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The Bioethics and Safety Act(hereinafter referred to as the “Bioethics Act”) was fully revised in 2012, and came into effect in 2013. The Act was revised and expanded to include not only genetic and genetic information but also human materials introducing the term, ‘human material bank.’ The Bioethics Act stipulates that human material bank has the ability to collect and provide human materials to others, as well as to directly collect and use human materials to be used for research. There is no clear regulation on qualification requirements of the person to collect. There is confusion and difficulty in interpreting the relevant regulations on whether or not for the institutional review board of human material bank to pre-review when a human material bank directly collects or asks others to collect human materials. In addition, there is no clear management protocol for human material bank to prevent its over-collecting human materials. Thus, we point out the problems of the vague legal regulation regarding human material banks under the Bioethics Act. In order to secure citizens’ trust on the operation of human material biobank and improve its quality, we provide clear interpretation of the relevant current regulations in Bioethics Act and suggest concrete legal contents for the revision of the problematic regulations related to human material bank or the introduction of new regulations. [ABSTRACT FROM AUTHOR]

This study aims to discuss the necessity of the ROK Armed Forces institutional review board(ROK Armed Forces IRB) and explore the direction of the operation. Under Bioethics and Safety Act, researchers who wish to carry out human subjects research or human derived materials research should submit a research proposal to be reviewed in terms of ethics and scientific validity. All the studies conducted in the ROK Armed Forces are no exception. However, the number of IRBs in the ROK Armed Forces is not enough to five, and the subjects of review are focused on medical science research and clinical trials. Accordingly, the present study proposed the establishment of the ROK Armed Forces IRB to develop a research system considering the special characteristics of the military and to secure ethical grounds for human subjects research and human derived materials research conducted in the military. Then, the basic operational directions of the ROK Armed Forces IRB were explored by comparing domestic and international regulations as well as the current operational status of the ROK and U.S. Armed Forces IRB. Specifically, the selection and composition of the IRB members, documents necessary for IRB review, and details to be discussed in IRB review were presented based on the special environment of the ROK Armed Forces. Finally, the expected effects and future suggestions were discussed. [ABSTRACT FROM AUTHOR]

Since the Korean Ministry of Food and Drug Safety (MFDS) issued the 'Human Research Protection Program (HRPP) Guideline' in 2014, they have provided incentives for investigator-initiated trials, education, and internal audits in clinical trial institutions that adhere to HRPP. However, despite the efforts of the government, only 10 of 190 institutions were approved HRPP operation by the MFDS, and the secondary medical institution was only one of them. Therefore, we surveyed the current status of HRPP basic operation and perceptions for secondary medical institutions as clinical trial institutions that have not yet been approved HRPP operation by the MFDS. We used the survey results to find a method for effective HRPP operation depending on institutional characteristics and the scale of clinical trials. The survey results showed that the responding institutions had problems of insufficient and unstable human resources, low awareness due to lack of incentives for HRPP operation, lack of inter-departmental cooperation systems, confusion about Institutional Review Board (IRB) operation support and HRPP basic operation, and lack of guidance about best practices for HRPP operation. To solve these problems, we suggest the following ways. First, it is to design a manpower standard that enables supply and maintenance of professional personnel and business continuity. Second, it is to induce voluntary HRPP operation by reflecting the criteria of HRPP operation in medical institution certification. Third, it is to amend as a guideline for specifying the IRB roles additionally. Finally, it is to provide practical guidelines through selection of model institutions depending on institution characteristics and scale of clinical trials. [ABSTRACT FROM AUTHOR]

Children are considered as those who have not reached the legal adult age, as well as those who need protection, because their physical and mental growth or maturity is not as developed as adults. ˹Bioethics and Safety Act˼ which includes legal provisions for research involving humans, stipulates that children as research participants should be protected by legal representatives, because they are incompetent and undeveloped. However, other than this, no further criteria are provided on how children should be perceived or how to protect them as research participants. In order for a child's rights to be protected, studies involving children must be conducted, and children should not be maximally excluded or minimally included only because they are vulnerable. At the same time, they must be properly understood and protected on the grounds of being children. In this paper, we analyzed the contents of the study on the protection of children as research participants in the "International Ethics Guidelines for Health-Related Research Involving Humans Subjects," which was revised and published in 2016 by the Council for International Organizations of Medical Science (hereafter, CIOMS). The study attempted to examine what kind of understanding researchers and Institutional Review Boards should have about children who are research participants, and what protections are appropriate. By comparing this study with the contents of the "International Ethical Guidelines for Biomedical Research Involving Human Subjects," which was published by CIOMS in 2002, as well as the Declaration of Helsinki and the Belmont Report, this paper attempts to identify the differences and changes in the understanding of children as research participants, and their protection. This is intended to help determine the necessary considerations in preparing future legal and policy criteria for the protection of child research participants. Therefore, CIOMS Guidelines 2016 presents the following new perspectives on children as research participants. First, children are not the ones who should be excluded or minimized in research but the ones who need to be actively studied as participants because they are vulnerable. Second, children are not the ones who must be protected by adults because of their immaturity, but the ones who have various levels of maturity in the process of developing into mature human beings. Third, children are not the ones who has incidentally formal assent with the legal representative's consent, but the ones who can express his or her true intention and must be respected in substance. Fourth, since the right to privacy and the right to self-determination of personal information should be respected, it may be unreasonable for children to assume the consent of the legal representative unconditionally. [ABSTRACT FROM AUTHOR]

This paper intended to address the issue of the protection of the donor's rights in the collection of residual human materials by medical institutions and the provision of them to the biobank under the ˹Bioethics & Safety Act˼ as amended in October 2019. In particular, we examined the procedural content issues regarding the adoption of the optout system, and also argued that the opt-in system was more appropriate. Of course, we agree that the medical institutions, which are intended to be amended by the law, will use the residual human materials for treatment and diagnosis purposes to lay the foundation for more efficient and active disease research for research purposes. In addition, the CIOMS guidelines stipulate that residual human materials can be stored and used in research, unless explicitly stated by the person who is the source of the residual human materials, and the conditions are set forth. That is opt-out system. However, the relevant details of the revised legislation suggest that the opt-out system, in which the residual human materials is donated to the biobank, unless the objector rejects it, will make it difficult for the informed consent to make integrated autonomous decisions. Because it is necessary to express the objection of rejection through the information received in writing, it is difficult for the patient to acknowledge that he has obtained enough information and understood and agreed to it. And, due to the subordinate hierarchical difficulties arising from the doctor-patient relationship, it is difficult to guarantee voluntary rejection of the donor. In addition, within three days after the human materials is collected, it is necessary to clarify the rejection of the offer, which is cumbersome and inconvenient to express the objection. Finally, privacy issues related to residual human materials may arise. Therefore, it is appropriate to adopt an opt-in system for protecting the donor's rights, which is more important than the effective progress of disease research and the result of excellent scientific results. First of all, we argued that sufficient training and information were required for the Institutional Review Board Member under consideration according to the revised law to work in consideration of this problems. [ABSTRACT FROM AUTHOR]

Everyone has a desire to live a healthy life, but no one is free from disease and aging. Therefore, various efforts- are being made to overcome health precariousness. A representative example in the biomedical science and- technology field is clinical trials(CTs) conducted to develop safer and more effective drugs. However, since CTs- are research to confirm safety and efficacy of investigational products for which safety and efficacy have not- yet been identified, which could have a negative impact on the participants in CTs. Thus, the protection of these- people has long been emphasized, and it has been of paramount importance that researchers conducting CTs- have the capability to conduct CTs ethically and scientifically. In particular, considering the quantitative increase- of CTs conducted in Korea as well as changes of the major field in CTs conducted in Korea, this capability will- be emphasized not only to researchers who are the mainstay of CTs, but also to those who are working on the- tasks directly or indirectly involved in CTs. This capability is basically directly related to the education of these- people. In recent years, the education for these people has become legally compulsory education under the name- of 'education to people engaged in CTs', and this education is aimed 'to improve their specialty' and 'to protect the- participants in CTs'. In this article, I tried to analyze the significance and limitations of the current law and policies- related to the education to people engaged in CTs by observing the main contents of the law and policies such- as the educational institution for CTs, subjects to legally compulsory education, time of education, educational- contents and methods. And, I would like to give some suggestions on how to overcome its limitations through- improvement measures in order to ensure that the education is appropriately carried out and that it achieves what it- is aiming to do. [ABSTRACT FROM AUTHOR]