The Ethical Limits of Domestication: A Critique of Henry Heffner's Arguments

ABSTRACT

Henry E. Heffner argues that “animals bred for research are properly viewed as animals who have successfully invaded the laboratory niche, relying heavily on kin selection to perpetuate their genes.” (1999, p. 134). This view of human–animal interactions is the corner-stone of his defense of animal experimentation in two widely-distributed papers (Heffner 1999, 2001). We argue that Heffner's defense lacks adequate attention to ethical distinctions and principles.     

Ordinary ethics: lay people's deliberations on social sex selection

Abstract

This article summarises the results of a research project that used a scenario about sex selection of embryos for social reasons as a basis for discussion groups with lay people. The aim of the research was to examine the processes by which non-professionals make ethical evaluations in relation to a contested area in medical genetics. We note in particular the role played in the discussions by expressions of instinct; making distinctions; rational argument; reference to principles; use of personal experience; analogies and examples; slippery slope arguments and meta-reflections. The implications for developing processes of public consultation and debate are also considered.     

Knowledge graphs of ethical concerns of cerebral organoids

ObjectivesThe rapid development of cerebral organoid technology and the gradual maturity of cerebral organoids highlight the necessity of foresighted research on relevant ethical concerns. We employed knowledge graphs and conducted statistical analysis with CiteSpace for a comprehensive analysis of the status quo of the research on the ethical concerns of cerebral organoids from a bibliometric perspective.Materials and MethodsWe performed a statistical analysis of published papers on cerebral organoid ethics, keyword co‐occurrence graph, literature co‐citation and knowledge clustering graph to examine the status of the ethics research, internal relationship between technological development and ethical research, and ethical concerns of the academia. Finally, we used a keyword time zone graph and related statistics to analyze and predict the trends and popular topics of future cerebral organoids ethics research.ResultsWe demonstrated that although the ethical concerns of cerebral organoids have long been discussed, it was not until 2017 that the ethical issues began to receive more attention, when cerebral organoids were gradually mimicking the human brain more closely and increasingly being combined with chimera research. The recent key ethical concerns are primarily divided into three categories: concerns that are common in life sciences, specific to cerebral organoids, and present in cross‐fields. These increasing ethical concerns are inherently related to the continual development of technology. The analysis pointed out that future research should focus on the ethical concerns of consciousness that are unique to cerebral organoids, ethical concerns of cross‐fields, and construction and improvement of legislative and regulatory systems.ConclusionsAlthough research on cerebral organoids can benefit the biomedicine field, the relevant ethical concerns are significant and have received increasing attention, which are inherently related to the continual development of technology. Future studies in ethics regarding cerebral organoid research should focus on the ethical concerns of consciousness, and cross‐fields, as well as the improvement of regulatory systems.

We performed a statistical analysis of published papers on cerebral organoid ethics, keyword co‐occurrence graph, literature co‐citation and knowledge clustering graph to examine the status of the ethics research. We also used a keyword time zone graph and related statistics to analyse and predict the trends and popular topics of future cerebral organoids ethics research.     

Risks and Benefits of Estrogen Therapy for a Male-to-Female Transsexual with a Prothrombin Gene Mutation

ObjectiveWe present the case of a male-to-female transsexual person in her 20s requesting hormone therapy in the setting of a history of a deep venous thrombosis and pulmonary embolus and carrying the prothrombin G20210A gene mutation.MethodsWe interviewed the patient and reviewed her medical records. We carefully weighed the risks and benefits of hormone therapy and took into account two important ethical principles: beneficence (to act in the patient’s best interest) and nonmaleficence (to avoid harm).ResultsOur patient presented to an outside facility with weight loss, generalized weakness, right lower extremity swelling, and chest pain. She was diagnosed with a pulmonary embolus and extensive deep venous thrombus by computed tomography (CT) scan and Doppler ultrasound, respectively. She was found to carry the pro-thrombin G20210A gene mutation. She was treated with anticoagulation therapy for 12 months, which was restarted prior to beginning therapy with transdermal estrogen.ConclusionWhile the exact risk of recurrent deep venous thrombosis and pulmonary embolus in our patient is unknown, we recommended that hormone therapy should only be given in conjunction with anticoagulation. We speculate that this strategy would allow the patient to experience the benefits to her overall well-being with hormone therapy while reducing the risks of venous thrombosis to acceptable levels. Prospective long-term follow-up of this patient is needed to verify the benefits and risk of the intervention chosen. (Endocr. Pract. 2013;19:e150-e153)     

GOING FROM PRINCIPLES TO RULES IN RESEARCH ETHICS

In research ethics there is a canon regarding what ethical rules ought to be followed by investigators vis‐à‐vis their treatment of subjects and a canon regarding what fundamental ethical principles apply to the endeavor. What I aim to demonstrate here is that several of the rules find no support in the principles. This leaves anyone who would insist that we not abandon those rules in the difficult position of needing to establish that we are nevertheless justified in believing in the validity of the rules. I conclude by arguing that this is not likely to be accomplished. The rules I call into question are the rules requiring:

• – that studies be designed in a scientifically valid way
• – that risks to subjects be minimized
• – that subjects be afforded post‐trial access to experimental interventions
• – that inducements paid to subjects not be counted as a benefit to them
• – that inducements paid to subjects not be ‘undue’
• – that subjects must remain free to withdraw from the study at any time for any reason without penalty

Both canons, the canon on principles and the canon on rules, are found in the overlap among ethical pronouncements that are themselves canonical: the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, CIOMS's International Ethical Guidelines for Biomedical Research Involving Human Subjects, and NBAC's 2001 report, Ethical Issues in International Research: Clinical Trials in Developing Countries.     

PRINCIPLISM AND THE ETHICAL APPRAISAL OF CLINICAL TRIALS

For nearly two decades, the process of reviewing the ethical merit of research involving human subjects has been based on the application of principles initially described in the U.S. National Commission's Belmont Report, and later articulated more fully by Beauchamp and Childress in their Principles of Biomedical Ethics. Recently, the use of ethical principles for deliberating about moral problems in medicine and research, referred to in the pejorative sense as “principlism”, has come under scrutiny. In this paper we argue that these principles can provide a foundation for the source of ethical appraisal of human research, but are not themselves wholly adequate for this purpose. Therefore, we further propose that (1) principles should be understood as heuristics that can be “specified” as described by DeGrazia (1992), and (2) that the principle-based approach should be supplemented by formally incorporating “sensitivity to context” into the evaluation of clinical trials     

Réflexions sur l’identification du patient dans les systèmes d’information de santé

PurposeThe aim of our study is to provide an update on the basic concepts and methodologies implemented in the healthcare information systems to identify the patient.MethodThe method used is an analysis of the existing intrinsic and extrinsic systems linked respectively to their objectives and ethical requirements, and an open methodological and scalable study based on finding a unique and universal identifier.ResultDespite many constraints our analysis of various tasks shows that some solutions are attainable. They are focused on a simple identification model responding to the different concepts developed and setting up systems for efficient and reliable networking. The model proposed here is based on the criteria shared by all. It portrays the main elements sought by the users of the healthcare information systems. However, its implementation requires a well-defined organization that allows a coherent and permanent usage over the time namely: a precise definition of features and the hash modalities, the processing of this information, the networking procedures… and so on. This proposal takes into account the existence of different information systems and subsystems. The consistency between these different systems must go with a good interoperability and above all a flawless identification of the data related to the patient.ConclusionThe solutions allow a reliable and versatile patient identification system consistent with the principles of privacy standards.     

Moral Principles for Allocating Scarce Medical Resources in an Influenza Pandemic

One of the societal problems in a new influenza pandemic will be how to use the scarce medical resources that are available for prevention and treatment, and what medical, epidemiological and ethical justifications can be given for the choices that have to be made. Many things may become scarce: personal protective equipment, antiviral drugs, hospital beds, mechanical ventilation, vaccination, etc. In this paper I discuss two general ethical principles for priority setting (utility and equity) and explain how these principles will often point in diverging directions. Moreover, each of these principles can be understood in different, again often competing, ways. Notwithstanding these controversies and conflicts, in the context of pandemic response there are at least some points of convergence: several policies can be justified by appeal to different ethical principles and theories. Convergence may be found with respect to a focus on saving the most lives (instead of other aggregative accounts); giving priority antiviral prophylaxis and therapy for life-saving pandemic responders; and, partly depending on epidemiology of the pandemic, to prioritise vaccination of children. Although decision-making about access to intensive care will involve choices with immediate tragic implications, the ethical complexity of these choices is relatively modest (although decisions will not be easy): there are persuasive moral reasons for giving priority to patients who are expected to benefit most within the shortest time. Finally, in the last section I tentatively argue that constraints on people’s freedom, as necessary for an effective public health approach, may support giving somewhat more weight to saving the most lives, than to concerns of equity.

Challenges Faced by Behavioral Genetic Studies: Researchers Perspective from the MENA Region

BackgroundBehavioral genetic studies are important for the understanding of the contribution of genetic variations to human behavior. However, such studies might be associated with some ethical concerns.MethodsIn the current study, ethical challenges related to studies of genetic variations contributing to human behavior were examined among researchers. To achieve the study purpose, the Middle East and North Africa (MENA) region researchers were taken as an example, where the after- mentioned ethical challenges were discussed among a group of researchers, who were the participants of an online forum. Discussions and responses of the participants were monitored and were later qualitatively analyzed.ResultsDiscussions revealed that several ethical challenges, including subjects’ recruitment, the difficulty of obtaining informed consents, and issues of privacy and confidentiality of obtained data as information leakage, in this case, will lead to social stigma and isolation of the participants and their immediate family members. Jordanian social and cultural norms, faith, and the tribal nature of the population were raised as a major challenge that might face conducting behavioral genetic studies in the Arab populations of the MENA. The lack of regulation related to the conduction of genetic studies, misunderstanding, and misuse of genetic information are other challenges. A full explanation of genetic research and the current and future possible benefits/risks of such research could be potential solutions.ConclusionIn conclusion, the MENA populations are tackled with major challenges in relation to conducting research studies in genetics/antisocial behavior field/s. Establishment of guidelines related to genetic studies, capacity building, increasing public awareness about the importance of genetic testing, and enhancing responsible conduct of research will facilitate the conduct of such sensitive studies in the future in the region.     

Mise en place humaine des systèmes d’information en cancérologie : mesure du degré d’applicabilité des moyens et de désordre (entropie)

ObjectivesWe conducted a human model to score the initial expectations (E1), the final realization (E2) and the means involved (E3) in developing an information system (IS) in oncology.MethodsOur field study is carried out using questionnaires (Q1, Q2 and Q3) based on a model built using four universal ethical principles: autonomy–beneficence–non-maleficence–justice we meet with environmental parameters of reality. We interviewed 14 designers of IS who have respectively set up their IS in a facility that supports cancer in the Bouches-du-Rhône. From scores of E1, E2 and E3, a degree of disorder (entropy: S) for an IS is measured.ResultsRegardless of the nature of the IS, the score E1 is always higher than E2. The score E3 is considered insufficient except in the mass screening of breast cancer. Finally, the degree of applicability of the means (M) used is correlated with the S existing within the IS.DiscussionWith over 14 participants, this study can have only qualitative value due to reduced statistical power too. Should expand the number of respondents to increase the effective intrinsic power of the analysis and thus reinforce the trend of our results.ConclusionEthical behavior shown by the means used would decrease the entropy as the information more meaningful, while an increase of entropy would be harmful.     

临床医生在基因检测咨询中面对伦理两难问题态度与选择 ——基于情景案例分析

目的 通过情景案例分析,聚焦基因检测咨询中的伦理两难事件,探究临床医生的伦理道德抉择及可能的影响因素。 方法 采用分层随机抽样方法,对624名临床医生进行了匿名问卷调查。 结果 对于XY染色体女性案件,88%的应答者选择告知敏感性信息;对于父系信息的披露,近60%的应答者选择单独告诉母亲;对于是否告知患儿其他亲属相关遗传病信息的案件,应答者的意见则相对分散。 结论 针对三个典型的基因检测咨询中的伦理两难问题,应结合国际相关指南的要求,进一步加大相关的法律与伦理理念、知识的教育与普及。     

上海市医疗机构基因临床研究与应用的现状分析

?????? 目的 分析上海市基因临床研究与应用中存在或可能存在的伦理问题。方法 对上海市22所医疗机构进行问卷调查,并对相关人员进行关键知情者访谈。结果 被调查的上海市医疗机构中有7所开展基因工作,2011年公立医院基因检测平均服务量比2009年增长1.75倍;31%的公立医院从事基因工作的人员在近一年内参加过伦理培训,体检机构未向员工提供伦理培训;3所开展基因检测的机构未要求签署知情同意书。结论 上海市基因临床研究与应用发展较快但应用不广,应进一步促进基因检测技术的临床应用,完善基因临床应用的伦理规范。     

RETRACTED: Continuous treatment with organic nitrate affects hepatic cytochrome P450

Abstract

This article has been retracted by the publisher since it has emerged that the article was published in a similar format elsewhere. The Editor and publisher acted in good faith on the basis of the information available to them and remain committed to the highest ethical and scientific standards in the peer review and publication of submissions.     

Opinion Practical and ethical considerations for students conducting ecological research involving wildlife

This commentary outlines relevant changes to the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes for ecologists and students active in field‐based wildlife research. All field‐based activities that require the approval of an Animal Ethics Committee (AEC) have now been detailed within the revised Code of Practice. Researchers and their students are required to give explicit consideration to the humane principles of replacement, reduction and refinement within their experimental protocols as a part of the AEC permission procedure. University‐based researchers also have obligations to train graduate students in the ethical as well as the practical components of wildlife research. In promoting this educational aim, a summary of ethical considerations in wildlife research is offered as a basis for discussion: the regulatory framework of research animal welfare (including an introduction to the Code of Practice, the AEC process and some thoughts on experimental design); and the humane principles on which the Code of Practice is based. Some practical considerations for field work relevant to students’ research training are also described.     

Conversations with Veterinary Students: Attitudes,Ethics, and Animals

Abstract

Interviews were conducted with 24 graduating veterinary students to examine (a) changes in their attitudes toward animals; (b) the types of experiences and procedures that they found personally distressing; (c) their perceptions of the most important ethical issues that they will face in private practice; and (d) their responses to euthanizing animals. Students' responses differed considerably. For example, about half of the students claimed that they were not affected by euthanasia, but another 25% still were struggling with this aspect of their professional role. Rationalization was a common mechanism by which the students attempted to deal with stressful experiences. It is argued that the moral dilemmas faced by veterinary students mirror the ethical ambiguities inherent in human-animal relationships.     

Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment

BackgroundCommunity-based randomized controlled trials are often complex pieces of research with significant challenges around the approach to the community, information provision, and decision-making, all of which are fundamental to the informed consent process. We conducted a rapid ethical assessment to guide the preparation for and conduct of a randomized controlled trial of podoconiosis treatment in northern Ethiopia.MethodsA qualitative study was carried out in Aneded woreda, East Gojjam Zone, Amhara Regional State from August to September, 2013. A total of 14 In-depth Interviews (IDIs) with researchers, experts, and leaders, and 8 Focus Group Discussions (FGDs) involving 80 participants (people of both gender, with and without podoconiosis), were conducted. Interviews were carried out in Amharic. Data analysis was started alongside collection. Final data analysis used a thematic approach based on themes identified a priori and those that emerged during the analysis.ResultsRespondents made a range of specific suggestions, including that sensitisation meetings were called by woreda or kebele leaders or the police; that Health Extension Workers were asked to accompany the research team to patients’ houses; that detailed trial information was explained by someone with deep local knowledge; that analogies from agriculture and local social organisations be used to explain randomisation; that participants in the ‘delayed’ intervention arm be given small incentives to continue in the trial; and that key community members be asked to quell rumours arising in the course of the trial.ConclusionMany of these recommendations were incorporated into the preparatory phases of the trial, or were used during the course of the trial itself. This demonstrates the utility of rapid ethical assessment preceding a complex piece of research in a relatively research-naive setting.     

Managing genetic testing: the relative powerlessness of actors in stable practices

Abstract

Genetics is a field in which ethical and social problems have been most pressing. Despite this, new tests often are introduced almost immediately after the isolation of a new gene. Considerations of whether a particular test should be introduced at all seem to have little effect on the development and introduction of new tests. This paper explores how this lack of social and ethical assessment can be understood. In order to do so, the sociohistorical context of clinical genetics and the way in which this practice came about will be analysed in this paper with respect to the Dutch service for clinical genetics. It will be argued that the fragmented way in which tasks and responsibility have become distributed within clinical genetics services has led to a situation in which actors seem to have no control over the introduction of genetic tests.     

Nudge strategies for behavior-based prevention and control of neglected tropical diseases: A scoping review and ethical assessment

BackgroundNudging, a strategy that uses subtle stimuli to direct people’s behavior, has recently been included as an effective and low-cost behavior change strategy in low- and middle- income countries (LMIC), targeting behavior-based prevention and control of neglected tropical diseases (NTDs). The present scoping review aims to provide a timely overview of how nudge interventions have been applied within this field. In addition, the review proposes a framework for the ethical consideration of nudges for NTD prevention and control, or more broadly global health promotion.MethodsA comprehensive search was performed in several databases: MEDLINE, PsycINFO, and Embase (Ovid), Web of Science Core Collection, CINAHL, ERIC and Econ.Lit (EBSCO), as well as registered trials and reviews in CENTRAL and PROSPERO to identify ongoing or unpublished studies. Additionally, studies were included through a handpicked search on websites of governmental nudge units and global health or development organizations.ResultsThis scoping review identified 33 relevant studies, with only two studies targeting NTDs in particular, resulting in a total of 67 nudge strategies. Most nudges targeted handwashing behavior and were focused on general health practices rather than targeting a specific disease. The most common nudge strategies were those targeting decision assistance, such as facilitating commitment and reminder actions. The majority of nudges were of moderate to high ethical standards, with the highest standards being those that had the most immediate and significant health benefits, and those implemented by agents in a trust relationship with the target audience.ConclusionThree key recommendations should inform research investigating nudge strategies in global health promotion in general. Firstly, future efforts should investigate the different opportunities that nudges present for targeting NTDs in particular, rather than relying solely on integrated health promotion approaches. Secondly, to apply robust study designs including rigorous process and impact evaluation which allow for a better understanding of ‘what works’ and ‘how it works’. Finally, to consider the ethical implications of implementing nudge strategies, specifically in LMIC.     

Looking back, looking beyond: revisiting the ethics of genome generation

This paper will explore some of the ethical imperatives that have shaped strategic and policy frameworks for the use of new genetic technologies and how these play a role in shaping the nature of research and changing attitudes; with an attempt to conceptualize some theories of genetic determinism. I analyse why there is a need to put bioethical principles within a theoretical framework in the context of new technologies, and how, by doing so, their practical applications for agriculture, environment medicine and health care can be legitimized. There are several theories in favour of and against the use of genetic technologies that focus on genes and their role in our existence. In particular the theory of geneticisation is commonly debated. It highlights the conflicting interests of science, society and industry in harnessing genetic knowledge when the use of such knowledge could challenge ethical principles. Critics call it a ‘reductionist’ approach, based on arguments that are narrowed down to genes, often ignoring other factors including biological, social and moral ones. A parallel theory is that there is something special about genes, and it is this “genetic exceptionalism” that creates hopes and myths. Either way, the challenging task is to develop a common ground for understanding the importance of ethical sensitivities. As research agendas become more complex, ethical paradigms will need to be more influential. New principles are needed to answer the complexities of ethical issues as complex technologies develop. This paper reflects on global ethical principles and the tensions between ethical principles in legitimizing genetic technologies at the social and governance level.