This paper explores the conduct of performance appraisals of nurses in a New Zealand hospital, and how fairness is perceived in such appraisals. In the health sector, performance appraisals of medical staff play a key role in implementing clinical governance, which, in turn, is critical to containing health care costs and ensuring quality patient care. Effective appraisals depend on employees perceiving their own appraisals to be fair both in terms of procedure and interaction with their respective appraiser. We (...) examine qualitative data from interviews and focus groups, involving 22 nurses in a single department, to determine whether perceived injustices impact on the effective implementation of the appraisal system. Our results suggest that particular issues had been causing some sense of injustice, and most of these were procedural. Potential solutions focus on greater formalisation of the performance appraisal process, and more training for appraisers and appraisees. (shrink)

Background: After their attempts to have patient safety concerns addressed internally were ignored by wilfully blind managers, nurses from Bundaberg Base Hospital and Macarthur Health Service felt compelled to ‘blow the whistle’. Wilful blindness is the human desire to prefer ignorance to knowledge; the responsibility to be informed is shirked. Objective: To provide an account of instances of wilful blindness identified in two high-profile cases of nurse whistleblowing in Australia. Research design: Critical case study methodology using Fay’s Critical Social Theory (...) to examine, analyse and interpret existing data generated by the Commissions of Inquiry held into Bundaberg Base Hospital and Macarthur Health Service patient safety breaches. All data was publicly available and assessed according to the requirements of unobtrusive research methods and secondary data analysis. Ethical considerations: Data collection for the case studies relied entirely on publicly available documentary sources recounting and detailing past events. Findings: Data from both cases reveal managers demonstrating wilful blindness towards patient safety concerns. Concerns were unaddressed; nurses, instead, experienced retaliatory responses leading to a ‘social crisis’ in the organisation and to whistleblowing. Conclusion: Managers tasked with clinical governance must be aware of mechanisms with the potential to blind them. The human tendency to favour positive news and avoid conflict is powerful. Understanding wilful blindness can assist managers’ awareness of the competing emotions occurring in response to ethical challenges, such as whistleblowing. (shrink)

In the latest reform of the National Health Service great emphasis has been placed on the achievement and maintenance of quality. Mechanisms for ensuring this are being set up under the general title of “clinical governance”. What is the meaning of this term? The metaphor behind the phrase is of navigation through stormy seas, but who guides the helmsman? Clinical ethics committees could have a part to play in these changes, provided their role is properly understood. (...) class='Hi'>Clinical governance is concerned with management according to an agreed set of aims. The task of ethics committees is Socratic rather than managerial. They should ask fundamental questions about the ethical norms of the services provided and give critical appraisal of the moral character of institutional policies. If these tasks are carried out then governance may become a watchword rather than just another buzzword. (shrink)

Traditionally, medical professionals have taken a paternalistic stance towards their patients and have relied on a traditional approach to medical ethics. In recent years, in Britain, however, a new ‘managerialism’ has developed in the National Health Service (the NHS). This stresses consumerism and greater patient choice and is changing the relationship between doctors and patients. This paper draws out the implications for patients. It describes the ethical characteristics of the two conflicting approaches and argues the need to stress again the (...) view of the patient as an individual person. (shrink)

In the United Kingdom, clinical governance has become a master narrative for health care over the last decade. While many see this political imperative as embodying both enlightening and humanistic goals, I argue that it has also become an apparatus for resuscitating a hypermodernist worldview which further conceals the political drivers of health care delivery. While resistance to clinical governance seems futile, insistence on the inclusion of historical analysis in understanding modern health care delivery may be (...) profitable. Drawing from selected dramatic texts by Henrik Ibsen, an historical moment of clinical governance may be analysed showing the complex interplay of the personal, social, empirical and ethical dimensions of health care delivery. (shrink)

Biobanking, the large-scale, systematic collection of data and tissue for open-ended research purposes, is on the rise, particularly in clinical research. The infrastructures for the systematic procurement, management and eventual use of human tissue and data are positioned between healthcare and research. However, the positioning of biobanking infrastructures and transfer of tissue and data between research and care is not an innocuous go-between. Instead, it involves changes in both domains and raises issues about how distinctions between research and care (...) are drawn and policed. Based on an analysis of the emergence and development of clinical biobanking in the Netherlands, this article explores how processes of bio-objectification associated with biobanking arise, redefining the ways in which distinctions between research and clinical care are governed. (shrink)

Acentral promise of human embryonic stem cell research is the potential to develop viable therapeutic approaches to a range of devastating diseases and conditions. Despite excitement over such advances, there are scientific and medical reasons to be cautious as stem cells and their products are introduced into patients. In response to such concerns, the International Society for Stem Cell Research as well as ad hoc groups and individuals have offered approaches to governance of this research. While there are similarities (...) among these governance models and they are in principle easily endorsable, in this paper I raise a set of concerns related to their implementation, suggesting areas where gathering data may facilitate more appropriate oversight. Next, I suggest areas that seem to have been neglected as these governance models have been developed so that they may be on the agendas of those seeking to revise these models in the future. Finally, I describe how some of the concerns that have arisen in considering the appropriate governance of stem cell research may be useful in science and translational research more broadly. (shrink)

The history of drug/vaccine development has included major advances guided primarily by risk/benefit analyses concerning the innovative agent, not by evidence-based clinical trials (Phase I–IV). Because the approval for new drugs is hindered under the present process, the system requires restructuring. The Phase I/II study period should be more flexible, using the “environment of knowledge” about the new agent, plus risk/benefit assessments. Phase III, as presently constructed, does not add new adverse events data, it provides a narrower profile of (...) drug efficacy than properly done Phase II studies, and placebo-controlled trials continue to raise unresolved ethical and social issues. Phase III studies should be abandoned for most drugs, and substituted with properly powered Phase II doseranging studies plus careful post-marketing surveillance. Phase III should be a penalty for poor drug development, not a regulatory requirement. (shrink)

The relationship between the ethical standards for the governance of clinical trials and market forces can be complex and problematic. This article uses India as a case study to explore this nexus. From the mid-2000s, India became a popular destination for foreign-sponsored clinical trials. The Indian government had sought to both attract clinical trials and ensure these would be run in line with internationally accepted ethical norms. Reports of controversial medical research, however, triggered debate about the (...) robustness and suitability of India's regulatory system. In response to civil society pressure and interventions by the Supreme Court, the Indian government proposed additional measures aimed at strengthening protections for clinical trial participants. Whilst the reforms can be seen as a victory for human rights activists, they have also been criticised as being overly burdensome for sponsors. Indeed, their announcement prompted an exodus of clinical trials from India. Fearful of losing business to ‘rival’ countries, the Indian government is revisiting some of its proposals. The Indian example suggests that research ethics frameworks and national policies for economic development are increasingly intertwined. Host countries are in theory free to improve the lot of research participants, but doing so may make them appear less attractive to foreign sponsors, who can simply shift their activities to more industry-friendly jurisdictions. Although these economic pressures are unlikely to lead to a regulatory ‘race to the bottom’, they may limit host countries' ability to enact socially desirable reforms. (shrink)

At least since the seminal work of the (US) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s, a fundamental distinction between research and practice has underwritten both conceptual work in research ethics and regulations governing research involving human subjects. Notwithstanding its undoubted historical importance, I believe the distinction is problematic because it misrepresents clinical inquiry. In this essay, I aim to clarify the character of clinical inquiry by identifying crucial contextual (...) constraints on justification constitutive of clinical science. This analysis shows that, from an epistemological point of view, clinical research and clinical practice are not sharply distinct but intimately intertwined. This result is important in its own right—an enriched understanding of the epistemology of clinical research is valuable in and of itself. But this result is also important because it has profound implications for the ethics of human subjects research. (shrink)

Clinical trials are a central mechanism in the production of medical knowledge. They are the gold standard by which such knowledge is evaluated. They are widespread both in the United States and internationally; a National Institute of Health database reports over 106,000 active industry and government-sponsored trials (National Institutes of Health n.d.). They are an engine of the economy. The work of trials is complex; multiple people with diverse interests working across multiple settings simultaneously participate in them, and they (...) are underwritten by multiple organizational structures and diverse funding mechanisms. In the past several years, concern about the ethics of clinical trials has spiked dramatically .. (shrink)

Background This article describes the issues encountered when designing a study to evaluate recruitment of minority ethnic groups into clinical cancer research in order to monitor adherence to the principles for good practice set out in the Department of Health, Research Governance Framework, England. Methods (i) A review of routine data sources to determine whether their usefulness as a source of data on prevalence of cancer in the population by ethnic category. (ii) A local case study at one (...) hospital trust to ascertain whether the ethnicity of cancer trial participants was representative of admitted cancer patients. Results (i) The lack of a comparator population makes it problematic to assess recruitment levels by ethnic group in clinical research. (ii) The odds of being in a trial were 30% lower for a member of a minority ethnic group compared to a white cancer patient after adjusting for disease, age and gender, OR 0.70 (0.53 to 0.94). These results differed for each ethnic group; Asian patients did not appear under-represented while Black and Chinese did so. However, there are important caveats to the findings based on the limited recording of ethnicity. Conclusions The lack of available data on the ethnicity of participants in clinical research and the prevalence of cancer in the population according to ethnicity makes it difficult to design a study to monitor representation of minority ethnic groups. This information is necessary to assess adherence to the Research Governance Framework principle that research evidence reflects the diversity of the population. (shrink)

To succeed, an accreditation process for clinical ethics fellowship programs (CEFPs) would need support from CEFP directors. To assess CEFP directors’ opinions, we surveyed all 36 CEFP directors in the United States and Canada, achieving a 100% response rate. We found that support for accreditation is strong, with 30.6% strongly supportive, 44.4% supportive, 22.2% neutral, 2.8% opposed, and 0% strongly opposed. Most directors (77.8%) would be likely to apply for accreditation within the next five years regardless of the availability (...) of government funding; even more (86.1%) would apply if government funding became available for accredited programs. Most directors thought that lack of a national accreditation process (75.0%), lack of agreed-upon standards (90.0%), and lack of funding for CEFPs (91.7%) were at least moderate problems for the field. When directors were asked what they thought was the greatest challenge or barrier to developing an accreditation process, many mentioned the diversity of programs and the challenge of achieving consensus on accreditation standards. Directors offered a variety of suggestions for how to overcome or manage challenges or barriers, including collecting data on existing programs, mirroring standards established for other health professions, and setting clear expectations on the need for compromise. When directors were asked how they expected that accreditation and government funding would affect their own programs, the field of clinical ethics, and patient care, directors mostly had very positive expectations; no director expected negative effects in any of these areas. Overall, this study provides evidence that developing an accreditation process for CEFPs would be both possible and desirable. Our findings have immediate practical implications for the field and will inform efforts that are already underway to establish an accreditation process for CEFPs. (shrink)

The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the (...) different steps including the registration of the trial in the European database; the preparation of documents to be submitted and their contents; the preparation of documents related to the information and consent process; the submission to competent bodies. Specific issues related to paediatric research and trials involving non EU/EEA countries have been addressed as well. Results reveal that the European legislation offers a well defined set of European rules covering different aspects of a Clinical Trial Application. However, these are not suitable to meet the challenges from multicentre and multinational clinical studies. A stronger set of rules, such as is available in a composite European Regulation has been adopted and is expected to harmonise practices and enable sponsors to carry out well conducted trials. But will the new regulation overcome the existing criticisms of Directive 2001/20/EC? (shrink)

This study addresses the current lack of empirical data on the experiences and attitudes of clinical research professionals towards AI-powered clinical trial management tools. Clinical research professionals affiliated with various Swiss and international clinical research networks were invited to participate in an online survey. The survey focused on nine use cases of AI-powered clinical trial management tools. Participants were asked to share their ethical considerations, and their experiences were assessed at both the individual and institutional (...) levels. Answers from 110 participants, primarily from Swiss academic institutions, were included in the data analysis. While participants generally held positive attitudes, mixed views were also common. Governmental attitudes were widely perceived as unclear or cautious, with the associated regulatory opacity possibly contributing to the limited adoption of AI in trial management observed in this study. In addition to a clear AI governance, ethical compliance and training emerged as crucial aspects. There was also broad consensus on the necessity of informing patients about tools’ uses and of ensuring an independent certification of the respective tools. The widespread adoption of AI-powered clinical trial management tools remains distant, entangled in a net of complexities that require further empirical investigation. Ethical concerns appear to play a crucial role, driven by distrust and the absence of a clear regulatory framework. Urgent actions are needed at both institutional and governmental levels, including the establishment of a governance framework and training provision. (shrink)

The Belmont Report’s distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which (...) the whole exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. (shrink)

Drawing on the findings of a series of empirical studies undertaken with boards of directors and CEOs in the United States, this groundbreaking book develops a new paradigm to provide a structured analysis of ethical healthcare governance. Governance Ethics in Healthcare Organizations begins by presenting a clear framework for ethical analysis, designed around basic features of ethics - who we are, how we function, and what we do - before discussing the paradigm in relation to clinical, organizational (...) and professional ethics. It goes on to apply this framework in areas that are pivotal for effective governance in healthcare: oversight structures for trustees and executives, community benefit, community health, patient care, patient safety and conflicted collaborative arrangements. This book is an important read for all those interested in healthcare management, corporate governance and healthcare ethics, including academics, students and practitioners. (shrink)

This is a personal account of life in the United Kingdom National Health Service by a pathologist who has worked there for 25 years. The principles of clinical governance are embraced by the medical profession, but their application is often insensitive, governmental and bureaucratic. A doctor’s working life is now less autonomous, less centred on the patient and less fun. Medical humanities are a balm for the sore spots but not, I think, used consciously so by management, likely (...) suffering from the same bureaucratic governmentality that sees value in nothing–unless it can be measured. (shrink)

Mayo Clinic is recognized as a worldwide leader in innovative, high-quality health care. However, the Catholic mission and ideals from which this organization was formed are not widely recognized or known. From partnership with the Sisters of St. Francis in 1883, through restructuring of the Sponsorship Agreement in 1986 and current advancements, this Catholic mission remains vital today at Saint Marys Hospital. This manuscript explores the evolution and growth of sponsorship at Mayo Clinic, defined as “a collaboration between the Sisters (...) of St. Francis and Mayo Clinic to preserve and promote key values that the founding Franciscan sisters and Mayo physicians embrace as basic to their mission, and to assure the Catholic identity of Saint Marys Hospital.” Historical context will be used to frame the evolution and preservation of Catholic identity at Saint Marys Hospital; and the shift from a “sponsorship-by-governance” to a “sponsorship-by-influence” model will be highlighted. Lastly, using the externally-developed Catholic Identity Matrix (developed by Ascension Health and the University of St. Thomas, Minnesota), specific examples of Catholic identity will be explored in this joint venture of Catholic health care institution and a secular, nonprofit corporation (Mayo Clinic). (shrink)

Objective To obtain information about the similarities and differences in regulating different types of medical research in the European Union .Methods Web searches were performed from September 2009 to January 2011. Notes on pre-determined topics were systematically taken down from the web pages. The analysis relied only on documents and reports available on the web, reflecting the situation at the end of 2010.Results In several countries, regulatory legislation applied only to clinical trials on drugs and medical devices, in other (...) states various types of research were also regulated but by laws different from those concerning trials, and in many countries, some research areas were not controlled by legislation at all. In very few countries was all medical research handled similarly from a legal point of view. The number of research ethics committees in a single country varied from one to 264. Their areas of responsibility, working principles and length of time to grant research permission varied as well as the rules for obtaining informed consent from vulnerable groups. In 10 EU countries, there was no appeal mechanism after a negative decision by an REC. The RECs were not accountable to any organisation in five EU countries.Conclusions There is a need for a fundamental debate regarding whether and which kinds of changes are needed for the further harmonisation of medical research governance in the EU and how cross-country medical research could be facilitated in the future. (shrink)

Governments are increasingly making use of field experiments to evaluate policy interventions in the spheres of education, public health and welfare. However, the research ethics literature is largely focused on the clinical context, leaving investigators, institutional review boards and government agencies with few resources to draw on to address the ethical questions they face regarding such experiments. In this article, we aim to help address this problem, investigating the conditions under which informed consent is required for ethical policy research (...) conducted or authorized by government. We argue that investigators need not secure participants' informed consent when conducting government policy experiments if: the government institution conducting or authorizing the experiment possesses a right to rule over the spheres of policy targeted by the research; and data collection does not involve the violation of participants' autonomy rights. (shrink)

This volume explores how conceptions of pragmatism set forth in American philosophy serve as orienting perspectives in psychotherapy. Drawing on the influential contributions of William James and John Dewey, the author demonstrates how realistic, comparative approaches to understanding strengthen everyday therapeutic practice. He also examines recent developments in neuroscience that shape training and practice in the broader field of psychotherapy, encompassing psychodynamic, behavioral, cognitive and humanistic traditions. By following a clinical pragmatism, psychotherapy can be viewed as an instrumental project (...) that is governed by _results_ rather than a commitment to particular theoretical perspectives, empirical findings, or technical strategies. Through a variety of case studies, this volume emphasizes the crucial role of experiential learning in change and growth, and the recognition of the person as an individual. (shrink)

Background Although the importance of clinical ethics in contemporary clinical environments is established, development of formal clinical ethics services in the Australia health system has, to date, been ad hoc. This study was designed to systematically follow and reflect upon the first 18 months of activity by a newly established service, to examine key barriers and facilitators to establishing a new service in an Australian hospital setting. Methods: how the study was performed and statistical tests used A (...) qualitative case study approach was utilised. The study gathered and analysed data using observations of service committee meetings, document analysis of agendas and minutes, and semi-structured interviews with committee members to generate semantic themes. By interpreting the thematic findings in reference to national capacity building resources, this study also aimed to provide practice-based reflections for other health agencies. Results: the main findings An overarching theme identified in the data was a strong commitment to supporting clinicians facing difficult patient care decisions and navigating difficult discussions with patients and families. Another key theme was the role of the new clinical ethics support service in providing clinicians with a pathway to raise system-wide issues with the organisation Executive. While there was strong clinical engagement, consumer and community participation remained a challenge, as did unresolved governance issues and a need for clearer policy relationship between the service and the organisation. Conclusions: brief summary and potential implications Considering these themes in relation to the national capacity building resources, the study identifies three areas likely to require ongoing development and negotiation. These are: the role of the clinical ethics support service as a link between the workforce and the Executive; the incorporation of consumers and patients; and ethical reasoning. To improve the effectiveness of the service, it is necessary to increase clarity on the service’s role at the governance and policy level, as well as develop strategies for engaging consumers, patients and families. Finally, the capacity of the service to reflect on complex cases may be enhanced through explicit discussions of various different ethical frameworks and ways of deliberating. (shrink)

The day-to-day work of clinical ethics consultants and healthcare ethics committees can easily become overly routine. Too much routine, however, comes with a risk that morally important practices will be reduced to mere bureaucratic formalities, while practitioners become desensitized to ethically significant distinctions between cases. Clinical ethics consultation and organizational ethics must be set within the broader social and cultural context of the healthcare environment. This practice requires looking beyond mere legal compliance and the routinely false assumption that (...) there are unambiguous ethical norms that easily govern clinical ethics and hospital policy formation. Together the essays in this issue of HEC Forum challenge readers to rethink taken-for-granted assumptions regarding patient care, physician obligation, clinical ethics consultation, and organizational ethics. (shrink)

Mechanistic studies may be defined as ‘an experiment, using an intervention in healthy subjects or patients, to better understand human biology and/or disease’. Such studies provide useful physiological insights into clinical conditions in humans and expand our knowledge of physiology in health and disease. Well-planned mechanistic studies are therefore a vital step in progressing drug discovery in humans. It is important in such studies that the rights and safety of research participants are preserved, while at the same time not (...) allowing lengthy and complex approval procedures to stifle and potentially prohibit this type of research. (shrink)

Background. Informed consent (IC) is not only a regulatory but also an ethical requirement to participate in any clinical trial. It is essential to determine that research participants understand what they consent to. Studies that evaluate participants’ understanding of IC conclude that recall and understanding of IC is often low, and researchers recommend that interactive multimedia interventions should be implemented to optimise understanding. Objectives. To assess participants’ understanding of IC of the research trial that they agreed to participate in.Methods. (...) A descriptive survey design, within a quantitative research approach, was used to conduct the study at two government hospitals in the Eastern Cape Province. A semi-structured, self-administered questionnaire was used to collect information from 170 participants in research studies. Descriptive statistics were used to analyse the results.Results. Participants were recruited from among women who enrolled in any of the three studies that were ongoing at the two sites during the recruitment period. The study participants had a mean age of 25.9 years. Nearly one-third (30%) could not recall the purpose of the original trial that they consented to. The concept of randomisation was not understood by any of the participants.Conclusion. Regardless of extensive efforts to ensure that participants understood their participation, this study unveiled poor recall of essential information on IC. It is proposed that IC should be short and only address essential components such as purpose, procedure, possible risks or benefits, alternative options if not participating and explaining the concept of voluntary participation. (shrink)

In this book, scholars with different disciplinary and national backgrounds argue for possible answers and analyse case studies on current issues of governance in biomedical research. These issues comprise among others the research-care distinction, risk evaluation in early human trials, handling of incidental findings, nocebo effects, cluster randomized trials, publication bias, or consent in biobank research. This book demonstrates how new technologies and research possibilities multiply or intensify already known governance challenges, leaving room for ethical analysis and complex (...) moral choices. Clinical researchers, research ethics committee members and research ethicists have all to deal with such challenges on a daily basis. While general reflection on core concepts of research ethics is seldom pointless, those confronted with hard moral choices do need more practical and contextualized reflection on the said issues. This book particularly provides such contextualized reflections and aims to inform all those who study, conduct, regulate, fund, or participate in biomedical research. (shrink)

The Belmont Report was written by a US Commission charged by the US Congress to advise on research supported by the US government. Its focus was understandably domestic. In the 40 years since its publication, clinical research has become increasingly international. Many clinical trials have sites in multiple countries, and many of the host countries are relatively impoverished. Such research raises some distinctive ethical issues. This paper outlines some of the key ethical challenges that have been raised by (...) clinical research conducted in low- and middle-income countries (LMICs) and sponsored by high-income country (HIC) institutions. It then considers whether the Belmont Report has the resources to address these problems and argues that it does not. The article closes by noting some parallels between this international research and domestic US research, which suggest that the US might benefit from the discussions abroad. (shrink)

Calls for the inclusion of women in clinical trials raise the obvious question: why have sponsors excluded them? The answer most often given is one tragically evocative word: Thalidomide. The tragedies of the children born with seal limbs because their mothers took this over-the-counter sleeping pill and cure for morning sickness showed that, contrary to previous perceptions, the placenta could not be depended upon to filter out toxins before they reached the fetus. The specter of birth defects spawned sponsors’ (...) fears of a variety of catastrophes which contributed to closing the doors of clinical trials for women.This paper will not argue that the possibility of birth defects arising from the ingestion of an experimental drug does not exist. Sadly, scientists do not yet have the ability to predict which drugs will cause birth defects. Rather, it will argue that case law does not provide a basis for sponsor liability when a woman gives informed consent and the regulations governing clinical trials are followed. (shrink)

BackgroundInternational guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned.MethodsIt was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon (...) National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety.ResultsIn total, 106 clinical trial protocols were identified from 2173 protocols seen in the archive and 104 included for review. Seventy six trials did not include the surveillance of adverse events as part of their objective. A total of 91 protocols did not budget for adverse event surveillance, 76 did not have a data safety management board, 11 included insurance for participants, 47 did not include a case definition for serious adverse events, 33 described procedures to detect adverse events, 33 described procedure for reporting and 22 described procedure for investigating adverse events.DiscussionsMost clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols.ConclusionClinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee. (shrink)

Clinical research is increasingly ‘offshored’ to developing countries, a practice that has generated considerable controversy. It has recently been argued that the prevailing ethical norms governing such research are deeply puzzling. On the one hand, sponsors are not required to offshore trials, even when participants in developing countries would benefit considerably from these trials. On the other hand, if sponsors do offshore, they are required not to exploit participants, even when the latter would benefit from and consent to exploitation. (...) How, it is asked, can it be worse to exploit the global poor than to neglect them when exploitation is voluntary and makes them better off? The present article seeks to respond to this challenge. I argue that mutually beneficial and voluntary exploitation can be worse than neglect when — as is typically true of exploitative international research — it takes advantage of unjust background conditions. This is because, in such cases, exploitation overlaps with another, less familiar wrong: complicity in injustice. Recognising complicity as a distinct wrong should make us judge exchanges arising from background injustice more harshly than we typically do, in research and elsewhere. (shrink)

In this volume, leading scholars in ethics, theology, and health care address conscience and how it relates to Catholic health care. Topics addressed include end-of-life care, abortion, and sterilization. The book is particularly useful for ethics boards and chaplains in Catholic hospitals, especially those merging with non-Catholic chains.

This paper provides information on different training models within clinical neuropsychology in Finland. Systematic specialization training program began in Finland in 1983. It was first organized mainly by the Finnish Neuropsychological Society and since 1997 by the Finnish universities. At present, close to 400 clinical neuropsychologists have completed the training. The number of professionals still does not cover the needs of the country, and geographical disparities are a constant concern. The training models in Finland have changed over the (...) years and will continue to evolve. Specialization training can be organized by national societies or by universities. It can lead to an academic degree or a diploma. It can be linked to doctoral studies or form a parallel track. Financial model can involve student fees or be governed by ministries. This paper describes and compares different strategies in education that have impact on the output of professionals. One model does not fit all, or even one country at all times. The strategies of the stakeholder ministries can change over time. The experiences from Finland can be useful for other countries that are developing their models. The estimated need of practitioners and the educational resources including the available financial models for training differ between countries. The guiding principles in specialist training should focus on the advanced competencies expected from the neuropsychologist when entering the profession. (shrink)

This paper examines the UK’s response to a recent European Clinical Trials Directive, namely the Department of Health, Central Office for Research Ethics Committee guidance, Governance Arrangements for NHS Research Ethics Committees. The revisions have been long awaited by researchers and research ethics committee members alike. They substantially reform the ethical review system in the UK. We examine the new arrangements and argue that though they go a long way toward addressing the uncertainty surrounding ethics committee function, the (...) system favours the facilitation of research over the protection of the dignity and welfare of research participants. (shrink)

Recruitment processes for clinical trials are governed by guidelines and regulatory systems intended to ensure participation is informed and voluntary. Although the guidelines and systems provide some protection to potential participants, current recruitment processes often result in limited understanding and experiences of inadequate decision support. Many trials also have high drop-out rates among participants, which are ethically troubling because they can be indicative of poor experiences and they limit the usefulness of the knowledge the trials were designed to generate. (...) Drawing on recent social-psychological and philosophical-ethical research on trial recruitment and patient participation in treatment decision-making, this paper identifies possibilities for improving communicative support for both initial decisions and ongoing participation in clinical trials. It highlights the potential of a shift in thinking about ‘voluntariness’, underpinned by relational understandings of autonomy, to encourage more nuanced judgements about the ethics of communication between trial staff and (potential) participants. The paper suggests that the idea of responsively enabling people to consider invitations or requests to participate in particular trials could serve as a general guide to communication. This might help ensure decisions about trial participation are meaningfully informed and voluntary, and that relationships between trial staff and participants contribute to positive experiences of trial participation and ultimately to the generation of the robust knowledge. (shrink)

Due to their financial incentive, clinicians who earn income from a firm that markets medical devices, pharmaceuticals, tests, etc. might inappropriately prescribe their products or services. The Cleveland Clinic’s conflict of interest (CI) policy creates rules governing clinicians who accept compensation from outside firms that market products they prescribe or use in their practice (hereafter, covered financial relationships). The CI policy is implemented by the Innovation Management and Conflict of Interest Program (IM&COI) (hereafter the Committee).