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)

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)

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)

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)

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)

Governance models for the oversight of human embryonic stem cell research have been proposed which mirror in large part familiar oversight mechanisms for research with human subjects and non-human animals. While such models are in principle readily endorsable, there are a set of concerns related to their implementation — such as ensuring that an elaborated informed consent process and conducting long-term monitoring of research subjects are tenable — which suggest areas where gathering data may facilitate more appropriate oversight. In (...) addition, it is unclear whether a new governance model based at individual institutions are sufficient to address the ethical issues inherent to this research. Regardless, some of the concerns that have arisen in considering the appropriate governance of stem cell research, particularly the important translational pathway of innovation in contrast to staged research, transparency and publication, and social justice, may be useful in science and translational research more broadly. (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)

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)

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)

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)

In an increasingly litigious society where ritual demands for accountability and “taking responsibility” are now commonplace, it is not surprising that members of clinical ethics committees (CECs) are becoming more aware of their potential legal liability. Yet the vulnerability of committee members to legal action is difficult to assess with any certainty. This is because the CECs which have been set up in the UK are—if the American experience is followed—likely to vary significantly in terms of their functions, procedures, (...) composition, structures and authority. As a consequence it is difficult to generalise about the legal implications. Nevertheless, despite these difficulties this article will outline the broad legal principles governing the potential liability of committee members. It will also consider the relationship between CECs and the courts. It begins, however, with a brief analysis of the relationship between ethics and law in committee deliberations, and in particular of the role of law and legal expertise on CECs. (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.

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)

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)

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)

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)

HIV infection and AIDS create many dilemmas in Chinese AIDS/HIV prevention policy. A strategy of clinical tolerance is proposed to address these dilemmas. The immediate purpose of the strategy of clinical tolerance is to win the cooperation of members of stigmatized groups at high risk for contracting HIV infection and AIDS, which occurs as a result of acts done in private and thus beyond the reach of regulation. The strategy of clinical tolerance differs from both tolerance as (...) liberal tolerance and tolerance as a moral ideal of tolerance. A strategy of clinical tolerance does not ask the government, health worker, health official or the public to change either laws or the disapproval of prostitution, homosexuality and drug use. A strategy of clinical tolerance asks, instead, that we weigh what we may regard as the wrong involved in prostitution, homosexuality, and drug use against the greater evil of an HIV/AIDS epidemic. A strategy of clinical tolerance offers the most effective and practical way to confront a growing and significant public health problem in China. (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)

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)

Child welfare clinics established in a rural Jamaican community for research purposes are described. These special clinics were able to devote more resources to the care of their children than is usual, yet the growth and health of these children were very similar to those in another group to whom this service was not available and who attended routine government welfare clinics only infrequently.

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)

There is a global shortage of organs for transplantation and despite many governments making significant changes to their organ donation systems, there are not enough kidneys available to meet the demand. This has led scientists and clinicians to explore alternative means of meeting this organ shortfall. One of the alternatives to human organ transplantation is xenotransplantation, which is the transplantation of organs, tissues, or cells between different species. The resurgence of interest in xenotransplantation and recent scientific breakthroughs suggest that genetically-engineered (...) pigs may soon present a realistic alternative as sources of kidneys for clinical transplantation. It is therefore important for nurses and allied health professionals to understand what is involved in xenotransplantation and its future implications for their clinical practices. First, we explore the insufficiency of different organ donation systems to meet the kidney shortage. Second, we provide a background and a summary of the progress made so far in xenotransplantation research. Third, we discuss some of the scientific, technological, ethical, and economic issues associated with xenotransplantation. Finally, we summarise the literature on the attitudes of healthcare professionals toward xenotransplantation. (shrink)

Bioethics is currently witnessing unprecedented debate over the moral and legal norms governing the conduct of clinical research. At the center of this debate is the duty of care in clinical research, and its most widely accepted specification, clinical equipoise. In recent work, we have argued that equipoise and cognate concepts central to the ethics of clinical research have been left unnecessarily vulnerable to criticism. We have suggested that the vulnerability lies in the conspicuous absence of (...) an articulated foundation in moral and legal theory of the physician-researcher's duty of care to the patient-subject. We have repeatedly suggested that the requisite foundation is in the ethics of trust and the law of fiduciaries.Curiously, despite the absence of a published thorough exposition of our position, some have preemptively criticized our suggestion that the relationship between physician-researcher and patient-subject is fiduciary. Others have offered their own accounts of the implications of fiduciary law for the relationship. (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)

Our society has long sanctioned, at least tacitly, a degree of conflict of interest in medical practice and clinical research as an unavoidable consequence of the different interests of the physician or clinical investigator, the patient or clinical research subject, third party payers or research sponsors, the government, and society as a whole, to name a few. In the past, resolution of these conflicts has been left to the conscience of the individual physician or clinical investigator (...) and to professional organizations. The public is no longer willing to allow health care providers to wholly govern their own conflicts of interest for several reasons. These include: new forms of health care financing and delivery that provide innovative and lucrative opportunities for physician or insurer enrichment at patient expense; the increased importance of commercial research support as peer-reviewed governmental research support has decreased; evidence that physicians and clinical investigators too frequently resolve conflicts of interest in their own favor; and a general societal mistrust of authority. This volume represents a multidisciplinary effort, drawing from philosophy, medicine, law, economics and public policy to identify and categorize conflicts of interest in medical practice and clinical research, and, where possible, to offer a mechanism for resolving them. Part I addresses conflicts of interest from a theoretical perspective, offering basic concepts and analytical frameworks. The second part discusses two topics prominent in current health care policy debates--self-referral and financial incentives to limit care. Part III examines conflicts of interest generated by pharmaceutical industry involvement in clinical practice and research. The final section deals with conflicts of interest in clinical research in several contexts, including institutional reviews boards, clinical trials, Cooperative Research and Development Agreements between government and private researchers, brokerage of research subjects by Contract Research Organizations, and cost-effectiveness studies. (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)

The federal government is funding a sea change in health care by investing in interventions targeting social determinants of health, which are significant contributors to illness and health inequity. This funding power has encouraged states, professional and accreditation organizations, health care entities, and providers to focus heavily on social determinants. We examine how this shift in focus affects clinical practice in the fields of oncology and emergency medicine, and highlight potential areas of reform.

The Toronto experience suggests that there may be several general lessons for academic health sciences complexes to learn from the Olivieri/Apotex affair regarding the ethics, independence, and integrity of clinical research sponsored by for profit enterprises. From a local perspective, the OAA occurred when there already was a focus on the complex and changing relationships among the University of Toronto, its medical school, the fully affiliated teaching hospitals, and off campus faculty because of intertwined interests and responsibilities. The OAA (...) became a catalyst that accelerated various systemic reforms, particularly concerning academic/industry relations. In this article, the evolving governance framework for the Toronto academic health sciences complex is reviewed and these policy and process reforms discussed. These reforms have created collaborative activity among research ethics boards and contract research offices of the partner institutions, and allowed the joint university/hospital ethics centre to play a role in governance and policy, while respecting the missions and mandates of the involved institutions. Although few of the policies are dramatically innovative, what is arguably novel is the elaboration of an overarching governance framework that aims to move ethics to a central focus in the academic complex. Time alone will tell how sustainable and effective these changes are. (shrink)

This article aims to revise the ethical and social implications for clinical biobanks and their application in Italy, in the Liguria Region and in a comprehensive cancer centre in Genoa. The policies already in place in the regional network and in the IST National Institute for Cancer Research in terms of involvement of the community of patients and citizens are described, as well as the future development of initiatives aimed at improving the active participation of the community. The author (...) is a biobank manager and not a professional bioethicist. The world of biobanks in Italy includes large numbers of small initiatives, and ‘biobankers’ are aware that public engagement is essential to ensure public trust and to give legitimacy to the research. The governance of these research infrastructures requires new tools in order to improve involvement of participants. The October 2011 Conference, ‘New Patient-Centric Perspectives in Medical Research: Ethical and Governance Challenges’ has been an important occasion for bringing together different experiences and expertise and for learning about new forms of participant-centric approaches and tools. (shrink)

In 1979 the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research in the US delivered a set of guidelines for the ethical conduct of research on human research subjects.1 In developing these guidelines, subsequently known as The Belmont Report, the Commission was “...directed to consider: the boundaries between biomedical and behavioural research and the accepted and routine practice of medicine”; and outline a set of ethical principles which would specifically govern research activities. The Report notes (...) that maintaining this distinction is important to ensure that all research activities are subjected to ethical review and, while it acknowledges that distinguishing research and clinical care is less easy in some cases, it suggests that this is a relatively simple and straightforward task. Forty years later, biomedical activities appear more complex: clinical activities are hybridised, trial design is no longer solely aimed at improving the evidence base, but at fostering closer integration with clinical activities and learning health systems reuse individuals’ health data to generate real-time improvements in patient care.2 In short, the conceptual boundaries between research and clinical care do not appear to be as distinct as the Belmont Report implies. Two papers in this issue and Ballantyne and Schaefer ) address some of the ethical challenges generated by merging of research and clinical care. The UK’s 100 000 Genomes Project is an example of a biomedical development in which research and clinical care are no longer understood as distinct activities. Patients in the 100kGP are offered clinical genomic sequencing on the understanding that their health data will be used for research purposes. Dheensa et al note that the 100kGP was designed with the dual purpose of providing patients with …. (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)

The Toronto experience suggests that there may be several general lessons for academic health sciences complexes to learn from the Olivieri/Apotex affair regarding the ethics, independence, and integrity of clinical research sponsored by for profit enterprises. From a local perspective, the OAA occurred when there already was a focus on the complex and changing relationships among the University of Toronto, its medical school, the fully affiliated teaching hospitals, and off campus faculty because of intertwined interests and responsibilities. The OAA (...) became a catalyst that accelerated various systemic reforms, particularly concerning academic/industry relations. In this article, the evolving governance framework for the Toronto academic health sciences complex is reviewed and these policy and process reforms discussed. These reforms have created collaborative activity among research ethics boards and contract research offices of the partner institutions, and allowed the joint university/hospital ethics centre to play a role in governance and policy, while respecting the missions and mandates of the involved institutions. Although few of the policies are dramatically innovative, what is arguably novel is the elaboration of an overarching governance framework that aims to move ethics to a central focus in the academic complex. Time alone will tell how sustainable and effective these changes are. (shrink)

The need to evaluate the performance of clinical ethics services is widely acknowledged although work in this area is more developed in the United States. In the USA many studies that assess clinical ethics services have utilized empirical methods and assessment criteria. The value of these approaches is thought to rest on their ability to measure the value of services in a demonstrable fashion. However, empirical measures tend to lack ethical content, making their contribution to developments in ethical (...) governance unclear. The steady increase of clinical ethics committees in the UK must be accompanied by efforts to evaluate their performance. As part of this evaluative work it is important to examine how the practice of clinical ethics committees can be informed by empirical measures. (shrink)

In light of the World Anti Doping Agency’s 2013 Code Revision process, we critically explore the applicability of two of three criteria used to determine whether a method or substance should be considered for their Prohibited List, namely its (potential) performance enhancing effects and its (potential) risk to the health of the athlete. To do so, we compare two communities of human guinea pigs: (i) individuals who make a living out of serial participation in Phase 1 pharmacology trials; and (ii) (...) elite athletes who engage in what is effectively ‘unregulated clinical research’ by using untested prohibited or non-prohibited performance enhancing substances and methods, alone or in combination. Our comparison sheds light on norms of research ethics that these practices exacerbate with respect to the concepts of multiplicity, visibility, and consistency. We argue for the need to establish a proper governance framework to increase the accountability of these unregulated research practices in order to protect the human guinea pigs in elite sports contexts, and to establish reasonable grounds for the performance enhancing effects, and the risks to the health of the athlete, of the methods and substances that might justify their inclusion on the Prohibited List. (shrink)