Bioethics
Online ISSN : 2189-695X
Print ISSN : 1343-4063
ISSN-L : 1343-4063
Volume 31, Issue 1
Displaying 1-12 of 12 articles from this issue
Contents
Foreword
Invited Articles
  • Satoshi KODAMA
    Article type: Invited Articles
    2021Volume 31Issue 1 Pages 4-11
    Published: September 28, 2021
    Released on J-STAGE: August 01, 2022
    JOURNAL FREE ACCESS

        There is an urgent need for bioethicists to inquire upon ethical, legal, and social issues concerning public policies and scientific and technological responses to the Covid-19 pandemic. This article focuses on the public health aspect of such pandemic responses. In particular, it addresses three ethical issues, namely: restrictions on civil liberties, fairness in resource allocation, and individual and collective responsibility for preventive action. These issues are not new and have appeared in the bioethics literature. However, the Covid-19 pandemic has put them in a new light and endowed them with particular importance. This article will describe these issues in detail but will not provide answers to each of them, as they are in need of more discussion than can be given in this short article. We need to examine our pandemic responses from a bioethics perspective and learn as many lessons from it as we can, in order to prepare better for the next pandemic.

        Covid-19 pandemic and three problematics in public health ethics.

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  • Tatsuya MIMA
    Article type: Invited Articles
    2021Volume 31Issue 1 Pages 12-19
    Published: September 28, 2021
    Released on J-STAGE: August 01, 2022
    JOURNAL FREE ACCESS

        Due to the COVID-19 pandemic in 2020, medical resources (especially ICU beds with advanced life support, such as respirators) have become scarce around the world, and the necessity of their allocation/rationing is discussed as an ICU triage. This paper reviews the bioethical discussions on ICU triage during the pandemic and addresses three issues: (1) treatment of the elderly, (2) priorities for medical resource allocation, and (3) medical resource re-allocation. Our analysis showed (1) that using age as exclusion criteria for ICU can be discrimination against the elderly, (2) that there were mainly three policies guiding the allocation; no triage, triage by medical needs, and triage by medical utility, while lacking the evidence-based medical assessments on the utility of the triage, and (3) that the reallocation of scarce medical resources in a utilitarian ICU triage scheme might not be legally secure. Finally, we discussed the social implications of utilitarian triage during the state of exception such as the COVID-19 pandemic in the framework of biopolitics theory.

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Reports
  • Kenji MATSUI, Yutori TAKAI, Keiichiro YAMAMOTO, Yusuke INOUE
    Article type: Reports
    2021Volume 31Issue 1 Pages 20-28
    Published: September 28, 2021
    Released on J-STAGE: August 01, 2022
    JOURNAL FREE ACCESS

        Innovative assisted reproductive technology (ART) has traditionally been introduced to clinical practice as an “individual treatment” or “clinical service” without sufficient verification through basic research, animal experimentations, or clinical trials/studies involving human subjects. This unique ART clinical application process, which significantly differs from the regular development process of medicinal substances or devises in general, is attributable to the paucity of arguments on the ethics of clinical trials/studies related to ART from the research ethics perspective of protecting human subjects. However, developers of recent innovative ARTs are now tending to follow the regular steps of clinical trials/studies with human subjects. This article first examines the unique ethical features of ART clinical trials/studies, followed by an argument that ethical issues of ART clinical trials/studies cannot be fully captured within the framework of traditional ethics on clinical human research, which is based on the ethical principles provided by the Belmont Report.

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  • Yutori TAKAI, Kenji MATSUI
    Article type: Reports
    2021Volume 31Issue 1 Pages 29-36
    Published: September 28, 2021
    Released on J-STAGE: August 01, 2022
    JOURNAL FREE ACCESS

        Under the COVID-19 pandemic, medical researchers have been striving to develop drugs and vaccines against the novel coronavirus. Currently, almost all curative treatments and vaccines are contraindicated for pregnant patients due to unknown efficacy and safety. Moreover, being excluded from studies related to COVID-19, pregnant women are likely to be left behind in the use of new vaccines as well. Historically, pregnant women have thoroughly been excluded from clinical trials due to ethical reasons, such as to ensure their protection, and researchers and regulation officers have taken it for granted that pregnant women should be excluded from clinical trials given their vulnerability. In fact, FDA guidelines issued in 1977 recommended that all fertile women be prevented from participating in clinical trials. According to a previous study, pregnant women were excluded from 95% of all industry-funded clinical studies conducted in the US between 2010 and 2011. In the present paper, we discuss ethical issues of exclusion of pregnant women from clinical trials, mainly by referring to the historical background and current situations in the US. In the first section, we present an overview of present COVID-19-realated drug and vaccine studies that broadly exclude pregnant women from participation. In the second section, we investigate the historical background that led to the exclusion of pregnant women from studies in the US. In turn, the third section takes a quick look at social and academic movements toward the inclusion. Drugs and vaccines suitable for pregnant women cannot be developed without clinical trials that include both pregnant and non-pregnant participants. To this end, from 2008 to 2010, many bioethics researchers advocated the importance of including pregnant women in clinical trials, leading to a radical revision of FDA guidelines and publication of the 2018 PRGLAC report that demanded additive justification on biomedical researchers for not inclusion but exclusion. Despite these changes, COVID-19 studies that began in 2020 broadly excluded pregnant women, raising alarms among researchers. In the last section, we examine philosophical arguments that justify and promote the inclusion of pregnant women in clinical studies in general, highlighting the importance of the principle of justice in research ethics.

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  • A Study Based on a Case in Which the Insurer Was Exempted from Liability under the Congenital Anomaly Clause
    Yuko MURAOKA, Kazuto KATO
    Article type: Reports
    2021Volume 31Issue 1 Pages 37-45
    Published: September 28, 2021
    Released on J-STAGE: August 01, 2022
    JOURNAL FREE ACCESS

        There is a debate in the insurance field concerning regulations on the use of genetic information.

        This article clarifies some problems surrounding this issue, beginning from one court case in which the court applied a “clause of congenital anomaly” and granted immunity to an insurance company on the grounds that the insured person's disease was hereditary. This court case shows us that when a patient is diagnosed with a genetic disease based on a clinical diagnosis rather than a genetic test, even if the insured party is treated disadvantageously because of this condition, the law will not recognize it as discriminatory treatment based on genetic information. These kinds of precedents could undermine the effectiveness of genetic information usage regulations.

        In order to avoid discriminatory treatment based on genetic information, and considering that it is often difficult to distinguish genetic information from medical information, it is vital to thoroughly discuss what kinds of genetic information are to be the subject of regulation. Furthermore, it is important to have an open discussion not only in the insurance industry but also in society as a whole concerning what kind of intervention is possible when people with hereditary conditions are put at a disadvantage such as in the abovementioned court case.

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  • Shunsuke AKIBA
    Article type: Reports
    2021Volume 31Issue 1 Pages 46-54
    Published: September 28, 2021
    Released on J-STAGE: August 01, 2022
    JOURNAL FREE ACCESS

        The relationship between self and others in the “emergency situation” associated with the spread of COVID-19 is premised on a reciprocal connection, and there is a growing discussion that appears to connect concern for self and concern for others. Particular attention has been paid to the debate over triages in emergency situations and the shortage of medical resources. This is a subject that has been deliberated in various ways in the past, but in the current debate, the topics of “triage in emergencies” and “self–other relationships in self-determination” are mixed together, and related issues and critiques are not properly coordinated. Therefore, this paper will first examine the relationship between “triage in emergencies” and “self–other relationships in self-determination” referring to “COVID-19's recommendations for the process of determining ventilator allocation during an infection eruption” issued by a research group on ethical, legal, and social implication in Japan. The relationship between self-determination and “relational autonomy” will then be examined using the consideration for self as a consideration for others as a clue, and the overall theoretical structure of this idea will be clarified.

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  • Aya TABUCHI
    Article type: Reports
    2021Volume 31Issue 1 Pages 55-63
    Published: September 28, 2021
    Released on J-STAGE: August 01, 2022
    JOURNAL FREE ACCESS

        In bioethics, respect for autonomy refers to associating with a patient's right to self-determination. The concept of autonomy does not consider the social status of a patient or their interpersonal relationships. For this reason, doctors may justify their own paternalism by unreasonably judging a patient to be not autonomous. This paper examines discussions on relational autonomy since 2000, giving particular attention to strong substantive accounts, weak substantive accounts, and self-answerability to resolve this matter and consider how respect for autonomy can be utilized to induce medical practitioners to support a patient's agency and right to choose. We argue that self-answerability, which serves as a standard for the autonomy of a patient's answerability, is the best form of relational autonomy for achieving applicable and desirable autonomy for medicine and care. Indeed, this is because it does not classify patients as autonomous or not autonomous, but rather it makes it possible to regard patients as diverse by reconsidering autonomy according to degree. It is also possible for medical practitioners to avoid forming contemptuous attitudes toward non-autonomous patients and develop generous and tenacious attitudes toward all patients.

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Program of the 32th Annual Meeting
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