Off-label prescription: developing a guideline and validating an instrument to measure physicians' and clinical pharmacists' knowledge and attitudes toward off-label medication use.

Purpose: Off-label medications have been challenging in healthcare systems, and their significance is emphasized throughout pandemics. The study was designed to develop an ethics guideline for prescribing off-label medications and also aimed to develop a valid instrument for evaluating physicians' and clinical pharmacists' knowledge and attitudes regarding off-label medication use. Methods: In 2021, the two-phase study was done. A gap analysis study and a review of relevant guidelines and peer-reviewed papers were conducted in the first phase. There were three hybrid expert panel discussions with nine specialists until a consensus was reached. In the second phase, a questionnaire was developed to assess physicians' and pharmacists' knowledge and attitudes toward off-label prescribing medications. An expert panel of nine ethicists, physicians, and pharmacists determined the face and content validity. To evaluate the reliability and construct validity of the instrument, 201 physicians and clinical pharmacists participated. Results: This guideline provides 24 recommendations classified into seven themes to assist clinicians, pharmacists, and policymakers in managing off-label medication use. The preliminary questionnaire contained 72 items. Items were removed if their I-CVI and CVR were less than 0.79 and 0.78, respectively. The S-CVI/Average ratio was 0.937. The Cronbach α was 0.848. Ten factors were identified through exploratory factor analysis. These ten factors comprised 64.652% of the variance. There was no significant difference between general physicians, specialist physicians, and clinical pharmacists in one-way ANOVA [F = 0.584, P = 0.559]. Conclusion: We developed an ethical guideline for off-label medication use that can integrate ethical principles into related practice. Moreover, our valid and reliable questionnaire can evaluate the ethical adherence of physicians and pharmacists to scientific and ethical challenges of off-label medications in the country, especially during pandemics. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-023-01288-0.

The ethical challenges of palliative care from the perspectives of pediatricians: A qualitative study in Iran.

Background: Adherence to ethical principles is a requirement for palliative care delivery to children and a main concern of healthcare providers. Physicians usually face ethical challenges during their daily practice in hospitals and need adequate skills and the ability to identify and manage them. This study sought to explore the ethical challenges of palliative care from the perspectives of pediatricians. Methods: This qualitative study was conducted between April and July 2019 using the content analysis approach. Participants were fifteen pediatric medical residents, specialists, and subspecialists purposively recruited from pediatric hospitals in Tehran, Iran. Data were collected using in-depth semi-structured interviews and were analyzed using Graneheim and Lundman's approach to conventional content analysis. Trustworthiness was ensured through the four criteria proposed by Guba and Lincoln. Results: Participants' experiences of the ethical challenges of palliative care for children were grouped into two main categories, namely "bewilderment in dealing with children and their families" (with two subcategories) and "conflicts in decision making" (with three subcategories). The final five subcategories were: (a) inability to effectively communicate with children and their families, (b) inability to tell the truth about the disease, (c) physician-parent conflicts, (d) parent-child conflicts, and (e) physician-physician conflicts. Conclusion: The main ethical challenges of palliative care from the perspectives of Iranian pediatricians are the inability to effectively communicate with children and their families, the inability to tell them the truth, and the inability to manage physician-parent, parent-child, and physician-physician conflicts. Identification and management of these challenges may help improve the quality of pediatric palliative care in Iran. Further studies are needed to confirm these findings in other settings.

Exploring the challenges and ethical requirements of medical sciences education during COVID-19: a qualitative study.

The controversial role of ethics in clinical education and its ability to draw the attention of a large audience is inevitable. The issues and challenges of the COVID-19 pandemic have transformed the clinical education environment. This study was conducted to explore the challenges and ethical requirements of medical sciences education during the COVID-19 pandemic in 2020. The study was qualitative research and the instrument was a semi-structured interview. The participants included faculty members of the basic and clinical Sciences at Iran University of Medical Sciences. After 16 rounds of interviews, theoretical saturation was achieved. Qualitative data were analysed using conventional content analysis, which resulted in 81 preliminary codes and 28 sub-categories. Finally, two themes of "ethical challenges" and "ethical requirements", and 10 categories were achieved. The categories were consisted of "being patient-centred", "social accountability of curriculums", "ethical challenges of the clinical environment", "the poor performance of the clinical faculty members and students", "being justice-centred", "raising awareness", "observing clinical research ethics", "preservation and promotion of mental health", "patient confidentiality", and "respect for individuals". We hope the ethical challenges in medical education that were created due to the emergence of Covid-19 can be reduced and eliminated by defining a framework for ethical requirements.

The second strategic plan of medical ethics: a national report.

Medical ethics faces several challenges in different aspects of education, research, and treatment in medicine and healthcare practice. Design and implementation of a national strategic plan can pave the way for the development of a roadmap in various countries to strengthen ethics and address these challenges. To create a comprehensive plan compatible with the Iranian healthcare system, a multidisciplinary team of main stakeholders compiled a national strategic plan of medical ethics following several focus group discussion sessions and two workshops (2014-2017). Ultimately, the plan was confirmed by the Supreme Council for the Medical Ethics of the Ministry of Health and Medical Education. The current paper is a national report of the process and the medical ethics strategic plan in Iran. We have also tracked signs of progress and achievements in the country. In conclusion, this valuable effort has led to significant success in the implementation of medical ethics in clinical medicine, medical research, and education by using all the resources in our country. The participation of all the stakeholders, especially healthcare professionals in this way is required.

General approaches to ethical reasoning in Islamic biomedical ethics discourse.

Islamic and non-religious ethics discourses have similarities and differences at the levels of meta-, normative, and applied ethics (e.g. biomedical ethics). Mainstream biomedical ethics (MBME) uses the language of contemporary, non-religious, Western ethics. Significant effort has been dedicated to comparing Islamic biomedical ethics (IBME) and MBME in terms of meta- and normative ethical positions, and final decisions on practical ethical issues have been reached. However, less attention has been given to comparing the general approaches of the two aforementioned discourses to ethical reasoning. Furthermore, IBME uses different languages to approach ethical reasoning, but identification and conceptualization of these approaches are among the important gaps in the literature. The aim of this study was to conceptualize general approaches to ethical reasoning in IBME. Through review and content analysis of the existing literature and the comparison between the languages employed by IBME and MBME, an inductive distinction have been made. The languages used in conceptualized approaches include the followings: (i) a language in common with the one employed by MBME; (ii) MBME language adjusted to the basic, common beliefs of Muslims; (iii) a language based on fatwas; and (iv) a language based on IBME principles. In the authors' opinion, major challenges of the above-mentioned four approaches include, respectively: identifying the lack of religious sensitivity or Islamic considerations regarding an issue; acknowledging specific beliefs as the basic, common beliefs of Muslims; diverse fatwas and relations between juridical soundness and ethical soundness; and agreement on the same principles and rules as well as who should apply them.

Consanguineous marriages in the genetic counseling centers of Isfahan and the ethical issues of clinical consultations.

Consanguineous marriage, which is common in many regions in the world, has absorbed much attention as a causative factor in raising the incidence of genetic diseases. The adverse effects may be attributed to the expression of the genes received from common ancestors and mortality and morbidity of the offspring. Iran has a high rate of consanguineous marriages. In recent years genetic counseling has come to be considered in health care services. This cross-sectional study was conducted in order to determine the prevalence and types of consanguineous marriages in the genetic clinics in Isfahan. We aimed to define the different types of marriages, specific categories of genetic disorders associated with consanguineous marriages, and mode of inheritance in the family tree. We also narratively reviewed the ethical aspects of the issue. The data were collected using a simple questionnaire. A total number of 1535 couples from urban and rural areas formed the study population. The marriages were classified according to the degree of the relationship between couples, including: double cousin, first cousin, first cousin once removed, second cousin and beyond second cousin. The SPSS software version 16 was used for data analysis. Data obtained through genetic counseling offered during a 5-year period revealed that 74.3% had consanguineous relationships, 62.3% were first cousins, 1% were double cousins and 7.8% were second cousins. In addition, 76% of the couples had at least one genetic disease in their family tree. Related ethical issues were also considered in this study, including autonomy and informed decision making, benefit and harm assessment, confidentiality, ethics in research, justice in access to counseling services, financial problems ethics, and the intellectual property of scientific success.

End-of-life care ethical decision-making: Shiite scholars' views.

Recent advances in life-sustaining treatments and technologies, have given rise to newly-emerged, critical and sometimes, controversial questions regarding different aspects of end-of-life decision-making and care. Since religious values are among the most influential factors in these decisions, the present study aimed to examine the Islamic scholars' views on end-of-life care. A structured interview based on six main questions on ethical decision-making in end-of-life care was conducted with eight Shiite experts in Islamic studies, and was analyzed through deductive content analysis. Analysis revealed certain points in Islamic views on the definition of death and the persons making decisions about end-of-life care. According to the participants, in addition to conventional criteria ('urf) such as absence of heartbeat and respiration, the irreversible cessation of human voluntary acts (as a sign that the soul has control over the body and the faculty of thinking) are considered to be the criteria in establishing death. The participants also recognized physicians as the main authorities in verifying signs of death. Furthermore, it was emphasized that life preservation and continuation of care must be sensible, and the patient can request not to have death-prolonging procedures started or continued. In the view of participants, patient's autonomy cannot be the sole basis for all measures, but Islamic ethical and jurisprudential principles should be relied upon to make correct and sensible decisions whether to continue or stop terminal patients' care. Final decisions should be made by a team of experts, and physicians must be at the center of such a team. Finally, we suggest that a guideline in keeping with Islamic norms on human life and death, purpose of life, God's will, boundaries of man's authority, and the physician's ethical duties and obligations should be developed.

Patient centred care in diabetology: an Islamic perspective from Iran.

Patient-centred system of care is essential in managing many disorders such as diabetes mellitus. The cultural and religious context can influence the involvement of patients and their families in such a care. We intend to discuss patient-centred care in diabetology in view of Islam. For more clarification, we will take into consideration a few illustrative lines of argument in detail about situation in Iran. In conclusion, dynamic spirit of Islamic jurisprudence is reflected in its adaptability to change in medical practice. In recent decades, Iranian religious scholars have provided scientists in new fields of science and research with appropriate directions and guidelines. Decree issued by Iranian religious leaders permitting research on stem cells for therapeutic purposes in many disorders including diabetes mellitus is one example. Understanding of the nature of Islam is importance for communication with patients in Islamic countries.

Ethical issues in the end of life care for cancer patients in iran.

BACKGROUND: In the recent years, advances in medical technologies for end stage cancer patients' care have affected the end-of-life decision-making in clinical practice and exposed oncologists to serious ethical dilemmas. But little is known about oncologists' viewpoints in our country regarding their ethical problems in this mention. We aimed to clarify the ethical dilemmas which Iranian oncologists may face in our health care setting and to determine factors influencing decision-making process. METHODS: In this qualitative study, a phenomenological approach was used. We interviewed 8 cancer specialists in teaching hospitals in Iran and used content analysis to identify codes and categorize themes in the data. RESULTS: DURING THE PROCESS OF ANALYSIS, THREE MAIN THEMES EMERGED ABOUT ETHICAL DILEMMAS IN END OF LIFE CARE FOR ADVANCED CANCER PATIENTS: illness factors, socio-cultural context and patient-physician relationship. Cancer specialists identified ethical problems on several main issues, the most important of which were telling the truth in Iranian cultural context, uncertainty in end stage definition, multidisciplinary team working and cost consideration in Iranian health care system. CONCLUSION: Health care and insurance system in Iran face to end of life care challenges; therefore, health care providers and policy makers need to allocate appropriate resources and programs to improve quality of care in terminal stages. Appropriate physicians' communication skills training, multidisciplinary team working and supplementary insurance services that provide essential health care can improve the quality of care of patients with end stages of cancer. The findings of this study can help us to provide ethical policies for decision-making in end-of-life care.

The challenge of truth telling across cultures: a case study.

Accompanied with various opinions across cultures, truth telling is a major debate in bioethics. Many studies have focused on attitudes toward truth disclosure. We intend to review several relevant research studies, and discuss the issue through a clinical case consultation. It seems that while "the right to know" is emphasized in bioethics, in some cultural contexts, health professionals fear communicating bad news. The patients may not receive information directly, because it is believed that the truth may make the patient feel hopeless and unable to cope with the problem. Nevertheless, some believe that sharing information may strengthen a trusting relationship between patients and medical professionals. Extensive efforts are in process in some societies to make patient rights to know the truth as a natural part of medical practice. However, in some cases, the principles of respect for patient autonomy require us to accept patient's refusal to know the truth, with the provision that he assigns someone to receive information and make medical decisions on his behalf. In conclusion, it is suggested that healthcare professionals should not act on a unique presumption in all cases and they should explore what the real interest of patient is, in order to respect individual autonomy.

Common principles and multiculturalism.

Judgment on rightness and wrongness of beliefs and behaviors is a main issue in bioethics. Over centuries, big philosophers and ethicists have been discussing the suitable tools to determine which act is morally sound and which one is not. Emerging the contemporary bioethics in the West has resulted in a misconception that absolute westernized principles would be appropriate tools for ethical decision making in different cultures. We will discuss this issue by introducing a clinical case. Considering various cultural beliefs around the world, though it is not logical to consider all of them ethically acceptable, we can gather on some general fundamental principles instead of going to the extremes of relativism and absolutism. Islamic teachings, according to the presented evidence in this paper, fall in with this idea.

Contemporary medical ethics: an overview from Iran.

The growing potential of biomedical technologies has increasingly been associated with discussions surrounding the ethical aspects of the new technologies in different societies. Advances in genetics, stem cell research and organ transplantation are some of the medical issues that have raised important ethical and social issues. Special attention has been paid towards moral ethics in Islam and medical and religious professions in Iran have voiced the requirement for an emphasis on ethics. In the last decade, great strides have been made in biomedical ethics, especially in the field of education, research and legislation. In this article, contemporary medical ethics in Iran, and the related moral philosophy, have been reviewed in brief and we have discussed some of the activities in the field of medical ethics that have been carried out in our country within recent years. These activities have included the establishment of the National and Regional Committees for Medical Research Ethics and the production of national codes of ethics in biomedical research in the 1990 s and the introduction of a comprehensive strategic plan for medical ethics at the national level in 2002. This paper will discuss these issues, along with the production, in 2005, of the Specific National Ethical Guidelines for Biomedical Research.

National bioethical legislation and guidelines for biomedical research in the Islamic Republic of Iran.

Rapid advances in biomedical science and technology, which have revolutionized medicine and health-care services in different societies, have been associated with inevitable ethical challenges. Undoubtedly, these innovations could lead to irreversible disasters if they are not limited by appropriate regulations. Substantial attempts have been made in the Islamic Republic of Iran to establish a structured approach for identifying, analysing and resolving ethical issues in clinical practice. Given the consensus of religious and scientific scholars, some laws recently approved by the parliament include the Deceased and Brain-Dead Patients Organ Transplantation Act (2000), Embryo Donation to Infertile Spouses Act (2003) and the Therapeutic Abortion Act (2005). National guidelines for ethical assessment and supervision of research proposals have also been compiled by the authorities. This paper reviews the main endeavours made in bioethics legislation in the Islamic Republic of Iran.

Strengthening medical ethics by strategic planning in the Islamic Republic of Iran.

To bring attention to medical ethics and to enhance the quality of health care in Iran, the Ministry of Health and Medical Education has introduced a strategic plan for medical ethics at a national level. This plan was developed through the organization and running of workshops in which experts addressed important areas related to medical ethics. They analysed strengths and weaknesses, opportunities and threats, and outlined a vision, a mission and specific goals and essential activities surrounding medical ethics. The current strategic plan has six main goals that will be reviewed in this paper. Some major activities that were carried out in recent years, and some future plans, will be also reviewed.

Household cardiovascular screening of high-risk families: a school-based study.

BACKGROUND: A parental history of cardiovascular disease has a strong relationship with risk factor clusters in the offspring. This study was performed to identify major cardiovascular risk factors in middle school-aged children and their parents in both high and low-risk families. DESIGN: A school-based, cross-sectional study. METHODS: The middle schools of the 6th district of Tehran were divided randomly into two groups. A total of 169 high-risk children with their families were recruited from the first group and 105 low-risk children with their families were recruited from the second group of schools. Anthropometric and metabolic measurements were performed. RESULTS: The means of the waist circumference and waist-to-hip ratio were significantly higher in high-risk fathers. The means of total and low-density lipoprotein (LDL) cholesterol were significantly higher in both parents and children of the high-risk group. The means of the fasting plasma glucose were significantly higher in fathers and offspring of high-risk families. More fathers in high-risk families were smokers. The prevalence of increased total cholesterol, LDL-cholesterol and hyperglycemia (> or = 100 mg/dl) were higher in high-risk parents and children. The prevalence of increased body mass index (> or = 25 kg/m for parents and 85th percentile for children) was higher in fathers and children of high-risk families. CONCLUSIONS: Cardiovascular risk factors are more prevalent and clustered in high-risk families. The screening of high-risk families is essential to prevent the progression of atherosclerosis from childhood and reduce the burden of cardiovascular disease in adulthood.