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  Ayesha Almemari, Abdussalam Alshehri (Author)

  Comparative Study of Medical Error Legislation in the League of Arab States (LAS). A proposal to Unify Medical error definition and its liability Legislations

  Background
  The concept of unifying medical error legislation offers multiple potential benefits to the League of Arab States (LAS).

  Methods
  This descriptive study examined LAS medical error legislation to highlight the current state of medical error legislation principles and proposes an approach that member states of the LAS could leverage to unify their regulations governing medical error.

  Result
  Among LAS countries, only 15 out of 22 (68%) had a specific medical liability law and only 12 of them (54%) defined medical error. The Civil and Penal Code was applied in 4 countries (18%) while information could not be found for 3 countries (13.6%).

  Conclusion
  The study recommends that LAS countries undertake medical error legislation reform to unify the definition, restrict criminal liability for actions prohibited by law, and limit medical error liability to corrective disciplinary and civil penalties (award), which will reflect positively in the healthcare system and practice of medicine.

  Background

  The League of Arab States (LAS) was established in 1945 to enhance mutual collaboration in economics, communication, peace, culture, social welfare, and health [1]. The organization includes 22 countries as member states from the Middle East and North Africa with similar legislative backgrounds. They applied the Ottoman Empire's “Kanun,” which stems from Sharia (Hanafi school of Islam - Madhhab Ḥanīfah), mandated by the Ottoman Empire when it was under its jurisdiction.
  The codes were compiled into 16 books and published as one journal, known as MAJALLA AL AHKAM AL ADALIYYAH - The Ottoman Courts Manual [2]. However, during the twentieth century and in the aftermath of World War I, Egypt took the lead in developing its system of codified law. Subsequently, numerous other countries in the Arab region followed suit and embarked on the path of legal development. Many of these nations drew inspiration from Egypt’s legal framework, which was initially derived from the French legal system, while also incorporating the principles of Sharia [2]. Medical Liability Law is a specific subset of civil law that outlines standards for medical practice and addresses professional negligence or deviation from the standard of care, resulting in injury or damage to the patient. It also outlines penalties for failing to comply with the law [3]. Healthcare services vary among LAS countries; however, they are evolving and developing in most jurisdictions [4].

  The Council of Arab Health Ministers was established in Cairo in 1975, with the primary objective of coordinating efforts to enhance healthcare services throughout the Arab world. The council aimed to foster collaboration in research, seeking unified solutions that would benefit the entire Arab region. Medical malpractice is defined as any commission or omission by a healthcare provider during management of a patient that deviates from accepted norms of practice and causes an injury to the patient, and internationally, it is addressed under the tort principle [3]. However, it is essential to note that medical error is the term used in all LAS countries to reflect medical malpractice. The definition of medical error, procedures for filing complaints, and penalties stipulated for committing medical errors that result in patient injury (medical malpractice) vary among countries within the Arab world. While all these countries uphold Sharia principles when formulating their laws, disparities arise when doctors from different Arab nations discuss medical liability of medical error and express concerns regarding the application of best practices, particularly fearing litigation when caring for high-risk patients where decisions are taken rapidly and under uncertainty, such as acute and emergency care. In these settings, the legal definition of medical error and liability may directly influence physicians’ willingness to act, assume risk, or initiate invasive but potentially life-saving interventions. Therefore; taking decisions urgency and time of contact with patients in consideration when assessing medical error is of important value which align with reasonable person standard theory rather than best care standard which is used for clinical trials, research and quality improvement purposes [5].
  Overall, there is a prevalent fear of legal repercussions if patient outcomes are unfavorable. This descriptive study aims to compare the existing medical liability legislation for medical error across all LAS countries, outline the current state, and propose a set of unified medical liability of medical error principles that can be universally applied throughout the LAS countries.

  Methods
  A descriptive comparative legal analysis to compare the medical liability of medical error legislation across the LAS countries. The study aims to examine the legislation of LAS countries regarding the following criteria: the existence of specific medical liability laws, the definition of medical error, the legal responsibility applied to medical errors, the process of medical error litigation, penalties stipulated for medical errors, and the presence of a statute of limitations. A comprehensive web search was conducted to identify the medical liability legislation of each LAS country. The study authors conducted web searches in April-June 2023 for medical liability legislation in English and Arabic. A second search was conducted in March 2025 to identify any new legislation enacted since the initial search. The following keywords were used: medical liability Law, Health Law, medical error definition, medical malpractice, and medical negligence. To ensure a thorough understanding of the subject, the study authors reviewed published research papers and law school theses that delved into medical liability within each country. When the information was unclear, the study authors consulted practicing physicians in specific countries for legislative insights; their expertise and firsthand experience helped verify and supplement our search findings. The study primary data sources (official legislative and regulatory texts) and secondary sources (interpretative legal papers) analysis followed a functional comparative legal approach, focusing on how different legal systems regulate similar issues related to medical error and professional liability.

  Results
  Among LAS countries, only 15 out of 22 (68%) had a specific medical liability law and only 12 of them (54%) defined medical error. The Civil and Penal Code was applied in 4 out of 22 (18%) countries when medical error occur. Information was not available on 3 out of 22 (13.6%) countries. Data was extracted and summarized in five tables in an intention to provide a comparative analytical overview of legislative approaches rather than an exhaustive codification of national legal systems. [Table 1] provides an overview of the medical liability legislation across all 22 LAS countries. It indicates whether each country has a specific Medical Liability Law, along with the dates of issuance and the presence or absence of a specific definition of medical error. Additionally, it indicates whether the Civil or Penal Code is used to address medical errors in countries that lack specialized legislation. This was extracted from published literature about medical error litigation in these countries. Regarding the definition of medical error, some countries briefly mentioned it, while others explicitly outlined it. However, across all countries, the concept of negligence formed the basis for defining medical errors. A few countries provided further details by specifying the actions considered negligent. [Table 2] lists the definitions of medical errors, and the penalties stipulated for medical errors in countries with specific medical liability laws. In nearly all countries, criminal and civil penalties were mandated for medical errors. Disciplinary penalties were stipulated in some of the medical liability laws examined however not in details as likely it is addressed in regulations governing practicing medicine and licensing in each country [Table 2].
  Regarding the medical error litigation process, only 9 out of 22 (40%) countries prohibit the arrest of the healthcare provider or interrogation by the prosecutor for a claim regarding a medical error or professional misconduct before a professional committee examines the allegation and confirms the occurrence of the medical error, [Table 3] list the Arab countries that have these specific legislations in this regard as well as the specific article from the medical liability Law. Only 3 out of 22 countries (13.6%) have a statute of limitation for medical error litigation mentioned and specified; the rest did not mention it and, hence, applied the general civil law principles which is 3 years since knowing the medical error or 15-years from the event occurrence, [Table 4], lists the countries that have specific statutes of limitation for medical error litigation, wirth noting Kingdome of Saudi Arabia stipulated statute of limitation on the public criminal action 1 year from the knowledge of the medical error however the civil liability will be following the general civil Law principles. Finally, 3 out of 22 countries (13.6%) mandate the establishment of a registry for medical error claims, including final judicial rulings to facilitate research and inform legislation improvement [Table 5].

  Discussion
  The study discussion focused on the elements of the comparative study conducted, which are the existence of specific medical liability law, the definition of medical error, the legal responsibility applied to medical error, the process of medical error litigation, and the penalty stipulated on medical error, in addition to the presence of a statute of limitations and presence of medical error registry.
  Existence of specific medical liability law
  Upon reviewing the medical liability legislation in the LAS countries, it was observed that many countries still lack specific laws to address medical liability, instead relying on civil and penal codes to handle allegations of medical error. There are two internationally recognized legal systems: the Civil Law and the Common Law. Traditionally, the literature describes customary and religious legal systems; however, these are rarely standalone and are usually integrated within the civil law system, which can then be referred to as a hybrid legal system. The LAS countries can be described as hybrid, as they adopt the Civil Law system in addition to applying Sharia principles to both civil and criminal legal frameworks [14]. The Civil Law system stems back to the Roman Empire and developed in Europe, the Ottoman Empire, and most of the world except North America and Britain. It is based on several theories and principles, one of which is legal positivism, which states that Law is a set of rules and norms set by the legislator [15, 16]. Then, the systematization of legislation theory, where similar law rules are consolidated in a specific code, becomes the primary source of legislation and paves the way for its implementation, guiding legal policies in that field [17]. The third principle of the civil legal system is that it is an inquisitorial system based on extensive pre-trial investigations to ascertain the truth where the judge is empowered to oversee the investigation and interrogation process. Such principles ensure that innocent people are not brought to trial [18]. In the civil legal system, the Civil Code is considered the primary source of legislation where general principles are laid out and referred to whether the case is civil or criminal. The civil code can be supplemented by specialized statutes such as consumer protection law, labor law, and medical liability law [19]. Having special statutes provides clear and specific definitions of terminology, which enhances legal certainty when adapting legal principles to the subject. In addition, specialized statutes offer a deeper understanding of the legal principles pertinent to the field, as penalties are tailored to enhance the field and address its challenges. Lastly, it may lead to increased efficiency in the judicial process, as all sets of rules are consolidated into a single statute [20].

  The definition of medical error
  Few LAS countries that had medical liability laws did not define medical error. LAS countries that had definitions of medical error, it was noted that all of them were based on the concept of negligence; some countries provided detailed descriptions of acts or omissions that constitute negligence, while others offered a more general definition. In addition, in Law a person is liable for negligent act only if it results in damages (Tort) and a causation relationship between the act and the damage can be established. When examining medical error definitions in LAS countries, some included damages in the definition while others focused on describing negligence and did not mention that it must cause damage to the patient which can be confusing to medical liability experts when assessing presence or absence of medical error from legal point of view [21]. Overall, medical liability in LAS countries is viewed under ‘Tort’ rather than contract liability principles. In Legal literature “Tort” is defined as an act of civil wrong done to another violating a protected right and resulting in damage or harm [22]. Adhering to Tort principle when addressing medical errors is consistent with most of the international legislation except for France, which shifted from tort principle to contractual liability in 1936. However, in 2002 patient rights law changed from contractually based liability to a specific independent legal regime structured as a combination of both Tort principle and contract [23]. The LAS countries share similar religious and cultural backgrounds, which effectively unify their understanding of errors in general, as well as the consequent legal liability and penalties for individuals who commit an error. Therefore, having a unified definition of medical error is possible and helpful in easing communication among healthcare professionals and policymakers, as no internationally agreed-upon definition currently exists [3, 24]. The United States Institute of Medicine defined medical error as “the failure of a planned action to be completed as intended or the use of an incorrect plan to achieve an aim”. Therefore, it is a failure, not necessarily due to negligence. However, realizing that despite being diligent, humans are error-prone and, hence, may still fail to enact a concise plan or that the plan itself may not be the most optimal for that patient [25, 26]. Not all medical errors in the United States warrant legal litigation, only medical malpractice, in another word, all medical malpractice involve medical error, but not all medical error are medical malpractice [3]. The definition of medical error in the United States aligns with the Islamic Fiqh of fault, which is “an act that, through ignorance, deficiency, or accident, departs from or fails to achieve what should be done”, referred to as “Galat, or Gala غلط" and scholar Ibn Manthoor called it “Mistake” [27, 28, 29]. On the other hand, Neglicance based error or fault (medical malpractice in USA) -referred to as “Khatt’a” in Arabic- is defined as “an error or defect in judgment or conduct that deviates from prudence or duty due to inattention, incapacity, perversity, bad faith, or mismanagement and may result in harm to another person and may be intentional or negligent.” [26].

  Therefore, LAS countries need to establish two definitions one of “Galat, or Gala غلط , 6 ” which is errors that occurs even when utmost care and diligence are exercised yet harm may occur despite taking all necessary precautions to prevent it which must be investigated at hospital or system level to improve quality of medical care provided and hold no legal liability. The second definition is of “Khatt’a” , خطأ which is a fault that is the result of negligence and a breach of the duty of care, and result in hard and necessitate legal liability. Hence, the use of “medical fault” as Englis term ( خطأ طبي )is more accurate to reflect negligence-based medical malpractice than “medical error” - غلط طبي. It is essential to accurately define these two definitions as one implies legal liability while the other does not, as not doing so can hinder the provision of necessary care due to fears of litigation. For instance, in emergency medicine, physicians frequently make rapid decisions under conditions of incomplete information. In such contexts, overlooking a diagnosis when clinical picture is unclear or previous patient data (history) may not be available or decisions are made under service and time pressure may be miss interpreted as medical error where in reality its explained by “reasonable person standard” for any physician working under similar circumstances that day, therefore emphasis on reasonable person standard which account for time pressure or clinical uncertainty of decision making in the Emergency Department or the Operating Room need to be clarified in the medical error definition or the medical liability Law illustrative document that follows . This illustrates how legal frameworks governing medical error may have unintentional practical consequences on clinical behavior, risk-taking, and ultimately patient safety if not detailed and clarified. Perhaps another approach might be to drop the medical error terminology and use the Kuwait approach of defining when physician is legally liable which include deviation from standard of care and neglecant which is like the United State approach where they use (medical malpractice) as a term rather than medical error.

  The legal responsibility applied to medical error

  Regarding legal responsibilities and penalties for medical error, all LAS countries impose civil, criminal, and administrative penalties on healthcare providers found to be negligent. The criminal liability of medical professionals for medical errors dates to ancient times, when the medical profession was not yet fully established. Doctors were often viewed with suspicion, likened to witches or individuals with malevolent intentions rather than being regarded as healers [30]. Punishment in the penal code is based on two philosophical theories, utilitarian and retributive theories. According to utilitarian theories, punishment is justified by its deterrence of criminal behavior and by its other beneficial consequences for both individuals and society. According to the utilitarian theory, criminal acts are penalized and punished to deter individuals and the community from committing crimes, thereby protecting society [31]. This does not apply to medical errors, as penalizing professionals who commit medical errors while caring for and serving patients holds no benefit to the patient, the community, or the healthcare practice. Indeed, it may be harmful to the community, as healthcare providers may be deterred from taking calculated risks in managing patients [32, 33]. The retributive theory involves three criteria, all of which must be met; first, a person may be punished only if the wrong act is voluntary. Second, the punishment must be equal to the damage caused, and third, the punishment must be justified on moral and just grounds [34]. Therefore, retributive theory also cannot justify punishment for medical error, given that it is not voluntary, nor is it moral or justifiable. In addition, two basic principles in criminal law do not apply to criminalizing medical errors, which are the “benefit of doubt” rule and the “acquittance is the rule.” The “benefit of the doubt” is a cornerstone of criminal law and necessitates that if reasonable doubt exists regarding the guilt of the accused (the healthcare professional), they should be accorded the benefit of that doubt and not deemed guilty as it must be proven that the accused is guilty “beyond all reasonable doubts”, in addition, the burden of proof is on the prosecution and the plaintiff not on the accused [35]. This, coupled with the legal principle that states “acquittance is the rule,” makes it challenging to criminalize medical errors. First, determining negligence is often subjective; thus, medical experts and professional committees cannot confirm whether negligence occurred solely based on objective evidence but rather through indirect signs. In addition, negligence is not exclusively the responsibility of the individual; there are indeed many confounding factors that may contribute to healthcare provider negligence, such as long working hours, working during non-social hours, inadequate administrative support processes, and a lack of social or collegial support. Therefore, imposing criminal liability on medical errors requires examination by LAS countries considering addressing medical errors under tort principle and sparing criminal penalties for healthcare professionals on actions that they are explicitly prohibited from undertaking, such as practicing without a license, performing illegal abortions, assisting patients to die, or facilitating the misuse of controlled drugs and other similar prohibited actions [36]. On the other hand focusing on compensating patients for the damage they suffer via valuable Civil Award to help them recover the damage if possible or mange it, is more beneficial for the patient and their families than punishing the healthcare professional criminally [25]. Additionally, the imposition of appropriate corrective disciplinary penalties will ensure that healthcare professionals are deterred from negligence [37]. By focusing on system-level and individual-level improvements rather than punitive measures against healthcare providers, the system can avoid negative consequences that may discourage doctors from managing high-risk patients or offering alternative treatment options that may have benefits not commonly recognized [27]. Conclusively, whether we consider the utilitarian or retributive theory or consider basic criminal law principles, “the benefit of doubt” rule and the “acquittance is the rule,” it is found that criminally charging a healthcare professional neither serves the public nor the patient nor the healthcare provider [28].

  The process of medical error litigation
  The process of medical error litigation across LAS countries is diverse. Only 9 of the 22 countries with medical liability-specific legislation state that physicians can't be brought to court except after a medical error is proven by the medical committee's final report (Table 3). The UAE Medical Liability Law explicitly describes the process where the claim investigation is purely administrative, with a professional medical liability committee investigating the claim to determine if a medical error occurred. Both parties, the claimant and the defendant, have 30 days to appeal, and afterward, another independent committee (the higher committee of medical liability) re-investigates the case and issues their decision administratively; their decision counts as final where if no medical error is found, claimant can’t file a case in court. In many LAS countries, where the medical malpractice litigation process is not outlined in law, patients can approach a prosecutor to file a claim, and the prosecution initiates an investigation involving healthcare workers before the medical error is proven. The role of the professional committee only comes into play once the case is referred to the court. During the process of prosecution investigations, healthcare professionals may be detained for days or weeks, which can be demoralizing to both the healthcare worker under investigation and their colleagues, as well as to the healthcare community in the perspective country, especially if the care provided meets the standards of care. Such harsh criminal investigation processes may harm medical practice, as doctors may be deterred from taking risks in managing high-risk patients, fearing criminal charges if complications arise [38]. Here is another area of medical liability reform for LAS countries which is preventing any prosecution or judicial litigation or investigation prior to confirming medical errors that necessitate legal liability.

  The presence of a statute of limitations
  Out of all the LAS countries' legislations reviewed, only Saudi Arabia, Tunisia and Palestine have explicitly stipulated a statute of limitations for medical error litigation. The absence of such a provision leaves the timeframe open for up to 15 years, according to standard rules of civil law. However, this extended timeframe becomes increasingly unrealistic over time due to the rapid advancement and changing standards of care, diagnostic methods, and treatment modalities. Implementing a statute of limitations would ensure a more realistic and fair approach to addressing medical error claims within a reasonable timeframe [3, 39]. In addition, the longer the time frame, the more difficult it is to perform robust investigations as most hospitals keep records for up to 5 years only; hence, evidence might be lacking if investigations are conducted on incidents that occurred longer than 3-5 years [40, 41].

  Recommendations
  Based on the comparison conducted, the review and analysis of current legislation regarding LAS Medical Liability of medical errors, the study suggests the following six legislative reform initiatives:
  1- To Consider adopting two definitions of medical error, one that is negligence based and imply legal liability, and another that is not negligent based and does not imply legal liability. They can consider using the term “fault” instead of error for negligence based medical error and call it (medical fault) “Khatt’a” (a medical error that infers legal liability, ie; medical malpractice) and use the term “Galat” medical errors which is ignorance-based and can occur despite exercising due diligence and does not imply legal liability.
  2- To provide an objective description of actions that will be considered negligence.
  3- To establish a unified framework for non-criminal liability of negligence-based medical error, reserving criminal liability for acts explicitly prohibited by law such as non-medical abortion, euthanasia, refusal to treat a patient in case of emergency and other similar actions.
  4- To adopt a unified statute of limitations to ensure a reasonable timeframe for medical error litigation.
  5- To create a centralized database within the LAS that records all medical error litigations, which can be utilized for research and educational purposes, promoting knowledge sharing and improving the healthcare system collectively.

  Strengths and limitations
  The research methodology stands out as the first comprehensive examination of medical liability legislation in the LAS countries. The proposal put forward, encompassing a unified definition of medical error, consistent principles for penalties, and other essential considerations, is poised to foster collaboration and improve healthcare provision among these nations. It is crucial to acknowledge the study's limitations. This research did not address administrative, disciplinary, and restorative aspects of medical error in detail, and we suggest these as areas for future research. This research heavily relied on online searches and the insights gathered from the authors' network of colleagues practicing in different Arab countries. Consequently, the most up-to-date medical liability legislation, as well as any updates that may not have been published online, may have been missed and not included. While formal communication with each country’s Ministry of Health could have provided more accurate information, the time constraints and logistical complexities led the authors to opt for an initial online review. Future studies are needed to build upon this groundwork, potentially led or facilitated by the Arab Health Council, to ensure a more robust and comprehensive exploration of medical liability in the LAS countries.

  
  Conclusion
  The League of Arab States shares a common cultural and legal background, presenting an opportunity for harmonizing medical liability legislation related to medical errors. By adopting a unified definition of medical error, applying civil and disciplinary non-criminal penalties, and establishing a unified statute of limitations in addition to other reform initiatives, these countries can positively impact their healthcare systems. Lastly, the study proposes that this review be conducted with the support of the Arab Healthcare Council to ensure the participation of all countries and achieve a comprehensive and accurate understanding of medical liability related to medical errors across the League of Arab States.

  Authors' contributions
  Both authors contributed equally to the manuscript and study. Both authors have a Bachelor of Laws and are interested in medical liability in addition to legislation related to healthcare. Both authors serve as medical examiners for medical malpractice cases in their respective jurisdictions of practice.

  Declarations
  Use of Artificial Intelligence declaration
  Authors would like to declare that Chat GPT was used to translate Law articles and Law titles from Arabic to English as many of the Legislations reviewed are available in Arabic and not available in English.
  Ethics approval and consent to participate
  This is a descriptive comparative study that compares published legislation; therefore, no ethics approval or consent was required.
  Consent for publication
  Not applicable
  Availability of data and materials
  All legislation and literature reviewed are referenced and available upon request.
  Competing interests
  Both authors declare no competing interests.
  Funding
  No funding was received for this study.

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• 

  Denis Oriot, Guillaume Alinier, Zineb Messarat-Haddouche, Hervé Thomazeau, Laetitia May-Michelangeli, Marie-Christine Moll, Jean-Claude Granry (Author)

  Suggestions for the Study of Ethics of Simulation in Healthcare

  Simulation can be used in healthcare education to provide learners with the opportunity to develop the knowledge and skills needed to manage complex situations and provide patient care, however one aspect easily overlooked and which has many ramifications, is that of ethical practice.

  Simulation-based education is a moral and ethical imperative. “Never the first time on the patient!” is displayed at the entrance of some clinical simulation centres, but the rest of the ethical obligations, besides the professional code of ethics, are either not mentioned or only sporadically.

  By using an interpretive framework based upon the 4 bioethics principles used for patients (autonomy, beneficence, nonmaleficence, and distributive justice), we propose, as a conceptual framework, an analysis on the stakeholders of simulation-based education (SBE) - educators, learners, and simulated participants - to broaden and explore in depth the conventional views of ethics in simulation. This article also discusses specific features in simulation which sometimes pose an ethical dilemma such as facing simulated death, breaking bad news, research, the use of biological tissue, teaching ethics, and computer simulation.

  This proposal to explore ethics in healthcare simulation is intended to stimulate reflection rather than serve as a model seeking external validation.

  Foreword

  Before embarking on exploring ethics in healthcare simulation as a conceptual framework, we believe it is important to clarify the relationship between a practice, its ethical aspects, and its legal aspects. The relationship between biomedical practice, ethics, and legislation is closely tied to a society’s historical, cultural, political, and religious context [1, 2]. More specifically, the relationship between ethics and the law regarding a given action evolves according to dynamics shaped by this context. Two examples related to simulation illustrate this point:

  1. In France, donating a body to science has been legal since 1953, provided there is prior consent from the donor and that it is done with due respect for the body [3]. In 2019, a scandal was revealed by the press at an anatomy laboratory at Paris-Descartes University involving the discovery of inappropriately managed dismembered bodies and scattered anatomical parts [4]. Yet it was legal and must have been practiced in other laboratories for years. The fact that there were also illegal practices (poor hygiene, removal of jewelry from corpses) triggered an investigation and revealed a set of practices that had become unethical. This, in addition to disciplinary action against an individual, was deemed unethical (in light of the evolving concept of due respect for the body since 1953) and prompted the government to put a new law in place to better regulate this practice [5]. Thus, French law is the product of what occurs within the context of French society and may or may not correspond to practices in other countries. It is neither transferable nor generalizable. It may inspire other communities to amend their legislation in accordance with their historical, cultural, political, and religious contexts. In this case, the practice of donating one’s body to science was originally legal and ethical; however, due to illegal abuses, it aroused appropriately founded concerns and came to be viewed as unethical in its current form, prompting lawmakers to strengthen the law to align with bioethical principles as perceived by the French public in 2022 [6].

  2. As of today, in France as elsewhere, the use of Artificial Intelligence (AI) is legal (or rather, not illegal) and ethical in simulation. However, certain developments in AI may be viewed as risks that challenge bioethical principles. In such situations, a country’s legislation might need to change to legally regulate the use of AI, for example, if there is a potential harm to individuals. In other countries, this use could continue unhindered. Finally, for certain communities, although legal, the use of AI should comply with a code of ethics established by one or more medical societies. We thus see the importance of the sociological context regarding the tensions between legislation and ethics that may arise over time, and the dynamics that enable their resolution. For example, would it be ethical to have an AI entity conduct a debriefing of a healthcare professional following a simulation-based activity in order to determine whether they can return to work after an extended sick leave? For now, this is neither mandatory nor illegal, but is it ethical? [7].
  Consequently, the approach we present here is closely tied to the sociological context of our country of origin and, therefore, to the evolution of its legislation. This is inevitable in any human community.

  Introduction

  The rapid and universal deployment of simulation in healthcare for educational or system testing or redesign purposes raises the question of its limits. Technological limits seem ephemeral, falling one after the other as years go by. However, simulation in healthcare, like any human activity, has ethical limits that codify and modulate the use of these technological advances.
  Here we propose a conceptual framework that allows us to broaden and explore in depth the conventional view of ethics in simulation, which is tied to the principle of beneficence toward the patient (“never the first time on the patient”). In fact, the rest of the ethical obligations besides the professional code of ethics, are either not mentioned or are mentioned only sporadically.
  Because simulation in healthcare education is an activity aiming to improve patient care, we have chosen to use the “bioethical principles” tool – usually reserved to patients or research participants – to describe these limits and apply them to activities concerning people who are upstream or downstream of the use of simulation as an educational approach, taking into account the different people who may use it, and highlighting the conflicts that may exist between certain bioethical principles in particular situations. Therefore, the objective of this article is to provide a broader and more detailed perspective on ethics in simulation using the framework provided by bioethical principles. It includes not only patients but also all stakeholders (educators, learners, and simulated participants) and to examine several specific simulation situations. This proposal to explore ethics through healthcare simulation is intended to stimulate reflection rather than serve as a model seeking external validation outside of its sociological context.
  This article is based on the simulation in healthcare good practice guide published in March 2024 by the French National Healthcare Authority [8].

  Simulation-based education is an ethical and moral imperative

  The benefits of simulation-based learning in healthcare have been demonstrated [9, 10], and like any human activity, it has both ethical and professional requirements and limits. The four principles of bioethics are autonomy, beneficence, non-maleficence, and distributive justice [11]. Simulation in healthcare education is an ethical and moral imperative for healthcare professionals and trainees with respects to their patients, as Ziv et al. put it over twenty years ago [12]. Simulation therefore begins with an important moral commitment: ‘’We must do the best we can to keep patients safe while training the next generation of clinicians and retraining current clinicians so that they are kept up to date. If we can introduce clinicians to patients when these clinicians have more “experience” with quasi-patients of a wide variety, we lessen the chances that vulnerable patients will be harmed. Ethics is not an add-on to simulation; an ethical claim drives the practices of simulation themselves’’ [13].
  Furthermore, simulation has an epistemic role in that it can transform theoretical knowledge into practical know-how, enabling the universal application of international recommendations for patient wellbeing [14, 15]. Simulation users as educators must therefore endorse a professional ethics and have the responsibility of training all healthcare professionals at the highest level of performance possible.

  Ethics and simulation-based education

  The principles of bioethics can also be extended to everything patient related. If the care provided to patients appears to be the primary concern - the ethics of simulation-based education (SBE) for the patient - so too is the learning of the healthcare professionals who will deliver this care. Indeed, better learning is the key to better care [16]. This objective can also include the ethics of those involved in the educational process. In this way, we can define the ethical aim and content of the various bioethical principles applied to these people and which we have summarised in Table 1.

  For patients
  The ethical aim for patients is that simulation should help them receive the best possible care according to current evidenced-based practice.

  Autonomy, the ability to decide for oneself, was reinforced by the French Law of March 4, 2002 [17]. It is essentially based on the principle of information and consent. In the domain of healthcare education, it can refer to informing patients that the training of healthcare professionals involves the use of simulation. This can be done through disclosure in the patients’ welcome booklet or on information boards, but also orally before a procedure is performed, for example. It has been reported that patients preferred to have a procedure performed by a simulation-trained professional rather than by a professional who has not been trained using simulation [18]. This also includes information on the fact that procedures performed by a junior simulation-trained clinician will be supervised by a more senior clinician, with the inevitable patient right of refusal without prejudice. Another aspect relates to the commercial independence of prescriptions (medical devices and drugs) made for the patient. In the case of in-situ simulation in a real clinical setting, it is imperative to inform patients on the unit that there are two teams: a care team and a simulation training team. The latter may cause some noise and temporary inconvenience, but it should never to the detriment of patient care. Once the patient has been given clear, fair information in a language they can understand, written consent for the treatment should be obtained.

  The principle of beneficence means looking for elements of the simulation that are intended to benefit the patient. The Kirkpatrick pyramid [19] can be used to classify them into levels.
  Simulation-based training aims to benefit the patient by improving the performance level of healthcare professionals (Kirkpatrick level 2 = K2), changing professional practices and increasing compliance with recommendations (K3). Simulation benefits patients by reducing morbidity (complications, worsening, etc.) and mortality in the rare studies that have reached K4 [20, 21]. Simulation has also been shown to reduce healthcare costs [20, 22], which can be considered as level 5 of the Kirkpatrick's pyramid (K5). The arguments are so numerous that this led to the saying “Never the first time on the patient” being displayed at the entrance of some clinical simulation centres [23].
  The principle of non-maleficence corresponds to tracking down conflicts of interest that would lead to harm for the patient. For example, excessive development of in-situ simulation at the expense of clinical timetables or human resources for patient care would be a case of maleficence. Similarly, the risk of mixing of simulated drugs and medical devices with those dedicated to real patients in a clinical unit where in-situ simulation is taking place, would also be a case of maleficence [24]. The same would apply if a patient room used for in-situ simulation was not cleaned before a patient was admitted. There could be unfortunate consequences in terms of iatrogenic and nosocomial infections.
  Applying the principle of distributive justice means, on the one hand, ensuring that all patients can benefit from healthcare professionals trained using SBE, and, on the other hand, that the care delivered by trained staff is provided to all patients, regardless of resources, religion, opinion, ethnicity, age or gender... irrespective of the type of service, the status of the staff and their working hours (day or night shift), 24 hours a day, 7 days per week.

  For educators
  Immersive scenario-based simulation probably provides the best possible learning experience in the field of health to learners so that they develop better skills, provide more humanistic care, avoid errors and adverse events, and minimize their consequences, and thus make medical practice safer [25]. As such, educators should have for ethical aim to foster the use of SBE at every opportunity.

  Autonomy. A first obstacle to this freedom would be resistance to the ''simulation'' concept by decision-maker (hospitals, universities, professional and accreditation bodies...). In this respect, it is interesting to go back to the beginnings of simulation in aeronautics, which encountered this same obstacle. As McLoed said in the late 1960s: ‘’I expressed my growing concern for the future of mankind and my intention of applying the technology of simulation to help alleviate the problems of society. It hasn't been easy. Among other things I have felt grave concern over the lack of acceptance of the results of modelling and simulation. In a time of increasing complexity of life, when decision-makers need all the help they can get, the very powerful tool of modelling is sometimes not used, or is misused, or the results of modelling, once obtained, are not acted upon’’ [26]. These words are still relevant today in the world of healthcare. This ethical obstacle has largely been overcome by the inclusion of SBE in initial and continuing training programmes, and other governmental or professional initiatives [27].
  Secondly, autonomy could correspond to the freedom to initiate SBE programmes without being dependent on commercial companies. However, freedom of choice in the acquisition of simulation equipment depends on sources of funding, and therefore on institutional, regional, and national political powers to supply these resources. Otherwise, these same institutions must guarantee and enforce ethical rules with regards to companies. These rules are now well established and guarantee the educators’ autonomy in the practice of healthcare simulation. Another problem that can hamper the freedom of the simulation educator is the growing competition between multiple companies, making this choice inevitably subject to commercial pressures (discounts on the purchase of several models, addition of complimentary devices in the event of an expensive purchase...). Paradoxically, the absence of freedom of choice linked to a governmental decision can make it possible to free oneself from financial influence struggles. An example is the recent purchase by each medical school in France of the simulation models required for Objective Structured Clinical Examinations according to a list prescribed by a national steering committee. This underscores the importance of drafting and disseminating recommendations on pedagogical efficiency, which should prevail over any costly investments in the field of healthcare SBE.
  One might think that the beneficence for the educator would be the ease with which they could deliver courses without institutional or financial obstacles, and that these courses could clearly benefit learners. This largely depends on the “simulation culture” of a country or region, and on the way in which legislative texts related to the use of SBE for healthcare professionals are applied, as well as on the acceptance and integration of simulation education concepts and tools by those involved.

  Non-maleficence. All too often, the use of simulation as a learning approach in the healthcare professions involves resolving professional practice conflicts. The primary conflict in many countries, is the educator's personal time dedicated to SBE when they have a full-time clinical role. This time is still often the educator's personal time, not identified or accounted for by the employer. Such personal time commitment initially made it possible, and is still an enabler to launch SBE activities in many institutions, but under no circumstances can it be made permanent, at the risk of undermining motivation. The second conflict concerns in-situ simulation. This often takes place in emergency care units and must be balanced against the care of real patients [24]. Limited staff resources hamper the development of in-situ simulation, which can only take place when the patient flow remains reasonable.
  Applying the principle of distributive justice to simulation educators means talking about access to SBE for educators in relation to their own training. This is largely dependent on country, culture, and mentality. Two examples illustrate this point. The first is the assistance in equipment and training provided by volunteer international educators in 2013 from the International Paediatric Simulation Society to the only paediatrician in Malawi to improve infant care in the country [28]. The second example is the beneficial action of the programme “Helping Babies Breathe” carried out in 2016 by the American Academy of Paediatrics, supported by the United Nations High Commissioner for Refugees, and sponsored by the Laerdal Foundation in Ghana, Rwanda, Indonesia, and Nepal. This involved the supply of low-cost newborn manikins with a training programme, teaching material, training of trainers, evaluators for initial and remote monitoring over several years, resulting in a significant reduction in neonatal mortality [29]. Another issue in some countries is the impossibility for healthcare professionals to have access to anatomical subjects for SBE purposes due to religious barriers. For example, Libyan surgeons have twice come to France to train on the SimLife model [30]. An alternative approach is the use of synthetic or digital simulation tools as they allow for the rapid dissemination of SBE, requiring only a power outlet and internet access.

  Other principles
  For educators, it is important to add two other aspects of ethics that cannot be included in bioethics principles: professional ethics and the ethics of responsibility.
  Professional ethics refers to procedural ethics including all the rules of good SBE practice [31], while keeping learners safe, preventing errors and facilitating learning, as described as imperatives in the Society of Simulation in Healthcare's Code of Ethics [13, 32]. Furthermore, SBE also involves training in the practice of debriefing so that it is relevant and non-offensive [33]. This benevolence towards learners is part of the rules of healthcare simulation and attempts to mirror the principle of beneficence that should guide healthcare professionals towards doing their best for their patients. It is an essential professional ethics principle, and this notion comes close to the ethics of virtue by “doing good” for the patient and for the learner [34], but also anchoring this ability in the absolute necessity of evaluating the performance of learners' actions and behaviours.
  The idea of an ethic of responsibility for the educator is that they must do everything possible to obtain results corresponding to the K2, K3, and even K4 levels of Kirkpatrick's pyramid [35, 36]. The ethical importance of evaluation in SBE can be seen here, as it is the only way to demonstrate progress in learning and performance.

  For learners
  The ethical aim for learners in a simulation programme is to benefit from the best possible education to develop their knowledge and competence to improve patient care.
  Autonomy. In initial training, like in continuing professional development, the validation of SBE has almost become an obligation [37]. Learners must be briefed concerning any SBE activity they get involved in and give their consent [38, 39]. Inappropriate briefing or consent increases the risk of a difficult debriefing which could impact the learning process [40, 41].
  Information within the briefing must include various elements:
  - Educators’ compliance with the Simulation Code of Ethics [32].
  - Context of the activity (pre-briefing and orientation): Review of prerequisite learning, presenting ground rules (confidentiality, benevolence, respect, neutrality, mutual trust), and type of activity (scheduled/unannounced, summative/formative) [36]. It is also important to help learners familiarise with the environment (centre or in-situ, peri-situ) and the medical and simulation equipment [42]. If there is a formative assessment of performance during the scenario, it is only for guiding the debriefing and it will not be transmitted to anyone in the clinical setting.
  - Briefing: Providing an introduction to the scenario; explaining that it may include specific critical procedures with a causal link to the survival of the “patient” [42].
  - Limitations of the simulation experience: Possible differences from practice in a clinical unit and potential technological issues with the manikin [43], up to the point where a scenario may have to continue in a verbal form.
  - Need for engagement – with the ‘’as if’’ concept so learners suspend disbelief about aspects that lack realism [43-45]. Suspension of disbelief becomes the core of the efficiency of SBE and is agreed upon as part of a fiction contract established with the learners [46].
  - Awakening to the knowledge of possible “intruders”. Unexpected external events may be planned in the scenario to approximate reality such as the visit of angry relatives, voluntary malfunction of a device, unavoidable death of the manikin, etc. In this case, the information is limited to: “You are required to deal with the present case as you would in real life”. Other elements independent of the scenario's story must also be given to learners, so that they can freely accept the simulation without feeling prejudiced [47].
  - Use of personal data: give full details of how any video recording of the activity or learners' computerized performance data collected by any type of sensors will be used.
  - Independence from any commercial interest: There should be no passive commercial seeding of learners, fraudulent reuse of digital data (mailing lists...), devices, healthcare services in all their forms, direct or indirect (48-50).
  - Assurance of the ethical aspect of the simulation model: for a simulated patient: acceptance of the role, irrespective of their age (51); for the use of cadavers: compliance with the rules governing the donation of the body to science (5); for an animal anatomical part: compliance with ethical rules related to animals (52, 53).

  For learners, the principle of beneficence amounts to asserting that SBE provides a benefit, and in the case of normative evaluation, training validation or recertification (54). This benefit is based on the rules of SBE, especially benevolence.
  - The scenario should be adapted to the learners' level so as not to set them up for failure but just to challenge them enough so they operate at the edge of their comfort zone whereby they may be expected to make mistakes without being completely overwhelmed (14, 55).

  - The realism, which corresponds to the fidelity of the “simulation” experience as perceived by the learners (environment, model, and scenario), should match the clinical reality required to achieve the activity’s learning objectives whilst also providing learner satisfaction (K1) (36, 43). This may also be linked to the possibility of interacting with the model: simulated patient, manikin, Virtual Reality simulator, cadaver, etc. (56-58). These elements (environment, model, scenario) combined with psychological fidelity (contextualization of the scenario and realistic and immersive engagement of the learners in the activity), constitute the 4 elements of simulation fidelity, which corresponds to the highest level of realism (43). This guarantees that learners are exposed to a valid SBE experience.
  - The increase in knowledge, know-how, interpersonal skills, as well as self-confidence and a sense of personal efficacy, corresponding to level K2 (36).
  - The debriefing should be of quality, respectful, non-offensive, and relevant. This is dependent on the training of the educators so they develop optimal debriefing skills (59).

  Respecting the principle of non-maleficence means avoiding any harm to learners or ensuring that any potential harm is associated with a positive benefit/risk ratio. This is about not “tricking” learners with bad intentions, nor purposefully provoking negative emotions. The feeling of being deceived can come from the scenario itself, from simulated participants, or from an intentional equipment malfunction [43, 47]. Negative emotions can also be generated by the provoked and unavoidable death of the “patient” [60]. It is important to realise that deception is often purposefully incorporated into scenarios to enhance their authenticity, and hence it is no related to
  non-maleficence but benevolence [43]. If the simulation is multi-professional, and even more so in-situ, then a tension arises between the “good for the team, the unit, the institution” (imagining all possible cases, even the most difficult) and the “good for the learner” (avoiding the feeling of deception). It also raises a dilemma between the scenario's loss of authenticity, which threatens the principle of beneficence, and the learners’ loss of psychological safety, which threatens the principle of non-maleficence [61].

  It is on this basis that a controversy has arisen in the world of SBE about whether or not it is possible to deceive learners for their own good. The key lies in the quality of upstream information, which is the learners’ preparation in the form the pre-briefing and associated learning contract [43].
  The principle of distributive justice applied to the learner is that all learners should benefit from SBE. This requires well trained simulation educators, sufficient training space, and good administrative and technical support and processes. All these elements ensure the reproducibility and accessibility of SBE to all learners.

  For simulated participants
  The ethical aim for a simulated (or standardized) participant or patient (SP) is to increase the realism of a scenario. Learners are still immersed in a controlled environment within which they can make mistakes and develop technical and communication skills without this being harmful to the patient [43].
  The principle of autonomy for the SP corresponds to the freedom to choose to be involved in a scenario depending on the level of physical exposure required, the type of physical assessment or procedures to be performed on them, and the type and tone scenario script language [62]. This is similar to an actor’s right to accept or not a role and its associated script for a movie. Prior information must be as exhaustive as possible, specifying the number of scenarios enacted over a set duration, the break times, and so on. It is also important to provide a framework that includes role portrayal training, image rights, and training to evaluate learners’ performance or providing feedback. Two examples illustrate the possible limits of the role of SPs: Their use to teach pelvic examination [63] or to receive repeatedly a diagnosis with a poor prognosis [64].

  Beneficence. Simulated patients need to work in good conditions, including a space where they can get changed, “get in” and “get out” of character, and wait between scenarios [62, 65].
  The benefits of participating in SBE for SPs can be of various kinds: 1/ Participation in improving the skills of healthcare professionals, particularly for expert patients; 2/ Personal development in another field of theatrical art for actors; 3/ Financial benefits through remuneration for preparation time, simulation-based activity with learners, and travel expenses [65, 66].
  Respecting the principle of non-maleficence corresponds to avoiding the simulated patient's insecurity. This is essentially psychological but also physical insecurity in relation to body parts exposure. This means ensuring the psychological safety and mental wellbeing of the SPs by taking care of not awakening negative prior experiences, evaluating the impact of the frequency of training situations on the SPs’ psyche (e.g., the consequences of being diagnosed with cancer several times a day/week), and debriefing the SPs regularly about their role and experience and offering the support of a psychologist if needed [65, 67].
  Distributive justice would correspond to the national and international availability and use of SPs for the training of healthcare professionals in SBE programmes.
  Other principles:
  There is a professional ethical principle whereby the SPs must accept to take part in training sessions to learn how to act as per the patient they need to impersonate and how to provide feedback to learners or complete evaluation forms about their performance. They need to accept receiving feedback on their own acting performance. They must respect a certain number of points linked to SBE [62]. These include adhering to the principles of simulation including confidentiality (especially for in-situ simulation) and benevolence.

  Special features

  Ethics and disclosure of bad news
  When it comes to breaking bad news in simulation, the psychological safety of learners and SPs cannot be ignored. It is part of professional ethics, without which learning becomes random or dangerous. Indeed, the disclosure of bad news refers to the emotions expressed by SPs that can provoke a psychological distress in relation to an event already experienced by learners [68]. This can raise ethical issues and cause trauma for learners [69]. For this reason, making sure at an earlier stage that this type of simulation does not disturb the learner and that the verbal and behavioural expressions of the SPs are not too destabilizing for a beginner learner helps to ensure their
  psychological safety.

  Such assessment can be based on the SPIKES method (Setting, Perception, Invitation, Knowledge, Empathy, Strategy, and Summary) [70] or its French translations – EPICES (Environnement, Perception, Invitation, Connaissances, Empathie, Stratégie et Synthèse) [71].

  Ethics and death in simulation
  After several decades of simulation during which educators advocated against allowing the simulator to die unless death was part of the learning objectives [72], this practice has been called into question.
  There is a profound discrepancy between cardiopulmonary resuscitation (CPR) management in simulation compared to real life: it is shorter and a lot less sad [73]. The risk is therefore a loss of “fidelity” of the scenario and thus a threat to the principle of beneficence as the learning experience no longer fully exposes learners to the reality of clinical practice.
  It has also been reported that presenting scenarios with a systematic death of the manikin leads to an increase in anxiety-depression with increased State-Trait Anxiety Inventory (STAI) scores [60]. This consequence was not reported in another randomized study [74]. But a recent meta-analysis has shown an association between an increased STAI score and anxiety or depression [75]. A randomized trial reported that students exposed to unexpected simulated patient death had more negative emotions, higher cognitive load, and were less competent to diagnose and manage a case [76]. This risk of negative impact is important to note as an element that could threaten the principle of non-maleficence. There is therefore a dilemma between the principle of beneficence and that of non-maleficence.
  In the context of death during SBE, the principle of autonomy involves fully informing learners about the possibility of death and obtaining learners' consent [42]. In one study learners had the same sense of self-efficacy having been informed or not of the possible manikin's death beforehand [77]. The unexpected death of the manikin in simulation is only conceivable and ethical if learners are informed during the pre-briefing and that they give their consent [43, 78].
  Thus, the possibility of the manikin's death in simulation appears ethical if: 1/ it is appropriate to the scenario; 2/ the learner is experienced and has already seen deteriorating patients; in another words, it should not be with novice learners, given the potentially deleterious effect of the emotional shock of being confronted with death early on in vocational training. [79]; 3/ the principle of autonomy is respected (learners are fully informed beforehand that the manikin may sometimes die) and learners give their consent. Prior to a particularly difficult scenario, it is important to inform learners that it involves 'critical' actions with a strong correlation with whether or not the manikin will survive (Table 2, Type 5).

  Table 2 presents different speculative possibilities in relation to the patient’s death during SBE activities. The first possibility is to mimic clinical reality with less than 10% of survival (and increase learning gains and therefore beneficence), but at the risk of learner dissatisfaction and therefore less non-maleficence. Conversely, the second option provides over 90% survival after simulated cardiac arrest, which increases learner satisfaction, but at the risk of being less realistic.
  The same applies to option 3 with the manikin surviving all the deleterious learners’ actions that could lead to death. On the other hand, the fourth possibility, which links each deleterious action to the manikin's death, although realistic, seems excessive and will greatly diminish learners' sense of satisfaction.
  The fifth possibility of presenting death in simulation seems ethically the least unfavourable. It allows the manikin to sometimes die in very specific cases where the action/inaction of the learners has a strong causal link with the outcome. It is therefore directed by the learners' performance and leads us to consider that a simulation educator may sometimes intentionally deceive learners for their own good (by authorizing the manikin's death if the action with a strong correlation with survival has not been carried out or if inaction is automatically linked to death). This way of representing death in simulation may, in some cases, reduce learner satisfaction and create a degree of frustration, but it also increases learning [43].
  Interestingly, this ethical resolution of the problem of death in simulation upsets Kirkpatrick's pyramid at its base, as far as it is not necessary to have learner satisfaction to improve their knowledge or skills. Further research is needed to fully explore this theme, and in particular, the psychological effects of manikin death.

  Ethics and research
  For the researcher, professional ethics include compliance with the Simulationist Code of Ethics [32, 37], the use of simulation according to one of the 4 modalities described (intervention, evaluation, context, pretext), and full information for the research participant on the same elements as the learner during a simulation session (Pre-briefing and briefing) [80].
  When a participant is included in a simulation-based research study, written consent is mandatory [81]. Often there are inconveniences associated with research evaluation studies such as biological sample testing (e.g. blood, urine, saliva), wearing sensors, completing numerous questionnaires, not smoking for 24 hours, etc [82]. To respect the principle of beneficence for all, researchers must provide an equal training opportunity to the “non-simulation” group (control group) participants after the research has been conducted [83].

  Ethics and the use of biological tissue
  The ethical aim here is not the professional protection of the learner (guaranteed by the educator), but rather the respect and protection of the biological tissue(s) used in the course of a mostly procedural simulation-based activity.
  For the educator, it is in all cases a professional ethics of respect for regulations concerning the use of animals or parts of animals [52, 53], and cadavers donated to science [5, 53] as presented in the first example of the foreword. The ethical guarantor with regards to biological tissues is the anatomy laboratory’s ethics committee acting as a protector of the ethics linked to the management of biological tissues [5]. However, the guarantor of ethics with regards to learners remains the educator, responsible for the application of learning regulations (see “Ethics for the learner” above). This dual ethical protection is specific to procedural simulation and must be precisely organized and validated in every SBE activity of this type.
  As far as the whole animal is concerned, the essential ethical aspect is to provide sufficient analgesia or anaesthesia so as not to cause suffering [52, 53]. The French National Committee for Ethical Reflection on Animal Experimentation is tasked with ethical issues related to animal experimentation [84].
  Concerning the use of cadavers in simulation (complete subjects or anatomical parts), the framework has been precisely defined by a recent French Decree [5], which sets out the principles and procedures (ethics, scientific, and educational committee).
  In addition to the guarantees provided by the various committees of the body donation centres (ethical, scientific, and pedagogical) of the Law [5], one must adhere to the respect due to the deceased human body [85], and provide a prevention of viral infections by searching for any viral infectious agents on bodies donated to science before they are used [86].

  Teaching ethics through simulation
  Learning ethics through simulation plays an important professional role. It contributes to the preservation of values and cultural heritage of societies and healthcare systems, which is a major concern of educational systems [87]. Although not frequently used, simulation enables learners to acquire bioethical principles for the patient [88]. Ethics in medicine and nursing takes place in situations that are inherently uncertain and open-ended [89]. Simulation can be designed to reflect the choices faced by patients and clinicians, and the factors that influence the dynamics between them, and present them in a context that emphasizes the need for a nuanced approach to ethics education and practice [89]. Simulation then provides learners with the opportunity to develop the knowledge and skills needed to manage complex situations and ethical dilemmas [90]. Nevertheless, the complex nature of the scenarios means that they are aimed at end-of-course learners who have already a wide experience of medico-technical situations.
  The teaching of bioethics in simulation has been reported in medical [91], nursing [92] and midwifery studies [90]. It is fundamental to teach about ethics in nursing education as nurses are considered the biggest human capital in the health care system [93]. In addition, simulation has been used to determine, on an assessment scale, the threshold value of skills needed in ethical decision-making [94]. Finally, SBE provides insights into the application of bioethics in other countries and cultures [95].

  Ethics and computer simulation
  According to Moor's Law, there is a correlation between technological advances and social and ethical impacts [96]. VR, and more broadly the sensory virtualization of all or part of the simulation environment, opens up a new dimension of ethical concerns. This development threatens virtue ethics like any new development in human activity [34].
  While the potential benefits of VR are heralded by some as limitless possibilities (Metaverse), there is in fact a necessary debate on its real educational efficiency and on the ethical implications that this technology represents in relation to its physiological, cognitive, and behavioural impacts. There may be visual or even pluri-sensory isolation of the educator/learner pair, as well as isolation regarding social dynamics and inter-individual relations [97]. The beneficence of this approach was the first to be raised as potentially threatened or modified by VR for clinicians and patients [98], as well as lay people [99].
  The second concern has been distributive justice as simulation using VR is not financially accessible to all training programmes, even though it promises to be an important teaching tool [100]. It seems that currently the crucial problem is that of “virtual ownership” of both the educational content and the information gathered and processed through machine learning. This is a threat to the principle of learner autonomy. For example, a user may be considered the owner of an island in a virtual world, but the entire world, including the island, may be the property of the company that created it and allows users to ”live” in it [101]. For example, the development of many surgical training software is in fact financed by industry, such as implant manufacturers, with the aim not only of promoting the implantation technique for the trained professional, but also of commercially seeding their product to inexperienced learners. A whole virtual economy can develop here, as in Second Life [102].

  VR presents a major potential ethical problem, as the technology and financing it imposes can generate a deleterious relationship of dependency between the financial world and the world of healthcare training, particularly through the exploitation of personal physical and psychological data, which may be collected without the knowledge of their authors and for unknown purposes. There is therefore a great vulnerability to this technique, which can be a source of abuse for malicious or financial purposes [103]. The same applies to augmented reality (AR), which can fall victim to misuse and whose data can also be the source of abuse [104]. In order to respect the integrity of human beings and their ability to decide for themselves what is done with their own data, it is essential to lay down precise operating rules for the collection and use of such data [105]. As technology and SBE practices evolve, it is necessary to ensure that ethical principles are always followed, especially as AI may easily ignore related core principles without us realising it. There lay further important ethical questions.

  Conclusion

  Bioethics was mainly developed for healthcare research and has been extended to patient care. We think it is mandatory to spread its principles to SBE activities with respects to all stakeholders, including the learners, educators, simulated participants, and the patients themselves. Healthcare SBE retains its core ethical foundation of beneficence: “Never the first time on the patient”. However, in its many developments and modalities, simulation must respect bioethical principles. This ethical perspective enables SBE to be seen in a different light and to meet requirements other than those hitherto accepted.
  This allows us to explore the ethical dimensions of each stakeholder’s practices in SBE and to see how changes over time can alter ethical tensions, prompting us to exercise greater caution. It also enables the development in each centre, of an SBE network built in accordance with bioethical principles, with the ultimate goal of improving patient care. Research is needed to develop a differentiated perspective based on cultures and practices, in order to better understand the specific characteristics of each.

  Author contributions
  All authors contributed equally and validated the final version of record.
  Declarations
  Conflicts Of Interests
  The Author declares that there is no conflict of interest.
  Funding
  This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
  Registration
  No registration applicable.
  Data availability statement
  The data that support the findings of this study are available from the corresponding author upon reasonable request.
  Ethical approval
  Ethical approval for this study was not required.

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  Johny El-Achkar, Maya El-Gharib, Nesrine Ahmad, Samar Al-Hajj (Author)

  The Burden of Road Traffic Injuries: A Global Perspective

  Introduction
       Road Traffic Injury (RTI) pose a significant health challenge. It represents the eighth leading cause of death globally, prompting the UN to designate 2011-2020 as the “Decade of Action for Road Safety”. This study aims to determine the global and regional burden of RTIs, and the impact of drink-driving and seatbelt-wearing on RTIs in 2017, while also assessing the UN Action Plan outcomes and forecasting the RTI rate for 2029.

  Methods
       Data on the global and regional RTI rates (2000-2019), regional seatbelt use (2017), and regional drink-driving (2017) were compiled from the Global Health Observatory Estimates. The investigated key metrics are global and regional RTI rate per 100,000 population in 2000-2019, percentage of regional seatbelt-wearing, drink-driving RTIs, and enforced seatbelt and drink-driving laws in 2017.

  Results
       This study reveals a heterogenous regional distribution of road traffic injuries in 2017. Africa sustained the highest RTI rate (27.6/100,000 population), while Europe reported the lowest rate (10.98/100,000 population). Regional variation in seatbelt laws exists, with the highest legalization in Europe (100%), and the lowest in Western Pacific (80.95%). Eastern Mediterranean (87.43%) and South-East Asia (46.8%) reported the highest and lowest driver seatbelt-wearing rates, respectively. All countries, except the Maldives, legislated drink-driving laws. Western Pacific (29.98%) and Eastern Mediterranean (1.65%) suffer from the highest and lowest burden of drink-driving RTI, respectively.

  Conclusion
       Despite a relatively stable global RTI rate from 2011-2020 and a steady decline till 2029, the future trajectory
  remains uncertain in developing countries bearing the highest burden, due to slow national law enforcement,
  rendering the UN Action Plan insufficient in curbing the burden of RTIs.

  INTRODUCTION
       Road traffic injury (RTI) is a major global health challenge, impacting millions of individuals worldwide [1]. With approximately 20-50 million non-fatal injuries, 70 million disability-adjusted life years (DALYs), and 1.3 million deaths annually, RTI remains a neglected yet major health problem globally [1, 2]. According to the World Health Organization (WHO), RTI is ranked the 6th and 8th leading cause of DALYs and mortality globally, respectively [1, 3, 4]. The current steady RTI trends suggest that traffic fatalities are expected to become the 7th leading cause of death worldwide by 2030 [4].

       RTI imposes a real threat to the health and well-being of all populations across all age groups, with a particularly heightened burden on the youth population [5]. In fact, RTI constitutes the primary cause of death for people aged 5 to 29 years; the majority of victims were among the male populations compared to their female counterparts [1, 2, 6]. Existing literature identifies multiple factors that contribute to the increased rate in RTI mortality and morbidity among the youth and the males’ population, including the tendency to violate traffic laws such as traffic signals, and the lack of seatbelts/helmets use, in addition to the potential engagement in high-risk driving behavior, including car racing and drink-driving [7-10]. Females are relatively safer drivers at all times (day/night), and in all road conditions (i.e. weather, road layout, etc.), which decreases their risk of sustaining road fatalities, with nearly 3 times less likelihood of females being killed in road traffic crashes [1, 11, 12].

       Besides the health impact, RTIs inflict a serious economic and societal toll on individuals, families, and communities, incurring large direct and indirect costing reaching up to 3% of most countries’ gross domestic product (GDP) [1]. The human and economic loss associated with RTI is disproportionately more prominent in low- and middle-income countries (LMICs), where 93% of road traffic deaths (RTI) occur [1]. The latter is explained by several factors, including the high proportion of vulnerable road users, such as pedestrians and cyclists, the absence of road safety regulations, and the extensive illiteracy and defiance of laws in LMICs [8]. RTIs are expected to further rise in LMICs with the increasing motorization and urbanization [10].

       In addition to environmental factors, human behavior is responsible for the majority of road crashes [13, 14]. Human observation, interpretation, and planning errors further predispose individuals to traffic crashes and impact injury severity and outcome [14]. Various factors are associated with RTIs including speeding, fatigue, poor driving skills, alcohol and substance consumption, poor vehicle conditions, violation of traffic laws (i.e. improper seatbelt/helmet/child seat use, use of mobile phone while driving, disregarding traffic signs, etc.), unsafe road environments (i.e. bad weather, poor infrastructure, poor lighting, lack of pedestrian facilities, etc.), and inadequate post-crash care (i.e. first aid care, fast access to medical personnel, rehabilitation services, etc.), amongst others, contribute to increased traffic mortalities and morbidities [2, 13]. Enforcing the required measures of road safety and adopting safer road behavior substantially reduce road traffic crashes and subsequently prevents RTIs [1].

       Alcohol use, even in insignificant amounts, impairs the cognition, vision, and reaction time of all consumers [4, 10, 15]. Accordingly, blood alcohol concentration (BAC) above zero has been identified as a primary risk factor in the causation and severity of traffic crashes for all road users, including motorists and pedestrians [15]. Notably, drink-driving with a BAC greater than 0.04 g/dl results in severe behavior impairments associated with reckless driving, speeding, unfastening seatbelt/helmet, and disobeying traffic laws, and in turn dire traffic crashes and injuries [1, 15]. Alarmingly, approximately 20% of traffic fatalities in high-income countries and 33-69% of traffic deaths in LMICs are attributed to alcohol consumption, predominantly affecting young and novice drivers [10, 16]. Several countries including Canada, Australia, and Italy have adopted strategies to reduce RTI injuries and deaths among this high-risk group including the decrease of the BAC limit to ≤0.02 g/dl for young and/or novice drivers. This policy lead to a substantial reduction in traffic crashes by up to 24% [2, 4]. Other RTI reduction successful measures were implemented by over one hundred countries to reduce drink-driving include public awareness, random breath testing, and police sobriety checkpoints [4, 17]. Yet, given that LMICs are currently exposed to the growing use of alcohol, hardly any developing countries have enforced measures to control drink-driving [18]. Assessing the contribution of drink-driving on RTIs is crucial to develop prevention strategies, though data on drink-driving remains limited in the majority of LMICs and some high-income countries (HIC) [2, 4].

       While functional seatbelt laws and increasing compliance are enacted in more countries compared to drink-driving laws, many LMICs lack mandatory safety requirements with limited law enforcement and compliance [2, 4, 19, 20]. The WHO, the FIA Foundation, and partners, have highlighted the urgent need to increase seatbelt and child restraint use, particularly in LMICs experiencing rapid motorization. Seat-belts can reduce vehicle occupant deaths by up to 50%, while child restraints can prevent up to 71% of fatalities among infants. Despite high compliance in regions such as Europe, usage remains low in other regions. Updated WHO guidelines, as noted by Dr. Khayesi, emphasize comprehensive programs combining legislation, enforcement, and public education to promote seatbelt use and convince governments and citizens of such need [23, 24].

       Since the vast majority of RTIs are both predictable and preventable, global efforts have been concerted for decades to address the burden of traffic fatalities and injuries [2, 4]. Almost 123 countries, representing around six billion people, amended laws on at least one of the five key risk factors of road injuries, such as speeding, seatbelt and helmet use, child restraint use, and drink-driving [2]. HICs succeeded in reducing the toll of RTIs by relying on data-driven evidence and resources to inform strategic safety rules and regulations [2]. With the lack of adequate data on any traffic crash-related risk factor, such as alcohol consumption and seatbelt use, LMICs continued to mismanage RTIs and traffic deaths [2, 4]. Accordingly, the United Nations (UN) General Assembly launched the Decade of Action for Road Safety 2011–2020, with a target to save 5 million lives by the year 2020 [25]. This approach focused on five main pillars: road safety management, safer roads, safer vehicles, safer road user behavior, and post-crash care [25]. Evaluating the success of this plan is key to developing successful future strategies regarding traffic injuries and deaths worldwide.

       This study aims to describe the current burden of road injuries worldwide, for the period from 2000 to 2019, to highlight the impact of two major risk factors including alcohol consumption and seatbelt usage in 2017, and to forecast the future trends in road traffic deaths. It further assesses whether the period ranging between the years 2011 and 2020 was indeed the “Decade of Action for Road Safety” as proclaimed by the UN General Assembly. Findings from this study help to suggest reliable measurements that can be implemented globally and nationally to reduce and mitigate injuries and deaths on the roads.

  METHODS
  Data Sources
       Data were retrieved from the Global Health Observatory Estimates generated by the WHO for Information, Evidence, and Research. Data on six regions (Americas, Africa, Europe, Eastern Mediterranean, South-East Asia, and Western Pacific) were extracted and analyzed [26]. Data posted by WHO on seatbelt wearing rate and attribution of RTIs to alcohol were only available for the year 2017. Road traffic mortality rates and the estimated number of deaths worldwide are reported for the time falling between the years 2000 and 2019.

  Data Processing
       The collected data were processed using Power BI (Microsoft, Redmond, USA). Power BI is an interactive data visualization software product developed by Microsoft and focuses on business intelligence [27]. To build the dashboard, the following datasets were uploaded and used: estimated number of RTIs per gender, estimated RTI rate per gender (per 100,000 population), seatbelt use rate (%), the impact of RTIs on alcohol (%), and drink-driving existing national law (Binary yes/no), road safety strategy (Binary yes/no), and seatbelt law (Binary yes/no). All data attributes had a categorical parent location (i.e., region), location (i.e., country), and numerical period (i.e., year).
       Before data visualization using Power BI, data were compiled, uploaded, and preprocessed. A unique identifier (composite key) was created for the first four tables on the dashboard. The key encompasses the location and period (e.g. Afghanistan2000). The created identifiers were used to link the tables, and ultimately create the dynamic dashboard. For data visualization, parent location, location, and period, were then referred to as region, country, and year, respectively.
       The key metrics that were investigated in this study are as follows: RTIs rate (per 100 000 population) during the period 2000-2019, average regional RTI rate (per 100 000 population) and percentage in 2000-2019, percentage of driver seatbelt wearing rate (%) in 2017 per region, percentage of drink-driving RTIs (%) in 2017 per region, and the percentage of legalization of seatbelt use and drink-driving laws per region.
       As for the projection, it was generated using a linear regression model based on historical data of road traffic fatalities. The model assumes a consistent trend over time and extrapolates future values accordingly. This approach was chosen to provide a basic forecast of the potential trajectory if current patterns persist, recognizing that more complex models were beyond the scope of this study.

  RESULTS
       Of the six regions examined, Africa sustained the highest burden of RTIs with 27.6 RTIs per 100,000 population between 2000 and 2019, followed by the Eastern Mediterranean region (EMR) with 21.05 RTIs per 100,000 population. South-East Asia (16.95 RTI per 100,000) and the Americas (16.5 RTI per 100,000) suffered from a comparable rate of road traffic injuries, while Western Pacific and Europe sustained only 13.51 RTI per 100,000 and 10.98 RTI per 100,000 of RTIs during the same period, respectively (Table 1).
       Inversely, Europe reports 82.1% driver’s seatbelt compliance in 2017 (62.72% of European countries reporting this rate). With 53.33% of American countries reporting this measure, the driver’s seatbelt-use rate was 67.23% in 2017. Although the seatbelt-use rate of drivers in the EMR was high in 2017 (87.43%), only 4 out of 19 EMR countries (21.05%) disclose relevant statistics. Africa has the lowest reporting rate (18.18% of African countries reporting) and average driver seatbelt-use rate (47.78%) compared to other regions. With relatively moderate reporting, South-East Asia, and the Western Pacific regions (30 and 38.1% countries reporting, respectively) disclose a 46.8% and 77.66% seatbelt compliance rate in 2017, respectively (Table 2).

       Assessing the contribution of alcohol consumption to RTIs in 2017 across different regions revealed that Western Pacific (29.98% attribution with around 71.42% countries in the Western Pacific reporting their numbers) suffers from a relatively large burden of drink-driving RTIs compared to other regions, particularly EMR (1.65% attribution with 42.1% countries in EMR reporting their numbers). With an average reporting of 43.33% of the countries in the Americas, alcohol consumption was linked to 16.91% of their RTIs in 2017. Africa (14.35% attribution with only 25% of countries in Africa reporting their numbers), followed by South-East Asia (13.2% attribution with 30% of countries in South-East Asia reporting their numbers) and Europe (12.97% attribution with 76.47% countries in Europe reporting their numbers), suffered from relatively moderate drink-driving RTIs in 2017 (Table 2).

       In 2017, all European, African, American, EMR, South-East Asian, and Western-Pacific countries have existing national drink-driving laws, except the Maldives in South-East Asia (Figure 1).

       A clear discrepancy exists between regions when assessing the presence of national seatbelt laws across all countries in 2017. All European countries have established seatbelt safety laws. Americas (93.33%), followed by South-East Asia (90%), EMR (89.47%), and Africa (88.64%), further established seatbelt safety policies. Yet, only 80.95% of the Western Pacific region countries successfully adopted such laws to increase seatbelt wearing in 2017 (Figure 2).

       Although the overall RTI burden declined from 19.2 RTIs per 100,000 population in the year 2000 to 17.1 RTIs per 100,000 population in the year 2019, this rate insignificantly fluctuated (≈ 17.1 RTIs per 100,000 population) during the period between 2011 and 2020. Forecasting the overall global burden of RTIs from the year 2020 till the year 2029 revealed that the RTI rate is expected to steadily decrease (Figure 3).

  DISCUSSION
       This study explored the global distribution of RTIs across different regions. It further examined the impact of various risk factors on RTIs including driver seatbelt use and drink-driving. Evidence from this study will be key to assessing the degree of success of the “UN Decade of Action for Road Safety Plan” from 2011 to 2020, and further facilitates the prediction of the upcoming pattern of global rates of traffic injuries and fatalities.

       Consistent with previous studies, a substantial discrepancy in the burden of RTI existed between different regions [22, 28, 29]. Despite the global increase in traffic jams and the use of motor vehicles, Africa sustains a three-time higher risk of RTIs compared to Europe. This can be attributed to the strong link between traffic injuries and fatalities, and the country’s income level [28], as well as the diverse terrain in Africa which was associated with increased risk of RTIs [30-32].
       Interestingly, RTI depicted an increasing trajectory with increasing GDP in LMICs, and decreasing patterns with an increased GDP in HICs [28]. One study suggests that besides the growing mobilization in developing countries, the common hazardous driving, unsafe roads, and the high proportion of vulnerable road users, collectively increase the prevalence of local RTIs [8, 28]. Developed countries can mitigate this burden with the establishment of safer roads, efficient road safety policies, and enhanced emergency transport and medical treatment [28]. Accordingly, the classification of the majority of the African and EMR countries as low and lower-middle-income countries explains the high RTI rate, compared to upper-middle and high-income countries in Europe, the Americas, Western Pacific, and South-East Asia [33].
       The varying RTI toll across regions is found to be further associated with informing and enforcing regional and national road safety policies. While a portion of the burden lies on the government’s inefficient and limited resources to invest in road safety, human behavior predominantly contributes to RTIs [34]. Among the leading risk factors of RTIs are drink-driving and failing to use seatbelts among vehicle occupants and child restraint systems [35]. Findings from this study reveal that although all countries, except the Maldives, had established drink-driving laws in 2017, alcohol consumption still majorly contributes to RTIs globally. Aligned with existing studies, the Eastern Mediterranean Region sustains the lowest burden of drink-driving injuries and mortalities [36, 37]. In addition to the national laws, the strict cultural and Muslim religious practices in most EMR countries prohibit drinking and restrict alcohol consumption [36].

       On the contrary, drink-driving remains an increasingly major concern in other regions, particularly the Western Pacific, followed by the Americas and Africa. The elevated alcohol-attributable burden of RTI in the Western Pacific region is associated with the uppermost alcohol consumption rates in many countries like Tongo, Cooks Island, Australia, Papua New Guinea, and New Zealand [36, 37]. An existing study suggests that more than half of the RTIs in Papua New Guinea and Tongo, and one-third of the RTIs in Australia and New Zealand in 2017 are attributed to alcohol consumption above the legal limit [36]. A similar trend is seen in the Americas and Africa where alcohol use massively increased during the past decade, thus chiefly contributing to the toll of RTIs in countries like Canada, the USA, and South Africa [35, 36].

       According to the WHO, 45 countries including Brazil, Canada, New Zealand, and Australia, in addition to the majority of European countries like France, established drink-driving laws meeting the best practices (BAC ≤ 0.05 g/dl and BAC for young/novice drivers ≤ 0.02 g/dl) [2]. By monitoring the patterns of traffic injuries and fatalities via injury registries, such countries were capable of further legislating and amending country-specific policies [38]. Not only did Brazil restrict the BAC limit (0 g/l), it further mandated random breath testing, doubled the fines for drink-driving, and enhanced police power, to reduce the burden of RTIs [2, 39]. In France, driving under the influence of alcohol remains the second leading cause of traffic fatalities [40]. One French-based study showed that 90.7% of alcohol-positive subjects had an alarmingly high BAC (>0.08 g/dl) while driving [41]. Accordingly, without effective law enforcement and safer road user behavior, notably through compulsory random breath testing, efforts to address drink-driving remain inefficient [22, 28, 38].

       Evidence from this study reveals that legislation and implementation of seatbelt use are critical to reducing the global burden of RTIs. A previous study assessing the impact of human behavior on seatbelt use found that seatbelt non-use is positively associated with severe traffic injuries and deaths [42]. Improper driver seatbelt use has been found to increase traffic fatalities by 45-50% [2]. The relatively low toll of RTIs in Europe can be associated with the full establishment of mandatory seatbelt-use laws, and with the high driver’s seatbelt-use rate. The latter reflects mature road user behavior, where the level of literacy and awareness, among other factors such as the law penalty and residing in urban areas, were found to be positively associated with seatbelt use [34, 43]. The interventions to increase the use of seatbelts in HICs, including enhanced police training and enforcement, public awareness, and health education, further improved seatbelt-use compliance [44]. Europe further adopted mandatory installation of seatbelt reminder systems, as studies showed that this method is highly effective in enforcing seatbelt use [45].

       Collectively, with the recent increasing motorization, high illiteracy, inadequate seatbelt-use laws, and the absence of intervention strategies in many LMICs, the toll of RTIs in developing regions, like Africa and South-East Asia, continues to rise [44, 46]. The assessment of intervention strategies in LMICs must account for country-specific factors, such as barriers, cost, and sustainability, making HICs’ intervention strategies untransferable [34]. In this regard, culture and religion are two significant factors to investigate. Existing studies report that the strong belief in fate and destiny in Africa, South-East Asia, and EMR has been linked to riskier driving and seatbelt non-use [47-52]. Other studies found that religiosity is positively associated with better self-protection practices such as seatbelt use and no alcohol consumption [53, 54]. Implementing national research-based customized awareness campaigns and policies must address such research gaps. However, the presence of limited data in LMICs represents another major barrier to the understanding and assessment of RTIs [2].

       Although our analysis covers data only up to 2019, the Global Status Report on Road Safety 2023 confirms that recent global trends continue to show growing disparities [55]. While the global target of halving road traffic deaths between 2011 and 2020 was not achieved worldwide, 10 countries, including Belarus, Brunei Darussalam, Denmark, Japan, Lithuania, Norway, the Russian Federation, Trinidad and Tobago, the United Arab Emirates and Venezuela, did achieve reductions of at least 50% in fatalities. A further 15 countries saw decreases of 40–49%, 20 countries had decreases of 30–39%, and 33 countries reduced deaths by 20–29%. The European Region experienced the largest overall decline, with a 36% decrease in road traffic deaths, and the Western Pacific Region reported a 16% reduction. These successes coincide with countries that have broadly implemented “safe system” approaches, combining comprehensive legislation, enforcement and infrastructure improvements. When adjusted for population growth, the global fatality rate also declined from nearly 18 per 100 000 people in 2010, to about 15 per 100 000 in 2021, a 16% reduction.

       By contrast, many LMICs, especially those in the African Region, have not seen comparable progress. During the same period, 66 countries reported increases in road traffic deaths, including 28 in Africa, where fatalities rose by 17% overall. The African Region continues to have the highest death rates globally, and more than 90% of all road traffic fatalities still occur in LMICs, with pedestrians, cyclists and motorcyclists making up more than half of the victims. These figures highlight a persistent imbalance: the policies and investments that have successfully reduced deaths in high-income settings have not been implemented, or have been far less effective, in resource-constrained contexts. Without targeted support, stronger enforcement, and scaled-up investment in road safety for LMICs, particularly in Africa, the global goal of halving road traffic deaths and injuries by 2030 is unlikely to be equitably achieved. According to the WHO, global progress was slow to allow the anticipated reduction in RTIs as on-ground implementation was limited, especially in LMICs. This heterogeneity can be attributed to the funding gap, poor civic engagement, and governmental support in many LMICs [56, 57]. Besides setting an action plan, political commitment and public support are key to the successful enforcement of good practices and intervention strategies [57]. The lack of global and national data regarding RTI and its relative risk factors, like seatbelt use and drink-driving, especially in LMICs, further misled the progress of the “UN Decade of Action for Road Safety (2011–2020)” [2].

       Investing in health policy research is important to reduce the burden of road traffic injuries. Relevant and representative data should be collected especially from countries where RTIs continue to increase, like Paraguay, Chad, and Pakistan [22]. The European Transport Safety Council has adopted evidence-based research to improve transport safety in Europe [22]. In the USA, the Insurance Institute for Highway Safety conducted extensive science-based multidisciplinary research to employ low-cost road safety programs to enhance traffic safety [22]. Building on these examples, increasing the routine use of proven child safety measures, such as booster seats, bicycle helmets, and graduated driver licensing, can save governments and payers substantial medical and productivity costs. However, these interventions remain underutilized due to barriers such as split savings across payers, long payback periods, and political or practical challenges [58].

       Based on the marginal global improvement of traffic safety during the past decade and the continuous international and national efforts to reduce RTIs, this study forecasted a steady decrease in the global rate of RTIs in the upcoming years until 2029. A comparable pattern was obtained in a previous study, where the rate of RTIs was estimated between the years 2017 and 2030. Specifically, the rate of RTI was forecasted to decline by 12%, from 16.3 RTIs per 100,000 population in 2017 to 14.3 per 100,000 population in 2030 [59]. An existing study further predicted a steady decrease in the global rate of pedestrian road-traffic injuries between 2020 and 2030, indirectly imposing a similar reduction pattern of RTIs [60]. Regardless, this estimation might not apply if drastic measures and technologies were implemented during this period, or if global and national efforts were halted.

       This study has some limitations and strengths. A key limitation is that data in many countries are underreported. The missing data from all regions, particularly from LMICs in Africa and EMR, further limited this study. This might underestimate the burden of traffic injuries in many countries, thus altering the design of efficient intervention strategies to reduce RTIs. Another limitation of this study is that it disregards the political and socio-economic discrepancies between countries in the same region. Thus, even if the regional RTI rate declined, some countries might report an increasing burden due to country-specific factors. Also, the collective association and effect of other risk factors have not been studied. This study did not assess the cost-effectiveness of the proposed interventions, which limits the ability to determine their practicality across different economic settings. The use of a linear regression model assumes a consistent trend, which may not capture sudden policy changes, technological advancements, or other external shocks that could influence road safety outcomes.

       On the other hand, this study's strengths reside in using advanced data visualization software to process, manage, analyze, and visualize the data. Power BI helped create data models and relationships between the imported datasets. Moreover, its predictive analytics feature provided estimates of RTIs in the coming years, thus encouraging proactive measures to be taken to help curb the RTI phenomenon. This study further provides a global as well as a regional view of the RTI phenomenon in terms of seatbelt-use wearing rate and alcohol consumption rate, two of the major risk factors of RTIs.

       This study’s overview of the current global and regional distribution of RTIs shows an alarming heterogonous burden. Findings from this study urge policymakers and stakeholders to adopt and enforce safer and more efficient road policies and intervention strategies, and citizens to practice safer and more responsible road traffic behavior.

  Recommendations
       Based on these findings, actionable strategies should be prioritized, especially in LMICs. First, establishing a standardized and sustainable national road injury surveillance system is crucial to overcome data gaps and accurately guide interventions. Second, governments should consider implementing low-cost, research-informed campaigns tailored to local culture and beliefs to address key risk factors. For example, partnerships with community leaders may help reinforce positive behaviors. In addition, we recommend investing in capacity-building for local law enforcement and emergency services to reduce the burden of RTIs globally.

  CONCLUSION
       The future of road safety is expected to show a steady decrease in RTI rates globally, but this trajectory will remain heterogeneous across regions and countries. With the lack of strong enforcement of evidence-based intervention strategies, the burden of road traffic injuries and fatalities will remain high in developing countries. Minor changes in road safety behavior, such as seatbelt use, will significantly accelerate the reduction of the RTI rate, particularly in LMICs. The high rates of drink-driving and low rates of seatbelt use globally should be addressed via collective global, governmental, and societal efforts.

       The socioeconomic discrepancies should be considered during legislation to secure large-scale adoption of safety measures and enforcement of road safety laws at a national level. The alarmingly high missing data reported in this study call for reliable national data registries to ensure the success of the current “UN Decade of Action for Road Safety (2020-2030)” via country-specific intervention strategies.

  Author contributions
  All authors contributed equally and validated the final version of record.
  Declarations
  Conflicts Of Interests
  The Authors declare that there is no conflict of interest.
  Funding
  This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
  Registration
  No registration applicable.
  Data availability statement
  The data that support the findings of this study are available from the corresponding author upon reasonable request.
  Ethical approval
  Ethical approval for this study was not required.

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