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Interventions performed on a pregnant woman's body can affect the fetus in multiple ways. Such effects can be harmful to beneficial to the fetus. Unfortunately, the effects of new drugs and compoun...

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Improving public understanding and acceptance are critical for promoting coronavirus vaccination. However, how to promote COVID-19 vaccine programs remains controversial due to various ethical issues. This study, thus, aimed to survey the acceptance of COVID-19 vaccines among Japanese citizens and discuss relevant ethical issues. A cross-sectional survey was conducted via an online platform. An anonymous, quantitative, self-administered online questionnaire was sent to 6965 registered Japanese residents, which included questions regarding the respondent’s general knowledge, experience, and opinions of vaccines, vaccine development, (...) COVID-19, and COVID-19 vaccines. Of the 1569 respondents, 730 and 839 were categorized into the younger and older groups, respectively. Most of the respondents possessed general knowledge of COVID-19 vaccines and their features. Of the respondents, 57.8% definitely agreed or somewhat agreed to receive COVID-19 vaccines. The older group showed significantly greater willingness to receive vaccines and higher literacy regarding vaccines in general. Possible reasons for the older group’s greater willingness to receive COVID-19 vaccines are a high risk of severe COVID-19 infection and their past accumulated experience of receiving various vaccinations. Although active public intervention could increase vaccination rates, most of the respondents did not agree with mandatory vaccination. Furthermore, a gap between the participants in the COVID-19 vaccine trials and the prioritized population in real-world vaccination should be adjusted in future vaccine development. (shrink)

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Background: Sharing of tissue samples for research and disease surveillance purposes has become increasingly important. While it is clear that this is an area of intense, international controversy, there is an absence of data about what researchers themselves and those involved in the transfer of samples think about these issues, particularly in developing countries. Methods: A survey was carried out in a number of Asian countries and in Egypt to explore what researchers and others involved in research, storage and transfer (...) of human tissue samples thought about some of the issues related to sharing of such samples. Results: The results demonstrated broad agreement with the positions taken by developing countries in the current debate, favoring quite severe restrictions on the use of samples by developed countries. Conclusions: It is recommended that an international agreement is developed on what conditions should be attached to any sharing of human tissue samples across borders. (shrink)

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Research ethics consultation services (RECS), which function as an advisory service to facilitate the resolution of complex ethical issues in clinical research, have been proliferating over the last decade. However, the qualification of an individual who provides RECS, or “a research ethics consultant,” has not been thoroughly investigated, in contrast to healthcare ethics consultants, whose core competencies have been discussed and clarified to a great extent. In this study, we investigated core competencies necessary for research ethics consultants, referring to the (...) core competency models of ethics consultants developed in the healthcare practice context, and propose a competency model for research ethics consultants. (shrink)

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Advanced new therapies, such as stem cell and gene therapies and xenotransplantation, represent challenges for regulatory and ethical review. Major drug agencies, such as in the U.S., India, and Europe, have asserted regulatory authority and require ethics review by local ethics review committees, using the same strict requirements as those for standard drug approvals. In spite of this, unapproved and undocumented stem cell clinics flourish in all of these places, suggesting that current approaches do not offer patients sufficient protection. Japan (...) has attempted another approach, requiring approvals at local levels for all regenerative medical procedures, and a faster approval of promising new interventions. The Japanese approach has, however, also been criticized as not striking a proper balance between early access and a proper assessment of safety and effectiveness. For smaller and less-resourced countries, such as Thailand, one major challenge is limited expertise to conduct the evaluation of these advanced new therapies. This article provides an overview of the issues facing regulators and proposes that countries should restrict the early adoption of advanced new therapies to specialized clinics with appropriate scientific and ethical expertise for review. Review in these institutions should focus on expert clinical benefit assessments for individual patients being offered such interventions, independently of whether they are offered as research or therapy. (shrink)

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Amid continuing social unrest from the Great East Japan Earthquake and subsequent Fukushima nuclear accident of 2011, the Japanese government announced plans for a major biobanking project in the disaster-stricken areas, to be administered by the ‘Tohoku Medical Megabank Organization’ (ToMMo). This project differs from previous biobanking projects in that it 1) was initiated mainly to boost post-disaster recovery and reconstruction; and 2) targets the area’s survivors as its primary subjects. Here, we review the ethics of the ToMMo biobanking project (...) within the wider context of disaster remediation. (shrink)

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BackgroundWhether and how to disclose genomic findings obtained in the course of genomic clinical practice and medical research has been a controversial global bioethical issue over the past two decades. Although several recommendations and judgment tools for the disclosure of genomic findings have been proposed, none are sufficiently systematic or inclusive or even consistent with each other. In order to approach the disclosure/non-disclosure practice in an ethical manner, optimal and easy-to-use tools for supporting the judgment of physicians/researchers in genomic medicine (...) are necessary.MethodsThe bioethics literature on this topic was analyzed to parse and deconstruct the somewhat overlapping and therefore ill-defined key concepts of genomic findings, such as incidental, primary, secondary, and other findings. Based on the deconstruction and conceptual analyses of these findings, we then defined key parameters from which to identify the strength of duty to disclose (SDD) for a genomic finding. These analyses were then applied to develop a framework with the SDD matrix and systematic decision-making pathways for the disclosure of genomic findings.ResultsThe following six major parameters (axes), along with sub-axes, were identified: Axis 1 (settings and institutions where findings emerge); Axis 2 (presence or absence of intention and anticipatability in discovery); Axis 3 (maximal actionability at the time of discovery); Axis 4 (net medical importance); Axis 5 (expertise of treating physician/researcher); and Axis 6 (preferences of individual patients/research subjects for disclosure). For Axes 1 to 4, a colored SDD matrix for genomic findings was developed in which levels of obligation for disclosing a finding can be categorized. For Axes 5 and 6, systematic decision-making pathways were developed via the SDD matrix.ConclusionWe analyzed the SDD of genomic findings and developed subsequent systematic decision-making pathways of whether and how to disclose genomic findings to patients/research subjects and their relatives in an ethical manner. Our comprehensive framework may help physicians and researchers in genomic medicine make consistent ethical judgments regarding the disclosure of genomic findings. (shrink)

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In 2005 Japan completed its first census after the Personal Information Protection Law went into force in April 2005. The debate about the new law raised privacy concerns for the first time among the public. The news-media also provided several examples of possible lack of safeguards in the data collection of sensitive personal information required for the census. The result was the highest non-response rate ever for the Japanese census. Consequently, its accuracy and role as a source for the reliable (...) national statistics for health/welfare policy-making is now critically threatened. In this paper we argue the necessity to adopt specific safeguards to protect personal data in any future census if the trend of increasing non-response rates is to be reversed. We provide some suggestions for such safeguards, and criticize the Japanese government’s response of focusing exclusively on the mechanism of data collection as a means of meeting the privacy challenge. (shrink)

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The role of research ethics consultants in biomedical research has increased to the point that they have an advisory capacity at all research institutes. For such professionals, we have established an educational system, which includes teaching materials, training methods, and nationwide educational workshops. These workshops have served to examine the developed system’s usefulness and to provide realistic training for consultant candidates. In addition, we have used the current workshop to encourage clinical research investigators to participate. Subsequently, we examined its usefulness (...) as an opportunity to provide exposure to research ethics. In October 2019, we held a 1-day pilot workshop in Tokushima, Japan, which included a basic lecture in research ethics. During the lecture, two sets of materials were used for case discussion: case 1, covering issues related to a clinical trial, and case 2, covering issues related to human biological specimens. At the end of the workshop, a 30-item self-reporting anonymous questionnaire was provided. Of the 13 total participants, 9 were clinical research investigators and related personnel, while 6 had no direct intention to act as consultants. Respondents indicated that case 2 was more difficult than case 1. However, both cases were generally accepted as educational materials; thus, satisfaction was expressed in relation to both. As the evaluations of the cases were generally positive, we will further examine the usefulness of participation in the workshop in the cultivation of research ethics in the investigator community. (shrink)

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