A Qualitative Research Survey on Cardiologist's Ethical Stance in Cases of Moral Dilemmas in Cardiology Clinics.

This study sought to determine cardiologists' degrees of ethical awareness and preferred courses of action for ethical dilemmas frequently encountered in clinical settings. For this evaluation, an online survey was created and sent to cardiologists affiliated with various academic posts in Ankara, Turkey. The survey included ten cases with various ethical considerations selected from our book, "Clinic Ethics with Cases from Cardiology." Four possible action choices were defined for each case. Participants were asked to choose one or more of these preferences. In addition, a fictional change was made in each case's context without changing the original ethical issue, and participants were asked whether an attitude different from the first chosen one was preferred. The participation ratio was 49/185 (26%), consent ratio 47/185 (25,4%), and completion ratio 44/185 (23,7%). Nine of the ten scenario changes did not change participants' preferred action. For most questions, action preferences were concentrated between the two options. Although legal regulations did not reduce ethical dilemmas, they clarified physicians' action preferences. Similarly, as an obscure moral issue gained prominence, physicians were forced to draw clearer lines in their actions. External factors such as healthcare emergencies can change physicians' ethical dilemma-solving attitudes.

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.

A theoretical framework for ethical decision-making during public health emergencies / Un marco teórico para la toma de decisiones éticas durante emergencias de salud pública / Um referencial teórico para tomada de decisão ética durante emergências de saúde pública

Abstract: The new theoretical ethical framework is a general frame or tool for ethical agents, developed to guide ethical reasoning during public health emergency preparedness and response. The TEF is based on the assumption that no existing ethical discourse in medical ethics alone is sufficient to address ethical issues of a PHE. The solutions suggested by existing approaches are limited in practicability and effectiveness, because they cannot address root problems and interplay among ethical problems. The reason for this insufficiency rests on the argument that ethical problems of PHEs have causal and reciprocal relationships, and any ethical decision-making framework should provide a wide enough perspective to consider relevant ethical norms and theories to suggest practical, implementable, coherent solutions compatible with the communal values and cultural norms. The TEF we suggest for PHEs embraces a holistic and integrated ethical perspective that enables us to comprehend that ethical problems that arise in various settings caused by PHE phenomena are in relationship with each other instead of addressing them as a standalone problem. The TEF provides decision-makers to achieve a coherent web of considered judgements compatible with ethical values and principles in various settings. This type of conceptualization offers a wide perspective to see causal and relational relationships among problems and produce outcomes that would not be possible by eclectic approaches.

Resumen: El nuevo Marco Ético Teórico (MET) es una estructura general o herramienta para eticistas, desarrollada para guiar el razonamiento ético durante la preparación y respuesta a emergencias de salud pública (ESP). Supone que no existe un discurso ético en la ética médica que por sí solo sea suficiente para abordar temas éticos de ESP. Las soluciones sugeridas de aproximaciones existentes son limitadas en la práctica y en la efectividad, debido a que no pueden abordar problemas de raíz sin considerar las interacciones entre los problemas éticos. Esta insuficiencia es porque los problemas éticos de ESP tiene relaciones causales y recíprocas, y cualquier estructura de toma de decisiones éticas debería proporcionar una perspectiva suficientemente amplia como para considerar normas éticas y teorías relevantes, y sugerir soluciones prácticas que sean coherentes y compatibles con valores comunes y normas culturales. El MET que sugerimos para ESP abarca una perspectiva ética integral e integrada, que posibilita la comprensión de que los problemas éticos que surgen en varías situaciones causadas por fenómenos ESP se hallan en relación entre ellos, en vez de abordarlos como un problema aislado. El MET proporciona a los que toman decisiones el lograr una red coherente de juicios compatibles con los valores y principios éticos en varias situaciones. Este tipo de conceptualización ofrece una amplia perspectiva para ver relaciones causales y relacionales entre problemas y producir resultados que no serían posibles mediante aproximaciones eclécticas.

Resumo: O novo referencial ético teórico (NT: TEF, sigla em inglês) é um referencial geral ou instrumento para agentes éticos, desenvolvido para guiar o raciocínio ético durante o preparo e resposta a emergências de saúde pública (NT: PHE, sigla em inglês). O TEF é baseado na suposição de que nenhum discurso ético existente em ética médica sozinho é suficiente para abordar aspectos éticos de uma PHE. As soluções sugeridas pelas abordagens existentes são limitadas em praticabilidade e efetividade, porque elas não podem abordar problemas fundamentais e inter-relacionar problemas éticos. A razão para essa insuficiência repousa no argumento de que problemas éticos de PHEs têm relações causais e recíprocas, e qualquer referencial para tomada de decisão ética deve propiciar uma perspectiva ampla o suficiente para considerar normas e teorias éticas relevantes para sugerir soluções práticas, implementáveis e coerentes, compatíveis com valores comunitários e normas culturais. A TEF que sugerimos para PHEs abarca uma perspectiva ética holística e integrada que nos permite compreender que os problemas éticos que surgem em diversos ambientes causados pelo fenômeno da PHE estão em relação entre si, ao invés de abordá-los como um problema isolado. O TFE propicia a tomadores de decisões alcançar uma rede de julgamentos considerados compatíveis com valores e princípios éticos em ambientes diversos. Esse tipo de conceitualização oferece uma perspectiva ampla para observar relações causais e relacionais entre problemas e produzir desfechos que não seriam possíveis por abordagens ecléticas.

Variability of Pharmacogenomics Information in Drug Labels Approved by Different Agencies and its Ethical Implications.

AIMS: The aim of this study was to determine if there are discrepancies among various agency-approved labels for the same active ingredient and where the labels approved by the Turkish Medicines and Medical Devices Agency (TMMDA) stand regarding the inclusion of PGx and discuss these ethical implications. BACKGROUND: The efficacy and safety of drugs can be improved by rational prescription and personalization of medicine for each patient. Pharmacogenomics information (PGx) in Drug Labels (DL) is one of the important tools for the personalization of medications because genetic differences may affect both drug efficacy and safety. Providing adequate PGx to patients has ethical implications. OBJECTIVE: The study aims to evaluate PGx in the DLs approved by TMMDA and other national agencies provided by the Pharmacogenomics Knowledgebase. METHODS: DL annotations from the Pharmacogenomics Knowledgebase and DLs approved by the TMMDA were analyzed according to information and action levels, which are "testing required", "testing recommended", "actionable", and "informative". RESULTS: There are 381 drugs listed in PharmGKB drug label annotations with pharmacogenomics information, and 278 of these have biomarkers. A total of 242 (63.5%) drugs are approved and available in Turkey. Of these, 207 (85.5%) contain the same information as in or similar to that in the labels approved by the other agencies. The presence and level of information varied among the DLs approved by different agencies. The inconsistencies may have an important effect on the efficacy and the safety of drugs. CONCLUSION: These findings suggest a need for the standardization of PGx information globally because it may not only affect the efficacy and safety of medications but also essential ethical rules regarding patient rights by violating not sufficiently sharing all available information.

Comparison of COVID-19 studies registered in the clinical trial platforms: A research ethics analysis perspective.

BACKGROUND: The coronavirus disease (COVID-19) treatment must be based on scientific methods such as clinical trials. Trials involving human subjects and those requiring a risk-benefit analysis may occasionally face challenges owing to the time limitations in the pandemic. METHODOLOGY: This study analyses the WHO's International Clinical Trials Registry Platform and clinicaltrials.gov, where most COVID-19 clinical trials are registered, according to ethical criteria including study design, conflicts of interest, enrollment of healthcare workers, study locations, site-, design-, and participant-related issues. The discussion is based on three aspects: the quality of the information to be produced, the relevance to significant health problems, and the creation or evaluation of interventions, policies, or practices that promote individual or public health. RESULTS: There were significant differences between the two platforms regarding the investigational medicinal product (IMP), the comparator, ethics committee/institutional review board approval, plan to share individual participant data, study phase, site, IMP, and design-related issues. Conflict of interest, sponsor information, and management of vulnerable groups were the main areas wherein both platforms lacked sufficient information. CONCLUSION: With this analysis, we aimed to define a minimum set of ethical criteria for clinical trial platforms to obtain standardization between these two platforms.

Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach.

OBJECTIVE: This study aimed to evaluate the content of informed consent forms (ICFs) used during cardiology interventions by the university, research and training (R-T), and private hospitals with regard to ethical standards and compare them with the Turkish Society of Cardiology (TSC) templates and among various institutions. METHODS: A total of 185 forms from the university, R-T, and private hospitals and 19 TSC templates were selected and analyzed for 26 criteria. Compliance with TSC templates was also evaluated. Data were presented as the percentage of ICFs satisfying the criteria and compared using the Fisher exact test, and 95% confidence intervals were calculated. RESULTS: TSC templates were more compatible and included more information to comply with ethical standards than ICFs of all 3 types of healthcare institutions. The areas of improvement for these templates were prospects of treatment and alternative treatments, quality of life, explanation for third-party consent, duration of hospitalization, and time to return to normal life. Among the 3 types of hospitals, R-T-ICFs were more compatible with templates. Private hospital ICFs had the poorest compliance with TSC templates. Separate anesthesia ICFs and detailed information about exposure to radioactivity were lacking. CONCLUSION: The current ICFs for cardiology interventions have major ethical deficiencies and need urgent improvement. Professional societies such as TSC are essential institutions to develop and provide guidance and templates for ICFs to meet the ethical standards during the informed consent process and standardization of the process among various institutions.

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.

Does content of informed consent forms make surgeons vulnerable to lawsuits?

BACKGROUND: Written informed consent forms (ICFs) are important for ensuring that physicians disclose core information to patients to help them autonomously decide about treatment and for providing substantial evidence for the surgeon in case of a legal dispute. This paper aims to assess the legal and ethical appropriateness and sufficiency of the contents of ICFs designed for several elective surgical procedures currently in use in Turkish hospitals. METHODS: One hundred and twenty-six forms were randomly selected and were analyzed for 22 criteria. The results were compared using the Fisher' exact test, and 95% confidence intervals were calculated. RESULTS: More than 80% of ICFs contained information about the risks of the proposed treatment, the diagnosis of the patient, and the patient's voluntariness/willingness, as well as a designated space for the signatures of the patient and the physician and a description of the proposed treatment. Some ICFs were designed for obtaining blanket consent for using patients' specimens. CONCLUSIONS: The ICFs for general elective surgery contain many deficiencies regarding disclosure of information, and there is significant variation among primary healthcare providers. Unrealistic expectations regarding the surgery or the post-operative recovery period due to insufficient information disclosure may lead patients, who experience post-surgical inconveniences, to file lawsuits against their surgeons. Although all ICFs, regardless of their institution, are generally insufficient for defending hospital administrations or surgeons during a lawsuit, ICFs of private hospitals might be considered better equipped for the situation than those of state or university hospitals. However, further research is needed to show if private hospitals have lower lawsuit rates or better lawsuit outcomes than state or university hospitals in Turkey.

Evaluation of Ethical Analyses in Seven Reports from the European Network for Health Technology Assessment.

OBJECTIVES: Ethics has been considered among the core domains of health technology assessment (HTA), but there are still disputes regarding ethical analysis. This study aimed to examine full final reports of the European Network for Health Technology Assessment (EUnetHTA) in terms of their compliance with the ethical methodology and ethical perspective of the HTA Core Model®. METHODS: The study examines seven full final HTA reports of EUnetHTA written based on the methodology proposed in the HTA Core Model®. The reports were analyzed using the following parameters: competency of the person/group who conducted ethical analysis, assessment elements, and the methodology of ethical analysis. RESULTS: The results show that, although the HTA Core Model® helped to standardize the final reports of the assessment, there are still concerns regarding the competency of the ethical analysis team, the perspectives on the purpose of ethical analysis, data sources and viewpoints of various stakeholders, use of ethical analysis methodology, and the evaluation of the ethical appropriateness of the entire HTA process. CONCLUSIONS: The HTA Core Model® helped to standardize the final reports on the HTA; however, not all issues with the content and outcomes were solved. The lack of expertise in ethics and insufficiency of the teams regarding ethical analysis are other existing problems. This study also demonstrated that stakeholder viewpoints in general and patient perspectives, in particular, have been overlooked in the HTA process.

A Survey Study Evaluating and Comparing the Health Literacy Knowledge and Communication Skills Used by Nurses and Physicians.

Health literacy (HL) is considered as an interaction between the demands of health systems and the skills of individuals. The current global approach demands health professionals to be more accountable for universal precautions approach and improve communication skills, and employ strategies to confirm patients' understanding. The aim of this study is to assess the knowledge and attitude of health care professionals (HCPs) about HL and their communication skills, and its effect on their practices, and to compare the findings among subgroups of HCPs. An online cross-sectional survey involving 29 items was developed for sociodemographic and professional characteristics and knowledge, attitude, and practices evaluation. Health care professionals reached by occupational organizations and social media platforms. Among the 277 participants that answered the questions, 184 were physicians and 78 were nurses, and 37.99% of physicians and 18.42% nurses heard about the term "HL" through this survey. Most of the participants stated their willingness to receive information/training on the subject and that knowing HL level would change their approach to and outcomes of the patients. Nurses were using a variety of methods that improve communication with patients and considered HCPs' lack of knowledge of the concept of "HL" and their neglect of HL as obstacles to its evaluation more than physicians. These results emphasize the urgent need of initiatives to be taken to improve the awareness of HCPs of HL and the subsequent incorporation of these initiatives into the daily health care services they provide. Nurses' awareness of HL is higher and they are already better at incorporating HL-sensitive items into their practices. Both graduate and continuing education programs need to be modified to improve HL knowledge of all HCPs and its positive effects on health care. The current structure of the roles and responsibilities of these professions needs to be improved to make it more HL sensitive.

Health Literacy Level of Casting Factory Workers and Its Relationship With Occupational Health and Safety Training.

Health literacy (HL) is a stronger predictor of an individual's health status than income, employment status, education level, and race or ethnicity. Lower levels of HL may contribute to low uptake or less adherence to occupational health and safety (OHS) training. This study was conducted among casting factory workers who received OHS training routinely. Data on sociodemographic characteristics, OHS training, and scores of the Health Literacy Survey-European Union (HLS-EU) were collected. Of the 282 of the 600 (47%) workers surveyed, 13.5% had inadequate, 47.5% problematic, 30.9% sufficient, and 8.2% excellent HL scores. There were no statistically significant differences between workers with limited and proficient HL with respect to age group or educational level. Workers with limited HL were less satisfied with OHS training content and were less likely to identify one-on-one health and safety training sessions as training. Limited HL is a universal problem both in the general and working populations, and it may be restricting the workers understanding of OHS training. Occupational health nurses should be aware of the detrimental effects of limited HL and modify their OHS training where needed for purposes of increasing the successful adoption of safe work practices.

Healthcare professionals' pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates.

Background: Spontaneous adverse drug reaction (ADR) reports prepared by healthcare professionals (HCPs) are the backbone of collecting post-marketing safety data. However, underreporting is a global problem creating health, economic, and ethical burden. Objectives: To determine the factors limiting ADR reporting rates from the HCPs' point of view. Methods: A questionnaire containing 43 questions evaluating sociodemographic characteristics, pharmacovigilance knowledge and activities, and prescription behaviors was prepared on "surveymonkey.com." The link was distributed mainly by professional organizations. Results: Although this survey aimed to reach all HCPs, most of the respondents were physicians and nurses. Of the 259 (69.6%) participants who encountered ADR at least once, only 105 (40.5%) reported ADR. The term "pharmacovigilance" was heard for the first time in this survey by 35.5% (n = 132) of the participants. Only 34.7% (n = 129) of the participants knew where to find the ADR reporting form, and 25.5% (n = 95) had previously filled the form and/or read it. Only 28.5% (n = 106) of the participants were aware of the ADR reporting and monitoring system of their institutions and related professionals. Almost all the participants agreed that pharmacovigilance and ADR reporting training are necessary. Conclusion: The main reason for underreporting is limited pharmacovigilance knowledge of HCPs. Training activities based on the needs and preferences of HCPs and close follow-up by authorities are the main steps to improve pharmacovigilance activities.

[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.

Patients' Rights in Cross-border Healthcare (Directive 2011/24/EU) and How It Applies to Turkey as a Negotiating Candidate Country.

Cross-border healthcare and patient mobility across European Union Member States has been on the agenda of EU Commission for the last decade. Directive 2011/24/EU on the application of patients' rights in cross-border healthcare went into force in 2013. The Directive mainly addresses the responsibilities of Member States in cross-border healthcare, regulates reimbursement procedure, and coordinates European reference networks and health technology assessment in the EU. The Directive has direct and indirect implications on Turkish health system. In this article, first an overview of Directive 2011/24/EU is addressed with special attention to its relation to patient rights and other EU legislations. Then, Turkish citizens' position in the scope of EU legislation on patient rights is considered. Finally, the ethical implications of the Directive, conceptualisation of cross-border patient mobility, and Turkey's particular position among other candidate countries regarding cross-border healthcare is discussed.

An increasing problem in publication ethics: Publication bias and editors' role in avoiding it.

Publication bias is defined as "the tendency on the parts of investigators, reviewers, and editors to submit or accept manuscripts for publication based on the direction or the strength of the study findings."Publication bias distorts the accumulated data in the literature, causes the over estimation of potential benefits of intervention and mantles the risks and adverse effects, and creates a barrier to assessing the clinical utility of drugs as well as evaluating the long-term safety of medical interventions. The World Medical Association, the International Committee of Medical Journals, and the Committee on Publication Ethics have conferred responsibilities and ethical obligations to editors concerning the avoidance of publication bias. Despite the explicit statements in these international documents, the editors' role in and ability to avoid publication bias is still being discussed. Unquestionably, all parties involved in clinical research have the ultimate responsibility to sustain the research integrity and validity of accumulated general knowledge. Cooperation and commitment is required at every step of a clinical trial. However, this holistic approach does not exclude effective measures to be taken at the editors' level. The editors of major medical journals concluded that one precaution that editors can take is to mandate registration of all clinical trials in a public repository as a precondition to submitting manuscripts to journals. Raising awareness regarding the value of publishing negative data for the scientific community and human health, and increasing the number of journals that are dedicated to publishing negative results or that set aside a section in their pages to do so, are positive steps editors can take to avoid publication bias.

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.