Good Clinical Practice is an international quality standard for conducting trials that involve participation of human subjects. Currently, the most widely accepted international document forming the base for GCP is the ICH Harmonised Tripartite Guideline for GCP, which defines in detail the responsibilities and obligations of parties engaged in clinical research. The purpose of this paper is to analyse how compliance with GCP provides protection of the trial subjects and assures quality and credibility of the data (...) obtained. (shrink)

With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise. Therefore, we developed (...) a simple auditing process and evaluated its feasibility and effectiveness. The screening audit was developed using a routine audit checklist based on the Severance Hospital’s Human Research Protection Program policies and procedures. The measure includes 20 questions, and results are summarized in five categories of audit findings. We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 2013 and 2017. We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. Investigator reply rates gradually increased, except for the first year. The studies were graded as “critical,” “major,” “minor,” and “not a finding”, based on findings and number of deficiencies. The auditors’ decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. Low-risk level studies, single center studies, and non-phase clinical research showed more prevalent frequencies of being “major” or “critical”. Inappropriateness of documents, failure to obtain informed consent, inappropriateness of informed consent process, and failure to protect participants’ personal information were associated with higher audit grade. We were able to observe critical GCP violations in the routine internal audit results of post-screening audit compliance checks in “non-responding” and “critical” studies upon applying the screening audit. Our screening audit is a simple and effective way to assess overall GCP compliance by institutions and to ensure medical ethics. The tool also provides useful selection criteria for conducting routine audits. (shrink)

German medical schools have not yet sufficiently introduced students to the field of good scientific practice. In order to prevent scientific misconduct and to foster scientific integrity, courses on GSP must be an integral part of the curriculum of medical students. Based on a review of the literature, teaching units and materials for two courses on GSP were developed and tested in a pilot course. The pilot course was accompanied by a pre-post evaluation that assessed students’ knowledge and (...) attitudes towards scientific integrity and scientific misconduct. A syllabus was designed that comprised the following six topics: theoretical foundations of GSP; scientific publishing; empirical data; scientific supervision and teamwork; clinical research; personal interests. The comparison pre versus post-intervention yielded statistically significant changes in regard to the participants’ knowledge and attitude toward all forms of scientific misconduct treated in the course. As the majority of participants was not familiar with the fundamental regulations or guidelines of GSP, it seems crucial to train students in actively applying such norms to real-world conflicts. Students’ unfamiliarity with the fundamentals of GSP can be linked to the fact that many students have already experienced forms of scientific misconduct. Thus, GSP syllabi should be closely adjusted to a student’s realm of experience. All in all, courses on GSP can be seen as a potential means to increase the number of young scholars. (shrink)

Clinical practice is where the clinical encounter and decision-making occur. Thus, it constitutes the focus of medicine. Since the time of Hippocrates, it has been composed of five activities that have come to be known as anamnesis, i.e., history taking or clinical interview, diagnosis, prognosis, therapy, and prevention. These five activities are fundamental features of the healing relationship. The present chapter is devoted to the analysis and discussion of their logical, methodological, and philosophical problems. Usually, the (...) patient expects the physician to be an expert of her specialty devoid of a bad reputation. This constitutes what may be called a good doctor, i.e., one whose clinical decisions are right and good in most cases, at least in as many cases as another expert in the same area also achieves. In what follows, we shall analyze the characteristics and presuppositions of such right and good clinical decisions. To this end, we shall undertake a conceptual analysis of the clinical encounter and its outcomes, in order to develop a theory of clinical practice. Our analysis consists of the following five parts: 9.1 The Clinical Encounter; 9.2 Anamnesis and Diagnosis; 9.3 Prognosis; 9.4 Therapy; 9.5 Prevention. (shrink)

Are clinical practice guidelines a means for improving the quality of health care? For saving money in the health care system? For solving the malpractice problem? For making the health care system work better for all? Or, are they a recipe for disaster? This overview sets out conceptual, definitional, and practical aspects of clinical practice guidelines as a broad framework for reflecting on the issue of what guidelines are and why they count. It draws mainly on (...) work done since 1990 at the Institute of Medicine and focuses on five questions. First, what are guidelines, and who develops them? Second, what criteria or principles should be used to create good guidelines? Third, what problems or pitfalls exist in developing and disseminating guidelines? Fourth, in what ways can guidelines help improve medical care, and in what ways will they not be as practical or useful, particularly with respect to quality of care? Finally, what ethical context might guide deliberations on this topic? (shrink)

In general, most, but not necessarily all, patients want truthfulness about their health. Available evidence indicates that truth-telling practices and preferences are, to an extent, a cultural artefact. It is the case that practices among nurses and doctors have moved towards more honest and truthful disclosure to their patients. It is interesting that arguments both for and against truth-telling are established in terms of autonomy and physical and psychological harm. In the literature reviewed here, there is also the view that (...) truth-telling is essential because it is an intrinsic good, while it is argued against on the grounds of the uncertainty principle. Based on this review, it is recommended that practitioners ought to ask patients and patients' families what informational requirements are preferred, and research should continue into truth-telling in clinical practice, particularly to discover its very nature as a cultural artefact, and the other conditions and contexts in which truth-telling may not be preferred. (shrink)

Critical thinking is a complex, dynamic process formed by attitudes and strategic skills, with the aim of achieving a specific goal or objective. The attitudes, including the critical thinking attitudes, constitute an important part of the idea of good care, of the good professional. It could be said that they become a virtue of the nursing profession. In this context, the ethics of virtue is a theoretical framework that becomes essential for analyse the critical thinking concept in nursing (...) care and nursing science. Because the ethics of virtue consider how cultivating virtues are necessary to understand and justify the decisions and guide the actions. Based on selective analysis of the descriptive and empirical literature that addresses conceptual review of critical thinking, we conducted an analysis of this topic in the settings of clinical practice, training and research from the virtue ethical framework. Following JBI critical appraisal checklist for text and opinion papers, we argue the need for critical thinking as an essential element for true excellence in care and that it should be encouraged among professionals. The importance of developing critical thinking skills in education is well substantiated; however, greater efforts are required to implement educational strategies directed at developing critical thinking in students and professionals undergoing training, along with measures that demonstrate their success. Lastly, we show that critical thinking constitutes a fundamental component in the research process, and can improve research competencies in nursing. We conclude that future research and actions must go further in the search for new evidence and open new horizons, to ensure a positive effect on clinical practice, patient health, student education and the growth of nursing science. (shrink)

The Human Fertilization and Embryology Authority policy on permitting ova provision for research purposes breaches good regulatory practice in being inconsistent, unaccountable and untargeted. This article will illustrate how these breaches have resulted in a policy which is unfair to ova providers who wish to contribute to stem cell research and undermines the intentions behind the policy's very inception. (This article is based on a paper entitled Appropriate Recompense for Oocytes in Stem Cell Research presented at the Stem (...) Cells: Hope or Hype debate, North West Genetics Knowledge Park, Manchester in May 2007.). (shrink)

Bioethics has begun to see the revaluation of affects in medical practice, but not all of them, and not necessarily in the sense of affects as we know them. Empathy has been accepted as important for good medical practice, but only in a way that strips it of its affectivity and thus prevents other affects, like sympathy, from being accepted. As part of a larger project that aims at revaluing the importance of affectivity in medical practice, (...) the purpose of this paper is to develop a clinical sympathy that can serve as a trainable skill for medical professionals. While everyday sympathy may be problematic as a professional skill for physicians, this does not imply that sympathy should be entirely rejected. As a natural part of our moral psychology, sympathy is an intersubjective affect that aids in our interactions with others and our decision-making abilities. I present here a theory of clinical sympathy as an affective response to patients, in which physicians are both attuned to their affective response and understand how their affects are influencing their beliefs and judgments. In this way, clinical sympathy serves as a trainable skill that can aid physicians in their interactions with their patients. (shrink)

The purpose of this study is to determine empirically the state of the art of the medical care, when healthcare personal is confronted with ethical dilemmas related with the care they give to the geriatric population. An observational, longitudinal, prospective and qualitative study was conducted by analyzing the correlation between healthcare personnel–patient relationship, and ethical judgments regarding dilemmas that arise in daily clinical practice with geriatric patients. Mexican healthcare personnel with current active practices were asked to write up (...) an ethical dilemma that arose frequently or that had impacted their medical practice. From the narrative input, we were able to draw up a database with 421 dilemmas, and those corresponding to patients 60 years and older were selected (n = 54, 12.8 %). The axiological analysis of the narrative dilemmas of geriatric patients was made using dialectical empiricism. The axiological analysis values found most frequently were classified into three groups: the impact of healthcare, the roles of the physician, and refusal of therapy; the healthcare role of educator, caring for the patients’ life and the risk of imminent death where the values found more often. The persistence and universality of certain dilemmas in geriatrics calls for awareness and requires a good training in the ethical discernment of these dilemmas. This would help to improve substantially the care and the life quality of this population. (shrink)

The aim of Language for those who have Nothing is to think psychiatry through the writings of Mikhail Bakhtin. Using the concepts of Dialogism and Polyphony, the Carnival and the Chronotope, a novel means of navigating the clinical landscape is developed. Bakhtin offers language as a social phenomenon and one that is fully embodied. Utterances are shown to be alive and enfleshed and their meanings realised in the context of given social dimensions. The organisation of this book corresponds with (...) carnival practices of taking the high down to the low before replenishing its meaning anew. Thus early discussions of official language and the chronotope become exposed to descending levels of analysis and emphasis. Patients and practitioners are shown to occupy an entirely different spatio-temporal topography. These chronotopes have powerful borders and it is necessary to use the Carnival powers of cunning and deception in order to enter and to leave them. The book provides an overview of practitioners who have attempted such transgression and the author records his own unnerving experience as a pseudopatient. By exploring the context of psychiatry's unofficial voices: its terminology, jokes, parodies, and everyday narratives, the clinical landscape is shown to rely heavily on unofficial dialogues in order to safeguard an official identity. (shrink)

Some traditional cultural practices assure expected wedding night bleeding, to help preserve the honor of all parties.

In lieu of an abstract, here is a brief excerpt of the content:"To make a difference...":Narrative Desire in Global MedicineByron J. Good and Mary-Jo DelVecchio GoodIf, as Arthur Frank (2002) writes, "moral life, for better and worse, takes place in storytelling," this collection of narratives written by physicians working in field settings in global medicine gives us a glimpse of some aspects of moral experience, practice, and dilemmas in settings of poverty and low health care resources. These essays (...) are written from the midst of practice, in diverse settings in Africa, South Asia, Latin America, the Caribbean, and the United States. The majority of the writers are practitioners of contemporary 'global medicine'—physicians from North America or Europe who spend part of their lives flying into settings of poverty or special need to practice medicine and work with on-going collaborative clinical and public health systems—while a smaller number are working in the societies in which they were born. Although a few work for classic humanitarian organizations or have developed their own local NGO's, the great majority are engaged in the 'hybrid life' described by Robert Riviello and noted by Renée Fox, moving between academic medical centers and distant health care systems that are supported by local governments, major international organizations and funding agencies, and international NGO's like Partners in Health. These diverse forms of practice have become a common model for contemporary clinicians engaged in what has emerged as a new discipline of global health or global medicine, and these narratives give us a glimpse of some of the enduring, as well as newly emerging, forms of moral practice and ethical dilemmas characteristic of today's global medicine.Many of these stories are filled with the tension and pathos that makes clinical narratives powerful to read. Physicians are forced to make unfathomable decisions about whether to resuscitate and keep a baby alive, using all means available, or to let the infant die, whether to carry out a procedure that will save an infant in birth but would put the mother at risk, about how to deal with a cancer found in a very advanced state. However, virtually all of the stories transcend these classical stories of the decisions physicians are forced to make by being placed in settings of great scarcity of resources, which stand in particular contrast to the academic medical settings in North America or Europe where many of these global medicine specialists have trained and many continue to practice. The unspeakable inequality of resources emerges throughout these narratives as a kind of master theme, as the underlying moral, as opposed to plot, which gives meaning and sense to the stories. For those who practice medicine in such settings, global inequalities and scarcity of medical resources are deeply felt. They produce the rage that Jeffrey Deal describes. ("I learned to despise American churches during that time, a time when my world encompassed a dying newborn in Sudan, as well as the air conditioned padded seats [End Page 121] of our affluent suburban church.") They produce the distinctive experiences of helplessness and pain felt by clinicians who cannot separate how they would be able to treat such a patient at home from how they have to practice in these settings. For those clinicians working in their own societies, scarcity of resources often produces deep anger at the corrupt governments that fail to support basic human services for the great majority of their population. ("We were temporary actors performing in the cynical play of scarcity on permanent display in Port-au-Prince," writes Haitian physician Paul Pierre about his experience prior to joining Partners in Health.)But for those who regularly travel back and forth across the divide between rich and poor, whether across national boundaries or within their own society, the challenge to live a moral life is unendingly complicated. While becoming a part of a struggle for global justice with colleagues and advocates from both sides of the divide, few of the narrators can avoid personal feelings of ambivalence and guilt at being able to easily move from one side of that divide to the other back home. Many fantasize about giving up their lives in the north to devote themselves... (shrink)

This article provides an ethical critique of the Good Clinical Practice (GCP) and Declaration of Helsinki (DoH) documents. While the previous criticisms of GCP are entirely correct, there is much more wrong with the document than has previously been acknowledged, including a circular definition and an astonishing vagueness about ethical principles. In addition to its failure to provide adequate ethical protection of participants, the procedurally dense nature of GCP lends itself to a box-ticking culture where important ethical (...) issues are overlooked because they are not ‘mentioned on the form’. In contrast, the DoH is a much more effective ethical document, but actually goes too far in one respect. It transpires that the best ethical guidelines for clinical research would be neither over-prescriptive in regard to particular ethical issues (as the DoH is) nor neglectful of them (as GCP is); correctly framed ethical principles will provide sufficient protection to participants while also ensuring a culture of ethicovigilance in clinical trials. (shrink)

This paper is an empirical inquiry into the nature of human communication and understanding. It is organized into three sections. First, there is an overview of the ethnomethodological critique of mainstream social scientific research methodology and the relevance of this critique to clinical behavioral research. Second, the details of an ethnomethodological study of communication practices in a family with an alingual, deaf-blind child are provided. Third, implications of the case study are presented.

Although science supplies medicine's “gold standard,” knowledge exercised in the care of patients is, like moral knowing, a matter of narrative, practical reason. Physicians draw on case narrative to store experience and to apply and qualify the general rules of medical science. Literature aids in this activity by stimulating moral imagination and by requiring its readers to engage in the retrospective construction of a situated, subjective account of events. Narrative truths are provisional, uncertain, derived from narrators whose standpoints are always (...) situated, particular, and uncertain, but open to comparison and reinterpretation. Reading is thus a model for knowing in both morality and clinical medicine. While principles remain essential to bioethics and science must always inform good clinical practice, the tendency to collapse morality into principles and medicine into science impoverishes both practices. Moral knowing is not separable from clinical judgment. While ethics must be open to discussion and interpretation by patients, families, and society, it is nevertheless substantively and epistemologically an inextricable part of a physician's clinical practice. (shrink)

Models for clinical ethics case consultation often make reference to ‘balancing’ or ‘weighing’ moral considerations, without further detail. In this paper, we investigate balancing in clinical ethics case consultation. We suggest that, while clinical ethics services cannot resolve ongoing deep philosophical debates about the nature of ethical reasoning, clinical ethicists can and should be more systematic and transparent when balancing considerations in case consultations. We conceptualise balancing on a spectrum from intuitive to deliberative, and argue that (...) good balancing in case consultation involves articulating reasons for giving something more or less weight. We develop a framework of four practical strategies for better balancing in clinical ethics case consultation: intuitions as a launchpad, drilling down, pairwise comparison and group deliberation. (shrink)

The goal of this article is to present a first list of ethical concerns that may arise from research and personal use of virtual reality (VR) and related technology, and to offer concrete recommendations for minimizing those risks. Many of the recommendations call for focused research initiatives. In the first part of the article, we discuss the relevant evidence from psychology that motivates our concerns. In Section “Plasticity in the Human Mind,” we cover some of the main results suggesting that (...) one’s environment can influence one’s psychological states, as well as recent work on inducing illusions of embodiment. Then, in Section “Illusions of Embodiment and Their Lasting Effect,” we go on to discuss recent evidence indicating that immersion in VR can have psychological effects that last after leaving the virtual environment. In the second part of the article, we turn to the risks and recommendations. We begin, in Section “The Research Ethics of VR,” with the research ethics of VR, covering six main topics: the limits of experimental environments, informed consent, clinical risks, dual-use, online research, and a general point about the limitations of a code of conduct for research. Then, in Section “Risks for Individuals and Society,” we turn to the risks of VR for the general public, covering four main topics: long-term immersion, neglect of the social and physical environment, risky content, and privacy. We offer concrete recommendations for each of these 10 topics, summarized in Table 1. (shrink)

This project is a philosophical analysis of the practice of bioethics consultation---what might be called the philosophy of bioethics. It assesses claims made about the purposes and appropriate aims of the field, in order to establish whether an identifiable conceptual unity underlies the practice. The conclusion is that no such unity exists. ;The project begins by assessing the history of the field, in the hope that a historical analysis will explain why the field arose at all, which reason (...) could then be used as a basis for claiming a particular purpose for bioethics consultation. However, it becomes clear that history has bequeathed diverse and sometimes conflicting goals to bioethics consultation. History suggests that the field exists both as a service to physicians and as a service to patients, though the interests of these two parties may be in tension. ;This work also assesses contemporary accounts of bioethics consultation and shows that they are radically divergent and incommensurable, in addition to often being too vague to guide the practice. An investigation of possible philosophical arguments regarding bioethics consultation also fails to disclose a single coherent foundation for the field. The project ends with a conceptual geography of twelve possible roles a bioethics consultant may play, and finds that though some are in tension, none may be ruled out of court on independent grounds in the absence of an overarching account of the appropriate aims of the field. ;What this project demonstrates is that there is no conceptual unity underlying the practice of bioethics consultation. Instead, the enterprise must be understood as comprised of a plurality of roles serving a diversity of purposes and a heterogeneity of goods with no single uniting purpose. (shrink)

In an age of professionalization and specialization, the practice of clinical ethics is facing an identity crisis. Are clinical ethicists moral experts, ethics experts, or merely quasi-lawyers giving legal advice? Are they extensions of the hospital, always working to advance the hospital’s interests? Or is there another option? Since 1998, when the American Society for Bioethics and Humanities first issued its Core Competencies for Healthcare Ethics Consultation, there has been debate about the role of standardization and proceduralism (...) in clinical ethics consultation. Now, as ASBH continues to move forward with its credentialing program, proceduralism in clinical ethics must be critically examined. In this paper, I argue that the proceduralist approach to clinical ethics consultation, as espoused by the ASBH’s call for credentialing, creates a demeaning experience for all parties involved and precludes goods internal to the practice of clinical ethics consultation from being actualized. As a practice embedded in medicine and in institutions such as the hospital, clinical ethics consultation must define and examine its own goods in order to bring about more than a sterile, law-like solution to difficult moral quandaries, as these sterile solutions leave patients, families, and providers unsatisfied, abandoned, and disappointed. Thus, in an effort to push back against this proceduralism in clinical ethics consultation, I will offer a preliminary exploration of what these goods might be. (shrink)

Healthcare organizations and workers are under pressure to produce increasingly complete and accurate data for multiple data-intensive endeavors. However, little research has examined the emerging occupations arising to carry out the data work necessary to produce “improved” data sets, or the specific work activities of these emerging data occupations. We describe the work of Clinical Documentation Integrity Specialists, an emerging occupation that focuses on improving clinical documentation to produce more detailed and accurate administrative datasets crucial for evolving data-intensive (...) forms of healthcare accountability, management, and research. Using ethnographic methods, we describe the core of CDIS’ work as a translation practice in which the language, interests, and concerns of clinicians and clinical documentation are translated via real-time “nudging” and ongoing education of clinicians into the language, interests, and concerns of medical coders, structured administrative datasets, and the various stakeholders of these datasets. Further, we show how the institutional context of CDIS’ work shapes the occupational virtues that guide CDIS’ translation practice, including financial reimbursement, quality measures, clinical accuracy, and protecting clinician’s time. Despite the existence of these multiple virtues, financial reimbursement is the most prominent virtue guiding CDIS’ limited attention. Thus, overall clinical documentation is “improved” in specific, partial ways. This research provides one of the first studies of the emergent data work occupations arising in the wake of digitization and big data opportunities, and shows how local data settings shape large scale data in specific ways and thus may influence outcomes of analyses based on such data. (shrink)

Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article, we share the experience of on-site monitoring of clinical trials by the Ethics Committee of a tertiary care, academic and research centre in India. We (...) found a large number of shortcomings in the areas of informed consent, adverse events, insurance and reimbursement, which would not have been detected by off-site document review. Interestingly, many shortcomings were also not detected by on-site monitoring arranged by clinical trial sponsors. We therefore conclude that on-site monitoring of ongoing clinical trials is a highly important activity for Indian Ethics Committees. (shrink)

Nurses and ethicists worry that the implementation of care at a distance or telecare will impoverish patient care by taking out ‘the heart’ of the clinical work. This means that telecare is feared to induce the neglect of patients, and to possibly hinder the development of a personal relation between nurse and patient. This study aims to analyse whether these worries are warranted by analysing Dutch care practices using telemonitoring in care for chronic patients in the Netherlands. How do (...) clinical practices of nursing change when telecare devices are introduced and what this means for notions and norms of good nursing? The paper concludes that at this point the practices studied do not warrant the fear of negligence and compromised relations. Quite the contrary; in the practices studied, telecare lead to more frequent and more specialised contacts between nurses and patients. The paper concludes by reflecting on the ethical implications of these changes. (shrink)

Nursing as a profession has a social mandate to contribute to the good of society through knowledge-based practice. Knowledge is built upon theories, and theories, together with their philosophical bases and disciplinary goals, are the guiding frameworks for practice. This article explores a philosophical perspective of nursing's social mandate, the disciplinary goals for the good of the individual and society, and one approach for translating knowledge into practice through the use of a middle-range theory. It (...) is anticipated that the integration of the philosophical perspective and model into nursing practice will strengthen the philosophy, disciplinary goal, theory, and practice links and expand knowledge within the discipline. With the focus on humanization, we propose that nursing knowledge for social good will embrace a synthesis of the individual and the common good. This approach converges vital and agency needs described by Hamilton and the primacy of maintaining the heritage of the good within the human species as outlined by Maritain. Further, by embedding knowledge development in a changing social and health care context, nursing focuses on the goals of clinical reasoning and action. McCubbin and Patterson's Double ABCX Model of Family Adaptation was used as an example of a theory that can guide practice at the community and global level. Using the theory-practice link as a foundation, the Double ABCX model provides practising nurses with one approach to meet the needs of individuals and society. The integration of theory into nursing practice provides a guide to achieve nursing's disciplinary goals of promoting health and preventing illness across the globe. When nursing goals are directed at the synthesis of the good of the individual and society, nursing's social and moral mandate may be achieved. (shrink)

ABSTRACT This article presents an overview of the Portuguese transposition of the European Directive on Good Clinical Practice (2001/20/e) concerning scientific and academic debates on bioethics and clinical investigation. Since the Directive was transposed into Portuguese law by its National Assembly, the bureaucracy of clinical trials has been ever more complex. Despite demands for swift application processes by the Pharmaceutical industry, supported by the European Parliament, the Directive's transcription to the national law has not always (...) delivered the expected outcome. However, this has led to an increased number of applications for clinical trials in Portuguese hospitals. In this article I revise bioethical publications and decree‐laws enabling an informed appraisal of the anxieties and prospects for the implementation of the clinical trials Directive in Portugal. This article also places the European Directive in the field of sociology of bioethics, arguing that Portuguese bioethical institutions differ from those of the US, and also from Northern European counterparts. The main divergence is that those people in Portugal who claim expertise in ‘legal’ bioethics do not dominate either the bureaucratic structure of research or ethics committees for health. Even experts in the applied ethics field now claim that ‘professional bioethicists do not exist’. The recent creation of a national Ethics Committee for Clinical Investigation (CEIC) in line with the European Directive on Good Clinical Practice (GCP) will not change the present imbalance between different professional jurisdictions in the national bioethical debate in Portugal. (shrink)

BackgroundThere is growing interest in the collection, storage and reuse of biological samples for future research. Storage and future use of biological samples raise ethical concerns and questions about approaches that safeguard the interests of participants. The situation is further complicated in Africa where there is a general lack of governing ethical frameworks that could guide the research community on appropriate approaches for sample storage and use. Furthermore, there is limited empirical data to guide development of such frameworks. A qualitative (...) study to address this gap was conducted with key stakeholders in Malawi to understand their experiences and perspectives regarding storage and usage of samples for future research.MethodsThis study conducted 13 in-depth interviews with ethics committee members, regulators and researchers, and five focus group discussions with community representatives and clinical trial participants in Malawi. Interviews and focus group discussions were audio-recorded, transcribed verbatim, and thematically analysed.ResultsOn the current regulatory guidelines that governs the collection, storage and reuse of samples in Malawi, participants highlighted their different understanding of it, with some indicating that it prohibited the reuse and sharing of samples, while others believed it permitted.Views on the informed consent model used in Malawi, some stakeholders expressed that the current model limited options for sample contributors regarding future use. Researchers supported storing samples for future use in order to maximize their value and reduce research costs. However, they expressed concern over the exportation of samples highlighting that it could lead to misuse and would not support the development of research capacity within Malawi. They recommended use of broad consent or tiered consent and establishment of biobanks to address these concerns.ConclusionsStudy findings highlighted the need for a review of the current regulatory guideline and the development of infrastructure to support the use of stored biological samples for future use among the research community in Malawi. At the moment, there are ethical and practical concerns arising from the collection, storage and secondary use of biological samples make it hard to reconcile scientific progress and the protection of participants. (shrink)

When discussing the safety of research subjects, including their exploitation and vulnerability as well as failures in clinical research, recent commentators have focused mostly on countries with low or middle-income economies. High-income countries are seen as relatively safe and well-regulated. This article presents irregularities in clinical trials in an EU member state, Poland, which were revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many European Union regulations, including European Commission directives concerning Good (...) class='Hi'>Clinical Practice, these irregularities occurred. Causes as well as potential solutions to make clinical trials more ethical and safer are discussed. (shrink)

Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients’ to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, (...) Good Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants’ consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant’s consent in emergency research exist and the regulations on surrogate consent of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should become a large part of important public health priorities. (shrink)

Clinical ethics support for health care professionals and patients is increasingly seen as part of good health care. However, there is a key drawback to the way CES services are currently offered. They are often performed as isolated and one-off services whose ownership and impact are unclear. This paper describes the development of an integrative approach to CES at the Center of Expertise and Care for Gender Dysphoria at Amsterdam University Medical Center. We specifically aimed to integrate CES (...) into daily work processes at the CEGD. In this paper, we describe the CES services offered there in detail and elaborate on the 16 lessons we learned from the process of developing an integrative approach to CES. These learning points can inform and inspire CES professionals, who wish to bring about greater integration of CES services into clinical practice. (shrink)

BackgroundClinical ethical practice (CEP) is required for healthcare workers (HCWs) to improve health-care delivery. However, there are gaps between accepted ethical standards and CEP in Ethiopia. There have been limited studies conducted on CEP in the country. Therefore, this study aimed to determine the magnitude and associated factors of CEP among healthcare workers in healthcare facilities in Ethiopia.MethodFrom February to April 2021, a mixed-method study was conducted in 24 health facilities, combining quantitative and qualitative methods. Quantitative (survey questionnaire) and (...) qualitative (semi-structured interviews) data were collected. For quantitative and qualitative data analysis, Stata version 14 and Atlas.ti version 7 were utilized. Multiple logistic regression and thematic analysis for quantative and qualitative respectively used.ResultsFrom a total of 432 study participants, 407 HCWs were involved in the quantitative analysis, 36 participants were involved in five focus group discussions (FGDs), and eleven key informant interviews (KIIs) were involved in the qualitative analysis. The score of good CEP was 32.68%. Similarly, the scores of good knowledge and attitude were 33.50% and 25.31%, respectively. In the multiple logistic regression models, satisfaction with the current profession, availability of functional CECs, compassionate leaders, previously thought clinical ethics in pre-service education and good attitude were significant factors associated with CEP. Among these significant factors, knowledge, compassionate leaders, poor infrastructure, a conducive environment and positive attitudes were also determinants of CEP according to qualitative findings.ConclusionsThe CEP in health care services in Ethiopia is low. Satisfaction with the current profession, functional CECs, positive attitude, compassionate leaders and previously thought clinical ethics were significant factors associated with CEP. The Ministry of Health (MoH) should integrate interventions by considering CECs, compassionate leadership, and positive attitudes and enhance the knowledge of health professionals. Additionally, digitalization, intersectoral collaboration and institutionalization are important for promoting CEP. (shrink)

Clinical ethics support (CES) for health care professionals and patients is increasingly seen as part of good health care. However, there is a key drawback to the way CES services are currently offered. They are often performed as isolated and one-off services whose ownership and impact are unclear. This paper describes the development of an integrative approach to CES at the Center of Expertise and Care for Gender Dysphoria (CEGD) at Amsterdam University Medical Center. We specifically aimed to (...) integrate CES into daily work processes at the CEGD. In this paper, we describe the CES services offered there in detail and elaborate on the 16 lessons we learned from the process of developing an integrative approach to CES. These learning points can inform and inspire CES professionals, who wish to bring about greater integration of CES services into clinical practice. (shrink)

Research ethics is a very exciting field at the moment. Important public debate is continuing at national and international levels, concerning the proposed revisions to the Declaration of Helsinki and the Council for the International Organisation of Medical Sciences (CIOMS) guidelines, the proposed European clinical trials directive and the recent Good Clinical Practice guidelines. There is also debate about obtaining, using and storing genetic, and tissue, samples. This ferment has resulted in a wealth of guidelines and (...) learned articles, but as yet there are few useful and up-to-date book-length discussions of the field. This is partly due to the increasing diversity of types of research (including research design), and the variety of the contexts of research (the hospital-based clinical trial is arguably no longer typical of medical research). However, it is also to do with what such a book is supposed to do. Recent works like Baruch Brody's Ethics of Biomedical Research (OUP, 1998) give, in effect, an …. (shrink)

Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication (...) of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process. (shrink)

Health checks identify disease in people without symptoms. They may be offered by the government through population screenings and by other providers to individual users as ‘personal health checks’. Health check providers’ perspective of ‘good’ health checks may further the debate on the ethical evaluation and possible regulation of these personal health checks. In 2015, we interviewed twenty Dutch health check providers on criteria for ‘good’ health checks, and the role these criteria play in their practices. Providers unanimously (...) formulate a number of minimal criteria: Checks must focus on treatable/preventable disease; Tests must be reliable and clinically valid; Participation must be informed and voluntary; Checks should provide more benefits than harms; Governmental screenings should be cost-effective. Aspirational criteria mentioned were: Follow-up care should be provided; Providers should be skilled and experienced professionals that put the benefit of users first; Providers should take time and attention. Some criteria were contested: People should be free to test on any disease; Health checks should only be performed in people at high risk for disease that are likely to implement health advice; Follow up care of privately funded tests should not drain on collective resources. Providers do not always fulfil their own criteria. Their reasons reveal conflicts between criteria, conflicts between criteria and other ethical values, and point to components in the organisation of health care that hinder an ethical provision of health checks. Moreover, providers consider informed consent a criterion that is hard to establish in practice. According to providers, personal health checks should meet the same criteria as population screenings, with the exception of cost-effectiveness. Providers do not always fulfil their own criteria. Results indicate that in thinking about the ethics of health checks potential conflicts between criteria and underlying values should be explicated, guidance in weighing of criteria should be provided and the larger context should be taken into account: other actors than providers need to take up responsibility, and ideally benefits and harms of health checks should be weighed against other measures targeting disease. (shrink)

Over the last decade, standards for when and how to undertake a wide range of medical interventions have poured forth from medical specialty groups, commercial and nonprofit organizations, and state and federal panels. Known by a variety of names—from practice parameters to clinical guidelines—and intended for a range of purposes—from diminishing the incidence of maloccurences in hospitals to cutting the costs of health care—these guidelines share one important feature: the intention of decreasing the range of variation in medical (...) practice. Such standardization immediately appeals to anyone interested in improving the quality of health care and, in particular, reducing inappropriate medical interventions, in light of the difficulties for a conscientious physician today in adhering to the best standard of practice when faced with ever increasing medical knowledge and the growing number and complexity of diagnostic, preventive, and therapeutic interventions. (shrink)

The aim of this study was to get a deeper understanding of student nurses’ experiences of personal caring ethics by reflection on caring encounters with patients in clinical practice, ethical caring ideals, ethical problems, and sources for inner strength that give courage to practice good caring. In all, 24 Scandinavian student nurses participated voluntarily in an interview study. The interviews were analyzed within a phenomenological–hermeneutical approach and revealed three themes. The students found themselves in two different (...) states of vulnerability: one in which they were overwhelmed by their vulnerability and began to suffer themselves and the other where their vulnerability became a source of development with focus on the patient. The students’ ethical caring ideals served as fixed reference points in their ethical development, but their ideals were at risk of decline. The students reflected on the barriers for performing ethical care and nurtured their ethical ideals by providing ethical care in secret. Caring in secret occurred also when student nurses did not experience a shared ethos. (shrink)

Evidence, as viewed through the lens of statistical significance, is not always as it appears! In the investigation of clinical research findings arising from statistical analyses, a fundamental initial step for the emerging fraud detective is to retrieve the source data for cross-examination with the study data. Recognizing that source data are not always forthcoming and that, realistically speaking, the investigator may be uninitiated in fraud detection and investigation, this paper will highlight some key methodological procedures for providing a (...) sounder evidence base for withdrawing from a study on grounds of integrity. The promotion of patient safety is paramount. However, there is a broader rationale for disseminating these ideas. This includes empowering researchers to optimize their personal integrity, make informed choices regarding membership of future research collaborations and successfully voice their concerns to journal editors, particularly where a conflict of interests can render such dialogues particularly difficult. Recommendations will be supported by topical case studies and practical steps involving data exploration, testing of baseline data and application of Benford’s Law. While this paper has a clinical focus, the advice provided is transferrable to a wide range of multidisciplinary research settings outside of Medicine. (shrink)

Most writing on informed consent in Africa highlights different cultural and social attributes that influence informed consent practices, especially in research settings. This review presents a composite picture of informed consent in Nigeria using empirical studies and legal and regulatory prescriptions, as well as clinical experience. It shows that Nigeria, like most other nations in Africa, is a mixture of sociocultural entities, and, notwithstanding the multitude of factors affecting it, informed consent is evolving along a purely Western model.Empirical studies (...) show that 70–95% of Nigerian patients report giving consent for their surgical treatments. Regulatory prescriptions and adjudicated cases in Nigeria follow the Western model of informed consent. However, adversarial legal proceedings, for a multiplicity of reasons, do not play significant roles in enforcing good medical practice in Nigeria. Gender prejudices are evident, but not a norm. Individual autonomy is recognized even when decisions are made within the family. Consent practices are influenced by the level of education, extended family system, urbanization, religious practices, and health care financing options available. All limitations notwithstanding, consent discussions improved with increasing level of education of the patients, suggesting that improved physician's knowledge and increasing awareness and education of patients can override other influences.Nigerian medical schools should restructure their teaching of medical ethics to improve the knowledge and practices of physicians. More research is needed on the preferences of the Nigerian people regarding informed consent so as to adequately train physicians and positively influence physicians’ behaviors. (shrink)

Ethics, communication skills, and the law ('practice skills') are important in all aspects of modern health care. Doctors and nurses must be sensitive to the ethical aspects of their work and understand the legal framework within which clinical decisions are made. Well developed skills of communication, with patients, their relatives and other members of the clinical team, are a key feature of good clinical practice Until recently, the important of practice skills has been (...) relatively neglected in health care education. This situation is changing. The UK General Medical Council, for example, has recently identified three aspects as part of the core of the medical course, and the move to degree courses in nursing has led to an increasing focus of practice skills in nurse education. The Oxford Practice Skills Project (OPSP) team have developed a course, within the University of Oxford Clinical School, which covers the teaching of practice skills in an integrated manner. This course is widely recognized as one of the most systematic developments of education in these areas. This manual describes the OPSP course in detail and provides teaching materials. Although developed initially for medical students, it should be helpful to all those involved in teaching ethics, communication skills, and law in health care. Each Seminar is described in detail Tutors' guides are provided Student handouts are included Contains guidelines for introducing 'practice skills' into a busy clinical curriculum Includes over forty case histories for teaching and examination Gives details of many useful sources and resources Details a variety of teaching methods together with their advantages and disadvantages Provides an ethics teaching toolkit for clinical teachers new to this area Readers are welcome to photocopy any part of this manual for their own teaching. (shrink)

It is generally accepted that appropriate documentation of activities and recommendations of ethics consultants in patients’ medical records is critical. Despite this acceptance, the bioethics literature is largely devoid of guidance on key elements of an ethics chart note, the degree of specificity that it should contain, and its stylistic tenor. We aim to provide guidance for a variety of persons engaged in clinical ethics consultation: new and seasoned ethics committee members who are new to ethics consultation, students and (...) trainees in clinical ethics, and those who have significant experience with ethics consultation so that they can reflect on their practice. Toward the goal of promoting quality charting practices in ethics consultations, we propose recommendations on a broad array of questions concerning clinical ethics consultation chart notes, including whether and when to write a chart note, and practical considerations for the tenor, purpose, and content of a chart note. Our broader aim is to promote discussion about good charting practices in clinical ethics, with the hope of contributing to clear standards of excellence in clinical ethics consultation. (shrink)

Children dependent on life-prolonging medical technology are often subject to a constant background risk of sudden death or catastrophic complications. Such children can be cared for in hospital, in an intensive care environment with highly trained nurses and doctors able to deliver specialised, life-saving care immediately. However, remaining in hospital, when life expectancy is limited, can considered to be a harm in of itself. Discharge home offers the possibility for an improved quality of life for the child and their family (...) but comes with significant medical risks.When making decisions for children, two ethical models predominate, the promotion of the child’s best interests or the avoidance of harm. However, in some circumstances, particularly for children with life-limiting and/or life-threatening illness, all options may be associated with risk. There are no good options, only potentially harmful choices.In this paper, we explore decisions made by one family in such circumstances. We describe a model adopted from risk management programmes beyond medicine, which offers a potential framework for identifying risks to the child that are morally permissible. Some risks and harms to a child, not ordinarily permitted, may be acceptable when undertaken in the pursuit of a specified desired good, so long as they are as low as reasonably practicable. (shrink)