Response to Emily A. Largent, Franklin G. Miller and Steven Joffe, A Prescription for Ethical Learning, Hastings Center Report, 43, s1, (S28-S29), (2013).

The “learning health care system” is being heralded as offering great potential for improving the quality and cost-worthiness of medical care by closely integrating the care of patients with the accumulation of aggregate data that can guide evidence-based medicine. By using electronic medical records, routine patient care and administrative data will be available for systematic observational studies. With the aid of these electronic medical records, quality-improvement studies of institutional practices and pragmatic, comparative effectiveness randomized (...) trials of individual treatments could become standard features of the medical care environment in the LHS. In this.. (shrink)

In this article we attempt to answer the question of how the ethical and conceptual framework (ECF) for a learning health‐care system (LHS) affects some of the main controversies in research ethics by addressing five key problems of research ethics: (a) What is the difference between practice and research? (b) What is the relationship between research ethics and clinical ethics? (c) What is the ethical relevance of the principle of clinical equipoise? (d) Does participation in research require (...) a higher standard of informed consent than the practice of medicine? and (e) What ethical principle should take precedence in medicine? These questions allow us to construct two opposite idealized positions on the distinction between research and practice: the integration model and the segregation model of research and practice. We then compare the ECF for an LHS with these two idealized positions. We argue that the ECF for a LHS does not, in fact, solve these problems, but that it is a third, separate position in the relationship between research ethics and clinical ethics. Moreover, we suggest that the ECF for a LHS raises new ethical problems that require additional ethical analysis and justification. Our article contributes to the discussion on the relationship between research ethics and clinical ethics, revealing that although a learning health‐care system may significantly change the landscape of health care, some ethical dilemmas still require resolving on both theoretical and policy‐making levels. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward (...) a new ethics framework for it. No such framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Institutional review boards distinguish health care quality improvement and health care quality improvement research based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR.

The authors of the two main articles in this supplement recognize the enormous potential of learning health care systems. Their first article argues that the development of these systems calls into question existing guidelines and practices that treat clinical care and clinical research as distinct activities. Their second article proposes to replace this traditional approach with a new framework, one intended to promote two important goals: support the transformation to a learning health (...) care system and help to ensure the ethical appropriateness of the activities carried out within such a system. To promote these goals, the authors propose a framework consisting of seven obligations. The authors are aware that their framework does not provide much guidance for promoting their second goal. At first glance, the seven obligations also might appear to offer little in the way of promoting the first goal. In what way, then, is the proposed framework novel and transformative, as the authors claim? The answer appears to lie largely in how the authors interpret the sixth obligation in the framework—the obligation to conduct learning activities. (shrink)

Health care systems in different countries and cultures differ and tend toreflect the particular values and, therefore, the particular socialstructure of a given society. Each of these has ethical problems unique toitself. Some of these problems are briefly discussed. So as to have anindividual ethical problem in the context of medical care, access tomedical care needs to be assured. It is argued that individual problems arethe primary issue in societies in which there is fair access (...) whereas theyare of lesser importance in societies which have thus far failed toprovide fair access. (shrink)

Pragmatic clinical trials (PCTs) serve an important function in the modern research landscape: studying interventions in an environment that reflects real-world conditions, rather than the relative...

Hastings Center Report, Volume 52, Issue 3, Page 34-36, May–June 2022.

Hastings Center Report, Volume 52, Issue 3, Page 2-2, May–June 2022.

There is a growing interest in comparison of international health care data with the hope that such studies will enable individual systems to learn from other systems. Such comparisons, however, presuppose that there exist common criteria for evaluating health care systems. The main thesis of this paper is that these comparative studies are misleading because they employ inappropriate operationalizations of these criteria because the operarionalizations are based upon mistaken global conceptualizations of the criteria (...) in question. The essay provides a methodological critique of what has been done and sets a new agenda for future research. (shrink)

The changing context of medical practice—bureaucratic, political, or economic—demands that doctors have the knowledge and skills to face these new realities. Such changes impose obstacles on doctors delivering ethical care to vulnerable patient populations. Modern medical ethics education requires a focus upon the knowledge and skills necessary to close the gap between the theory and practice of ethical care. Physicians and doctors-in-training must learn to be morally sensitive to ethical dilemmas on the wards, learn how to make professionally (...) grounded decisions with their patients and other medical providers, and develop the leadership, dedication, and courage to fulfill ethical values in the face of disincentives and bureaucratic challenges. A new core focus of medical ethics education must turn to learning how to put ethics into practice by teaching physicians to realistically negotiate the new institutional maze of 21st-century medicine. (shrink)

We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter (...) associated risks. In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency, and partnership. (shrink)

A learning health system (LHS) seeks to establish a closer connection between clinical care and research and establishes new responsibilities for healthcare providers as well as patients. A new set of technological approaches in medication adherence monitoring can potentially yield valuable data within an LHS, and raises the question of the scope and limitations of patients’ responsibilities to use them. We argue here that, in principle, it is plausible to suggest that patients have a prima facie obligation (...) to use novel adherence monitors. However, the strength of the obligations depends considerably on the extent to which data that adherence monitors generate are, in fact, used to further the goals of LHSs. The way in which data ownership is structured in the USA poses a considerable challenge here, while the European Union framework offers a more promising alternative. (shrink)

All health care systems face problems of justice and efficiency related to setting priorities for allocating a limited pool of resources to a population. Because many of the central issues are the same in all systems, the United States and other countries can learn from the successes and failures of countries that have explicitly addressed the question of health care priorities. We review explicit priority setting efforts in Norway, Sweden, Israel, the Netherlands, Denmark, New (...) Zealand, the United Kingdom and the state of Oregon in the US. The approaches used can be divided into those centered on outlining principles versus those that define practices. In order to establish the main lessons from their experiences we consider the process each country used, criteria to judge the success of these efforts, which approaches seem to have met these criteria, and using their successes and failures as a guide, how to proceed in setting priorities. We demonstrate that there is little evidence that establishment of a values framework for priority setting has had any effect on health policy, nor is there evidence that priority setting exercises have led to the envisaged ideal of an open and participatory public involvement in decision making. (shrink)

A special report of The Hastings Center and the Association of American Medical Colleges addressed the ethical oversight of learning health systems, which seek to combine high‐quality patient care with routine data collection aimed at improving patient outcomes. The report contained two position papers, authored by a number of distinguished bioethicists, and several commentaries. The position papers urged two changes. First, they urged a rethinking of our approach to the regulation of human subjects research, so as (...) to make it easier in the future for learning health systems to function well. Second, they argued that the rethinking required dispensing with a strict distinction between research and therapy, which has been a major tenet of bioethics since the Belmont Report, which explicated basic ethical principles governing human subjects research. We fully support the objectives of the authors, and we agree that the learning health system is an important advance that serves patients well. Unnecessary regulatory burden ought not impede this progress. We disagree, however, that the best way to bring about these needed changes in the regulatory environment is to reject the basic distinction between research and treatment. Unfortunately, we find the arguments in favor of that strategy to be, in places, reminiscent of what we take to be basic conceptual errors that hampered the ethical understanding of human subjects research prior to adoption of the Belmont Report. To see why one need not reject the research‐treatment distinction in order to promote learning health systems, we first investigate in some detail the arguments offered for eliminating the distinction. We next turn to an issue not addressed by those authors, namely, the relationship between the physician or investigator and the patient or subject, to illustrate why the distinction is important and what is lost if it is jettisoned. (shrink)

Mixtecs and Zapotecs, originating from the Oaxaca area in Mexico, are among the largest indigenous groups of workers in California. Many adults in this community only access the health care system when sick and as a last resort. This article describes the development of a radionovela to inform the community about the importance of preventive health care. It was developed following the Sabido Method. The methodology to develop a radionovela may be of interest to other public (...) health practitioners who want to develop educational materials in an engaging format, especially for communities that rely on oral, not written information. (shrink)

This essay argues that our national efforts at health reform ought to be informed by eleven key lessons from Oregon. Specifically, we must learn that the need for health care rationing is inescapable, that any rationing process must be public and visible, and that fair rationing protocols must be self-imposed through a process of rational democratic deliberation. Part I of this essay notes that rationing is a ubiquitous feature of our health care system at present, (...) but it is mostly hidden rationing, which is presumptively unjust. Part II argues that the need for health care rationing is inescapable. Although Oregon is flawed as a model of health rationing, it gives us worthy moral lessons for health reform at the national level, which I analyze and defend in Part III. The most significant of these lessons is the importance of rational democratic deliberation in articulating fair rationing protocols for a community. In Part IV I sketch the philosophic justification for this approach and respond to some important criticisms from Daniels. Keywords: cost containment, democratic deliberation, fairness, justice, rationing CiteULike Connotea Del.icio.us What's this? (shrink)

In 2012, a U.S. Institute of Medicine report called for a different approach to health care: “Left unchanged, health care will continue to underperform; cause unnecessary harm; and strain national, state, and family budgets.” The answer, they suggested, would be a “continuously learning” health system. Ethicists and researchers urged the creation of “learning health organizations” that would integrate knowledge from patient‐care data to continuously improve the quality of care. Our experience (...) with an ongoing research study on atrial fibrillation—a trial known as IMPACT‐AFib—gave us some insight into one of the challenges that will have to be dealt with in creating these organizations. Although the proposed educational intervention study placed no restrictions on what providers and health plans could do, the oversight team argued that the ethical principle of beneficence did not allow the researchers to be “bystanders” in relation to a control group receiving suboptimal care. In response, the researchers designed a “workaround” that allowed the project to go forward. We believe the experience suggests that what we call “bystander ethics” will create challenges for the kinds of quality improvement research that LHOs are designed to do. (shrink)

The paper makes a strong plea for the health care system itself to strive for better health. It argues that a growing weakness of the health care system is high level psychological stress. This, in turn, is caused by the overuse of memory-linked analytical process thinking in managing the affairs of health care organizations. The author strongly recommends a shift towards a greater use of natural flow thinking which is more supple, spontaneous, creative (...) and stress free. She argues for this shift on the basis of several years of personal engagement with and learning of flow thinking practices in different parts of the world, including India. (shrink)

Is positive thinking really so healthy that, as Martin Seligman (2000) and Mihaly Csikszentmihalyi passionately thus argued, "we believe that a psychology of positive human functioning will arise, which achieves a scientific understanding and effective interventions to build thriving individuals, families, and communities"? This optimistic view on positive thinking for health can be contrasted with an opposing view by Barbara Ehrenreich (2009), who "extensively critiqued 'positive psychology'" and showed "how obsessive positive thinking impedes productive action, causes delusional assessments of (...) situations, and people are then blamed for not visualising hard enough and thus 'attracting' failure even in situations when 'masses of lives were lost'." (WK 2013; R Byrne 2006) Contrary to these opposing views (and other ones as will be discussed in the book), health care (in relation to mental health and physical health in the context of mind and body) are neither possible (or impossible) nor desirable (or undesirable) to the extent that the respective ideologues (on different sides) would like us to believe. Surely, this questioning of the opposing views on health care does not suggest that the study of health care is worthless, or that those fields (related to health care) like medicine, chiropractic, health system, dentistry, health info tech, nursing, psychiatrics, clinical psychology, occupational therapy, pharmacy, allied health, and so on are unimportant. Needless to say, neither of these extreme views is reasonable. Instead, this book offers an alternative (better) way to understand the future of health care, especially in the dialectic relationships between mental health and physical health in the context of mind and body -- while learning from different approaches in the literature but without favouring any one of them (nor integrating them, since they are not necessarily compatible with each other). More specifically, this book offers a new theory (that is, the interconnected theory of health care) to go beyond the existing approaches in a novel way and is organised in four chapters. (shrink)

Patient data is used to drive an ecosystem of advanced digital tools in health care, like predictive models or artificial intelligence‐based decision support. Patients themselves, however, receive little information about these technologies or how they affect their care. This raises important questions about patient trust and continued engagement in a health care system that extracts their data but does not treat them as key stakeholders. This essay explores these tensions and provides steps forward for (...) class='Hi'>health systems as they design advanced health information‐technology (IT) policies and practices. It centers patients, their concerns, and the ways they perceive trustworthiness to reframe advanced health IT in service of patient interests. (shrink)

Healthcare systems across the globe are struggling with increasing costs and worsening outcomes. This presents those responsible for overseeing healthcare with a challenge. Increasingly, policymakers, politicians, clinical entrepreneurs and computer and data scientists argue that a key part of the solution will be ‘Artificial Intelligence’ (AI) – particularly Machine Learning (ML). This argument stems not from the belief that all healthcare needs will soon be taken care of by “robot doctors.” Instead, it is an argument that rests (...) on the classic counterfactual definition of AI as an umbrella term for a range of techniques that can be used to make machines complete tasks in a way that would be considered intelligent were they to be completed by a human. Automation of this nature could offer great opportunities for the improvement of healthcare services and ultimately patients’ health by significantly improving human clinical capabilities in diagnosis, drug discovery, epidemiology, personalised medicine, and operational efficiency. However, if these AI solutions are to be embedded in clinical practice, then at least three issues need to be considered: the technical possibilities and limitations; the ethical, regulatory and legal framework; and the governance framework. In this article, we report on the results of a systematic analysis designed to provide a clear overview of the second of these elements: the ethical, regulatory and legal framework. We find that ethical issues arise at six levels of abstraction (individual, interpersonal, group, institutional, sectoral, and societal) and can be categorised as epistemic, normative, or overarching. We conclude by stressing how important it is that the ethical challenges raised by implementing AI in healthcare settings are tackled proactively rather than reactively and map the key considerations for policymakers to each of the ethical concerns highlighted. (shrink)

The European Biomedical Ethics Practitioner Education Project (EBEPE), funded by the BIOMED programme of the European Commission, is a five-nation partnership to produce open learning materials for healthcare ethics education. Papers and case studies from a series of twelve conferences throughout the European Union, reflecting the ‘burning issues’ in the participants' healthcare systems, have been collected by a team based at Imperial College, London, where they are now being edited into a series of seven activity-based workbooks for individual (...) or group study. These draft workbooks are now being read by a network of critical readers across Europe, whose comments will be incorporated into the final versions of the workbooks. The result will be the first European-wide and Europe-centred resource for teaching students, practitioners, and members of ethics committees. Topics covered include: • Resource allocation and rationing • The rights of children and young people • Long-term care of the elderly • Mental health and mental illness • Autonomy and patient choice • Decisions at the end of life • A study guide to using the workbooks The collaborative nature of the project has highlighted differentiated national approaches in medical ethics. Against the British and Dutch rights-orientated approach have emerged two other alternative models: the Nordic preference for administrative resolution of entitlement disputes, and the southern European emphasis on deontological codes. A genuinely European reconstruction of autonomy and rights, using hermeneutic, feminist and narrative approaches to counterbalance individualistic models, is emerging across the workbooks. The programme has also uncovered national differences in how ethics should be taught, with the workbooks' style being an experiential approach. Thus the EBEPE project is developing new models in both substantive and pedagogic senses, about both what should be taught and how it should be presented. (shrink)

In 2012, a U.S. Institute of Medicine report called for a different approach to health care: “Left unchanged, health care will continue to underperform; cause unnecessary harm; and strain national, state, and family budgets.” The answer, they suggested, would be a “continuously learning” health system. Ethicists and researchers urged the creation of “learning health organizations” that would integrate knowledge from patient‐care data to continuously improve the quality of care. Our experience (...) with an ongoing research study on atrial fibrillation—a trial known as IMPACT‐AFib—gave us some insight into one of the challenges that will have to be dealt with in creating these organizations. Although the proposed educational intervention study placed no restrictions on what providers and health plans could do, the oversight team argued that the ethical principle of beneficence did not allow the researchers to be “bystanders” in relation to a control group receiving suboptimal care. In response, the researchers designed a “workaround” that allowed the project to go forward. We believe the experience suggests that what we call “bystander ethics” will create challenges for the kinds of quality improvement research that LHOs are designed to do. (shrink)

This paper analyses various approaches to the concept of a ‘safety culture’ in terms of their epistemological assumptions regarding the nature of learning. As a result of this analysis, the study proposes a relational-interpretive framework for the promotion of safety in health care, which is based on relational theories and the philosophy of conceptual pragmatism as this can be used to integrate the various strands of current safety research. In particular, the approach based on a relational-interpretive perspective (...) can bridge the apparent dualist gap that exists between the rational objectivist perspective and the relativist perspective on the role of learning in developing a safety culture. According to the relational-interpretive perspective of safety management that is proposed here, organizational members need to give continuous attention to the accepted organizational norms and values, which shape the safety culture. A case study from a health care safety project in Sweden is utilized to illustrate the ideas advanced in this paper. (shrink)

Guidelines orient best practices in medicine, yet, in health care, many real world constraints limit their optimal realization. Since guideline implementation problems are not systematically anticipated, they will be discovered only post facto, in a learning curve period, while the already implemented guideline is tweaked, debugged and adapted. This learning process comes with costs to human health and quality of life. Despite such predictable hazard, the study and modeling of medical guideline implementation is still seldom (...) pursued. In this article we argue that to systematically identify, predict and prevent medical guideline implementation errors is both an epistemic responsibility and an ethical imperative in health care, in order to properly provide beneficence, minimize or avoid harm, show respect for persons, and administer justice. Furthermore, we suggest that implementation knowledge is best achieved technically by providing simulation modeling studies to anticipate the realization of medical guidelines, in multiple contexts, with system and scenario analysis, in its alignment with the emerging field of implementation science and in recognition of learning health systems. It follows from both claims that it is an ethical imperative and an epistemic responsibility to simulate medical guidelines in context to minimize harm in health care, before guideline implementation. (shrink)

This four-volume collection covers the organization, financing and regulation of health care systems in four distinct contexts: financing and delivering health care, reforming health care systems, new forms of health system, and rethinking health care systems. A general introduction provides a review of the collection as a whole, and individual introductions set the context for each volume, providing a unique and valuable resource for student and scholar alike.

Background Machine learning (ML) is utilized increasingly in health care, and can pose harms to patients, clinicians, health systems, and the public. In response, regulators have proposed an approach that would shift more responsibility to ML developers for mitigating potential harms. To be effective, this approach requires ML developers to recognize, accept, and act on responsibility for mitigating harms. However, little is known regarding the perspectives of developers themselves regarding their obligations to mitigate harms.Methods We (...) conducted 40 semi-structured interviews with developers of ML predictive analytics applications for health care in the United States.Results Participants varied widely in their perspectives on personal responsibility and included examples of both moral engagement and disengagement, albeit in a variety of forms. While most (70%) of participants made a statement indicative of moral engagement, most of these statements reflected an awareness of moral issues, while only a subset of these included additional elements of engagement such as recognizing responsibility, alignment with personal values, addressing conflicts of interests, and opportunities for action. Further, we identified eight distinct categories of moral disengagement reflecting efforts to minimize potential harms or deflect personal responsibility for preventing or mitigating harms.Conclusions These findings suggest possible facilitators and barriers to the development of ethical ML that could act by encouraging moral engagement or discouraging moral disengagement. Regulatory approaches that depend on the ability of ML developers to recognize, accept, and act on responsibility for mitigating harms might have limited success without education and guidance for ML developers about the extent of their responsibilities and how to implement them. (shrink)

Book reviewed in this article: Medicine and Culture: Varieties of Treatment in the United States, England, West Germany, and France. By Lynn Payer. Health Care Systems: Moral Conflicts in European and American Public Policy. Edited by Hans‐Martin Sass and Robert U. Massey.

This book takes Edmund Husserl's phenomenology and applies it to help psychotherapy practitioners formulate complex psychological problems. The reader will learn about Husserl's system of understanding and its concepts that point to first-person lived experience, and about the work of Husserl scholars who have developed a way to be precise about the experiences that clients have. Through exploring the connection between academic philosophy of consciousness and mental health, themes of biopsychosocial treatment planning, psychopathology of personality and psychological disorders, and (...) the treatment of complex psychological problems become clear. The author shows that Husserlian phenomenology can be used in the design of interventions for clients in a process called formulation. Once the intentionality of consciousness is understood, by asking simple questions, it becomes possible to define problematic experiences. This is a means of creating informed consent for treatment and it makes it clear to clients what is happening for them, so helping them understand themselves and how they see the world. We also see how Husserl's phenomenology is a vehicle for psychotherapists to present their knowledge about the research literature of what has been found to be effective care. This volume applies the concepts and practices of phenomenology in a concrete way, relating them to the practice of therapy and showing the value of a qualitative approach to understanding mental processes and the nature of human beings as motivated by values, meanings and other conscious experiences. This is a readable text in simple language that condenses key aspects of Husserl's thinking in relation to the theory and practice of psychotherapy, and it is suitable for philosophers and practitioners of psychology, psychiatry, and the psychotherapies, including psychoanalysis. (shrink)

Hastings Center Report, Volume 52, Issue 3, Page 29-31, May–June 2022.

Restructured health care reimbursement systems and new requirements for nonprofit hospitals are transforming the U.S. health system, creating opportunities for enhanced integration of public health and health care goals. This article explores the role of public health practitioners and lawyers in this moment of transformation. We argue that the population perspective and structural strategies that characterize public health can add value to the health care system but could get lost (...) in translation as changes to tax requirements and payment systems are rapidly implemented. We urge public health leaders to take a more active role in hospital assessments of community health needs and evaluation of the patient outcomes for which providers are accountable. (shrink)

Hastings Center Report, Volume 52, Issue 3, Page 18-29, May–June 2022.

The Israeli health care system is looked upon by some people as one of the most advanced health care systems in the world in terms of access, quality, costs and coverage. The Israel health care system has four key components: (1) universal coverage; (2) ‘cradle to grave’ coverage; (3) coverage of both basic services and catastrophic care; and (4) coverage of medications. Patients pay a (relatively) small copayment to see specialists and to (...) purchase medication; and, primary care is free. However, during 2011 the Israeli Medical Association (IMA) spent 5 months on a strike, justifying it as trying to ‘save’ the Israeli public health. This paper describes some aspects of the Israeli Health Care System, the criteria for setting priorities for the expenditures on health care and values underlying these criteria. The paper observes that the new agreement between the IMA and the government has given timely priority to problematic areas of specialization (in which there is an acute shortage of physicians) and to hospitals in the periphery of the country. Yet weak points in the health system in Israel remain. Particularly, the extent to which national health care expenditures are being financed privately—which is rising—and the parallel decline in the role of government financing. (shrink)

This study aims to compare and contrast how specific information health technologies (IHTs) have been debated, how they have proliferated, and what they have enabled in Germany’s and England’s healthcare systems. For this a discourse analysis was undertaken that specifically focussed on future-scenarios articulated in policy documents and strategy papers released by relevant actors from both healthcare systems. The study reveals that the way IHTs have been debated and how they have proliferated depends on country-specific regulatory structures, (...) their respective values, actors’ and institutions’ organized interests, and the status of health professionals. These conditions have enabled IHTs to promote a new and similar concept of patienthood in both countries, although they tend to affect practitioners’ practices more dramatically in England. The conclusion is drawn that with the usage of IHTs, healthcare systems reproduced existing patterns of health provision while also enabling a sort of convergence. Future research should investigate whether the new concept of patienthood emerging in both welfare states actually suits patients’ and professionals’ needs and requirements. (shrink)

The prevailing “segregated model” for understanding clinical research sharply separates it from clinical care and subjects it to extensive regulations and guidelines. This approach is based on the fact that clinical research relies on procedures and methods—research biopsies, blinding, randomization, fixed treatment protocols, placebos—that pose risks and burdens to participants in order to collect data that might benefit all patients. Reliance on these methods raises the potential for exploitation and unfairness, and thus points to the need for independent ethical (...) review and more extensive informed consent. In contrast, it is widely assumed that clinical care does not raise these ethical concerns because it is designed to promote the best interests of individual patients. The segregation of clinical research from clinical care has been largely effective at protecting research participants. At the same time, this approach ignores the fact that several aspects of standard clinical care, such as clinician training and scheduling, also pose some risks and burdens to present patients for the benefit of all patients. We argue that recently proposed learning health care systems offer a way to address this concern, and better protect patients, by developing integrated review and consent procedures. Specifically, current approaches base the need for independent ethical review and more extensive informed consent on whether an activity is categorized as clinical research or clinical care. An ethically sounder approach, which could be incorporated into learning health care systems, would be to base the need for independent ethical review and more extensive informed consent on the extent to which an activity poses risks to present patients for the benefit of all patients. (shrink)