Concordance of International Regulation of Pediatric Health Research.

OBJECTIVE: To assess the comparability of international ethics principles and practices used in regulating pediatric research as a first step in determining whether reciprocal deference for international ethics review is feasible. Prior studies by the authors focused on other aspects of international health research, such as biobanks and direct-to-participant genomic research. The unique nature of pediatric research and its distinctive regulation by many countries warranted a separate study. STUDY DESIGN: A representative sample of 21 countries was selected, with geographical, ethnic, cultural, political, and economic diversity. A leading expert on pediatric research ethics and law was selected to summarize the ethics review of pediatric research in each country. To ensure the comparability of the responses, a 5-part summary of pediatric research ethics principles in the US was developed by the investigators and distributed to all country representatives. The international experts were asked to assess and describe whether principles in their country and the US were congruent. Results were obtained and compiled in the spring and summer of 2022. RESULTS: Some of the countries varied in their conceptualization or description of one or more ethical principles for pediatric research, but overall, the countries in the study demonstrated a fundamental concordance. CONCLUSIONS: Similar regulation of pediatric research in 21 countries suggests that international reciprocity is a viable strategy.

Physicians' empathy levels in a primary care setting: perceptions of patients and their physicians, a qualitative study.

BACKGROUND: The physician-patient relationship is a crucial element in successful medical care. Empathy is the ability to understand an individual's subjective experience yet remain as an observer. It plays a major role in establishing a good physician-patient relationship. OBJECTIVE: The aim of this study was to evaluate the perspectives of patients and their corresponding emergency physicians regarding physicians' empathy levels and to extract themes that both patients and their doctors considered as important for an empathic encounter. METHODS: This is a qualitative study conducted at a Middle Eastern tertiary care centre Emergency Department (ED) using in-depth semi-structured interviews administered to each participating patient and his/her corresponding ED physician. Empathy-related themes were identified using inductive thematic analysis. RESULTS: This study shows that both patients and physicians believe in the importance of empathy in the ED based on four major themes: emotions, interpersonal skills, time and chief complaint. Time and the chief complaint were perceived as barriers by physicians, but not by their patients. CONCLUSIONS: A gap lies in the expressive communication phase of empathy between the two groups. The four major themes retrieved could form the basis of an empathy measure in the medical encounter in Lebanese and similar settings.

Disclosure of medical errors: physicians' knowledge, attitudes and practices (KAP) in an oncology center.

BACKGROUND: Between the need for transparency in healthcare, widely promoted by patient's safety campaigns, and the fear of negative consequences and malpractice threats, physicians face challenging decisions on whether or not disclosing medical errors to patients and families is a valid option. We aim to assess the knowledge, attitudes and practices (KAP) of physicians in our center regarding medical error disclosure. METHODS: This is a cross-sectional self-administered questionnaire study. The questionnaire was piloted and no major modifications were made. A day-long training workshop consisting of didactic lectures, short and long case scenarios with role playing and feedback from the instructors, were conducted. Physicians who attended these training workshops were invited to complete the questionnaire at the end of the training, and physicians who did not attend any training were sent a copy of the questionnaire to their offices to complete. To assure anonymity and transparency of responses, we did not query names or departments. Descriptive statistics were used to present demographics and KAP. The differences between response\s of physicians who received the training and those who did not were analyzed with t-test and descriptive statistics. The 0.05 level of significance was used as a cutoff measure for statistical significance. RESULTS: Eighty-eight physicians completed the questionnaire (55 attended training (62.50%), and 33 did not (37.50%)). Sixty Five percent of physicians were males and the mean number of years of experience was 16.5 years. Eighty-Seven percent (n = 73) of physicians were more likely to report major harm, compared to minor harm or no harm. Physicians who attended the workshop were more knowledgeable of articles of Jordan's Law on Medical and Health Liability (66.7% vs 45.5%, p-value = 0.017) and the Law was more likely to affect their decision on error disclosure (61.8% vs 36.4%, p-value = 0.024). CONCLUSION: Formal training workshops on disclosing medical errors have the power to positively influence physicians' KAP toward disclosing medical errors to patients and possibly promoting a culture of transparency in the health care system.

Fair, just and compassionate: A pilot for making allocation decisions for patients requesting experimental drugs outside of clinical trials.

Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or 'preapproval', access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients' best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee (CompAC). Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice.

When a physician and a clinical ethicist collaborate for better patient care.

Bioethics is a relatively new addition to bedside medical care in Arab world which is characterized by a special culture that often makes blind adaptation of western ethics codes and principles; a challenge that has to be faced. To date, the American University of Beirut Medical Center is the only hospital that offers bedside ethics consultations in the Arab Region aiming towards better patient-centered care. This article tackles the role of the bedside clinical ethics consultant as an active member of the medical team and the impact of such consultations on decision-making and patient-centered care. Using the case of a child with multiple medical problems and a futile medical condition, we describe how the collaboration of the medical team and the clinical ethics consultant took a comprehensive approach to accompany and lead the parents and the medical team in their decision-making process and how the consultations allowed several salient issues to be addressed. This approach proved to be effective in the Arab cultural setting and indeed did lead to better patientcentered care.

Bioethicsing.

This article describes the components of a unique 9 month required course in bioethics for 3rd year medical students at the American University of Beirut. The blended (hybrid) learning format emphasizes three innovative learning activities: the bioethics documentary, edutainment games, and the bioethics log book. Sample student responses are included as well as an outline of limitations.

Uterine Transplantation: Ethical Considerations within Middle Eastern Perspectives.

The field of reproductive medicine witnessed a breakthrough in September 2014 with the first successful live birth post uterine transplantation. This success represents the culmination of decades' worth of research on infertility and reproductive medicine. This subject of infertility gathers special attention in the Middle East, as childbearing is given paramount importance in the family unit. And as with any new medical advancement, Middle Eastern people look to their religious authorities for guidance. This paper describes the various ethical quandaries related to uterine transplantation, from a perspective of the religious and societal factors that are unique to the Middle East, and embeds them within the conversation of its alternative solutions.

Survival at the threshold of viability: a nationwide survey of the opinions and attitudes of physicians in a developing country.

BACKGROUND: To explore physicians' opinions and attitudes regarding resuscitation of extremely premature infants (EPIs) in a developing country with suboptimal resources. METHODS: A survey was developed, revised, and pilot-tested. All 964 paediatricians registered in the Lebanese Order of Physicians were contacted; physicians involved in resuscitation of EPIs were eligible. Between February and April of 2009, anonymous surveys were mailed to consenting participants. RESULTS: Three hundred twenty-eight eligible physicians agreed to participate. One hundred twenty (36%) returned the survey, 45.3% of which were neonatologists. The vast majority agreed that parents would like to be informed and to participate in the resuscitation decision of an EPI. The majority of physicians considered infants at gestational age of ≤25 weeks (78%) or ≤800 g (89%) as non-viable. Physician's age, years of practice, and practising neonatal intensive care unit level were significantly associated with the choice of birthweight at which infants were considered non-viable. CONCLUSIONS: The majority of surveyed physicians consider infants at gestational age less than or equal to 25 weeks gestation or 800 g at birth as non-viable, and therefore would not attempt their resuscitation. Factors influencing threshold of viability in developing countries need to be addressed and explored further.

War on healthcare services in Gaza.

This article looks at the October 2023 war on Gaza in the context of the effects of wars on healthcare systems. I will begin with a brief historical overview of the so-called Israeli-Palestinian conflict to clarify the special status of the Gaza Strip and the hostilities since October 7, 2023. This will be followed by a description of the major distinguishing characteristic of this war, namely, the systematic assault on the healthcare system. Finally, I will attempt to explain the conduct of this war using a necropolitical lens.

The Fourth Industrial Revolution: Its Impact on Artificial Intelligence and Medicine in Developing Countries.

Artificial intelligence (AI) is the ability of a digital computer or computer-controlled robot to perform tasks commonly associated with intelligent beings. Artificial intelligence can be both a blessing and a curse, and potentially a double-edged sword if not carefully wielded. While it holds massive potential benefits to humans-particularly in healthcare by assisting in treatment of diseases, surgeries, record keeping, and easing the lives of both patients and doctors, its misuse has potential for harm through impact of biases, unemployment, breaches of privacy, and lack of accountability to mention a few. In this article, we discuss the fourth industrial revolution, through a focus on the core of this phenomenon, artificial intelligence. We outline what the fourth industrial revolution is, its basis around AI, and how this infiltrates human lives and society, akin to a transcendence. We focus on the potential dangers of AI and the ethical concerns it brings about particularly in developing countries in general and conflict zones in particular, and we offer potential solutions to such dangers. While we acknowledge the importance and potential of AI, we also call for cautious reservations before plunging straight into the exciting world of the future, one which we long have heard of only in science fiction movies.

International scope of biomedical research ethics review.

Many countries consider long-term implications for society.

The Key Features of a Genetic Nondiscrimination Policy: A Delphi Consensus Statement.

Importance: Governments worldwide have become increasingly cognizant of the spread of genetic discrimination (negative treatment or harm on the basis of actual or presumed genetic characteristics). Despite efforts by a number of governments to establish regulations addressing this phenomenon, public concern about genetic discrimination persists. Objective: To identify key elements of an optimal genetic nondiscrimination policy and inform policymakers as they seek to allay genetic nondiscrimination and related public anxieties. Evidence Review: Sixty multidisciplinary experts from 20 jurisdictions worldwide were consulted to understand their views on effective genetic nondiscrimination policies. Following standard requirements of the Delphi method, 3 rounds of surveys over the course of 1.5 years were conducted. Round 1 focused on assessing participants' understanding of the intricacies of existing genetic nondiscrimination policies, while rounds 2 and 3 invited participants to reflect on specific means of implementing a more effective regime. A total of 60 respondents participated in the first round, 53 participated in round 2, and 43 participated in round 3. Findings: While responses varied across disciplines, there was consensus that binding regulations that reach across various sectors are most useful in preventing genetic discrimination. Overall, experts agreed that human rights-based approaches are well suited to preventing genetic discrimination. Experts also agreed that explicit prohibition of genetic discrimination within nondiscrimination policies can highlight the importance of genetic nondiscrimination as a fundamental right and ensure robust protection at a national level. While most participants believed the international harmonization of genetic nondiscrimination laws would facilitate data sharing worldwide, they also recognized that regulations must reflect the sociocultural differences that exist among regions. Conclusions and Relevance: As the reach of genetic discrimination continues to evolve alongside developments in genomics, strategic policy responses that are harmonious at the international and state levels will be critical to address this phenomenon. In seeking to establish comprehensive frameworks, policymakers will need to be mindful of regional and local circumstances that influence the need for and efficacy of unique genetic nondiscrimination approaches across diverse contexts.

Healthcare Under Fire: Stories from Healthcare Workers During Armed Conflict.

This symposium includes twelve narratives from individuals or groups who have worked to help the sick and injured receive healthcare during armed conflict. Four commentaries on these narratives are also included, authored by experts and scholars in the fields of bioethics, human rights, sexual violence in armed conflict, the forced displacement of civilians, and policy development for resource constrained healthcare. The goal of this symposium is to call attention to the the difficulties and ethical dilemmas of providing healthcare during violent armed conflict.

Truly intensive clinical ethics immersion at the Washington Hospital Center.

Opportunities for practical, hospital-based training in those skills demanded by clinical ethics consultation (CEC) have been limited. Given the number of individuals who provide part-time CEC, greater access to condensed, practical training such as the clinical ethics immersion course offered by the Washington Hospital Center, is necessary. Two participants in the initial cohort evaluate their CE training at a busy, urban referral center, exploring prior expectations, perceptions of its utility and suggestions for improvement. Such training will prove valuable not only for bioethicists who lack practical CEC experience "at the bedside" but also for ethics consultants whose ethics services have a low consult volume who wish to sharpen their skills.

Everyone Is Harmed When Clinicians Aren't Prepared.

War and conflict are now common, lingering like an endemic disease in most countries of the Global South. Population displacement, infectious disease outbreaks, food and water shortages, damage to infrastructure, anxiety, and posttraumatic stress are among the phenomena to which clinicians are expected to respond as professionals. Yet curricula in health professions do not prepare trainees to cultivate the skills needed to develop intervention pathways to meet the needs of populations in conflict zones. This article argues that decolonization of curricula in health professions is key to preparing clinicians to respond with care and competence to vulnerabilities and disease burden exacerbated by conflict.

Prenatally diagnosed foetal malformations and termination of pregnancy: the case of Lebanon.

Termination of pregnancy (TOP) is offered in many countries, for foetuses prenatally diagnosed with congenital malformations that are deemed incompatible with life or that are associated with a high morbidity. In Lebanon, a middle income country where religion plays a focal role, the law prohibits any form of TOP unless it is the only means to save the mother's life. It is the contention of the authors of this article that even if the foetus is a person, if it were medically revealed that there is a substantial risk that the newborn will suffer severe physical abnormalities that will cause it to be seriously handicapped; it is morally acceptable to terminate the pregnancy. Hence, TOP carried out for these indications is justified in the interest of the foetus and the child. Whatever the status of the foetus is, once born, it will become a full-fledged sentient being with all that this entails. When given the option of starting an existence, this person-to-be has the right to a minimum that allows him/her to enjoy a relatively good quality of life. Today, Lebanese obstetricians are confronted with the burden placed on them under the law to refuse TOP, or, when performing them, to forge records or deny having done them. This is why we strongly believe that the Lebanese policy on abortion should be amended.

The lures of modern medicine.

The profession of medicine is first and foremost a moral enterprise. Yet, modern day medicine has suffered from a number of flaws that led to some of its downfalls. This article looks at the profession of medicine from a contemporary lens. What has gone wrong? What does it mainly suffer from? What is the central issue that should be dealt with in order to help the profession of medicine regain its status as an ideal and moral endeavour. While I do not allege that one article is enough to unveil all that is needed to say, this article at least sheds the light on some of the important issues that we cannot afford to brush aside any longer.

Moral and Professional Values of Nurses in Lebanon.

BACKGROUND: Moral and professional values vary among cultures. The purpose of this study was to explore the moral and professional values of registered nurses at a university medical center in a Middle Eastern country and determine the relationship among formal ethics education, background variables (age, gender, nursing degree, regular daily prayer), and nurses' professional and moral values. METHOD: A cross-sectional survey method with 123 nurses was used. Data on background variables, moral and professional values, and confidence in ethical decision-making were assessed. RESULTS: Professional values were significantly higher among older nurses and nurses with master's degrees compared with younger nurses and nurses with bachelor's degrees. Daily prayer was related to higher mean scores for moral values. Nurses were confident in their ethical decision-making; however, formal education in ethics did not influence professional or moral values. CONCLUSION: Although formal education in ethics did not influence the professional or moral values of nurses in Lebanon, this finding does not negate the need for future studies to investigate the content and duration of ethics education that is likely to affect professional or moral values. [J Contin Educ Nurs. 2021;52(9):429-437.].