Iranian Journal of Medical Ethics and History of Medicine

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Backgrounds: Nowadays one of the major problems in research ethics, especially in medical researches, is how to make bioethics codes practical and how to oblige researchers to perform them. In this essay, we have tried to suggest all detailed activities of different management sides which have a role in different phases of performing a research project, to make codes more practical. Materials and Methods: In order to provide a practical guideline in medial research ethics issue from different points of view, a workshop was held by the presence of some representatives from type1 medical universities, 9 research centers, Pasteur Institute, molecular research and stem cells networks, and members of national research ethics committee. Results: Participants were divided into 5 groups based on their proficiency and management scopes and edited the task's descriptions. These groups included: 1) task's description for ethics committee of universities 2) task's description for research executive managers and research deputies of universities and research centers 3) task's description for professors, executors, managers, research deputies of departments and research council's department 4) task's description for international relationship committees of universities 5) task's description for publishing committees. These 5 groups were chosen deliberatively. Conclusion: Considering importance of bioethics, interference of environmental and sociological factors, local area culture and existence of executive facilities, providing practical codes of ethics needs group assistance and researchers' national impetus, research affairs accomplishment and massive country management.

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One of the manifestations of patient autonomy in practice is gaining informed consent prior to any invasive procedure. In Iran, the process of obtaining informed consent to surgical procedures is currently limited to the patient signing a consent form that often does not offer specific information on the procedure, and patients are not given adequate time to read the form. In order to improve the present circumstances, authors of this study created information sheets specific to each class of surgical procedure, and performed an evaluation of the effectiveness of these sheets in increasing patient awareness and satisfaction. Handouts containing specialized information on various surgical procedures were distributed among 110 patients hospitalized to undergo elective surgeries in surgical wards 1, 3, 4 and 5 of Imam Khomeini Hospital Complex and surgical ward 3 of Sina Hospital the patients received the handouts prior to procedures, and were free to use the information as they wished. These patients were then interviewed through an oral questionnaire after the procedure and at the closest time possible to their discharge. At a different time, 110 other patients in similar conditions and locality were interviewed after surgical operations and as close to being discharged as possible, but without receiving information sheets. The above-mentioned questionnaire contained essay type questions regarding patients’ information about their medical conditions and the required surgical procedures, and patients were also asked about their level of satisfaction with the information they had received. The mean score for patients’ overall knowledge in the intervention group was 48.8%, and the same score was 44.6% in the control group. Distribution of specific information on the surgical procedures among the patients in the intervention group did not have a significant effect on their overall knowledge (p = 0.140), and only raised their awareness of the side effects associated with the procedures (p  0.001). Similarly, patient satisfaction levels were 60.2% in the intervention group and 56.4% in the control group, and distribution of information sheets did not affect the overall satisfaction level of patients significantly (p = 0.166), and it only increased their satisfaction with the information they had received regarding their convalescence period after surgery (p = 0.033). Since distribution of specialized information sheets like the ones used in this study generally appears to be inadequate in increasing patient awareness and satisfaction, it is recommended that in the process of obtaining informed consent, physicians dedicate enough time to educate patients on their conditions and their different aspects rather than simply present them with a consent form.

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Breaking bad news to the patients does not back to a long history and is a controversial issue between patients and physicians. Many physicians are reluctant to breaking bad news to patients and this is not desirable for most patients. For example, in Northern European countries and United States, most physicians usually break bad news to the patients, while in Southern and Eastern European countries or many Asian countries they would not do so. In Iran, physicians prefer to break bad news to patient's family rather than the patient. Cultural differences also influence people's viewpoints about breaking bad news. In Western countries, most people agree with breaking bad news to patients while it is not common in the other populations. Nowadays, the dominant view in the most countries is that it is the duty of the physicians to break bad news to patients. Some advantages of breaking bad news to patients including strengthening the trust between physician and patient, preventing non - maleficience, increasing patients satisfaction and reducing legal action against the doctors. There are some exceptions to breaking bad news the most important is serious psychological damage to the patient. Quality and quantity of information that should be released depends on situation of each patient. Breaking bad news needs specific communication skills and physicians must be trained for this purpose.

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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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Because of complications of medical treatments, informing patients about the rate of treatment success, potential risks, and side- effects, is considered as an indispensable part of treatment contracts. Patients' deprivation of this information can be considered as a major obstacle in obtaining informed consent. Clearly treatment without patients' or their legal guardians informed consent may lead to civil and penal liability for the physicians.
Consenting without getting enough information about the disease, and its treatment is the most important issue in this regard. Now can such consent be valid and legalize the treatment or not? In this article informed consent and the physicians duty of informing patients are compared in three legal systems of Iran, England and France and then the physicians' duty of notification will be analyzed and some suggestions for safeguarding patients rights will be offered.

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Quality of nursing care services directly influences individuals' health status. Compiling codes of ethics according to the religion and culture of each population could be an appropriate approach in improving quality of health care services especially nursing care. Hence, the most important priority in our national health system is developing ethical guidelines.
For this purpose a task force has been established in collaboration with nurses, physicians, lawyers and clergymen who were expert in the field of medical ethics. The code of ethics for Iranian nurses was drafted in 2010. The draft that included 12 values and 71 regulations of professional ethics were finally approved in the second session of the Ethics Supreme Council of the Ministry of Health and Medical Education on 6 March, 2010.
The values consist of concepts such as maintaining human dignity, adherence to professional obligations, accountability and responsibility, patient privacy, promotion of scientific and practical competence and respect to individual's autonomy.
Also, 71 regulations of professional ethics divided to five sections including "Nurse and Community" consisting of 9 items, "Nurse and Professional Commitments" with 14 items, "Nurse and Clinical Services" with 23 items, "The Nurse and Other Healthcare Providers in Medical Team" with 15 items, and also "Nurse, Education and Research" including 10 items.

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Birth of a poor prognosis neonate (premature and/or congenitally affected) may potentially burden the family and/or society with many ethical, social, legal, etc challenges. Most of the decision making criteria used in handling the care of these neonates, such as disability, quality of life, etc., are multidimensional and heavily ethical bearing. In this study, we have tried to explore and present a perfect view on the existing challenges and different dimensions of the discussed criteria. In the end, the prominent standpoint of the Islamic school in confronting a severely disabled newborn has been introduced and analyzed. Most related discussions boil down to some fundamental and unanswered questions, for instance whether human beings should be permitted to make decisions about the life of severely diseased neonates, the decision making criteria themselves and their appropriateness, etc. Even though many scientists have theorized on the subject, a multilateral explanation of life and death criterion has not been presented yet. One thing is for certain and that is, in answering the basic questions of the subject, our present knowledge and experience is limited and insufficient. The authors have tried to show that despite many western views, decision making about the life of a neonate has no place in Islamic teachings, since it could be considered an unauthorized human action. Instead, it is proposed that any attempt to provide an ethical rationale, while utilizing today's science and technology, be in compliance with God's commandments.

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Medical professionalism has recently received attention in Iran, so we aimed to assess it in a single specialty educational hospital.In the present study, we evaluated observation of medical ethics principles from the viewpoints of physicians, nurses and patients. Eight principles of medical ethics were evaluated in these three groups through modified questionnaires containing 43 questions for physicians, 42 questions for nurses, and 25 questions for patients. The mean scores of those principles are as: enhancing professional efficiency (68.7 ± 23), confidentiality (67.9 ± 21), maintaining an appropriate relationship with the patients (61.7 ± 21), improving access to services (59.6 ± 21), distributing limited resources fairly (60.2 ± 25), knowledge production (61.4 ± 23), promotion of trust through management of conflicts of interests (64.8 ± 23), and perform professional responsibilities (59.6 ± 23). There were significant differences in the two parameters of “enhancing professional efficiency” and “confidentiality” between the viewpoints of the patients and the viewpoints of physicians and nurses (P < 0.0001). The difference in “maintaining an appropriate relationship with the patients”, “improving access to services”, and “distributing limited resources fairly” was significant between the viewpoints of the nurses and that of the patients and physicians. The viewpoints of the nurses and patients were significantly different only in “knowledge production”, “promotion of trust through management of conflicts of interest”, and “perform professional responsibilities” (P < 0.0001). With respect to these significant differences, the nurses’ viewpoint regarding “enhancing professional efficiency” may be more dependable due to their more accurate knowledge of the physicians’ performance and more extensive contact with them. This has also resulted in significant differences between nurses and patients or physicians in other principles as well.

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Genetic research was initially limited to the screening and diagnosis of known hereditary diseases. After the completion of the Human Genome Project (HGP), studies became concerned with the diagnosis and treatment of many non-communicable diseases threatening the public health. Aside from this, genetic engineering, in its new form, is also concerned with the development of recombinant medications, genetic enhancement, and genetically modified organisms and their applications. The climax of these achievements is the advent of transgenic creatures. These are organisms with a genetic makeup different from their natural one created through biotechnology. Transgenic products have become more popular in recent years, especially in agriculture and livestock sectors. At the same time, genetics and biotechnology are trying to keep pace with modern advancements. Genetic modifications have resulted in larger yields in agriculture and livestock as well as the development of new medications and vaccines. Despite the large profits that genetic engineering and transgenic organisms can bring for us, they may pose dangers in certain fields. Furthermore, there are ethical concerns about the application of these technologies.

The present study attempted to address the ethical issues in new genetic technologies and analyze them with regard to the four principles of bioethics. For this purpose, keywords were first looked up in scientific sources and the data were classified; ethical considerations were then analyzed in the light of the four principles of bioethics.

In the results section first the merits of such products for humanity and their contributions to saving the limited available resources are pointed out; subsequently, potential threats in some fields are addressed, along with considerations about the mass production and consumption of genetically engineered products, autonomy of individuals, the importance of raising awareness about the pros and cons of genetically modified organisms (GMOs), and their labeling. Finally, equity is addressed, and general benefits and harms, costs and effectiveness are discussed.

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Increasing attention to individual liberties in last decades, has led to considering respect to patients autonomy and involvement in making medical decisions as a critical ethical principle. In spite of a general emphasis on the Importance of the mentioned principle, there is a wide controversy about the logical limitations of respect to patients' wishes and preferences in medical decision making. While a significant number of theoreticians believe in necessity of considering rigid limitations for respect to patients' autonomy, others emphasize on respect to patients' absolute and unconditional right of self-determination. This article explains and analyzes each group's main arguments and finally suggests a functional and logical approach to the principle. This method helps avoidance of disadvantages of unconditional respect to patients' preferences while considering autonomy as an important ethical maxim.