Interventions in medicine require multicenter clinical trialson 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 trialsarecriticizedforthe 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. (shrink)

Artificial intelligence 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. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

BackgroundThe 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. MethodologyThis 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. ResultsThere 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. ConclusionWith this analysis, we aimed to define a minimum set of ethical criteria for clinical trial platforms to obtain standardization between these two platforms. (shrink)

BackgroundThe 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. MethodologyThis 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. ResultsThere 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. ConclusionWith this analysis, we aimed to define a minimum set of ethical criteria for clinical trial platforms to obtain standardization between these two platforms. (shrink)

BackgroundThe 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. MethodologyThis 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. ResultsThere 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. ConclusionWith this analysis, we aimed to define a minimum set of ethical criteria for clinical trial platforms to obtain standardization between these two platforms. (shrink)

BackgroundThe 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. MethodologyThis 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. ResultsThere 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. ConclusionWith this analysis, we aimed to define a minimum set of ethical criteria for clinical trial platforms to obtain standardization between these two platforms. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

Vulnerability is a broad concept widely addressed in recent scholarly literature. Lesbian, gay, bisexual, and transgender people are among the vulnerable populations with significant disadvantages related to health and the social determinants of health. Medical ethics discourse tackles vulnerability from philosophical and political perspectives. LGBT people experience several disadvantages from both perspectives. This article aims to justify the right to health for LGBT people and their particular claims regarding healthcare because they belong to a vulnerable group. Rawls’ theory of justice (...) and Norman Daniels’ normal functioning approach will be discussed in this context. Despite the fact that the right to health can be justified by Daniels’ normal functioning approach, there is still a theoretical gap in justifying the right to health for particular vulnerable populations such as LGBT peopleand discussing society’s duty to compensate for these disadvantages. In search of solid theoretical grounds for the justification of the right to health for LGBT people, the present author takes the opportunity to utilize Daniels’ flexible definition of normal functioning to show that normal functioning not only varies by age but also by different states of human existence, including sexual orientation and gender identity, and to propose replacing the life span approach with normal states of human existence. (shrink)