Showing 22 results for Informed Consent
Alireza Ismailabadi, Amir Bastani,
Volume 1, Issue 1 (7-2008)
Abstract
Background: The first experimental lobotomy was performed in psychiatric patients at 1930. At the beginning, the purpose of such experiments was the treatment of certain patients such as psychotics, sexual offenders and schizophernics, but during the years, the unpredictable results and harms appeared. Nowadays the treatment is limited to medical treatment and psychosurgery which includes two new forms of lobotomy named cingulotomy and capsulotomy. Previously physicians were performing dangerous surgery on a wide rage of patients irrespective of their consent and objections. In fact they treated them in the favor of “patients’ and public (social) interests” and some claims have risen against it. In this regard some legislators such as Canadian legislator enacted or amended their regulations and these regulations criticized.
Method: We selected the most related articles and books among the related resources. For completing this article, we searched by the keywords of Lobotomy, enforced offender to treatment, ethics.
Results & Conclusion: Studying some known cases demonstrated harmful effects of this special surgery and regarding to the ethical and legal points of view, operating patients only for the interest of patients or public, irrespective of their consent is not legitimate.
Maryam Abbasi Nejad, Ali Jafariyan, Fariba Asghari, Alireza Parsapoor, Mohammadreza Zafarghandi,
Volume 4, Issue 5 (10-2011)
Abstract
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.
Lila Nekooei Nejad ,
Volume 4, Issue 5 (10-2011)
Abstract
Human cloning is one of the latest and most complicated developments in the field of medical and genetic sciences that could fulfill man’s dream of eternal life. Scientists’ achievements in this respect, however, have brought about many concerns for thinkers, particularly ethics scholars.
Human and animal cloning have been examined from different angles, but one basic aspect of human cloning has received less attention from researchers and scientists, and that is the autonomy of the cloned person the reason is that gaining informed consent, which is one of the most important principles of medical ethics in human experiments, is impossible in the case of human clones.
Free will lies at the core of human perfection and divine revelation, and one important issue that the present study concerns itself with is whether or not technologies such as cloning or embryonic genetic modification violate the autonomy of cloned persons. This paper attempted to look into such issues regarding human cloning through library research.
Mohammad Bagher Parsapoor, Seyyed Rohollahe Ghasemzadeh,
Volume 5, Issue 1 (12-2011)
Abstract
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.
Mina Mobasher, Jamileh Mahdavinia, Kazem Zendehdel,
Volume 5, Issue 1 (3-2012)
Abstract
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.
Behzad Joodaki, Abolfath Khaleghi,
Volume 5, Issue 6 (12-2012)
Abstract
One of the important issues in the field of medical ethics is the patient's consent to treatment. This issue has also been addressed in the law, and Islamic legislators have clarified the conditions of gaining patient's consent and approached questions such as legitimacy of treatments or surgical operations, capacity of the person giving consent and so on. In medical ethics, there are different types of consent including expressed, implied and informed consent, while the Islamic Criminal Act concerns itself only with the expression of consent and it is unclear which type of consent the legislators are referring to. The importance of this issue lies in the fact that gaining the patient's consent without meeting the specified legal conditions causes liability for the physician. This article attempts to clarify the legal conditions for gaining patient's consent and at the same time answer questions such as whether the consent mentioned in the Islamic Criminal Act includes various types in medical ethics or not, how failure to meet the legal conditions for gaining consent should be penalized, what the liabilities are in the event that the patient's consent is not gained, and other questions related to the issue
Maliheh Ameri, Zahra Safavi Bayat, Tahereh Ashktorab, Amir Kavoosi, Atefeh Vaezi,
Volume 6, Issue 1 (4-2013)
Abstract
Moral distress is considered as an important issue in nursing. Nurses participation in ethical decision making and taking deliberate action are facing them with many ethical challenges in their work environment. Confronting those challenges can lead to moral distress.
This descriptive study was conducted to determine moral distress and its contributing factors from the perspective of oncology nurses in Tehran teaching hospitals in 2011.
Data collection was done through a demographic questionnaire, the Moral Distress Scale – revised (MDS-R) and a questionnaire on moral distress related factors administered to all oncology nurses with inclusion criteria.
Findings showed that nurses reported a high level of moral distress overall. The highest level of moral distress was associated with giving inadequate information to patients about informed consent and carrying out a physicians’ order for unnecessary tests and treatments. A significant correlation was found between oncology nurses’ age, their work experience and employment status with moral distress. Institutional factors such as managers’ support, nurses’ autonomy and having determined duties had the greatest effect on moral distress from oncology nurses’ view.
Oncology nurses commonly encounter situations that are associated with high levels of moral distress, and therefore strategies need to be developed in order to mitigate moral distress.
Nazafarin Ghasemzadeh , Nazila Nikravan Fard , Mohammad Hossein Rahimi Rad , Sara Mousavipour , Fatemeh Faramarzi Razini ,
Volume 6, Issue 2 (5-2013)
Abstract
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.
Mansoureh Madani, Ensieh Madani,
Volume 7, Issue 4 (11-2014)
Abstract
Refusal of medical treatment is among the most important rights of patients and a natural consequence of informed consent, although it can result in harm to patients or others and even the health care system.
Treatment refusal may have various clinical manifestations whose recognition and proper understanding is essential to their management. In some cases the legal aspect is primarily dominant, such as when there is the possibility of harm to a third party. In other cases, for instance in absence of patient capacity, there are clear guidelines for decision-making. Major ethical challenges in the field of treatment refusal frequently pertain to capable patients, and this paper is mainly about the practical issues related to this group. The problems that these patients face are mostly due to improper physician-patient relationship or fleeting emotions. Caregivers should be prepared to deal with these issues and try their best to overcome obstacles and achieve patient satisfaction, with the exception of critical emergencies where treatment is carried out without consent. If all measures fail, patients’ refusal must be documented and other therapeutic interventions should be offered.
Hooman Khorshidi, Saeed Raoofi,
Volume 9, Issue 2 (8-2016)
Abstract
Replacement of missing teeth with dental implants has received growing popularity in recent years. In order to select the proper treatment plan the clinician should provide a list of all applicable options. Decisions on the treatment of the edentulous area should be performed in consultation with the patient while taking into account the four principles of bioethics, that is, respect for autonomy, non-maleficence, beneficence, and justice. The dentist must inform the patient of all available treatment options and point out the advantages and disadvantages of each modality. Rendering dental services should not be based on wrong principles, so dentists’ knowledge and professional skills must be up-to-date. Informed consent is crucial, and when obtained prior to implant placement, typically will bring about better results and prevent many ethical and legal issues and conflicts. Understanding and approval are two important components of informed consent that can hasten the process of patient recovery. Moreover, patient requests and expectations should not lead to incorrect and unethical decisions on the part of the dentist. Implant dentistry may be a suitable option in replacing missing teeth, but it does not license tooth extraction in any way, as natural teeth should not be extracted in the hope of dental implants. Dental implants are not permanent, are not resistant to infection and disease, are not without risks and complications, and more importantly, require comprehensive care.
Fateme Fadaei, Ladan Naz Zahedi, Zahra Farahani, Nazafarin Ghasemzadeh,
Volume 9, Issue 3 (10-2016)
Abstract
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.
Seyed Saied Seyed Mortaz, Parvin Delavar, Nafiseh Zafarghandi, Mohammad Reza Yektaei, Qolamreza Moarefi, Ali Davati, Shiva Rafati, Siamak Afshin Majd, Ahia Garshasbi,
Volume 11, Issue 0 (3-2018)
Abstract
A 62-year-old man referred to the emergency department 48 hours ago with chief complaint of repeated bloody vomiting. The patient is admitted and the necessary measures are taken. Within 24 hours, he received 6 units of blood. The patient has undergone endoscopy, but endoscopic endorsement has failed to stop the bleeding. The surgeon consulted and visited the patient. He considered urgent emergency laparotomy. The patient is alert and refuses surgery. The hemodynamic status of the patient is not stable and gastrointestinal bleeding continues. These questions are posed to medical staff and hospital managers: "What is our duty”? "Should we respect the choice of the patient and witness the progress of the disease and deterioration of the patient's condition"? "Can he be discharged from the hospital on the basis of the patient's refusal to take medical treatment"? "Can we take appropriate diagnostic and therapeutic measures with the use of legal capacity and support despite patient’s opposition? "How can one regard autonomy, beneficence, and nonmaleficence at the same time, in this situation "? In this study, which is one of the problems of medical ethics, the ethical, legal, and health aspects of the presented patient are discussed.
Roghayeh Zare, Sedigheh Ebrahimi,
Volume 11, Issue 0 (3-2018)
Abstract
Involving children in their own treatment decision-making improves their abilities. Factors such as the ability to reason, previous children's experiences in relation to the subject as well as information, and their general understanding of the subject affect the child's ability to make decisions. The current laws of informed consent in children allow alternate decision makers to decide on their own. Our goal in this study was to examine the current conditions for the informed consent of children in to provide appropriate guidelines in this regard. In this qualitative study, participants were selected through targeted sampling. The data were collected by semi-structured interview with open questions. Coding and classification was carried out using continuous comparative analysis. Participants included 6 admitted children, 15 parents of children, and 4 pediatricians. Three general categories of "satisfaction culture", "environmental conditions", and "child world" were extracted. Parents and children were not clear about the purpose of obtaining consent. The gender of children was not significantly affected by the process of obtaining formal consent in medical settings. The existing conditions have created a non-appropriate balance in the expectations of parents regarding the treatment decisions and giving vital information and treating the child by doctors disregarding child’s competency. This defective balance can, in the meantime, cause instability and harm to human dignity and autonomy of parents and children, waste of resources, challenging the sense of trust in the community towards doctors and the lack of growth in child’s decision-making power.
Omid Asemani, Maryam Shabani Abadeh, Sedigheh Ebrahimi,
Volume 12, Issue 0 (3-2019)
Abstract
Obtaining informed consent is for protection of patients' rights. The aim of informed consent is not decreasing physicians' responsibility.Informed consent assists the patient in making a decision concerning their care, improve their satisfaction, and decrease legal litigations. This study examined patients' attitude toward the quality of informed consent and its challenges in educational -clinical settings. Current qualitative research was simple content analysis. Semi-structured interviews were conducted with 15 hospitalized patients who were selected by purposeful sampling method considering type and severity of the disease, gender, age, and satisfaction or dissatisfaction from the management. The data was analyzed using MAXQDA 2007 software. Primary codes and categories were extracted then the findings were presented based on the main. Five themes were extracted from the data: "meaning, importance and status of consent in medicine", "consequences of obtaining consent", "the role of patient and therapist in the process of informed consent", "challenges of making informed consents" and "facilitators in the process of informed consent"; all could define and compile the main theme “doctor, patient, and procedural elements, three pillars of informed consent”. Inadequate explanation to the patient, signing the form prior to read it, lack of trust to the practitioner, disregarding patients' psychologic needs and stress and obtaining the consent by someone other than the physician was among the main reported challenges of informed consent. Correction and standardization of obtaining informed consent's culture requires knowledge about current situation followed by training, enforcement, supervision, encouragement, and punishment. Collaboration of health care team needs comprehension of necessity and importance of this issue and its consequences.
Mohamad Nader Sharifi, Pooneh Salari,
Volume 13, Issue 0 (3-2020)
Abstract
One of the most challenging aspects of treatment is when patient seriously refuses the desired by treating physician. On the other hand, refusing treatment is a condition of the patient's right to be aware, but does such a right also imposes a moral obligation on the treating physician or not? This study discusses the diagnosis of Systemic Lupus Erythematosis disease. This article attempts to provide an overview of the ethical considerations for obtaining informed consent for a patient who refuses treatment. In this report, according to the patient's age, it can be concluded that although the patient has the capacity to make decisions, but because her age is below the legal age and does not have the authority to decide, her refusal to receive treatment cannot be accepted and it is necessary to make a decision based on the supreme interests of the patient with the opinion of a qualified legal guardian in this regard, taking into account the scientific aspects.
Nahid Khademi, Fariba Asghari,
Volume 15, Issue 1 (3-2022)
Abstract
Confidentiality in AIDS patients is one of the necessities of medical ethics, which has attracted the attention of policymakers in the health field in the last few decades because, on the one hand, it increases the trust between patients and doctors. On the other hand, it encourages them to adhere to treatment and do necessary care to patients in order to prevent the transmission of the disease to others. However, it may lead to a breach of benevolence and others’ right to health and cause problems in providing health care. Here we discuss a practical solution for this problem through a clinical case presentation.
Kobra Rashidi, Pooneh Salary,
Volume 16, Issue 1 (3-2023)
Abstract
One of the most important patient rights is to respect the patients’ autonomy and their participation in the process of treatment decision-making. This is of particular importance for the patients in the emergency department, who require due care in differential diagnosis leading to illness and death. However, the problem arises when this right is negligently ignored and despite the fact that it seems a simple matter, it is difficult to manage and control. Accordingly, this study aimed to investigate this issue through the case report of a patient diagnosed with acute abdomen. Moreover, an attempt was made to briefly review how negligence occurs, its causes and consequences, as well as its management strategies. In this report, the results highlighted the importance of patient participation, obtaining informed consent from the patient in the entire treatment process (diagnosis, treatment, rehabilitation, and prevention), and maintaining privacy and confidentiality regarding all medical and non-medical information of patients that are provided to the treatment staff in verbal, written, partial, and even electronic forms, especially in sensitive and stigmatizing cases. It seems that there are certain strategies to manage such negligence including timely detection, investigation of the causes and consequences, compensation for the damage, enhancing the cultural competence of the treatment staff, developing relevant local guidelines and instructions, having an efficient system with the support of the organization for handling it, and strengthening communication skills and teamwork.
Rasool Esmalipour, Narges Dastmalchi , Khalil Hajiasgharzadeh,
Volume 17, Issue 0 (12-2024)
Abstract
Stem cell technology and regenerative medicine are interdisciplinary fields that integrate engineering, molecular and cellular biology, and medical science to repair tissues and treat diseases using stem cell-based methods. The primary goal of this scientific field is to enhance the quality of life by replacing damaged cells and tissues with healthy ones, thereby improving injuries and disabilities. With recent advances in biomedical science and the unique potential of stem cells in treating diseases, ethical considerations surrounding this technology have become increasingly significant. Following a brief introduction to stem cell technology, this review explores ethical challenges, including the justifications for using stem cells, informed consent from patients, preservation of human dignity, and the social and cultural impacts associated with their application. As research in this field continues to expand, yielding numerous innovative findings and attracting growing interest from researchers, there has also been an increase in unproven commercial treatments that have not undergone necessary regulatory stages. The direct marketing of products in preclinical stages to consumers further underscores the importance of ethical considerations in the use of stem cells. Additionally, the unprincipled use of stem cells may lead to adverse effects, such as cancer or vascular diseases, exacerbating patients' conditions rather than improving them. The findings of this review emphasize the need to adapt existing laws and regulations to address ethical concerns and provide recommendations for enhancing ethical standards in clinical research involving stem cells. The results can serve as a guide for researchers and policymakers in addressing ethical challenges in stem cell research, ultimately improving the quality and safety of clinical research in cell therapy and regenerative medicine.
Fatemeh Hekmatian, Akram Hashemi, Soodabeh Hoveida Manesh, Saeedeh Saeedi Tehrani,
Volume 17, Issue 0 (12-2024)
Abstract
Obtaining informed consent is a fundamental ethical and legal right of participants in clinical trials. It ensures that individuals are adequately informed about the research, including its nature, potential risks and benefits, and their role in the study. This knowledge empowers participants to make informed decisions about their involvement. This study aimed to evaluate the awareness of participants regarding the information provided in informed consent forms (ICFs) for clinical trials conducted at Iran University of Medical Sciences (IUMS) in 2020. This study evaluated the accuracy of the content of ICFs of registered clinical trials and assessed participants' understanding of the information presented. ICFs were reviewed using a ministerial checklist. Participants were subsequently contacted to assess their comprehension of key aspects of the trial as outlined in the ICF. Analysis revealed a discrepancy between the information presented in the ICFs and participants' actual understanding. Despite adequate coverage of certain aspects, such as the research nature of the interventions (98.2%) and the mention of specific benefits (92.7%), significant gaps were observed in participants' comprehension of crucial information. Notably, lower levels of understanding were observed regarding the possibility of invasive interventions (25.7%), the random assignment of participants to study groups and the potential use of placebos (44%), and the possibility of not personally benefiting from the research outcomes (44%). Additionally, only 47.7% of participants reported understanding the confidentiality of their information. These findings highlight the need for improvements in the process of obtaining informed consent. While researchers may adequately address the overall research objectives and potential benefits, crucial aspects such as the potential for invasiveness, randomization procedures, and the possibility of no direct personal benefit may not be adequately communicated to participants. Enhancing participant understanding of these critical aspects is crucial for ensuring truly informed consent and upholding ethical research practices.
Alireza Zare, Mohammad Hossein Taklif, Alireza Javid, Zahra Amadeh, Negin Farid,
Volume 17, Issue 0 (12-2024)
Abstract
Nurses, as key members of the healthcare team, face complex ethical issues when caring for patients with chronic mental illnesses. These challenges include maintaining confidentiality, obtaining informed consent from patients with limited cognitive abilities, managing conflicts between patient rights and safety requirements, and addressing social stigma. Inadequate attention to these challenges may lead to reduced care quality and psychological stress for nurses. A better understanding of these challenges and the provision of appropriate solutions is essential. This study was conducted through a simple review approach. A comprehensive search was first conducted in PubMed, Scopus, PsycINFO, and Google Scholar databases. Combined keywords such as "ethical challenges," "nursing," "chronic mental illness patients," and "ethical care" were used. Inclusion criteria included studies published in English and Persian from 2010 to 2023, including research, review, and qualitative articles related to the topic. A total of 150 articles were identified, and after evaluating their quality and relevance, 30 articles were selected for final analysis. Data were analyzed using thematic and comparative analysis methods. The findings revealed that nurses face multiple challenges, including maintaining confidentiality when interacting with families, obtaining informed consent from patients with cognitive disorders, and managing ethical conflicts between patient safety and individual freedom. Additionally, a lack of specialized ethical training, the absence of clear protocols, and the pressure from the social stigma of patients were identified as key challenges. The ethical challenges faced by nurses in caring for patients with chronic mental illness require special attention from relevant organizations. Providing continuous education, developing ethical guidelines, and creating psychological and legal support can help mitigate these challenges. Further studies on practical, experience-based solutions to address these issues are recommended.