Policy and practice
Nazanin Soleimani1,2, Fatemeh Bahmani3, Alireza Parsapour4, Bagher Larijani4,5 and Ehsan Shamsi-Gooshki4,6
1Health Policy and Management Research Center, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Islamic Republic of Iran. 2Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Islamic Republic of Iran. 3Department of Medical Ethics, School of Medicine; Iran University of Medical Sciences, Tehran, Islamic Republic of Iran. 4Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran. 5Institute of Endocrinology and Metabolism, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran. 6Monash Bioethics Center, Monash University, Melbourne, Australia (Correspondence to Ehsan Shamsi-Gooshki: ehsanshamsi713@ gmail.com;
Abstract
Background: Ethical considerations are important in pandemic preparedness and response, however, there is a noticeable scarcity of ethical codes that are tailored to disease outbreaks and health emergencies.
Aim: To document the development of guidelines for ethical management of infectious disease outbreaks in Islamic Republic of Iran, as a model for low- and middle-income countries.
Methods: We conducted a non-systematic scoping review on PubMed and Google Scholar for drafting the guidelines for ethical management of infectious disease outbreaks in Islamic Republic of Iran. The draft was discussed and revised following consultations with different groups of experts and the Medical Ethics Council of the Iranian Academy of Medical Sciences.
Results: The joint assembly of the National Clinical Ethics Committee and the Supreme Council of Medical Ethics endorsed and introduced the revised document as official guidelines for ethical response to infectious disease outbreaks in Islamic Republic of Iran. The guidelines were based on a set of core values and principles: human dignity, liberty, maximizing benefits and minimizing risks, and justice and transparency. In 3 distinct sections, the document provides ethical guidance for healthcare system management and leadership; provision of health services; and for education, research and use of technology during health emergencies.
Conclusion: The guidelines have been very useful in responding ethically to the COVID-19 pandemic, there may be a need to adapt some of the recommendations for optimum benefits in specific contexts. It is necessary to create awareness of the existence of the document and educate healthcare professionals about its importance so they can apply the recommendations in their practice.
Keywords: COVID-19, pandemic, ethics guidelines, public health, infectious disease, outbreak, ethical code, Iran
Citation: Soleimani N, Bahmani F, Parsapour A, Larijani B, Shamsi-Gooshki E. Developing guidelines for ethical response to infectious disease outbreaks in Islamic Republic of Iran. East Mediterr Health J. 2024;30(6):440–447. https://doi.org/10.26719/2024.30.6.440.
Received: 28/07/23; Accepted: 31/10/23
Copyright: © Authors 2024; Licensee: World Health Organization. EMHJ is an open access journal. All papers published in EMHJ are available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo).
Background
Although ethical considerations are as important to pandemic planning and response as the logistic and scientific aspects (1), they are often undervalued (2). There is a noticeable scarcity of ethical codes tailored to disasters (3). The COVID-19 pandemic prompted ethical inquiries in all areas of healthcare, including research, clinical practice, public health and medical education. The WHO guidance for managing ethical issues in infectious disease outbreaks (IDOs) addresses these aspects of healthcare while encouraging countries to adhere to its principles and formulate contextually relevant ethics strategies (2).
Recognising the need for comprehensive guidance on the ethical challenges encountered during the COVID-19 pandemic in the Islamic Republic of Iran and for a national ethical guidance tailored to its healthcare system and cultural norms, the Supreme Council of Medical Ethics* initiated a project to develop ethical guidelines for managing and controlling IDOs in the country.
This paper documents the principles adopted for responding ethically to IDOs by the Islamic Republic of Iran based on the cultural and social contexts, and highlights the distinctive characteristics of the guidelines. It may serve as a model for other low- and middle-income countries.
Methodology
We conducted a non-systematic, limited literature review and used the information to develop draft guidelines for ethical response to infectious disease outbreaks or pandemics in the Islamic Republic of Iran. The draft was reviewed by different expert panels, revised and submitted to the joint assembly of the National Clinical Ethics Committee and the Supreme Council of Medical Ethics for endorsement and approval (Table 1).
Results
The guidelines present the ethical requirements for IDOs under 4 themes (Table 2).
I: Core values and principles
Human dignity
Human dignity serves as the foundation for human rights; healthcare systems are established on this fundamental value, mandating that governments ensure that their citizens receive appropriate healthcare.
Liberty
Liberty and the right to decide can only be restricted when it is necessary to protect people's freedom and uphold societal order under the law. This right ensures that medical interventions respect people’s autonomy and informed choice in healthcare. During IDOs, liberty must be balanced with the principle of public health preservation. The values of privacy and confidentiality are derived from this core value.
Maximizing benefits and minimizing risks
Policymakers should make the well-being of patients and recipients of health services their top priority. Health authorities should formulate pandemic interventions with the primary objective of safeguarding the health and lives of individuals.
Justice
Resource scarcity is an inherent challenge during IDOs; therefore, policymakers must ensure fair allocation of extremely scarce resources, prioritise vulnerable groups’ health, and avoid discrimination and stigmatisation.
Transparency
Transparency preserves social capital and strengthens public trust in medical professionals and health systems.
II: Ethics guidelines for healthcare system management and leadership
Increasing capacity for ethical decision-making in public health
Continuous, current and robust intersectoral collaboration is needed to effectively manage IDOs. This
includes promptly educating managers, officials and key
stakeholders on the technical, medical, managerial and social dimensions of such outbreaks.
Policymakers should fully commit to international obligations and consider regional, national and local aspects of managing ethical issues. They must observe the social and cultural norms of Iranian society and local communities in law-making.
Managers and health system policymakers must prepare well-defined laws and regulations for addressing public health emergencies, including IDOs. The planning and policymaking process should include broad societal engagement, for example, with non-government organizations and influential community figures, clergy and teachers. Recognizing the cultural, social and economic diversity among different groups within the country is crucial. Actions, policies and programmes should be evidence-based, relying on the highest quality and most reliable scientific evidence.
Communicating with the public and media
To preserve their trust, the public should receive clear information about the fallibility of evidence and the possibility of guidelines adjustments as new evidence emerges. The Ministry of Health, Treatment and Medical Education (MOHME) should offer transparent and truthful information to the public and local media.
Sharing information about IDOs through unofficial media outlets can undermine public trust. Therefore, MOHME should establish effective communication with the national and local media, monitor social media, engage with and provide training to media personnel, and prioritize the dissemination of information related to epidemic mitigation. Stakeholders should refrain from making unsupported comments about the outbreak, as taking a one-sided position may limit the knowledge about other aspects and technical details.
The confidentiality and privacy of individuals must be safeguarded when sharing news about epidemics and broadcasting from medical centres. Broadcasting images of patients should be strictly prohibited unless when necessary and informed consent has been obtained from the patients.
Resource allocation
Decisions to restrict health care services for specific populations should be evidence-based, drawing upon expert opinions and meticulously assessing the potential advantages and drawbacks of these limitations.
Prioritising health care services, such as allocation of intensive care unit beds and scarce medications, should be based on scientific evidence, intervention effectiveness, treatment needs and technical necessities. It should not be influenced by factors like ethnicity, race, religion or socioeconomic status. MOHME should swiftly create a comprehensive guide for prioritising health services in cases of resource scarcity during IDOs.
When resource constraints require prioritisation, the primary criterion should be the greater likelihood of saving lives among individuals with similar conditions. While age may indirectly influence prioritisation, health authorities should avoid setting age-based cut-offs for health care services. It is vital to ensure that no patient is overlooked, and palliative care should be extended to those unable to receive health care due to resource limitations.
In an IDO, equitable access to health care services should be ensured for all individuals within the Islamic Republic of Iran’s borders, including immigrants and refugees, regardless of their legal status. The allocation and use of medications, laboratory tests and medical equipment, even those donated by other countries or international organisations, should be efficiently managed nationwide, guided by transparent and fair criteria.
Pandemic mitigation
The ethical acceptability of implementing restrictions like quarantine, travel surveillance and contact reduction measures relies on scientific evidence. The reasoning behind these restrictions must be transparent and continually assessed. Applying these measures should minimize individual burdens and respect human dignity. However, such measures can alter human relationships and affect lifestyles, potentially increasing domestic violence and harming mental health. Policies are needed to mitigate the resulting damages, respond promptly to severe cases, raise public awareness and provide counselling and support services for victims of violence.
During IDOs, a balance must be created between the potential risks of religious and cultural gatherings for public health and individuals’ psychological, social and spiritual well-being.
Innovative and technological methods, such as mobile phones or financial transaction locations, must be integrated for digital contact tracing and case investigation. However, the data collected through such methods should be used exclusively for outbreak control purposes. The use and duration of these technologies must be subject to approval, with legal authorities overseeing any extensions beyond the initially specified timeframe.
Frontline healthcare workers rights and responsibilities
A safe and secure work environment for frontline hetlahcare workers (HCWs) is paramount. While some level of risk is inherent in clinical and paraclinical fields, healthcare authorities must employ all possible measures to safeguard the health of medical staff. Facilities and support must be offered to HCWs who are required to stay or self-isolate in hospitals due to medical conditions.
In a protracted IDO, meticulous and equitable planning is needed to guarantee adequate supply of human resources for delivering services to patients and providing support to vulnerable populations among HCWs.
Safe access to top-level facilities for frontline HCWs and their infected first-degree family members is paramount. These individuals must have priority access to health services when resources are scarce. Stakeholders at every level must strictly adhere to decisions made by authorities to uphold the system’s resilience.
Providing service to other patients
Fear of infection may make some individuals to delay seeking health care, putting their well-being at risk. Medical institutions must ensure a safe environment for all patients and educate the public on safe health care processes. They should establish admission criteria and proactively engage and guide previously registered patients in need of care, including those who have undergone chemotherapy.
A platform for doctors and patients should be created to effectively sustain their therapeutic connection remotely. Healthcare institutions, such as MOHME and the Medical Council of Iran (IRIMC), and insurance organisations should facilitate the delivery of remote primary care and promptly establish required regulations.
An immediate mechanism for disciplinary action against unscientific health practice
During an IDO lacking a known cure or vaccine, non-experts or inadequately qualified individuals may endorse potentially harmful and unscientific treatments. The Islamic Republic of Iran’s judicial system and IRIMC should swiftly create and enforce mechanisms to handle such instances to protect patients’ rights and uphold public trust.
Strengthening health system infrastructure
The healthcare system must enhance its infrastructure to effectively manage crises due to IDOs. This includes developing robust guidelines for accountability, integrated management, notification systems and training for crisis commanders.
III: Ethics guidelines for providing health care services
Compliance with general considerations of medical ethics and patients’ rights
In the intense context of IDOs, ethical standards must be upheld. Health care delivery should adhere to professional rules and responsibilities, with a focus on prioritising patients’ well-being, respecting autonomy and privacy, ensuring confidentiality and obtaining informed consent. When confronted with novel ethical dilemmas, suitable resolutions should be sought through established decision-making processes.
Health professionals’ duty of care
Healthcare professionals must follow the rules and regulations established by official authorities during an outbreak. When summoned for duty, they should promptly report to their assigned department. Strictly following official directives on attendance at private clinics, offices and medical institutions is mandatory. IRIMC must establish a mechanism to ensure that its members comply with the health system’s instructions.
However, healthcare professionals must balance their duty of care with their right to access personal protective equipment. Authorities should provide such equipment in sufficient quantities to healthcare professionals.
Mandatory reporting of patients
Medical professionals must strictly adhere to confidentiality rules following existing laws. However, in certain circumstances, legal authorities may mandate the reporting of information related to IDOs. This requirement must be communicated clearly to both patients and the public.
IV: Ethics guidelines for education, research and technology use
Governance of research projects
During emerging IDOs, research rush can disrupt patient care when clinical professionals serve as researchers and practitioners. To manage this effectively, outbreak-related research must follow established procedures, including scientific and ethical reviews by research ethics committees. Research institutions must streamline this process. All randomized clinical trials should be registered in MOHME’s randomized clinical trial registry before commencement. Research must not interfere with patient health care delivery.
To address the unknown nature of IDOs, like COVID-19, the government should allocate adequate financial resources to beneficial research. All research, especially clinical trials sponsored by pharmaceutical or medical equipment companies, must be supervised by the Iran Food and Drug Organization (IFDA).
IFDA should implement efficient processes to expedite project approvals and establish mechanisms for emergency authorisation of unapproved medical products, such as vaccines and diagnostics, to address life-threatening outbreaks. A monitoring system should be established for authorized items with regard to issuing emergency authorisations.
University research councils and research ethics committees must decline funding for unscientific and technically unsound procedures and prevent their implementation on patients.
Ethical review of research protocols
Medical research conducted during outbreaks must strictly adhere to the established standards, rules and regulations of research ethics. The research ethics committees responsible for approving studies have the additional responsibility of monitoring researchers’ proper conduct. Research authorities must prioritise protection of the rights of research participants, including their right to informed consent, particularly during outbreaks.
Unapproved drugs
In the absence of standardised treatment for an emerging infectious disease, all medical interventions, except for palliative care, are regarded as potential research. Ethical handling of clinical data is pivotal for building robust scientific evidence to save lives and restore community health.
Managers should establish infrastructure for systematic data collection and oversight by relevant authorities. Health authorities are encouraged to implement the ethics framework detailed in WHO guidelines for the clinical use of unapproved drugs or monitored emergency use of unregistered and investigational interventions during public health emergencies (2).
Publishing and communicating research results to the public
To alleviate anxiety due to IDOs and effectively manage public expectations, announcements regarding scientific achievements in the development of new medicines or vaccines should only be made with official authorisation from the authorities at IFDA.
The principal researcher should promptly share any positive and scientifically valid research findings with the scientific community and relevant authorities for further evaluation and potential use without a delay for formal publication in scientific journals.
During IDOs, publication of research results should adhere to information privacy rules and be conducted with a high level of vigilance to avoid stigmatising those populations with higher disease prevalence.
Key research stakeholders, including national research authorities, should prevent research misconduct and the publication of invalid or suspect data.
Participation in international research
A transparent policy is essential for international research collaboration and the distribution of investigational products from multicentre research. Fair distribution must follow the research protocol under IFDA supervision.
To safeguard sovereignty and national interests in international research collaborations during outbreaks, exporting biological samples requires approval from the National Research Ethics Committee. Research publication should not be avoided, even if the results indicate treatment ineffectiveness or reveal significant side effects. The MOHME national research authority must monitor all registered clinical trials until they receive their final reports.
Clinical education during IDOs
Education authorities must address ethical concerns related to education during IDOs. While clinical training of students should not be completely suspended during pandemics, educational administrators must ensure safe participation of learners in clinical care.
Role-modelling the principles of professionalism
Healthcare professionals see serving during IDOs and taking personal risks as a professional duty. Despite infection risks, providing care in resource-limited settings benefits medical trainees’ learning and instils professional values. A clinical faculty’s leadership and support serve as a positive role model, promoting moral growth.
Physicians from diverse residency specialties can effectively manage the medical needs of infectious disease patients, therefore, care for infected patients in IDOs should not be left only to infectious disease specialists and general physicians.
Engaging a broad range of specialties in patient care can alleviate the workload of specialty residents.
Assessment of medical students
During IDOs, clinical training may be interrupted due to factors such as elective service suspensions, departmental shifts towards infectious disease patients and reduced patient visits for non-infectious health concerns. Educational administrators must ensure that learners are competent before graduation.
In cases where postponing graduation is not feasible due to urgent physician workforce requirements, educational administrators should seek approval from the vice-chancellor of education at MOHME. Competency deficiencies in graduated doctors should be promptly addressed, and only with MOHME approval can medical universities independently graduate such students.
With regard to remote learning during IDOs, educational leaders must adapt their teaching and assessment methods to reduce the risk of student cheating or academic dishonesty.
Discussion
The principles and values in our guideline show a high degree of commonality with other relevant documents (Table 3). Table 4
Our guidelines, developed in response to WHO’s call, is not exclusive to COVID-19 but addresses ethical issues applicable to IDOs in general (2). The primary distinction between this guideline and other existing documents is the comprehensive coverage of ethical issues relating to education during IDOs. This includes attention to clinical training for learners, applying medical professionalism principles in training medical students, emphasizing learners’ participation in health care delivery during outbreaks, ensuring equitable distribution of burden and risk among various healthcare workers and students, conducting post-pandemic evaluations of learners’ education by educational administrators, and adapting teaching and evaluation methods to address ethical concerns related to online learning.
Our document emphasizes that both the public and private sectors – including dental clinics – are accountable for delivering appropriate and timely public health services.
Study limitations
The literature review for this project was non-systematic and limited due to time constraints. We recommend that authorities in low- and middle-income countries conducting similar national guidance perform a systematic review for a more robust conceptual framework.
Another limitation was the low level of public participation during its development. The resulting document could not undergo public consultation due to time constraints, given the rapidly evolving nature of the COVID-19 pandemic. However, we made efforts to involve community representatives at various stages, for example, the head of the Iranian non-government organization, Patients’ Rights Watch, held a representative role for the patients in the National Clinical Ethics Committee and the Supreme Council of Medical Ethics during the guidelines development process.
It is worth noting that the Medical Ethics Council of the Iranian Academy of Medical Sciences is not classified as a government executive body; instead, it operates as a high-level consultative advisory body, comprising experts from diverse social science and humanities disciplines.
The guide has yet to incorporate post-pandemic experiences, as it was developed during the COVID-19 pandemic, leaving essential lessons, especially for the post-COVID-19 era, still to be covered.
Conclusion
These guidelines provided a timely response to the urgent needs of the Iranian healthcare system for an ethical response to the COVID-19 pandemic.
We suggest additional efforts to develop focused and detailed ethics guidelines, particularly for controversial issues in this general guidelines. Professional organizations like IRIMC and its scientific associations should align their codes of ethics with this guide to enhance applicability. Teaching the guidelines to health professionals through various educational courses is recommended, and adherence to can be assessed through further research.
Élaboration de lignes directrices pour assurer une riposte éthique aux flambées épidémiques de maladies infectieuses en République islamique d’Iran
Résumé
Contexte : Les considérations éthiques sont primordiales dans la préparation et la riposte aux pandémies. Cependant, on constate un manque notable de codes éthiques adaptés aux flambées de maladies et aux urgences sanitaires.
Objectif : Documenter l'élaboration de lignes directrices pour la gestion éthique des flambées de maladies infectieuses en République islamique d'Iran, qui serviront de modèle pour les pays à revenu faible et intermédiaire.
Méthodes : Nous avons réalisé une revue exploratoire non systématique sur PubMed et Google Scholar en vue de rédiger ces lignes directrices. Le projet a été examiné et révisé à l'issue de consultations avec différents groupes d'experts et avec le Conseil d'éthique médicale de l'Académie iranienne des sciences médicales.
Résultats : L'assemblée conjointe du Comité national d'éthique clinique et du Conseil suprême d'éthique médicale a approuvé et adopté le document révisé en tant que lignes directrices officielles régissant la riposte éthique aux flambées épidémiques de maladies infectieuses en République islamique d'Iran. Ces lignes directrices étaient basées sur un ensemble de valeurs et de principes fondamentaux : la dignité humaine, la liberté, la maximisation des avantages et la minimisation des risques, ainsi que la justice et la transparence. Le document fournit, dans trois sections distinctes, des recommandations en matière d'éthique concernant la gestion et la supervision des systèmes de santé, la prestation de services de santé, ainsi que pour l'éducation, la recherche et l'utilisation de la technologie pendant les situations d'urgence sanitaire.
Conclusion : Les lignes directrices ont été très utiles pour répondre de manière éthique à la pandémie de COVID-19, mais il est nécessaire d'adapter certaines des recommandations pour en tirer le meilleur parti dans des contextes spécifiques. Sensibiliser les professionnels de santé à l'existence et à l'importance de ce document est essentiel pour permettre son application dans la pratique.
وضع مبادئ توجيهية بشأن الاستجابة الأخلاقية لفاشيات الأمراض المُعدِية في جمهورية إيران الإسلامية
نازانين سليماني، فاطمة بهماني، علي رضا بارسابور، باقر لاريجاني، إحسان شمسي-جوشكي
الخلاصة
الخلفية: الاعتبارات الأخلاقية مهمة في التأهب للجوائح والتصدي لها، ومع ذلك، ثمة ندرة ملحوظة في المدونات الأخلاقية المصممة كي تلائم فاشيات الأمراض وحالات الطوارئ الصحية.
الأهداف: هدفت هذه الدراسة إلى توثيق عملية وضع مبادئ توجيهية بشأن الإدارة الأخلاقية لفاشيات الأمراض المعدية في جمهورية إيران الإسلامية، بوصفها نموذجًا للبلدان ذات الدخل المنخفض والمتوسط.
طرق البحث: أجرينا استعراضًا استكشافيًّا غير منهجي على قاعدة بيانات PubMed ومحرك البحث Google Scholar لصياغة مسودة "المبادئ التوجيهية للإدارة الأخلاقية لفاشيات الأمراض المعدية في جمهورية إيران الإسلامية". ونُوقشت المسودة ونُقحت عقب مُشاوَرات مع مجموعات مختلفة من الخبراء ومجلس الأخلاقيات الطبية التابع للأكاديمية الإيرانية للعلوم الطبية.
النتائج: اعتمدت الجمعية المشتركة للجنة الوطنية المعنية بالأخلاقيات السريرية والمجلس الأعلى للأخلاقيات الطبية الوثيقة المنقحة، وطرحتها بوصفها مبادئ توجيهية رسمية بشأن الاستجابة الأخلاقية لفاشيات الأمراض المعدية في جمهورية إيران الإسلامية. واستندت المبادئ التوجيهية إلى 4 قيم ومبادئ أساسية، وهي: الكرامة الإنسانية، والحرية، وتحقيق أقصى الفوائد وتقليل المخاطر إلى أدنى حد، والعدالة والشفافية. وتقدم الوثيقة إرشادات أخلاقية بشأن إدارة نظم الرعاية الصحية وقيادتها، وتقديم الخدمات الصحية، والتعليم والبحوث واستخدام التكنولوجيا في حالات الطوارئ الصحية.
الاستنتاجات: كانت المبادئ التوجيهية مفيدة للغاية في تحقيق استجابة أخلاقية لجائحة كوفيد-19، وقد تستدعي الحاجة تكييف بعض التوصيات لتحقيق الفوائد المثلى في سياقات محدَّدة. ومن الضروري التوعية بوجود الوثيقة وتثقيف المهنيين الصحيِّين بشأن أهميتها حتى يتمكنوا من تطبيق التوصيات في مجال ممارستهم.
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