The view of synthetic biology in the field of ethics: a thematic systematic review.

Synthetic biology is designing and creating biological tools and systems for useful purposes. It uses knowledge from biology, such as biotechnology, molecular biology, biophysics, biochemistry, bioinformatics, and other disciplines, such as engineering, mathematics, computer science, and electrical engineering. It is recognized as both a branch of science and technology. The scope of synthetic biology ranges from modifying existing organisms to gain new properties to creating a living organism from non-living components. Synthetic biology has many applications in important fields such as energy, chemistry, medicine, environment, agriculture, national security, and nanotechnology. The development of synthetic biology also raises ethical and social debates. This article aims to identify the place of ethics in synthetic biology. In this context, the theoretical ethical debates on synthetic biology from the 2000s to 2020, when the development of synthetic biology was relatively faster, were analyzed using the systematic review method. Based on the results of the analysis, the main ethical problems related to the field, problems that are likely to arise, and suggestions for solutions to these problems are included. The data collection phase of the study included a literature review conducted according to protocols, including planning, screening, selection and evaluation. The analysis and synthesis process was carried out in the next stage, and the main themes related to synthetic biology and ethics were identified. Searches were conducted in Web of Science, Scopus, PhilPapers and MEDLINE databases. Theoretical research articles and reviews published in peer-reviewed journals until the end of 2020 were included in the study. The language of publications was English. According to preliminary data, 1,453 publications were retrieved from the four databases. Considering the inclusion and exclusion criteria, 58 publications were analyzed in the study. Ethical debates on synthetic biology have been conducted on various issues. In this context, the ethical debates in this article were examined under five themes: the moral status of synthetic biology products, synthetic biology and the meaning of life, synthetic biology and metaphors, synthetic biology and knowledge, and expectations, concerns, and problem solving: risk versus caution.

Global Neurology: The Good, the Bad, and the Ugly.

Global health programs engaging in isolated or short-term medical missions can and do cause harm, reinforce health care disparities, and impede medical care in the regions where it is so desperately needed. Related ethical, medical, and legal concerns are reviewed in this article. The authors recommend abandoning these ill-considered missions and focusing attention and resources on advancing neurology through ethically congruent, multisectoral, collaborative partnerships to establish sustainable, self-sufficient training programs within low- and middle-income countries.

An ethical analysis of a prospective new paradigm of life: Nanotechnology-enabled human beings within the framework of principlism.

Nanotechnology (NT)-enabled disease-free life is a form of reconstruction of the human body that promises a paradigm shift toward a new form of human existence in an imaginable life. However, as human reconstruction may be within the limits of the concept of "human enhancement," it is not clear to what extent "enhanced humans" will be ethically acceptable or desired. This study discusses the ethical implications of NT-embedded enhanced humans and this new imaginable life. First, ethical concerns arising from the existence of a grey zone of certain dilemmas regarding benefits and possible/unpredicted risks are addressed in terms of the four main principles of bioethics. Then, we focus on the ethical problems in human nano-enhancement. Finally, we study the methods of analyzing these ethical problems within the framework of principlism to conceive a comprehensive and coherent bioethical understanding.

Challenges and practices arising during public health emergencies: A qualitative survey on ethics committees.

The particular dynamics of public health emergencies urge scientists and Ethics Committee (EC) members to change and adapt their operating procedures to function effectively. Despite having previous pandemic experiences, ethics committees were unprepared to adapt to COVID-19 pandemic challenges. This survey aims to learn and thoroughly discuss the most salient issues for ECs during the COVID-19 pandemic. The results indicate that the main problems faced by ECs were lack of/insufficient regulations, lack of data/experience/knowledge, sloppy review, poor research design, and poor adaptation to quarantine measures. Coping with factors that threaten the autonomy and independence of ECs, the ethical dilemma regarding maximizing common good versus protecting the rights and well-being of study participants, comprehending the change in the context of vulnerable populations, and redefining the role of ECs to strengthen trust in science and vaccine confidence were outstanding issues.

Risk disclosure in prodromal Parkinson's disease - A survey of neurologists.

INTRODUCTION: In the absence of a disease-modifying treatment and prognostic uncertainty, ethics of risk disclosure in prodromal Parkinson's disease (PD) is challenging. Previous studies highlighted several facets of these challenges from the perspective of involved parties. However, to date, the view of neurologists who may encounter individuals with prodromal PD remained unrepresented. Moreover, cross-cultural differences intrinsic to the ethics of risk disclosure are yet to be elucidated. Therefore, we investigated the attitude of neurologists toward risk disclosure in prodromal PD. METHODS: In this observational study, Turkish neurologists were invited to fill out a questionnaire evaluating their stance on risk disclosure regarding an individual with polysomnography-confirmed REM sleep behavior disorder, which is the strongest risk factor for PD. RESULTS: More than 90% of the participating 222 neurologists were familiar with prodromal PD. While 15.3% stated that the risk should be disclosed in any case, 6.8% chose no disclosure. The remaining 77.9% favored disclosure only under certain circumstances, the plurality of which was the individual's consent to know about the risk. After reminding the potential neuroprotective effects of exercise and diet, neurologists who chose the option of "no disclosure" decreased to 3.2% (McNemar's test p = 0.008). No significant differences among the neurologists were found regarding sex, academic title, or field of interest. CONCLUSION: The majority of the neurologists found it appropriate to disclose the risk of future PD only if the individual expresses a desire to know. Also, recognition of the impact of lifestyle factors on PD is important in prognostic counseling.

Resolving Ethical Issues in the Field of Anaesthesia: A Mixed-Methods Study.

OBJECTIVE: Ethical problems related to the field of anaesthesia and reanimation are generally addressed within the scope of reanimation and intensive care medicine by overseeing the particular issues of medical ethics in the practice of anaesthesia. The existing literature shows that a very limited number of studies are found on this issue. This research aims to address this gap in the academic literature and to discuss ethical approaches to these problems. METHODS: A search was conducted to compile key themes of ethical problems. These were combined with similar themes in the limited existing literature. Next, a questionnaire consisting of 20 multiple choice and open-ended questions and two Likert scales were developed. The answers to the questionnaire were collected on-line after 2 months. RESULTS: The survey was conducted with 226 participants. 82.79% of the participants received ethics training only before graduation, and 95.40% stated that ethics training is required during their residency training. 67.80% of participants think that informed consent forms are sufficient in terms of content and readability, but 89.90% note that such forms are not read by patients. In the preoperative period, communication with patients, interaction with surgical teams, long working hours and high workload, problems in informing patients, lack of institutional support in malpractice cases, lack of authority, responsibility and rights of anaesthesiologists are the most important ethical and legal issues in the field. CONCLUSION: There are complex ethical issues in the field of anaesthesiology that should be discussed with in the frame of deficiencies in training, ethical reasoning for patient autonomy, informed consent, paternalism and professional satisfaction to shed light on potential solutions.

A critical perspective on guidelines for responsible and trustworthy artificial intelligence.

Artificial intelligence (AI) is among the fastest developing areas of advanced technology in medicine. The most important qualia of AI which makes it different from other advanced technology products is its ability to improve its original program and decision-making algorithms via deep learning abilities. This difference is the reason that AI technology stands out from the ethical issues of other advanced technology artifacts. The ethical issues of AI technology vary from privacy and confidentiality of personal data to ethical status and value of AI entities in a wide spectrum, depending on their capability of deep learning and scope of the domains in which they operate. Developing ethical norms and guidelines for planning, development, production, and usage of AI technology has become an important issue to overcome these problems. In this respect three outstanding documents have been produced:1. The Montréal Declaration for Responsible Development of Artificial Intelligence2. Ethics Guidelines for Trustworthy AI3. Asilomar Artificial Intelligence PrinciplesIn this study, these three documents will be analyzed with respect to the ethical principles and values they involve, their perspectives for approaching ethical issues, and their prospects for ethical reasoning when one or more of these values and principles are in conflict. Then, the sufficiency of these guidelines for addressing current or prospective ethical issues emerging from the existence of AI technology in medicine will be evaluated. The discussion will be pursued in terms of the ambiguity of interlocutors and efficiency for working out ethical dilemmas occurring in practical life.

Cerebral palsy litigation after fifty years: A hoax on you.

The worldwide cerebral palsy (CP) litigation crisis is predicated on the hoax that electronic foetal monitoring (EFM) predicts and prevents CP. There are decades of research disproving this hoax, yet EFM continues to be performed in the vast majority of labours in developed countries with resultant harm to mothers and babies alike through unnecessary caesarean sections with all of the attendant complications and ramifications of that procedure. This article reviews the history and evolution of EFM, explores the reasons for its misuse, discusses how obstetricians have abandoned their ethical mandate by failing to obtain informed consent for EFM, and proposes a realistic, practical solution that would effectively change the standard of care.

[Ethical overview of health research with regard to the protection of personal health data]. / Kisisel saglik verilerinin korunmasi kapsaminda saglik arastirmalarinda etik bakis.

Retrospective file research is very common in daily medical practice. Approval is required under current law for the review of personal genetic data, and the informed consent of all research subjects is necessary before conducting non-prospective research. In this article, the protection of personal data will be reviewed within the context of informed consent, the protection of confidentiality, the use of good anonymization techniques, research ethics, and medical law.

[Ethical and legal problems arising from off-label use of medical devices and some solution recommendations]. / Tibbi cihazlarin endikasyon disi (off-label) kullanimindan kaynaklanan etik ve yasal sorunlar ve çözüm önerileri.

The off-label use of medical devices is becoming increasingly widespread. Though the off-label use of drugs has been controlled with the establishment of legal and ethical rules, similar regulations have not been implemented for medical devices. Legal gaps in this field, and the broad initiative granted to physicians have led to the emergence of problems in practice, and physicians are vulnerable to potential criminal sanctions that may emerge as a consequence of these off-label applications. Since the off-label use of medical devices cannot rely on scientifically proven, evidence-based information, evaluation of the risks creates critically important ethical problems that may have serious deleterious effects, despite the good intent of a physician tying to be helpful. During the process of obtaining informed consent from the patient for the off-label use of a device, the physician has crucial responsibilities. The ethical responsibilities of physicians particularly increase in vulnerable patient groups that should be protected from harm. In addition to the physician, the family members who make decisions on behalf of the patient also assume some responsibilities. The development of ethical norms and guidelines enforced by legal regulations concerning this issue, an effective role for ethics committees in the decision-making process, and collaboration between patients, scientists, nongovernmental organizations, medical device companies, specialists in the field of medical ethics, and legal authorities will be important in solving this problem.

A half century of electronic fetal monitoring and bioethics: silence speaks louder than words.

Bioethics abolished the prevailing Hippocratic tenet instructing physicians to make treatment decisions, replacing it with autonomy through informed consent. Informed consent allows the patient to choose treatment after options are explained by the physician. The appearance of bioethics in 1970 coincided with the introduction of electronic fetal monitoring (EFM), which evolved to become the fetal surveillance modality of choice for virtually all women in labor. Autonomy rapidly pervaded all medical procedures, but there was a clear exemption for EFM. Even today, EFM remains immune to the doctrine of informed consent despite continually mounting evidence which proves the procedure is nothing more than myth, illusion and junk science that subjects mothers and babies alike to increased risks of morbidity and mortality. And ethicists have remained utterly silent through a half century of EFM misuse. Our article explores this egregious ethical failure by reviewing EFM's lack of clinical efficacy, discussing the EFM related harm to mothers and babies, and focusing on the reasons that this obstetrical procedure eluded the revolutionary change from the Hippocratic tradition to autonomy through informed consent.

The Ethics of Teaching Physicians Electronic Fetal Monitoring: And Now for the Rest of the Story.

Electronic fetal monitoring (EFM) does not predict or prevent cerebral palsy (CP), but this myth remains entrenched in medical training and practice. The continued use of this ineffectual diagnostic modality increases the cesarean section rate with concomitant harms to mothers and babies alike. EFM, as it is used in defensive medical practice, is a violation of patient autonomy and raises serious ethical concerns. This review addresses the need for improved graduate medical education so that physicians and medical residents are taught both sides of the EFM-CP story.

Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights.

Interventions in medicine require multicenter clinical trials on a large rather than limited number of subjects from various genetic and cultural backgrounds. International guidelines to protect the rights and well-being of human subjects involved in clinical trials are criticized for the priority they place on Western cultural values. These discussions become manifest especially with regard to the content and methodology of the informed consent procedure. The ethical dilemma emerges from the argument that there are fundamental differences about the concept of respect for the autonomy of individuals in different cultures and religions. Some communities prioritize the consent of community leaders or the head of family - usually men - over the voluntary and free consent of the individual. The aim of this work is to discuss this ethical dilemma to determine a base for a consensus that satisfies the sensibilities of different cultures without damaging the rights and autonomy of human subjects.

A Review of the Scientific Misconduct Inquiry Process, Ankara Chamber of Medicine, Turkey.

The aim of this study is to review the inquiry process used in scientific misconduct cases in the Ankara Chamber of Medicine between the years 1998 and 2012. The violations of the "Disciplinary Regulations of the Turkish Medical Association" have been examined by keeping the names of the people, institutions, associations and journals secret. In total, 31 files have been studied and 11 of these files have been identified as related to scientific misconduct. The methods of inquiry, the decisions about the need for an investigation process, the types of scientific misconduct, and the adjudication processes have all been reported. Furthermore, the motives of researchers who made allegations, the study approaches of investigators, and the objections to the decisions about guilt and innocence have also been examined. Based on the findings obtained, the reasons for scientific misconduct and the distribution of responsibilities among the people in the inquiry process have been discussed. A major conclusion is the need to standardize the process of conducting inquiries about scientific misconduct cases for the regional chambers of medicine in Turkey.

Evaluation of the informed consent procedure for total knee arthroplasty patients in Turkey.

OBJECTIVE: The purpose of this research is to evaluate the ethical aspects of informed consent process of total knee arthroplasty (TKA) patients in Turkey. METHODS: The study included 50 patients undergoing TKA in Gazi Mustafa Kemal State Hospital Orthopedics Clinic. A face to face survey was conducted to determine the ethical appropriateness of the main components of informed consent process such as; disclosure of material information about the disease and alternative treatment options, understanding the disclosed information, comprehending the written consent form and voluntariness in deciding. RESULTS: The survey revealed that all TKA patients signed informed consent form, 80% of the participants received material information about their disease, 62% were disclosed information about TKA operation, 56% read (in personal or with the assistance of a relative) the written informed consent form, 28% received information regarding possible complications of TKA and 85% were not given any information about the alternative treatments. CONCLUSIONS: Informed consent process in TKA patients have flourished compared to previous years, but still there are some aspects in need of improvement. Using short and understandable language, developing multi-media sources and involving patients to informed consent form development process would contribute to the process.

[AN EVALUATION OF JUSTICE AND RIGHT TO HEALTH CONCEPTS IN THE PERSPECTIVES OF ETHICAL THEORIES]. / TEMEL ETIK KURAMLAR AÇISINDAN ADALET ve SAGLIK HAKKI KAVRAMLARININ DEGERLENDIRMESI.

Right to health is considered as a fundamental human right. However the realization of right to health is facing obstacles due to the scarce resources which are needed for the provision of health services. Besides the vast technological improvements in medical area leads to the development of diagnosis and treatment possibilities each and every day. Thus, the provision of health services becomes a subject of distributive justice. To define the concept of justice, first one should identify the conditions of demanding right to have something and then determine how and who is obliged to give the deserved. Ethical theories form their own paradigms of acting right regarding their anchor points and priority values. The basic concepts such as justice or right to health are considered and conceptualized within the paradigms of the ethical theories. Thus some ethical theories consider right to health as a natural constituent of human being, while some may consider it contextual and others may reject it completely. In a similar vein, justice and related concepts of justice such as formal and material principles of justice differ regarding the paradigm of the ethical theory in which we position ourselves. The paradigms of ethical theories demand different approaches from each other both in defining the concepts and implementations in practical life. This paper sets forth how justice and right to health is conceptualized in the virtue ethics, deontological ethics, liberal ethical theory and communitarian ethical theories. To this end first the general frame of each ethical theory and how justice is conceptualized within this frame is defined. Following that a discussion of the possibility of justification of the right to health within the context of ethical theory is perused.

Enhancing John Rawls’s theory of justice to cover health and social determinants of health / Mejora de la teoría de justicia de John Rawls para abordar temas de salud y los determinantes sociales de la salud / Enfatizando a teoria da justiça de John Rawls para envolver a saúde e as determinantes sociais da saúde

The vast improvements in medical technology reviled the crucial role of social determinants of health for the etiology, prevalence and prognosis of diseases. This changed the content of the right to health concept from a demand of health services, to a claim of having access to all social determinants of health. Thus, the just allocation of scarce resources of health and social determinants of health became an issue of ethical theories. John Rawls developed a theory of justice. His theory suggests that the principles of justice should be determined by individuals in a hypothetic initial position. In the initial position, individuals agree on principles of justice. Rawls puts forth that the institutions of the society should be structured in compliance with these principles to reach a fair social system. Although Rawls did not justify right to health in his theory, the efforts to enlarge the theory to cover right to health flourished quite fast. In this paper first the basic components of Rawls theory is explained. Then the most outstanding approaches to enlarge his theory to cover right to health is introduced and discussed within the discourse of Rawls theory of justice.

Los grandes avances en tecnología médica desafían el papel crucial de los determinantes sociales de la salud en la etiología, prevalencia y prognosis de las enfermedades. Esto cambio el contenido del concepto de derecho a atención de salud desde la demanda de servicios de salud a la demanda por tener acceso a todos los determinantes sociales de la salud. Por lo tanto, la distribución de escasos recursos en salud y los determinantes sociales de la salud llegaron a ser tema de teorías éticas. John Rawls desarrolló una teoría de la justicia. Su teoría sugiere que los principios de justicia deberían ser determinados por los individuos desde una posición inicial hipotética. En la posición inicial, los individuos se ponen de acuerdo en principios de justicia. Rawls establece que las instituciones de la sociedad deberían estructurarse para cumplir con estos principios para poder alcanzar un sistema social justo. Aunque Rawls no justificó el derecho a la atención de salud en su teoría, se introduce y discute dentro del discurso de la teoría de justicia de Rawls, los esfuerzos para ampliar su teoría para cubrir el derecho a la atención de salud.

Os amplos aperfeiçoamentos da tecnologia médica deturparam o papel crucial das determinantes sociais para a etiologia, prevalência e prognóstico das doenças. Isto tem mudado o conteúdo do conceito do direito à saúde originado da demanda de serviços de saúde para a reclamação de acesso a todas determinantes sociais da saúde. Assim, a adequada alocação de escassos recursos para a saúde e as determinantes sociais de saúde tornam-se um tema de teorias éticas. John Rawls desenvolveu uma teoria de justiça. Sua teoria sugere que os princípios de justiça deveriam ser determinados pelos indivíduos numa situação hipoteticamente inicial. Na situação inicial, os individuos concordam sobre os princípios da justiça. Rawls coloca objetivamente que instituições sociais deveriam ser estruturadas em conformidade com estes princípios para alcançar o sistema de justiça social. Embora Rawls não tenha justificado o direito à saúde em sua teoria, os esforços para ampliar a teoria para envolver o direito à saúde floresceu rapidamente. Neste artigo primeiramente os componentes básicos da teoria de Rawls são explanados. Então, as mais importantes abordagens para ampliar esta teoria para alcançar o direito à saúde são introduzidas e discutidas dentro do discurso da teoria de Rawls sobre a justiça.