2019, Vol.20, No.1

The need and legal Issues to approve exceptions to principles of obtaining informed consent from legally acceptable representative in research involving children

Seulbi Choi , Eunae Kim | 2019, 20(1) | pp.1~24 | number of Cited : 5

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In principle, in order to enroll children as research participants, informed consent(hereafter, IC) from their legally acceptable representatives(hereafter, LAR) should be in place. Children are deemed incapable of giving complete IC. 「Bioethics & Biosafety Act(hereafter, BioAct)」 stipulates that, for children under the age of 18 years old, researchers must obtain IC from their LAR. However, forcing researchers to obtain IC from children’s LAR(here after, LAR’s IC) can cause some problems both to protect children as research participants and to conduct research involving children. For example, it may not be appropriate to obtain LAR’s IC in research on violations of social norms or privacy, such as child's deviation, domestic violence, or sexual experience. Despite differences in children's understanding and maturity depending on age, prohibiting all children to participate in research unless LAR’s IC is too restrictive. Therefore, this article points out that there is a need to approve the exceptions to LAR’s IC in research involving children and analyses legal issues under the 「Bio Act」. Finally, this article suggests that the provisions including a basis for granting authority to the Institutional Review Board(hereafter, IRB) for approval of exceptions must be established in 「Bio Act」. And this article proposes that consideration to approve exceptions by IRB review should be made in that provisions such as research purpose and characteristics, research, procedures and method of the research, associated risks and benefit(especially to children as research participants), effect of obtaining LAR’s IC on children’s self-determination and privacy protection, ability to give IC or assent of children as research participant and preparation by researcher to obtain IC or assent of children, and special additional protections for children as research participants so that both the adequacy of the exercise of rights and the protection of children as research participants are possible.

Legal and political suggestions to ensure the health and self-determination of living organ donors : Focused on the Kidney donors

Sujung Yoo , Bomyee Lee , PARK SO YOUN | 2019, 20(1) | pp.25~44 | number of Cited : 2

With increased prevalence of chronic diseases as a result of increased lifespan and aging of population, the number of people waiting for kidney transplantation is consistently on the rise. Due to the low brain-dead donor rate in Korea, living kidney transplantation has been considered an alternative. However, living kidney donors have no medical benefits from the transplantation and instead exposed to a risk, so multilateral—ethical, medical, and legal—discussions are crucial regarding its implementation. Nevertheless, the diverse physical, psychological, and socioeconomic risks facing living kidney donors before and after organ donation have not been reviewed with significance in Korea. Therefore, this article proposes the following legal and political suggestions for a comprehensive and systematic management, from pre-donation protection of living kidney donors to fully informed consent for organ donation and follow-up care for post-donation health management. First, to ensure the compatibility of living kidney donors and minimize the risk of organ donation, specific guidelines for feasible pre-donation compatibility test process and medical assessment criteria should be set based on relevant literature and transplantation outcomes. Second, to ensure that living kidney provide their consent for organ transplantation based on sufficient information, standardized consent forms should be prepared and provided for each organ that contains information about medical recommendations, such as post-donation health management plans and care, in addition to the essential information stipulated by the Organ Transplantation Act. Third, a specific procedure should be set to ensure autonomous decision-making and confidentiality of potential kidney donors during the process of providing consent and receiving results after a physical examination. Fourth, it is necessary to seek financial support for post-donation health care of living kidney donors. Finally, for systematic health care after donation of living kidney donors, it is necessary to prepare post-care and long-term tracking observation programs.

A Study on the Model of life-sustaining treatment Decision Making through Shared Decision Making at the end of life

Kwon kyeung eun | 2019, 20(1) | pp.45~61 | number of Cited : 6

Interpretation of Exemption of RB Review Under Bioethics and Biosafety Act & Proposal for Improvement in Practice

Gangmi Lee , Won Bok Lee | 2019, 20(1) | pp.63~82 | number of Cited : 1

A Proposal to Activate Organ Donation on the basis of Capability Approach

Kwangsu Mok | 2019, 20(1) | pp.83~101 | number of Cited : 2

In this paper, I argue that capability approach suggests a theoretical foundation to activate organ donation ethically and efficiently. People who have been forced to die due to the damage of organs, have been theoretically able to prolong their life through organ transplantation due to the development of modern science and technology, but in reality, many people are dying without organ transplants. This is because, in the current situation where the supply of organs for organ transplantation depends only on organ donation, the number of organ donors is significantly smaller than that of transplant recipients. In order to resolve this imbalance, financial incentive and ethical incentive strategies have been proposed but they are not only ethically unjustified, but also effectively infeasible. This is because, financial incentive is against the fundamental spirits of organ donation such as volunteerism and altruism, it leads to injustices to exploit the poor, and its effects are doubtful in history. Although ethical incentive strategies offer many non-financial incentive strategies in order to complement the weaknesses of financial incentive, their effects are doubtful because they do not propose a theoretical discussion on how non-financial strategies work with financial strategies. However, capability approach is effective in activating organ donation for three reasons. First, capability approach, which highlights the importance of health, is relevant to be a foundational discussion to justify the ethical legitimacy of organ transplantation and donation. Second, capability approach, which is a framework, rather than a theory, is appropriate to propose a systematic framework to cover not only theoretical discussions but also practical discussions to activate organ donation. Third, capability approach is effective to overcome limitations of established prior incentive strategies, through the systematical strategy of institutional, non-institutional, and individual aspects in order to promote capability. I hope that this theoretical work will effectively guide the practical work to activate organ donation sustainably.

KJCKorea
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Journal of the Korea Bioethics Association 2023 KCI Impact Factor : 0.55

2019, Vol.20, No.1