Informed Consent, the Ethical Cornerstone of Medical Intervention, Especially within the Conduct of Clinical Trials

Introduction: This paper outlines and explains a new approach to informed consent, especially within clinical trials. Background: Autonomy implies the patient has control for what happens to his/her body. There is a problem with lack of equipoise between clinician and patient, especially when the clinician, conducting a trial, is also the patient’s physician. Beran et al adopted a novel approach to informed consent, especially within clinical trials. The patient is introduced to the trial coordinator who assumes responsibility of discussing the nature, risks and benefits of the trial. If the patient accepts and signs the informed consent document, with the coordinator, the doctor counter-signs it, offering the opportunity to ask further questions, criticize the process and feel confident that the decision was correct. Discussion: Where the investigator is also the patient’s treating clinician, it must be recognized that there might be a perception of potential coercion, asking a patient to join a trial. The practice employed a trial coordinator, a recent university, science graduate, a young person with less influence over the patient. Patients completed the bulk of the informed consent with the trial coordinator, given every opportunity to decline inclusion into a trial. With the trial coordinator, being responsible for discussing the elements of the trial, there is a reduced potential for undue influence, with ultimate respect for autonomy and selfdetermination. This procedure offers a novel approach to gain informed consent for inclusion in clinical trials with the doctor retaining ultimate responsibility, for informed consent, and countersigning the consent document.

CIRSE Clinical Practice Manual

Background Interventional radiology (IR) has come a long way to a nowadays UEMS-CESMA endorsed clinical specialty. Over the last decades IR became an essential part of modern medicine, delivering minimally invasive patient-focused care. Purpose To provide principles for delivering high quality of care in IR. Methods Systematic description of clinical skills, principles of practice, organizational standards and infrastructure needed for the provision of professional IR services. Results There are IR procedures for almost all body parts and organs, covering a broad range of medical conditions. In many cases IR procedures are the mainstay of therapy, e.g. in the treatment of hepatocellular carcinoma. In parallel the specialty moved from the delivery of a procedure towards taking care for a patient’s condition with the interventional radiologists taking ultimate responsibility for the patient’s outcomes. Conclusions The evolution from a technical specialty to a clinical specialty goes along with changing demands on how clinical care in IR is provided. The CIRSE Clinical Practice Manual provides interventional radiologist with a starting point for developing his or her IR practice as a clinician.

Responsibilities of the Marketing Authorisation Holders in Respect of GMP Compliance (Review)

Introduction. The article is focused on differences in quality assurance-related obligations and responsibilities between Marketing Authorisation Holders (MAHs) and manufacturing authorisation holder (manufacturers) in pharmaceutical industry. In case of outsourcing and technical agreements there is a need to differentiate responsibilities related to quality assurance between the above mentioned categories.Text. The guidelines for the pharmaceutical sector of the European Union (EU) provide guidance on the responsibilities of the MAHs in relation to the GMP rules, which are scattered throughout the various chapters of the GMP and its appendices. In addition, certain provisions on this topic are contained in the EU directives. With this in mind the European Medicines Agency (EMA) issued in January 2020 a draft Reflection paper on Good manufacturing practice and Marketing Authorisation Holders. The draft clarifies that while certain activities of an MAH may be delegated to the manufacturer, MAH retains ultimate responsibility for the performance of a medicinal product, its safety, quality and efficacy. The important obligation of MAH in this context is to facilitate GMP compliance by establishing a robust two-way communication system with national competent authorities, manufacturing sites, Qualified Persons (QPs) certifying batches before release, and other interested parties. The MAH ought to communicate to manufacturing personnel, normally through QPs, production processes and related quality control procedures, including subsequent variations, described in registration dossiers.Conclusion. A general one conclusion: in view of rapid developments in the EU GMP Guide, the Eurasian Economic Union GMP requirements ought to be updated. In respect of specific responsibilities of MAH pertaining to GMP compliance the EMA draft Reflection paper merits attention as a guidance regarding separation of obligations and responsibilities between MAH and personnel of manufacturing sights.

The micro-politics of energy efficiency: An investigation of ‘eco-social interventions’ in western Switzerland

Households have a role to play in the so-called ‘energy turn’ in Switzerland, a policy framework that calls for more efficient energy usage. Against this backdrop, this article critically analyses the mechanisms and running of a programme aimed at improving energy usage among low-income households in western Switzerland, bringing together both environmental and social objectives or what was termed an ‘eco-social intervention’. Based on ethnographic fieldwork and informed by a Foucauldian governmentality approach, the power dynamics of this programme are exposed, and its effect on the lived experience and subjectification of both household members and energy ambassadors are discussed. We argue that while presenting the appearance of technical rationality and political neutrality, this type of programme seeks to govern behaviours and leaves the ultimate responsibility for the protection of the environment on individuals, rather than promoting more collective and inclusive actions. Furthermore, we unravel how this programme participates in the reproduction of social differentiation by aiming at a particular social group, low-income households living in subsidised housing. We conclude with a discussion on how initiatives aimed at households could engage with the more complex arrangements of everyday life, rather than solely individual eco-gestures, while accounting for power dynamics.

Ethics of Artificial Intelligence in Radiology: Summary of the Joint European and North American Multisociety Statement

This is a condensed summary of an international multisociety statement on ethics of artificial intelligence (AI) in radiology produced by the ACR, European Society of Radiology, RSNA, Society for Imaging Informatics in Medicine, European Society of Medical Imaging Informatics, Canadian Association of Radiologists, and American Association of Physicists in Medicine. AI has great potential to increase efficiency and accuracy throughout radiology, but it also carries inherent pitfalls and biases. Widespread use of AI-based intelligent and autonomous systems in radiology can increase the risk of systemic errors with high consequence and highlights complex ethical and societal issues. Currently, there is little experience using AI for patient care in diverse clinical settings. Extensive research is needed to understand how to best deploy AI in clinical practice. This statement highlights our consensus that ethical use of AI in radiology should promote well-being, minimize harm, and ensure that the benefits and harms are distributed among stakeholders in a just manner. We believe AI should respect human rights and freedoms, including dignity and privacy. It should be designed for maximum transparency and dependability. Ultimate responsibility and accountability for AI remains with its human designers and operators for the foreseeable future. The radiology community should start now to develop codes of ethics and practice for AI that promote any use that helps patients and the common good and should block use of radiology data and algorithms for financial gain without those two attributes.

“Ubuntu philosophy” for public leadership and governance praxis

Purpose Leadership and governance are all about “people” and the “common welfare”. Africans have an Ubuntu philosophy which culturally calls on individuals to promote the welfare of collective society. It is therefore paradoxical to note how African leaders and governance regimes perform poorly when it comes to the usage of public resources to create conditions for collective human welfare. Why do leaders instead of championing societal advancement rather advance their selfish, egoistic and sectional interests? This study aims to unpack a prevalent paradox and discuss a new approach of linking the rich Ubuntu philosophy to Africa’s governance and leadership discourse. Design/methodology/approach This study discusses from secondary sources of data, mainly drawn from journal articles, internet sources and scholarly books relevant to leadership and public administration in developing African countries and how Ubuntu African philosophy can be deployed to ensure leadership ethos. In attempt to obtain a more comprehensive and systematic literature review, the search covered all terms and terminologies relevant to the objective of the study. The search process mainly comprised four categories of keywords. The first category involved the concept as approximately related to leadership: “leadership and civic culture”, “Ubuntu culture” and “African collectivist culture”. For the final category, words such as “crisis”, “failure” and “experiences” were used. Findings This study contends that the preponderance of corruption and poor leadership in Africa is anti-cultural, anti-human, anti-ethical and anti-African; hence, those individuals who indulge or encourage leadership paralysis are not “true Africans” by deeds but merely profess to be. Linking the African Ubuntu philosophy to public leadership, the study maintains that the hallmark of public leadership and governance is to develop the skills of all and caring for the society. Practical implications This study draws attention to the need for leaders to espouse virtues so that leadership becomes a tool to promote societal welfare. The hallmark of public leadership and governance is to develop the skills of all and caring for the society. It involves weighing and balancing professional and legal imperatives within a democratic and ethical context with an ultimate responsibility to the people and public interest. It is not a responsibility to a particular set of citizens, but a commitment to be just and equitable to all. The preponderance of corruption and bad leadership is anti-cultural, anti-human, anti-ethical and anti-African; hence, individuals who indulge or encourage leadership paralysis are not true Africans by deeds but merely profess to be. Originality/value This study draws a clear link between indigenous African cultural value system and ethical public leadership. It draws congruence between Africa's Ubuntu philosophy of civic virtue and Africa's leadership/governance. This will bring about a renewal of thoughts and practice of public leadership on the continent, as it has been demonstrated that a true African seeks collective social welfare and not selfish interest.

Ethics of artificial intelligence in radiology: summary of the joint European and North American multisociety statement

This is a condensed summary of an international multisociety statement on ethics of artificial intelligence (AI) in radiology produced by the ACR, European Society of Radiology, RSNA, Society for Imaging Informatics in Medicine, European Society of Medical Imaging Informatics, Canadian Association of Radiologists, and American Association of Physicists in Medicine. AI has great potential to increase efficiency and accuracy throughout radiology, but also carries inherent pitfalls and biases. Widespread use of AI-based intelligent and autonomous systems in radiology can increase the risk of systemic errors with high consequence, and highlights complex ethical and societal issues. Currently, there is little experience using AI for patient care in diverse clinical settings. Extensive research is needed to understand how to best deploy AI in clinical practice. This statement highlights our consensus that ethical use of AI in radiology should promote well-being, minimize harm, and ensure that the benefits and harms are distributed among stakeholders in a just manner. We believe AI should respect human rights and freedoms, including dignity and privacy. It should be designed for maximum transparency and dependability. Ultimate responsibility and accountability for AI remains with its human designers and operators for the foreseeable future. The radiology community should start now to develop codes of ethics and practice for AI which promote any use that helps patients and the common good and should block use of radiology data and algorithms for financial gain without those two attributes.

Artificial intelligence in oncology, its scope and future prospects with specific reference to radiation oncology

Objective: Artificial intelligence (AI) seems to be bridging the gap between the acquisition of data and its meaningful interpretation. These approaches, have shown outstanding capabilities, outperforming most classification and regression methods to date and the ability to automatically learn the most suitable data representation for the task at hand and present it for better correlation. This article tries to sensitize the practising radiation oncologists to understand where the potential role of AI lies and what further can be achieved with it. Methods and materials: Contemporary literature was searched and the available literature was sorted and an attempt at writing a comprehensive non-systematic review was made. Results: The article addresses various areas in oncology, especially in the field of radiation oncology, where the work based on AI has been done. Whether it’s the screening modalities, or diagnosis or the prognostic assays, AI has come with more accurately defining results and survival of patients. Various steps and protocols in radiation oncology are now using AI-based methods, like in the steps of planning, segmentation and delivery of radiation. Benefit of AI across all the platforms of health sector may lead to a more refined and personalized medicine in near future. Conclusion: AI with the use of machine learning and artificial neural networks has come up with faster and more accurate solutions for the problems faced by oncologist. The uses of AI,are likely to get increased exponentially . However, concerns regarding demographic discrepancies in relation to patients, disease and their natural history and reports of manipulation of AI, the ultimate responsibility will rest on the treating physicians.