Pub Date : 2022-12-01Epub Date: 2022-08-06DOI: 10.1007/s40592-022-00162-8
Wayne Shelton
How far can smart machines, or carebots, go in performing the profoundly intimate human work of patient caregivers? How will mechanization alter how we understand the essential features of the human task of caregiving and the role of the caregiver? It is these complex questions, with real world implications, that this article discusses in reviewing "Caregiving, Carebots, and Contagion" by philosopher and bioethicist Michael Brannagan.
{"title":"A review of \"Caregiving, Carebots, and Contagion\".","authors":"Wayne Shelton","doi":"10.1007/s40592-022-00162-8","DOIUrl":"https://doi.org/10.1007/s40592-022-00162-8","url":null,"abstract":"<p><p>How far can smart machines, or carebots, go in performing the profoundly intimate human work of patient caregivers? How will mechanization alter how we understand the essential features of the human task of caregiving and the role of the caregiver? It is these complex questions, with real world implications, that this article discusses in reviewing \"Caregiving, Carebots, and Contagion\" by philosopher and bioethicist Michael Brannagan.</p>","PeriodicalId":43628,"journal":{"name":"Monash Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40674253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-01DOI: 10.1007/s40592-022-00173-5
Ana S Iltis, Nataliya Shok
{"title":"Co-editors of the special issue \"East European post-communist legacy in medicine, health care, and bioethics\".","authors":"Ana S Iltis, Nataliya Shok","doi":"10.1007/s40592-022-00173-5","DOIUrl":"10.1007/s40592-022-00173-5","url":null,"abstract":"","PeriodicalId":43628,"journal":{"name":"Monash Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10493684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-01DOI: 10.1007/s40592-022-00158-4
Silviya Aleksandrova-Yankulovska
Background: Over the years, Bulgarian bioethics has been mainly an academic enterprise and fallen short of providing health professionals with skills for ethical decision-making. Clinical ethics support (CES) was piloted by the author through two bottom-up models - METAP (Modular, Ethical, Treatment, Allocation of resources, Process) and MCD (Moral Case Deliberation).
Aims: This paper aims to present and analyse developments in the area of clinical ethics and the first experiences in CES in Bulgaria.
Methodology: The project reported here included a review of relevant literature on CES methods and evaluation and a documentary review of data from two CES pilot projects: METAP and MCD.
Results: Most of the 69 METAP ethics meetings reviewed were first time meetings (88,4%); the average duration was 36 min and the average number of participants was four (44,9%). The meetings were organized in response to cases of severely or critically ill patients. The ethical dilemmas included choice of treatment (31,9%) and conflicts with the patient or their relatives (23,2%). Consensus was achieved in 34,8% of the cases. The situation was clarified with the patient (27,5%) and within the team (15,9%). The rights and obligations of both sides were discussed in 7,2% of the cases. The experience of the members of the Bulgarian Association of Bioethics and Clinical Ethics (BABCE) with MCD was also presented to justify the inference about the applicability of the two CES models in a Bulgarian context.
Conclusion: Among Eastern European countries Bulgaria has made progress in CES. Both METAP and MCD have been found to be useful methods.
{"title":"Bulgaria at the onset of clinical ethics consultation.","authors":"Silviya Aleksandrova-Yankulovska","doi":"10.1007/s40592-022-00158-4","DOIUrl":"https://doi.org/10.1007/s40592-022-00158-4","url":null,"abstract":"<p><strong>Background: </strong>Over the years, Bulgarian bioethics has been mainly an academic enterprise and fallen short of providing health professionals with skills for ethical decision-making. Clinical ethics support (CES) was piloted by the author through two bottom-up models - METAP (Modular, Ethical, Treatment, Allocation of resources, Process) and MCD (Moral Case Deliberation).</p><p><strong>Aims: </strong>This paper aims to present and analyse developments in the area of clinical ethics and the first experiences in CES in Bulgaria.</p><p><strong>Methodology: </strong>The project reported here included a review of relevant literature on CES methods and evaluation and a documentary review of data from two CES pilot projects: METAP and MCD.</p><p><strong>Results: </strong>Most of the 69 METAP ethics meetings reviewed were first time meetings (88,4%); the average duration was 36 min and the average number of participants was four (44,9%). The meetings were organized in response to cases of severely or critically ill patients. The ethical dilemmas included choice of treatment (31,9%) and conflicts with the patient or their relatives (23,2%). Consensus was achieved in 34,8% of the cases. The situation was clarified with the patient (27,5%) and within the team (15,9%). The rights and obligations of both sides were discussed in 7,2% of the cases. The experience of the members of the Bulgarian Association of Bioethics and Clinical Ethics (BABCE) with MCD was also presented to justify the inference about the applicability of the two CES models in a Bulgarian context.</p><p><strong>Conclusion: </strong>Among Eastern European countries Bulgaria has made progress in CES. Both METAP and MCD have been found to be useful methods.</p>","PeriodicalId":43628,"journal":{"name":"Monash Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10555214","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-01Epub Date: 2021-09-12DOI: 10.1007/s40592-021-00136-2
Corinna Porteri
During the covid-19 pandemic a huge number of research projects have been promoted internationally, nationally and locally. This also happened in Italy which was the first affected European country. Among these studies, research protocols based on the use of online questionnaires to evaluate the reaction of health workers and researchers to the emergency situation and their state of well-being were promoted. This contribution focuses on research protocols based on the use of online questionnaires and presents as a case study three different research proposals with the purpose of showing their different degree of compliance to scientific and ethical requirements and the need for a clear regulation. A guideline for the assessment of studies based on questionnaires is then suggested, in the absence of a national regulation on the issue. Having established rules, albeit flexible, can help to guarantee transparency in the evaluation process and contribute to the scientific and ethical compliance of the research.
{"title":"Assessment of studies based on the use of questionnaires in the time of Covid-19 pandemic.","authors":"Corinna Porteri","doi":"10.1007/s40592-021-00136-2","DOIUrl":"https://doi.org/10.1007/s40592-021-00136-2","url":null,"abstract":"<p><p>During the covid-19 pandemic a huge number of research projects have been promoted internationally, nationally and locally. This also happened in Italy which was the first affected European country. Among these studies, research protocols based on the use of online questionnaires to evaluate the reaction of health workers and researchers to the emergency situation and their state of well-being were promoted. This contribution focuses on research protocols based on the use of online questionnaires and presents as a case study three different research proposals with the purpose of showing their different degree of compliance to scientific and ethical requirements and the need for a clear regulation. A guideline for the assessment of studies based on questionnaires is then suggested, in the absence of a national regulation on the issue. Having established rules, albeit flexible, can help to guarantee transparency in the evaluation process and contribute to the scientific and ethical compliance of the research.</p>","PeriodicalId":43628,"journal":{"name":"Monash Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8435156/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39407114","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
We propose an emerging conceptualization of "intervention hesitancy" to address a broad spectrum of hesitancy to disease prevention interventions among healthcare personnel (HCP) beyond vaccine hesitancy. To demonstrate this concept and its analytical benefits, we used a qualitative case-study methodology, identifying a "spectrum" of disease prevention interventions based on (1) the intervention's effectiveness, (2) how the intervention is regulated among HCP in the Israeli healthcare system, and (3) uptake among HCP in the Israeli healthcare system. Our cases ultimately contribute to a more nuanced conceptualization of hesitancy that HCP express towards disease prevention interventions. Our case interventions included the seasonal influenza vaccine, the Mantoux test, and the hepatitis B (HBV) vaccine. Influenza and HBV are vaccine-preventable diseases, though their respective vaccines vary significantly in effectiveness and uptake among HCP. The Mantoux test is a tuberculin skin test which provides a prevention benchmark for tuberculosis (TB), a non-vaccine preventable disease. We conducted semi-structured interviews with relevant stakeholders and analyzed them within Israeli and international policy context between 2016 and 2019, a period just prior to the COVID-19 pandemic. We propose the conceptualization of "intervention hesitancy"-beyond "vaccine hesitancy"-as "hesitancy towards a wide range of public health interventions, including but not limited to vaccines". Results suggested that intervention hesitancy among HCP is rooted in weak trust in their employer, poor employment conditions, as well as mixed institutional guidelines and culture. Conceptualizing intervention hesitancy expands the ability of healthcare systems to understand the root of hesitancy and foster a supportive institutional culture and trust, cognizant of diverse disease prevention interventions beyond vaccination.
{"title":"Intervention hesitancy among healthcare personnel: conceptualizing beyond vaccine hesitancy.","authors":"Rachel Gur-Arie, Nadav Davidovitch, Anat Rosenthal","doi":"10.1007/s40592-022-00152-w","DOIUrl":"10.1007/s40592-022-00152-w","url":null,"abstract":"<p><p>We propose an emerging conceptualization of \"intervention hesitancy\" to address a broad spectrum of hesitancy to disease prevention interventions among healthcare personnel (HCP) beyond vaccine hesitancy. To demonstrate this concept and its analytical benefits, we used a qualitative case-study methodology, identifying a \"spectrum\" of disease prevention interventions based on (1) the intervention's effectiveness, (2) how the intervention is regulated among HCP in the Israeli healthcare system, and (3) uptake among HCP in the Israeli healthcare system. Our cases ultimately contribute to a more nuanced conceptualization of hesitancy that HCP express towards disease prevention interventions. Our case interventions included the seasonal influenza vaccine, the Mantoux test, and the hepatitis B (HBV) vaccine. Influenza and HBV are vaccine-preventable diseases, though their respective vaccines vary significantly in effectiveness and uptake among HCP. The Mantoux test is a tuberculin skin test which provides a prevention benchmark for tuberculosis (TB), a non-vaccine preventable disease. We conducted semi-structured interviews with relevant stakeholders and analyzed them within Israeli and international policy context between 2016 and 2019, a period just prior to the COVID-19 pandemic. We propose the conceptualization of \"intervention hesitancy\"-beyond \"vaccine hesitancy\"-as \"hesitancy towards a wide range of public health interventions, including but not limited to vaccines\". Results suggested that intervention hesitancy among HCP is rooted in weak trust in their employer, poor employment conditions, as well as mixed institutional guidelines and culture. Conceptualizing intervention hesitancy expands the ability of healthcare systems to understand the root of hesitancy and foster a supportive institutional culture and trust, cognizant of diverse disease prevention interventions beyond vaccination.</p>","PeriodicalId":43628,"journal":{"name":"Monash Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8934537/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47749958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-01DOI: 10.1007/s40592-022-00160-w
Žydrūnė Luneckaitė, Olga Riklikienė
Regulation and clinical practices regarding end of human life care differ among the nations and countries. These differences reflect the history of the development of state health systems, different societal values, and different understandings of dignity and what it means to protect or respect dignity. The result is variation in the ethical, legal, and practical approaches to end-of-life issues. The article analyzes the diversity of strategies to strengthen dignity at the end of life of terminally ill patients and to highlight the legal preconditions and limitations for implementing these strategies in independent Lithuania, as a former state of the Soviet Union. It is based on the critical analysis of philosophical literature, legal national and international documents and scientific evidence related to the issue. The author argues that the legal system in Lithuania is not sufficient to ensure the patient's dignity at the end of life and remains far behind other Western European countries. Legal regulations in Lithuania do not guarantee the right of the patient to express his or her will regarding the future treatment, including the refusal of resuscitation, do not regulate the termination of burdensome, non-viable and meaningless treatment that is undesired by the patient, and limit the accessibility of palliative care with its necessary quality and comfort.
{"title":"Dignity at the end of life: from philosophy to health care practice - Lithuanian case.","authors":"Žydrūnė Luneckaitė, Olga Riklikienė","doi":"10.1007/s40592-022-00160-w","DOIUrl":"https://doi.org/10.1007/s40592-022-00160-w","url":null,"abstract":"<p><p>Regulation and clinical practices regarding end of human life care differ among the nations and countries. These differences reflect the history of the development of state health systems, different societal values, and different understandings of dignity and what it means to protect or respect dignity. The result is variation in the ethical, legal, and practical approaches to end-of-life issues. The article analyzes the diversity of strategies to strengthen dignity at the end of life of terminally ill patients and to highlight the legal preconditions and limitations for implementing these strategies in independent Lithuania, as a former state of the Soviet Union. It is based on the critical analysis of philosophical literature, legal national and international documents and scientific evidence related to the issue. The author argues that the legal system in Lithuania is not sufficient to ensure the patient's dignity at the end of life and remains far behind other Western European countries. Legal regulations in Lithuania do not guarantee the right of the patient to express his or her will regarding the future treatment, including the refusal of resuscitation, do not regulate the termination of burdensome, non-viable and meaningless treatment that is undesired by the patient, and limit the accessibility of palliative care with its necessary quality and comfort.</p>","PeriodicalId":43628,"journal":{"name":"Monash Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10498572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-01Epub Date: 2022-01-23DOI: 10.1007/s40592-021-00150-4
Konrad Szocik
Despite the fact that people usually believe that individual health rights have an intrinsic value, they have, in fact, only extrinsic value. They are context dependent. While in normal conditions the current societies try to guarantee individual health rights, the challenge arises in emergency situations. Ones of them are pandemics including current covid-19 pandemic. Emergency situations challenge individual health rights due to insufficient medical resources and non-random criteria of selection of patients. However, there are some reasons to assume that societal and technological processes in the near future will threaten permanently individual health rights in normal conditions. Such processes include progress in commonly available human enhancement technologies, and progress in robotics and automation. In this paper I show how individual health rights will be challenged in both scenarios including catastrophic events and future technological progress. In both cases, the idea of assisted dying is discussed as possibly the unique healthcare principle available for people whose individual health rights will be limited or canceled due to catastrophes or technological and financial exclusion. The special case of future space missions is also discussed as an example of an extreme environment affecting the way moral norms are viewed in health care ethics.
{"title":"Why catastrophic events, human enhancement and progress in robotics may limit individual health rights.","authors":"Konrad Szocik","doi":"10.1007/s40592-021-00150-4","DOIUrl":"https://doi.org/10.1007/s40592-021-00150-4","url":null,"abstract":"<p><p>Despite the fact that people usually believe that individual health rights have an intrinsic value, they have, in fact, only extrinsic value. They are context dependent. While in normal conditions the current societies try to guarantee individual health rights, the challenge arises in emergency situations. Ones of them are pandemics including current covid-19 pandemic. Emergency situations challenge individual health rights due to insufficient medical resources and non-random criteria of selection of patients. However, there are some reasons to assume that societal and technological processes in the near future will threaten permanently individual health rights in normal conditions. Such processes include progress in commonly available human enhancement technologies, and progress in robotics and automation. In this paper I show how individual health rights will be challenged in both scenarios including catastrophic events and future technological progress. In both cases, the idea of assisted dying is discussed as possibly the unique healthcare principle available for people whose individual health rights will be limited or canceled due to catastrophes or technological and financial exclusion. The special case of future space missions is also discussed as an example of an extreme environment affecting the way moral norms are viewed in health care ethics.</p>","PeriodicalId":43628,"journal":{"name":"Monash Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8783799/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39939863","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-01DOI: 10.1007/s40592-022-00154-8
Roman Tarabrin
This article assesses the role of an important Russian public institution, the Russian Orthodox Church (ROC), in shaping the religious discourse on bioethics in Russia. An important step in this process was the approval of 'The Basis of the Social Concept of the Russian Orthodox Church' (2000), one chapter of which is devoted to bioethics. However, certain inadequacies in the creation of this document resulted in the absence of a clear position of the Russian Orthodox Church on some end-of-life issues, reproductive technologies, embryo stem cells, and other topics.Using the example of reproductive dilemmas, the author researches how the ROC clarifies its teaching on issues relating to bioethics. In the 2010s the ROC introduced a new method of taking into account the views of believers and the articulation of the church's position. This article examines the extensive public discussion of a new document, 'Ethical issues Associated with In Vitro Fertilization'.
{"title":"Russian orthodox church on bioethical debates: the case of ART.","authors":"Roman Tarabrin","doi":"10.1007/s40592-022-00154-8","DOIUrl":"https://doi.org/10.1007/s40592-022-00154-8","url":null,"abstract":"<p><p>This article assesses the role of an important Russian public institution, the Russian Orthodox Church (ROC), in shaping the religious discourse on bioethics in Russia. An important step in this process was the approval of 'The Basis of the Social Concept of the Russian Orthodox Church' (2000), one chapter of which is devoted to bioethics. However, certain inadequacies in the creation of this document resulted in the absence of a clear position of the Russian Orthodox Church on some end-of-life issues, reproductive technologies, embryo stem cells, and other topics.Using the example of reproductive dilemmas, the author researches how the ROC clarifies its teaching on issues relating to bioethics. In the 2010s the ROC introduced a new method of taking into account the views of believers and the articulation of the church's position. This article examines the extensive public discussion of a new document, 'Ethical issues Associated with In Vitro Fertilization'.</p>","PeriodicalId":43628,"journal":{"name":"Monash Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9101335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-01Epub Date: 2022-06-15DOI: 10.1007/s40592-022-00156-6
Mabel Rosenheck
During the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and 2021. The pharmaceutical company Johnson and Johnson, the National Institutes of Health in the United States, and a private-public partnership of industry, university, and government partners in Britain all undertook preparations. The United Kingdom's consortium began their Human Challenge Programme in March of 2021.Beyond documenting each effort, the essay puts these scientific and ethical debates in dialogue with the social, epidemiological, and institutional conditions of the pandemic as well as the commercial, intellectual, and political systems in which medical research and Covid-19 challenge studies operated. It shows how different institutions understood risk, benefit, and social value depending on their specific contexts. Ultimately the example of Covid-19 challenge studies highlights the constructedness of such assessments and reveals the utility of deconstructing them retrospectively so as to better understand the interplay of medical research and research ethics with larger social systems and historical contexts.
{"title":"Risk, benefit, and social value in Covid-19 human challenge studies: pandemic decision making in historical context.","authors":"Mabel Rosenheck","doi":"10.1007/s40592-022-00156-6","DOIUrl":"10.1007/s40592-022-00156-6","url":null,"abstract":"<p><p>During the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and 2021. The pharmaceutical company Johnson and Johnson, the National Institutes of Health in the United States, and a private-public partnership of industry, university, and government partners in Britain all undertook preparations. The United Kingdom's consortium began their Human Challenge Programme in March of 2021.Beyond documenting each effort, the essay puts these scientific and ethical debates in dialogue with the social, epidemiological, and institutional conditions of the pandemic as well as the commercial, intellectual, and political systems in which medical research and Covid-19 challenge studies operated. It shows how different institutions understood risk, benefit, and social value depending on their specific contexts. Ultimately the example of Covid-19 challenge studies highlights the constructedness of such assessments and reveals the utility of deconstructing them retrospectively so as to better understand the interplay of medical research and research ethics with larger social systems and historical contexts.</p>","PeriodicalId":43628,"journal":{"name":"Monash Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9200217/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41937447","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-01Epub Date: 2022-11-10DOI: 10.1007/s40592-022-00165-5
Hiroyuki Nagai, Eisuke Nakazawa, Akira Akabayashi
The Belmont Report continues to be held in high regard, and most bioethical analyses conducted in recent years have presumed that it affects United States federal regulations. However, the assessments of the report's creators are sharply divided. Understanding the historic reputation of this monumental report is thus crucial. We first recount the historical context surrounding the creation of this report. Subsequently, we review the process involved in developing ethical guidelines and describe the report's features. Additionally, we analyze the effect of unfolding events on the subsequent creation of federal regulations, especially on gene therapy clinical trials. Moreover, throughout this paper we evaluate the ethical principles outlined in this report and describe how they overlap with the issue of protecting socially vulnerable groups. Based on the analysis, we conclude that the features of the Belmont Report cannot be considered as having affected the basic sections of the federal regulations for ethical reviews that were made uniform in 1981. Nevertheless, regarding the regulations on gene therapy clinical trials-which were at first expected to be applicable to research involving children-in addition to implementing policies regarding the public review of protocols that passed ethical review, this report's principles are clearly reflected in the key notes that should have been referred to when the report was created.
{"title":"The creation of the Belmont Report and its effect on ethical principles: a historical study.","authors":"Hiroyuki Nagai, Eisuke Nakazawa, Akira Akabayashi","doi":"10.1007/s40592-022-00165-5","DOIUrl":"10.1007/s40592-022-00165-5","url":null,"abstract":"<p><p>The Belmont Report continues to be held in high regard, and most bioethical analyses conducted in recent years have presumed that it affects United States federal regulations. However, the assessments of the report's creators are sharply divided. Understanding the historic reputation of this monumental report is thus crucial. We first recount the historical context surrounding the creation of this report. Subsequently, we review the process involved in developing ethical guidelines and describe the report's features. Additionally, we analyze the effect of unfolding events on the subsequent creation of federal regulations, especially on gene therapy clinical trials. Moreover, throughout this paper we evaluate the ethical principles outlined in this report and describe how they overlap with the issue of protecting socially vulnerable groups. Based on the analysis, we conclude that the features of the Belmont Report cannot be considered as having affected the basic sections of the federal regulations for ethical reviews that were made uniform in 1981. Nevertheless, regarding the regulations on gene therapy clinical trials-which were at first expected to be applicable to research involving children-in addition to implementing policies regarding the public review of protocols that passed ethical review, this report's principles are clearly reflected in the key notes that should have been referred to when the report was created.</p>","PeriodicalId":43628,"journal":{"name":"Monash Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.6,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9700634/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40456189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}