The qualitative analysis of the ethical aspects of ICSAR cases shows the diversity and importance of possible critical incidents that have their origin in poorly handled ethical conflicts. It demonstrates the importance of the ethical dimension in the clinical and organizational environment and supports the case in expanding the scope of risk and quality management by adding an ethical perspective to ICSAR. It is also worth noting the amount of human resources in the area of patient safety. In other words, quality assurance depends on the quantity of workers. Therefore, in order to avoid similar incidents, it is essential to provide a sufficient number of employees at the bedside (12). Berger ZD, Boss EF, Beach MC. Communication behaviour and patient autonomy in hospital care: a qualitative study. Patients educate couns. 2017;100:1473–81.
Vincent C, Taylor-Adams S, Chapman EJ, Hewett D, Prior S, Strange P, et al. Clinical Incident Investigation and Analysis: Division of Clinical Risk and Linking Litigation and Risk Management Protocol. Bmj. 2000;320:777-81. Establishing patient safety involves different individual, professional and organizational aspects with a particular focus on ethics. Professional and organisational commitment leads to the detection and reporting of one`s own mistakes and those of others (10). The evaluation of ethical cases from open-source CIRS databases, in-hospital ICRS cases, and ethics advice in combination with literature research and author experiences resulted in a comprehensive set of possible ethical CIRS cases. Four main categories of ethically critical incidents/cases were derived: (1) patient-related communication; (2) the consent, autonomy and interest of the patient; (3) conflicting economic and medical interests; (4) Communication with employees and corporate culture. Sub-categories that identify potential problems, exemplary cases and ethical principles that may be associated with them are listed in Tables 1, 2, 3 and 4. A comparison with real cases showed that assignment to appropriate categories is feasible, although their various facets and complexity sometimes overlap between different categories or subcategories. Primarily relevant biomedical principles could be roughly mapped to demonstrate ethical relevance, but cross-checking showed that the set of relevant principles often needs to be adapted in practice.
DuBois JM, Anderson EE, Chibnall JT, Mozersky J, Walsh HA. Serious Ethical Violations in Medicine: A Statistical and Ethical Analysis of 280 Cases in the United States from 2008 to 2016. At J Bioeth. 2019;19:16–34. As a rule, reported incidents are classic clinical problems, e.g. confusion of drugs (similar/sound drugs) and a subsequent measure, e.g. the introduction of patient identification bracelets. However, dangers to patients can also include ethical dimensions. Examples of this can be found either in the context of clinical ethics, for example a report on a controversial practice of assisted dying, or in organizational ethics, for example a critical shortage of staff that leads to an increase in patient mortality [11, 12]. Khorsandi M, Skouras C, Beatson K, Alijani A. Quality testing of an adverse event reporting system and root cause analysis of serious adverse surgical incidents at a teaching hospital in Scotland.
Patient Saf Surg. 2012;6:1-6. It is difficult to distinguish between CIRS cases with and without an ethical dimension. ICSAR flags suboptimal situations and conditions in patient care and, as a result, each incident can harm patients, employees or society. Frequently cited examples are protocol violations, i.e. unaddressed standard operating procedures, missing checklists, or avoidable processing errors [46, 47]. The bottom line is that medical treatment and ethics are inextricably linked: avoidable defective processes, reduced quality, inadequate medical care are always unethical, and conversely, sufficient ethical considerations are an intrinsic aspect of good quality. According to this interpretation, each CIRS case has an ethical dimension that cannot be denied.
However, in “unethical” cases of ICSAR, there is no challenge to ethical principles. If, for example, a patient is injured because a doctor confuses the surgical side, the error is undeniably a violation of the principle of no harm – there is no need for an ethical discussion. If the same error is not adequately communicated, there may be a conflict between the autonomy, benevolence, non-malignancy of the patient on the one hand and the interests of the physician or organization on the other. For this work, we focused on the latter type of cases, i.e. ICRS cases with a possible unresolved underlying ethical conflict and a potential increase in moral burden among staff or patients [48]. Of course, in practice, the boundaries between ethical and non-ethical incidents are blurred, and precise discrimination is neither always possible nor important: the objective is not a clear task like “one or the other”. or” but an extension in the sense of a “not only. but also” and thus place a virtual emphasis on ethical reflection and problem solving. Bell SK, White AA, Yi JC, Yi-Frazier JP, Gallagher TH. Transparency in case of problems: attitude of doctors to report medical errors to patients, colleagues and institutions.
J Patient Saf. 2017;13:243-8. Professional ethics and patient safety are closely related fundamental concepts in medicine. Patient safety is based on ethical principles, which are considered indicators of quality of care (15). Patient safety requires the establishment and implementation of a code of professional ethics. According to the Iranian Code of Conduct for Health Professionals, all patients must be treated with dignity and protected from potential harm (16). Therefore, adherence to ethical principles requires health care providers to identify potential safety deficiencies in order to prevent fall incidents (15). Since patient safety is multidimensional and based on ethical and legal imperatives, ethical and legal challenges must be addressed. In this context, during the monthly ethics cycle at the Children`s Medical Center of Tehran University of Medical Sciences, Iran, a case of a 12-day-old newborn fall was discussed, and the ethical and legal dimensions of patient safety were discussed by experts from various fields. Snellman CL. Ethics Management: How to Achieve Ethical Organizations and Management? Bus Manag Educ. 2015;13:336–57.
Legal and ethical issues related to patient recruitment in clinical trials: the case of competitive recruitment. Health Law Review 13(2-3): 58-61, 2005 Miller L.