processing of personal information. In addition, scientific and ethical validity of medical big data research is indispensable. Such ethical healthcare data is the only key that will lead to innovation in the future.