BackgroundThe pursuit of a cure for HIV is a high priority for researchers, funding agencies, governments and people living with HIV (PLWH). To date, over 250 biomedical studies worldwide are or have been related to discovering a safe, effective, and scalable HIV cure, most of which are early translational research and experimental medicine. As HIV cure research increases, it is critical to identify and address the ethical challenges posed by this research.MethodsWe conducted a scoping review of the growing HIV cure (...) research ethics literature, focusing on articles published in English peer-reviewed journals from 2013 to 2021. We extracted and summarized key developments in the ethics of HIV cure research. Twelve community advocates actively engaged in HIV cure research provided input on this summary and suggested areas warranting further ethical inquiry and foresight via email exchange and video conferencing.DiscussionDespite substantial scholarship related to the ethics of HIV cure research, additional attention should focus on emerging issues in six categories of ethical issues: (1) social value (ongoing and emerging biomedical research and scalability considerations); (2) scientific validity (study design issues, such as the use of analytical treatment interruptions and placebos); (3) fair selection of participants (equity and justice considerations); (4) favorable benefit/risk balance (early phase research, benefit-risk balance, risk perception, psychological risks, and pediatric research); (5) informed consent (attention to language, decision-making, informed consent processes and scientific uncertainty); and (6) respect for enrolled participants and community (perspectives of people living with HIV and affected communities and representation).ConclusionHIV cure research ethics has an unfinished agenda. Scientific research and bioethics should work in tandem to advance ethical HIV cure research. Because the science of HIV cure research will continue to rapidly advance, ethical considerations of the major themes we identified will need to be revisited and refined over time. (shrink)

Hastings Center Report, Volume 52, Issue 1, Page 51-58, January/February 2022.

The target articles in this issue advance our understanding of bioethical considerations in pragmatic trials (Garland, Morain, and Sugarman 2023; Morain and Largent 2023). Both articles appreciate...

Books reviewed:John Barton, Joel and Obadiah: A Commentary John P. Meier, A Marginal Jew, Volume III: Companions and CompetitorsWilliam E. Arnal, Jesus and the Village Scribes: Galilean Conflicts and the Setting of QRichard A. Horsley, Hearing the Whole Story: The Politics of Plot in Mark's GospelMaurice Casey, Aramaic Sources of Mark's GospelPhilip Jenkins, Hidden Gospels: How the Search for Jesus Lost its WayChristopher M. Tuckett, Christology and the New Testament: Jesus and His Earliest FollowersMarkus Bockmuehl, The Cambridge Companion to JesusShelly (...) Matthews, First Converts: Rich Pagan Women and the Rhetoric of Mission in Early Judaism and ChristianityStephen J. Davis, The Cult of Saint Thecla: A Tradition of Women's Piety in Late AntiquityJ. Nimmo Smith, A Christian's Guide to Greek Culture. The Pseudo‐Nonnus Commentaries on Sermons 4, 5, 39 and 43 by Gregory of Nazianzus: Introduction, Translation and Notes.David Thomas, Early Moslem Polemic Against Christianity: Abu Isa al‐Warraq's ‘Against the Incarnation’Thomas O'Loughlin, Celtic Theology: Humanity, World and God in Early Irish WritingsCaroline M. Baron and Jenny Stratford, The Church and Learning in Later Medieval Society: Essays in Honour of R. B. Dobson Owen Chadwick, The Early Reformation on the Continent Benson Bobrick, The Making of the English BiblePeter Marhall and Alec Ryrie, The Beginnings of English ProtestantismRobert Tittler, The Reformation and the Towns in England. Politics and Political Culture, c. 1540–1640Peter Marshall, Beliefs and the Dead in Reformation EnglandNicholas Tyacke, Aspects of English Protestantism, c.1530–1700John Coffey, Persecution and Toleration in Protestant England, 1558–1689William Gibson, The Church of England 1688–1832: Unity and AccordWarwick Gould and Marjorie Reeves, Joachim of Fiore and the Myth of the Eternal Evangel in the Nineteenth and Twentieth CenturiesJames M. Byrne, God: Thoughts in an Age of Uncertainty Michael Palmer, The Question of God: An Introduction and SourcebookMichel René Barnes, The Power of God: ΔYNAMIΣ in Gregory of Nyssa's Trinitarian TheologyThomas Aquinas, Disputed Questions on VirtueStanley M. Hauerwas, Wilderness Wanderings: Probing Twentieth‐Century Theology and PhilosophyDavid Toole, Waiting for Godot in Sarajevo: Theological Reflections on Nihilism, Tragedy, and ApocalypseJohn Sullivan, Catholic Education: Distinctive and InclusiveGeorge Dennis O'Brien, The Idea of a Catholic UniversityGunnar Skirbekk and Nils Gilje, A History of Western ThoughtEllen Wagner, Essays on Plato's PsychologyAnthony Kenny, Aquinas on BeingJame Daly, Deals and Ideals: Two Concepts of EnlightenmentManfred Kuehn, Kant: A BiographyP. Travis Kroeker and Bruce K. Ward, Remembering the End: Dostoevsky as Prophet to ModernityStephen Mulhall, Inheritance and Originality: Wittgenstein, Heidegger, KierkegaardDavid Braybrooke, Natural Law ModernizedMaría Pía Lara, Rethinking EvilW. W. Meisner, Freud and PsychoanalysisJennifer Jackson, Truth, Trust and MedicineJeremy Sugarman and Daniel P. Sulmasy, Methods in Medical EthicsH. Tristram Engelhardt, Jr. and Mark J. Cherry, Allocating Scarce Medical Resources: Roman Catholic PerspectivesMaura A. Ryan, The Ethics and Economics of Assisted Reproduction: The Cost of LongingMichael Walsh, Dictionary of Christian Biography. (shrink)

The long-standing overarching policy governing research with human subjects conducted and supported by most federal agencies and departments in the United States, known as the Common Rule, has recently been revised, with most requirements slated to become effective in 2018. Although there are multiple alterations to the current regulations, some of the most significant changes aim to enhance consent for research. While some of the particular provisions in this regard will be easy to apply and promise to help meet this (...) goal, others may be more challenging to implement despite their intuitive appeal. In this article, I examine some of the provisions in the revised Common Rule that relate to consent: new required consent elements; the goal of comprehension in the consent process; consent forms; and broad consent. By raising issues about these provisions now and suggesting possible ways to overcome their potential shortfalls, the hope is that future efforts can be taken to help clarify and appropriately implement them. (shrink)

Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from (...) considering them in their decisions. Yet IRBs often do consider the social implications of research protocols and sometimes create significant delays in initiating or even prevent such research. The social implications of research are important topics for public scrutiny and professional discussion. This article examines the reasons that the federal regulations preclude IRBs from assessing the social risks of research, and examines alternative approaches that have been used with varying success by national advisory groups to provide such guidance. The article concludes with recommendations for characteristics of a national advisory group that could successfully fulfill this need, including sustainability, independence, diverse and relevant expertise, and public transparency. (shrink)

Empirical research in bioethics can be defined as the application of research methods in the social sciences to the direct examination of issues in [bioethics]. As such, empirical work is a form of descriptive ethics, focused on describing a particular state of affairs that has some moral or ethical relevance. For example, empirical research can help to describe cultural beliefs about the appropriateness of providing health-related information, such as the diagnosis of a life-threatening illness, which informs deliberations about the extent (...) to which it is morally important for clinicians to provide comprehensive information to patients in different cultural contexts. Similarly, empirical research can delineate popular attitudes and experiences related to contentious issues such as abortion, cloning, stem-cell research, and physician-assisted suicide to enlighten discussions and policy formulations regarding them. (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)

Despite concern that patients in the intensive care unit (ICU) may not be treated with respect and dignity, there is not conceptual clarity regarding what constitutes such treatment. In addition, measures specific to treatment with respect and dignity in the ICU are unavailable. Accordingly, a multidisciplinary group developed a conceptual model for treatment with respect and dignity in the ICU and used mixed methods to gather data on this issue. This effort included interviews with patients and families, focus groups with (...) health care professionals, and direct observations. These data were then compared and contrasted to synthesize what was learned. Finally, pilot quantitative patient and family survey data were collected and analyzed. Each of these approaches, which comprise the papers in this supplement to Narrative Inquiry in Bioethics, is briefly described in this article. (shrink)

Complementary and alternative medicine is used by many in hopes of achieving important health-related goals. Survey data indicate that 42 percent of the U.S. population uses CAM, accounting for 629 million “office” visits a year and expenditures of 27 billion dollars. This high prevalence of use calls for a careful evaluation of CAM so as to ensure the well-being of those using its modalities. Such an evaluation would obviously include assessments of the safety and efficacy of particular approaches, the training (...) and integrity of practitioners, and the appropriateness of modalities for different conditions or uses. Given the lack of published data concerning many of these aspects of CAM, the likely unfamiliarity of its practitioners to the approaches available to clinicians practicing modern scientific medcine, and the need to respect the unique preferences of persons seeking assistance with achieving health-related goals, it is also important to assess the potential roles of informed consent for the use of CAM. Examining such roles is the central task of this paper. (shrink)

Through an exacting yet accessible reconstruction of eleven of Freud's essential theoretical writings, Susan Sugarman demonstrates that the traditionally received Freud is the diametric opposite of the one evident in the pages of his own works. Whereas Freud's theory of the mind is typically conceived as a catalogue of uninflected concepts and crude reductionism - for instance that we are nothing but our infantile origins or sexual and aggressive instincts - it emerges here as an organic whole built from (...) first principles and developing in sophistication over time. Sugarman's exciting interpretation, tracking Freud's texts in the order in which he wrote them, grounds his claims in the reasoning that led to them and reveals their real intent. This fresh reading will appeal to specialists and students across a variety of disciplines. (shrink)

Criticisms of the traditional clinical research pathway and its extensive oversight often focus on proposals for deregulation or assert that as in clinical treatment, clinical research should always offer benefit to patient-subjects. Proponents of medical innovation take a different, middle path, arguing that innovation is distinguishable from both research and treatment. This article considers this third pathway by examining stem cell-based innovation.Stem cell-based medical innovation is one pathway toward clinical translation. In fact, such an approach was taken in developing umbilical (...) cord blood transplantation, which is now widely viewed as a safe and effective means for treating a range of malignant and non-malignant conditions. While the Guidelines for the Clinical Translation of Stem Cells created by the International Society for Clinical Research provide an approach to clinical translation that involves “responsible innovation” as an alternative to clinical research, there are at least four sets of unanswered questions regarding the use of an innovation pathway in this context that warrant careful attention. (shrink)

: In light of information uncovered about human radiation experiments conducted during the Cold War, an important charge for the Advisory Committee on Human Radiation Experiments was to assess the current state of protections for human research subjects. This assessment was designed to enhance the Committee's ability to make informed recommendations for the improvement of future policies and practices for the protection of research subjects. The Committee's examination of current protections revealed great improvement over those from the past, yet some (...) problems remain. Although the data collected by the Committee highlight specific areas in need of attention, the Committee's work should be viewed in part as the beginning of a series of ongoing assessments of the adequacy and effectiveness of the protections afforded to human subjects. (shrink)

The Promise of Phenomenology: Posthumous Papers of John Wild includes articles that remained unpublished during Wild's lifetime, some of which he was preparing for publication, a journal that he kept, as well as a masterful exposition and commentary on Emmanuel Levinas' book, Totality and Infinity. This book gives a lively picture of a master philosopher at work conveying the vitality and importance of philosophy to everyday life.

Researchers and others involved in the research enterprise from 12 African countries met with those working in ethics and oversight in the United States as part of an effort to develop research ethics capacity. Drawing on a wealth of experience among participants, discussions at the meeting revealed five categories of issues that warrant careful attention by those engaged in similar efforts as well as international policymakers and those charged with oversight of research. (1) Principal investigators should build ‘true research teams’ (...) where members of the team are meaningfully involved in decisions regarding the protocol and its implementation. (2)There should be explicit discussion about the ‘standard of care’ at the outset of project planning that includes clarification of the terminology that is being used. (3) While internationally collaborative research may involve populations that have inherent vulnerabilities, it is important to recognize the limitations of host country solutions (such as elaborated consent processes) and look for means to negotiate appropriate protections for those willing to participate. (4) In conducting research involving biological materials it would be prudent to develop material transfer agreements at the outset of the study to clarify expectations and to minimize the likelihood of harm. (5) Those engaged in internationally collaborative research need to be alert to the potential conflicts of interests of host country ethics committees during the approval process and to take measures to manage them if they indeed exist. (shrink)

American universities are increasingly proactive in dealing with conflict of interest problems of their faculty. Changing social norms, publicized scandals, and more have made both university administrators and faculty extra alert to the dangers of faculty infidelity to their roles as teachers and scholars. Personal interests — both financial and non-financial — appear increasingly to pressure faculty to behave inappropriately. Most faculty members resist those pressures. Yet, enough conduct that either is, or appears to be, improper has occurred to prompt (...) the adoption by universities of an ever-more complex regulatory regime. This regime no longer relies primarily upon threats of after-the-fact punishment for gross deviations from professorial norms. Instead, universities have also enacted a wide array of in-advance restrictions. These include required disclosures by faculty members of certain private interests, prohibitions of specific faculty behavior, and specified instances in which faculty members must temporarily withdraw from their professorial roles in light of their private interests. This article draws especially upon the author’s experience at the University of California to illustrate the new system of regulation. (shrink)

There has been considerable debate about the ethical acceptability of using placebo-controls in clinical research. Although this debate has been rich in rhetoric, considering that much of this research is predicated upon the assumption that data from this research is vital to clinical decision-making, it is ironic that researchers have introduced little data into these discussions. Using some published research concerning the use of placebo-controls in clinical research in hypertension and psychiatric drug trials, I suggest some ways that such data (...) might be incorporated into the ethical analysis concerning placebo use in clinical trials. This approach promises to be important for enhancing conceptual and scientific understanding as well as public policy decision-making. (shrink)

Introduction While quizzing during informed consent for research to ensure understanding has become commonplace, it is unclear whether the quizzing itself is problematic for potential participants. In this study, we address this issue in a multinational HIV prevention research trial enrolling injection drug users in China and Thailand. Methods Enrolment procedures included an informed consent comprehension quiz. An informed consent survey followed. Results 525 participants completed the informed consent survey (Heng County, China=255, Xinjiang, China=229, Chiang Mai, Thailand=41). Mean age was (...) 33 and mean educational level was 8 yrs. While quizzing was felt to be a good way to determine if a person understands the nature of clinical trial participation (97%) and participants did not generally find the quiz to be problematic, minorities of respondents felt pressured (6%); anxious (5%); bored (5%); minded (5%); and did not find the questions easy (13%). In multivariate analysis, lower educational level was associated with not minding the quizzing (6–10 yrs vs 0–5 yrs: OR=0.27, p=0.03; more than 11 yrs vs 0–5 yrs: OR=0.18, p=0.03). There were also site differences (Heng County vs Xinjiang) in feeling anxious (OR=0.07; p=<0.01), not minding (OR=0.26; p=0.03), being bored (OR=0.25; p=0.01) and not finding the questions easy (OR=0.10; p=<0.01). Conclusions Quizzing during the informed consent process can be problematic for a minority of participants. These problems may be associated with the setting in which research takes place and educational level. Further research is needed to develop, test and implement alternative methods of ensuring comprehension of informed consent. Trial Registration clinicaltrials.gov number NCT00270257. (shrink)

Presents the transcendental interpretation approach to psychological inquiry based on the use of the Kantian transcendental argument, which relies on the criterion of consistency. Kant's purpose in employing this argument was as a means for justifying particular knowledge claims. Use of this approach is illustrated by examining the intersubjective and moral conditions necessary for the practice of selfhood. It is argued that phenomena of interest to psychological study differ fundamentally from those of natural science, rendering some of the methods applied (...) in the latter inappropriate to the study of the former. The transcendental argument can provide a direction for psychological research in 2 ways: By helping it to lend intelligibility to its subject matter, and extending ordinary practices by making explicit the goods and norms that motivate them. 2012 APA, all rights reserved). (shrink)

The author describes and examines Ian Hacking’s approach to historical ontology and its application to psychological description. Historical ontology is concerned with the study of phenomena that come in and out of being. Phenomena under psychological description not only are historical, but also are particularly susceptible to what Hacking calls dynamic nominalism. Dynamic nominalism characterizes the ways our descriptive practices of naming interact with things named. More precisely, in describing ourselves psychologically, we humans are uniquely capable of reacting to such (...) self-descriptions in ways that can constitute or reconstitute a relation with ourselves. Humans come to define and act toward themselves under psychological descriptions and, in the process, form and alter the kinds of persons they are. Furthermore, it is suggested that an indispensible precondition of historical ontology, and all that is entailed by it, is a uniquely human agency that not only is responsive to psychological descriptions, but also is self-interpreting and self-determining. The author concludes with some impressions about historical ontology and psychological description and their implications for psychology. 2012 APA, all rights reserved). (shrink)

John Macmurray's philosophy of "the form of the personal" is examined with particular interest in his emphasis on persons as agents, his account of psychological development, his claim that our self-awareness as persons is acquired from the mutuality of personal relations, and his important contribution in placing personhood at the center of inquiries into the human condition. Subsequently, it is argued that the reality of psychologically capable personhood so construed is irreducible to physical, biological, or social categories frequently deemed by (...) psychologists as more fundamental and, further, that psychological capacities and their development are best understood in terms of the personal. 2012 APA, all rights reserved). (shrink)

Volume 33, Issue 7, October 2020, Page 1048-1051.

In this insightful set of essays, the concept of the psychological humanities is defined and explored. A clear rationale is provided for its necessity in the study and understanding of the individual and identity in a discipline that is largely occupied by empirical studies that report aggregated data and its analysis. Contributors to this volume are leading scholars in theoretical psychology who believe that psychology must be about persons and their lives. In these essays, they draw from a variety of (...) disciplines that include art, literature, life writing, and history to make a case for the psychological humanities. A final chapter provides a critical commentary on the value of the psychological humanities. It is argued that psychology must draw on the knowledge and practices of the humanities, as well as the sciences and social sciences, in order to attain a greater understanding of personhood. This book is aimed at upper level undergraduate and postgraduate students and scholars of psychology, particularly theoretical psychology, philosophy of the mind, and those from a humanities background interested in exploring the concept of the psychological humanities. (shrink)

Recent legislation, such as the Patient Self-Determination Act, establishes advance directives as an acceptable procedural means of incorporating patients’ preferences for life-sustaining treatments into their medical care. Advance directives can enhance medical decision making since they provide patients with an opportunity to communicate their preferences before suffering from an acute illness that may preclude their ability to do so.Although patients expect discussions about life-sustaining therapies to be initiated by their physicians, very little is known about what prompts physicians to discuss (...) advance directives with their patients. As in other areas of clinical decision making, there is evidence that patients’ sociodemographic factors influence whether discussions about advance directives occur between patients and their physicians. In one study of persons with the acquired immunodeficiency syndrome, those who had not had discussions about advance directives with their physicians tended to be non-white, have no prior hospitalization, and were more likely to have been cared for in a health maintenance organization than in a teaching hospital. (shrink)

Bioethical, legal, and professional discussions concerning human stem cell science have moved away from the contentious, and possibly irreconcilable, debates about human embryos to other sources of pluripotent stem cells. While there is an array of ethical and legal issues associated with all types of pluripotent stem cells, in recent years complex issues have arisen with regard to the premature use of somatic or "adult" stem cells. Of particular concern is the global emergence of an industry selling products and services (...) marketed as stem cells direct to the consumer, typically over the internet, for a range of serious medical conditions that lack credible evidence of safety and efficacy (Sipp et... (shrink)

BackgroundCritical public health measures implemented to mitigate the spread of the novel coronavirus disease (COVID-19) pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/aids pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network (HPTN) Ethics Guidance Document (EGD) to situate and analyze key (...) ethical challenges related to the conduct of HIV prevention research during the COVID-19 pandemic as well as identify potential areas for refinement of the guidance document based on this unprecedented state of affairs.Main bodyNecessary actions taken for HIV prevention research studies due to the COVID-19 pandemic involve an array of ethical issues including those related to: (1) risk mitigation; (2) behavior change; (3) compounding vulnerability; (4) community engagement; (5) trial reopening; and 6) shifting research priorities.ConclusionsIn the context of the dueling HIV and COVID-19 global pandemics, research teams and sponsors must be nimble in responding to the rapidly changing environment by being sensitive to the associated ethical issues. The HTPN EGD provides a rich set of tools to help identify, analyze and address many of these issues. At the same time, future refinements of the HPTN EGD and other research ethics guidance could be strengthened by providing explicit advice regarding the ethical issues associated with disrupted research and the reopening of studies. In addition, additional consideration should be given to appropriately balancing domains of risk (e.g., physical versus social), addressing the vulnerability of research staff and community partners, and responding to un-anticipatable ancillary care needs of participants and communities. Appropriately addressing these issues will necessitate conceptual work, which would benefit from the careful documentation of the actual ethical issues encountered in research, the strategies implemented to overcome them, and their success in doing so. Throughout all of these efforts, it is critical to remember that the HIV pandemic not be forgotten in the rush to deal with the COVID-19 pandemic. (shrink)

The overriding theme of the conference honoring Bob Cooter and his work is the question whether law and policy can change people’s preferences. The conventional “law and economics” answer is “no.” People have preferences that are fixed. What changes in law and policy do is to change how people behave by altering the costs and benefits people face in pursuit of their preferences. Put simply, the assumption of the “law and economics” model is that people respond to financial incentives by (...) changing how they act, not what they want. So, to take a simple example, imagine two people at the same starting point, both wanting to drive separately to visit a mutual friend. Their preference to get there promptly and safely is common to both of them, but how they act in pursuit of that goal may well differ. Moreover, government can alter how they drive to their friend’s by making changes such as putting in a freeway, or adding a new lane to the road, or installing lots of new traffic signals or stop signs along one route. The two people may have driven different routes previously, and they may alter their driving strategy in response to the policy changes government has adopted and may still decide that different routes are better for them. But they do not change their desire to see their friend in a prompt and safe manner. In this Article I offer a counterexample — an instance in which changes in law and policy can not only alter the behavior of some with fixed preferences, but also can impact the preferences of others. My example is about changes in society that can alter parenting style (of those parents with a fixed preference to have their children succeed) and can also change the underlying preferences that those children have as to how their lives should play out. (shrink)

Active monitoring of research with human subjects is no longer reserved for especially complex research or investigating research alleged to be problematic. Rather, many human research subjects’ protection programmes now engage in routine monitoring. Although limited data concerning such monitoring are available, the Association for the Accreditation of Human Research Protection Programs , reports that in 2011 its accredited organisations conducted many routine audits .1 While accredited organisations currently represent a small subset of human subjects’ research programmes, these data are (...) consistent with AAHRP's standard : ‘The Organization measures and improves, when necessary, compliance with organizational policies and procedures and applicable laws, regulations, codes, and guidance. The Organization also measures and improves, when necessary, the quality, effectiveness, and efficiency of the Human Research Protection Program.’2In this issue of Journal of Medical Ethics …. (shrink)

The patient safety movement seeks to reduce the number of avoidable injuries and diseases that patients suffer while in hospital. Two regulatory strategies in support of that movement are explored here. “Required disclosure” would rely on market responses to an increase in publicly available information about hospital errors. “Performancebased regulation” would require hospitals to reduce their error rate or suffer substantial financial penalties. Both approaches are designed to give medical service providers incentives to promote safety without resorting to “command and (...) control” regulation under which government experts tell hospitals how to act. (shrink)