Iranian Journal of Medical Ethics and History of Medicine

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Philosophers of ethics and those who are involved in the debates concerning Medical Ethics have discussed the issue of human dignity and its cluster of meaning from different angles and have suggested many interesting points in this respect. However, a cursory glance at the published works in this field reveals that most of those writers who have contributed to this issue have either based their arguments on notions such as rights or justice, or have used theological doctrines, or have conducted their debates within the frameworks of pragmatic or particularistic ethics. In the present paper, I shall approach the issue from a new viewpoint which is mostly inspired and informed by the ideas of some analytic philosophers. The main argument of the paper revolves around the pivotal notion of “value of life”. All those who take positions vis-à-vis stem-cell researches and the morality or otherwise of using embryos for such investigations, or those who form opinions concerning the ethicality or otherwise of abortion, or those who try to find satisfactory solutions for the vexing issue of the allocation of limited medical resources, maintain, at least in an intuitive way, that the life of a human organism, in whatever shape or form, has intrinsic value. The life of such an organism whether it is a newly conceived egg or an embryo ready to be implanted in the womb or a foetus whose neurological system has just emerged, or a morally fallen adult, is intrinsically valuable. The idea that some things or events are valuable in themselves, namely, we respect them not because they serve our interests but because they are intrinsically valuable, is a familiar intuition. We have developed this ‘intuition’ through our long existential experiences. Now if we reflect upon this very intuition we will be able to discover further layers of meaning in it. For example, we realize that from the belief that ‘human’s life is intrinsically valuable’ one cannot conclude that one should multiply human life as much as possible. On the contrary, some of our other intuitions would inform us that at least some parts of the world would be better off if less populated than crowded. Thus the question arises that if the intrinsic value of human life does not mean its multiplication, then how the continuation of human life, once it has appeared, can have intrinsic value? In the present paper I shall try to use the apparatus of analytic philosophy to explore the ways of reconciliation between the two seemingly contradictory notions of ‘the intrinsic value of life’ and ‘the morality of sacrificing life under particular circumstances’.

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Although there is no more propensity for measuring patient's satisfaction as an important qualitative scale of health services, the thing which is slightly seems to be forgotten is the attention towards the concept and expansion of theory framework. The purpose of this study is to remark the meaning of satisfaction and to offer a qualitative definition for that. This research is a qualitative study and content analysis. During the study period  fifteen patients who were hospitalized in Semnan hospitals (2009) were selected. The data were gathered by half-structured interview and analyzed. The results of this study shows four two major themes and four subthemes including feeling of satisfaction and the reception of nurses by patients. Accordingly, satisfaction is a calm sense that the patient feels it after the emotional and logical reception of nurses. The feeling will be sensed by intelligent and sometimes emotional feeling of patient towards the nurse in his/her care unit environment. The results of this study indicate the real and basic meaning of patient's satisfaction from nurses' views. This meaning is even beyond the imagination of experts and managers. These results can be put into work for designing suitable tools to measure the scale of patients' satisfaction of nurses based on their real perception.

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By the ever-increasing discovery of pharmaceutical and chemical substances, their  adverse effects  will be considered too. To evaluate adverse effects, animals are used, and factors like standardization of species and breed, storage condition and biochemical system will be effective for animal selection. In Islamic education, animal issues are important. The principles of keeping animals, using them and prohibition of animal abuse are mentioned in this article. The information were gathered from electronic and non-electronic resources including articles and books. Based on this, the following issues need specific attention:

• 1- Infrastructure of rights: In Hajj and Nahl chapters of Quran (verses 18 and 49) it is mentioned that animals will bow down to God. This is the basis of animal rights.
• 2- Animal rights for keeping them: For this case Sheikh Tousi and martyr Saani mentioned that it is necessary for the owners to feed and water the animals enough.
• 3- The exploitation rights: In the Holy Quran, it is said that the power and the hygiene of the animals must be considered and it is major to exploitation.
• 4- Rights of animal's damages: It is advised to keep and defend the animal species and human beings are forbidden to harm and kill animals. Therefore, from Islam point of view, although animals lack the speech power, they must be treated emotionally and their owners have some responsibilities, too.

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The aim of this study was to explore experiences of family members of patients confronting brain death diagnosis and the request for organ donation.
A qualitative study was designed focusing on content analysis. Data collection process included 38 unstructured in- depth interviews with relatives of 26 brain death patients who were candidate for organ donation and field notes. Sampling method began as purposive and continued as theoretical until saturation.
Five main themes were extracted from the current dataset that indicated family experiences and perceptions of brain death concept while being informed. The themes were included internal conflict, internal barriers against external realities, imminent sense of loss and grief, surrender and acceptance.
The results showed that facing the diagnosis of brain death for relatives and family members is a condition surrounded by many challenges, ambiguities and conflicts that is become more complicated when emotional responses related to grieving and defensive psychological reactions emerge. So it is recommended before any organ request, at first medical team provide conditions for brain death acceptance. Respecting family members experiences and their perceptions about the situation will resolve their internal ambiguities and conflicts. At this situation requesting organ donation seems to be rational.

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In medical etiquette and ethics, benefit and harm assessment includes risk evaluation, rational risk, distinction between medical and non medical utilitarian considerations, individual and community benefit ratio, and issues of the like. This article explores philosophical foundations of this issue. In philosophy, benefit/harm reduces to pleasure/pain and good/bad. Pleasure (spiritual and non-spiritual) is considered a subjective criterion for benefit, whereas applied ethics needs an objective criterion. To achieve such a criterion, we need a specific model for casuistry evaluation and a holistic and organic approach. This article advocates the public sphere model and presumes it is the missing link of ethical confusions and the solution to ethics lack of quantifiability. Public sphere sits between public authority and private sphere, and supervises them impartially. Benefit/harm evaluation components in medical research requires such sphere for clarity and distinction.

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Although we have diverse methods in laboratory studies, such as cellular and molecular sciences, understanding many issues related to human health requires research on animals. An ethical duty of every researcher is to respect animal rights. In our country, educational and research activities are carried out frequently on animals. Therefore, guidelines for ethical use of animals in Iran were developed in 2004 after a review of international resources and considering the needs of researchers working with animals. This guideline was written in four sections, including animal transportation, facilities, animal care personnel, and research users. However, some studies show that researchers need comprehensive and easy to use instructions on the ethical use of laboratory animals. On the other hand, inadequate knowledge about ethics principles in research on laboratory animals have revealed the need to update guideline to be more practical, applicable, and in line with researchers' requirements. In this study, the above mentioned guideline was revised and completed in five parts, including transportation, facilities, animal care personnel, research users, and the use of animals in experimental procedures. In the first section, points on transport of animals and facilities, including location, cage, ventilation, humidity, light, temperature, noise, water and food are presented. The new revision, contains additional paragraphs, and some previous paragraphs are split. Another part of the findings is presented in terms of fundamental duties and ethical performance of persons who work in laboratory animals' houses and researchers working with animals. The final section of the findings is related to the use of animals in laboratory processes which are not presented in the previous formulation of the guideline, and includes basic ethical issues in regard to categorizing, anesthesia, surgery, and euthanasia. Therefore, the guideline was revised to be much more practical, more applicable, and should lead to some form of researchers' training in this field.

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The Declaration of Helsinki, the most creditable ethical guideline for medical research on human subjects, has been updated 8 times since its establishment and the last revision was in 2008. Researchers, medical research subjects, authors, members of ethics committees, and editors of medical journals must be informed of the tenets of the Helsinki declaration in order to improve achievements of medical research and respect the rights of participants in medical research. In this study, the evolution of the Helsinki declaration is examined, and the provisions of the last version are compared with the previous version (2004). Finally, we made a practical interpretation of the last version, and discussed its differences from previous version. There are seven new paragraphs in the last version of the declaration. Four new paragraphs concern informed consent in areas of its being written and voluntary, renewed consent for using human materials, participants' right to revoke the consent, and exceptions from informed consent requirements. The other three new paragraphs focus on the research subjects' right to being informed of the declarations' provisions, vulnerable groups gaining benefit from research, and registration of randomized clinical trials. It is important for researchers to recognize international guidelines such as the Declaration of Helsinki, because it enables them to use correct scientific and ethical standards in medical research. In the last version of the Helsinki Declaration more emphasis was placed on informed consent and vulnerable groups than previous versions.

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Healthy volunteers are the first group who take part in experimental studies on the efficacy of new drugs. Parallel with expanding the boundaries of medical science, medical research has shown rapid growth which has caused new and critical ethical challenges in medical research.A clinical trial is one of the essential methods in clinical research and a very challenging method from the ethical viewpoint.Recruiting healthy volunteer participants is necessary in clinical trials of drugs, and it requires special and careful ethical considerations. Although recruiting healthy volunteers is not limited to clinical trials, we have focused our discussion on ethical issues of research on healthy volunteers in this kind of study. In this paper, ethical challenges of involving healthy volunteers in clinical trials have been discussed in four domains of risk-benefit assessment, fair subject recruitment, incentives, and informed consent. The authors believe and argue that using the daily life risks standard as the acceptable risk for healthy volunteers is impractical. We suggest defining a reasonable risk that is acceptable to the research ethics committee. The ethical committee, as a jury, can then evaluate the public acceptance of the risks.

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In many countries around the world, we find important evidence about violation of ethics in medical research. In the United States, the history of unethical or even inhuman experiments on human subjects dates back to the time of slavery, and unfortunately, most subjects of these experiments were poor or black people, slaves, prisoners and physical/mentally ill patients. For instance, we refer to the Tuskegee study that was done on black people. Other examples are tormenting experiments on American or Nazi prisoners. In this paper, we will review some infamous unethical experiments and researches in terms of neglecting human dignity and the validity of the research. On the other hand, in response to these dreadful events, some ethical codes and guidelines have been established which we shall review. For instance, the Belmont Report and the Nuremberg Code which were developed in response to the Tuskegee study and Nazi experiments on human subjects, respectively. The medical history of our country, Iran, is free of such troubling acts however, this does not mean that ethical standards in medical research are fully observed. Therefore, in addition to items that have been enacted so far, to prevent such faults, it is necessary to enact professional codes and guidelines or legislated laws and regulations too.

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Research ethics, as one of the main issues of modern bioethics, has attracted the interest of scientists and ethicists in various areas of science and technology around the world. Research Ethics Committees (RECs) have been established to improve putting ethics into practice in the field of research. RECs, fortunately, have received a great deal of attention in different countries, and their mission, goals, and tasks have been described in many national and international guidelines. Ethical guidelines for biomedical research and RECs administrative regulations have been developed in Iran too. The need for special training courses for capacitating members has been emphasized in both international guides and our national administrative regulations for RECs. In this brief article, we present suggestions concerning course presentation and contents, which are provided by international assemblies. In view of the fact that many RECs in our country do not have specific plans for their members' primary training and continuing education, there seems to be a need for fundamental changes in the educational prerequisites for membership in this important organization.

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Pediatric research is a complicated and sensitive field of research that involves specific legal, ethical, and even philosophical aspects therefore the guideline of pediatric research is considered one of the important ethical guidelines in research. Although this ethical guideline has been used for some years, a need for its revision is always felt with the passing of time. Accordingly this study was carried out through library search, aiming to present a critical ethical review of the national guidelines for pediatric research. One important ethical issue is obtaining informed consent from children of various age groups, and the performance of the ethical committee in case of conflict between the child and his parent(s) or guardian. Recent studies show that getting informed consent needs to be revised and a new guideline must be developed for each age group. Another important issue is the unlawfulness of monetary incentives in pediatric research, which is nowadays being questioned. Among the topics discussed in ethical codes is the beneficence and non maleficence of the research for children, while the ruling philosophy in pediatric research has posed great challenges in the process. This has caused some research to lack quality and researchers are reluctant to do pediatric research. In terms of information dissemination and confidentiality, there seems to be a lot of debate regarding the child's age, and therefore these issues should be taken into account for revision. Hence we propose that in order to improve the quality of research, the present ethical guideline be revised and based on past experiences, legal and ethics professionals as well as philosophers and lecturers be involved in the process.

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Considering the importance of medicine and the ever-increasing developments in medical research, the implementation of such research according to the ethical principles and criteria of creditable national and international declarations is of great significance. According to these declarations, the researcher has the highest responsibility to observe the rights and safety of participants. The present study intends to survey the rate of observance of research ethics in proposals approved at Urmia University of Medical Sciences between the years 2003 and 2008. Three hundred and twenty four research proposals that had been approved between 2003 and 2008 were evaluated retrospectively. Related checklists (self- constructed ones and World Health Organization checklists) were completed for each project, a statistical analysis of the results was done by SPSS software, and descriptive statistics were subsequently extracted.  A summary of the most important results is as follows: In 85.5% of the proposals, the ethical considerations part was completed. In 68.4% of the cases the participants were aware of participating in the study and in 67.9% of the cases the informed consent of participants was obtained, 50.9% of which was in written form. Among clinical trials, in 80% of the proposals informed consent was obtained, 85% of which was written. Out of 60 clinical trials, 37 projects (62%) were confirmed by the ethics committee. Considering the results obtained in this study, principles of research ethics were applied more closely in this study compared to similar studies in Iran. It seems this is due to the establishment and launch of regional ethics committees in 2003 and afterwards. However, in order to bring these measures closer to current standards, holding educational workshops for honorable members of scientific boards and students is recommended. Moreover, more accurate supervision of ethics committees, especially in clinical trials and animal experimentations, seems to be beneficial.

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Breaking bad news to patients and their families is an important issue in health care services. Since access to information is among the basic rights of the patient, investigating the experiences of patients and their families after receiving bad news can make the process more purposeful and prevent unnecessary suffering. This study aimed to describe the experiences of patients and their families after hearing bad news from health providers.The present study was conducted with a qualitative, phenomenological approach. Participants were selected through purposive sampling from people who had the experience of receiving bad news during 2013 in Birjand, Iran. The sampling process continued up to the point of data saturation, which reduced the number of participants to 10. Note-taking was used to complete the data collection process. In this study Colaizzi's method was used for data analysis, while robustness of the study was assessed based on the criteria of precision.The subjects were between 25 and 70 years of age. First, according to Colaizzi's Method, 280 codes were obtained which were the same as the developed concepts. At this point, the code lists were extracted. Different thematic categories with similar meanings were placed in 5 thematically larger groups as follows: 1) tension at the beginning of the encounter, 2) adaptive responses, 3) spiritual relief, 4) family crises, and 5) seeking support.Patients and their families showed different reactions upon receiving bad news. The study showed that health providers can contribute to a better adjustment of patients and families and promote peace by acquiring a methodical approach while delivering bad news. This can be achieved by identifying the reactions, confusions and tensions, as well as introducing adaptive or supportive resources to patients and their families.

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Medication errors are among the most common medical errors that place patients at risk, and their prevalence is considered a measure of patient safety in hospitals. Using the experiences and opinions of experts is an important source of information for developing strategies to prevent medication errors. The aim of this study was to define strategies for the prevention of medication errors in hospitals of Hamedan University of Medical Sciences.This qualitative study was conducted on 10 nurses with experience of working in various hospital wards, selected through purposive sampling using the maximum variation technique. Semi-structured interviews were used to collect record and transcribe the data, which were then typed and stored on the computer. The collected data were analyzed using content analysis. After combining similar cases, we were able to develop 11 main categories, 43 sub-categories, and 3 themes: human factors, administrative principles and organizational structures. Our findings present the experiences of nurses regarding strategies related to the prevention of medication errors. Proper planning, coordination of human resources within wards, development of a comprehensive system to monitor prescription charts, suitable hospital equipment and favorable environmental conditions are some factors that can prevent the dangerous and perhaps irreversible consequences of medication errors.

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The Declaration of Helsinki is one of the most important international documents in medical research ethics on human subjects which has been revised 7 times and the last revision was in 2013. Researchers must be informed of the principle of Helsinki declaration and the latest changes in order to respect the rights of participants in medical research. In this study, the last version of the declaration are compared with the previous version (2008). The evaluation of the changes and challenges of the final revision can be helpful in modification of the ethical codes of our country. The 2013 version included a number of important changes; it has been categorized into more clear and detailed sections. So this version has a better structure and more practical as well. The 2013 version places more emphasis on vulnerable groups and includes a separate section on the compensation and treatment of injuries due to research. The revised version of the Declaration of Helsinki also emphasizes obtaining of the informed consent (even in researches on material or data contained in biobanks) and post-trial access.

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More than two decades have passed since the establishment of research ethics committees in Iran. With many years of experience of research ethics committees, Iran Ministry of Health and Medical Education revised previous regulations and developed “Regulation on the Establishment, Leveling, and Duties of the Biomedical Research Ethics Committees”. Following publish and notification of “Regulation on the Establishment, Leveling, and Duties of the Biomedical Research Ethics Committees” in 2014, research ethics committees formed in national, academic, and organizational levels. In this regard, due to cooperation of the Iran Ministry of Health and Medical Education with the Iran Ministry of Science, Research and Technology, “the single article of the Act for Prevention and Combating Fraud in Scientific Publications” was approved in the Parliament of Iran in 2017; its executive bylaw was notified for implementation by the Cabinet of Ministers in 2019 and accordingly research ethics committees found a legal status in Iran. For promotion and update of the mentioned regulation and adaption to the Act, the secretariat of the national ethics committee proposed revised version of the regulation after obtaining opinions of stakeholders and several expert meetings. Then the new regulation entitled “Regulation on the Establishment, Procedures, and Duties of the Research Ethics Committees” was approved by the Iran National Committee for Ethics in Biomedical Research and the High Council of Medical Ethics of Iran in 2021. Structure of the committees in the new regulation includes “the National Committee for Ethics in Biomedical Research”, “Regional Research Ethics Committee”, “Institutional Research Ethics Committee”, “Biomedical Research Ethics Committee”, and “Specialized Committee”. This article introduces this new regulation.