Showing papers in "Hastings Center Report in 2013"

An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics

Abstract: 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.

The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight

Abstract: The rise of quality improvement research and comparative effectiveness research in health care settings constitutes progress toward the goal of what the Institute of Medicine has called a “learning healthcare system,” in which we are “drawing research closer to clinical practice by building knowledge development and application into each stage of the healthcare delivery process.” As clinical research and clinical practice move closer to a deliberately integrated system, the distinction between the two is increasingly blurred, although the sharp distinction in U.S. regulations and research ethics literature remains in place. In the 1970s and for two decades thereafter, this distinction was helpful: for some forms of research, it sheds light on which activities require ethical oversight. Research that is closely integrated with health care—notably, health delivery research—was then uncommon, however. That is no longer the case, and regulations and research ethics need to change to accommodate the new landscape. In this paper, we argue that conceptual, moral, and empirical problems surround the received view that we can and should draw sharp distinctions between clinical research and clinical practice. We start with the history of the research-practice distinction in the reports of a U.S. national commission and in U.S. federal regulations, and then offer a critical assessment of five characterizations of research that have been used in policy documents and the scholarly literature to try to make a sharp distinction between research and practice. We challenge the clarity and the tenability of these characterizations as a way of distinguishing research from practice. We argue that the received view of the research-practice distinction leads to overprotection of the rights and interests of patients in some cases and to underprotection in others. We contend that a new ethical foundation needs to be developed that facilitates both care and research likely to benefit patients, and that provides oversight that, rather than being based on a distinction between research and practice, is commensurate with risk and burden in both realms.

Obesity: chasing an elusive epidemic.

Abstract: Obesity in America is so widespread and such a product of our culture that combating it is nearly impossible. We need to change almost everything about the way we live, more or less simultaneously. In order to succeed, an edgier strategy is needed.

Quality Attestation for Clinical Ethics Consultants: A Two-Step Model from the American Society for Bioethics and Humanities

Abstract: Clinical ethics consultation is largely outside the scope of regulation and oversight, despite its importance. For decades, the bioethics community has been unable to reach a consensus on whether there should be accountability in this work, as there is for other clinical activities that influence the care of patients. The American Society for Bioethics and Humanities, the primary society of bioethicists and scholars in the medical humanities and the organizational home for individuals who perform CEC in the United States, has initiated a two-step quality attestation process as a means to assess clinical ethics consultants and help identify individuals who are qualified to perform this role. This article describes the process.

On Noncongruence between the Concept and Determination of Death

Abstract: The debate about exactly when a person dies can benefit from distinguishing the strict biological concept of death from the medical standards for determining death.

Broad versus Blanket Consent for Research with Human Biological Samples

Abstract: The first of two commentaries on “Respecting Donors to Biobank Research,” from the January-February 2013 issue.

The research-clinical practice distinction, learning health systems, and relationships.

Abstract: 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.

Incidental Findings in the Era of Whole Genome Sequencing

Abstract: The rise of technologies that can inexpensively sequence entire genomes means that researchers and clinicians have access to ever vaster stores of genomic data, some of which could be of great use to research participants or patients, and most of which, at least for today, will be of little, uncertain, or no use. Those facts are essential features of a new ethical territory we are now entering with genetics research. As we explore that territory, we should try to be as clear as possible about the issues at hand. Clarity about the ethical issues that delineate this new territory requires that we be wary about too hastily importing into it concepts from the old territory. We want to suggest a way in which the term “incidental findings” can impede our ability to see clearly some of the most important issues we face. To show how that term can sometimes obscure more than it illuminates, we focus on how it is being deployed in the context of research. Although it may have been useful, when considering older forms of genetic research, to speak about researchers stumbling across clinically significant findings, and although that way of speaking has certainly not yet become wholly obsolete, it is ever less appropriate as the technology becomes ever more powerful.

Respecting donors to biobank research.

Abstract: The most common way for people to consent to research with their banked biological material is through signing a blanket consent, which allows any future use, giving the donor no information or control. This does not respect the donor or the philosophy if donation.

H5N1 avian flu research and the ethics of knowledge.

Abstract: Scientists and policy-makers have long understood that the products of research can often be used for good or evil. Nuclear fission research can be used to generate electricity or create a powerful bomb. Studies on the genetics of human populations can be used to understand relationships between different groups or to perpetuate racist ideologies. While the notion that scientific research often has beneficial and harmful uses has been discussed before, the threat of bioterrorism—a concern that has only grown since 2001—has led to increased awareness about the need to prevent the misuse of biomedical research, particularly when it involves dangerous pathogens or toxins. In 2012, the concern was ratcheted up another notch by two papers reporting the results of research on genetically engineered strains of the H5N1 avian influenza virus. Although the H5N1 papers have potential scientific and social value, some scientists and policy-makers opposed their publication because they feared that terrorists (or others with nefarious motives) could use the research to create a bioweapon that could trigger a global pandemic. The H5N1 papers raise difficult questions concerning the ethics of knowledge. Should scientific research with dangerous applications be published? Should some types of research be kept secret or not be conducted at all? What type of government oversight of dangerous research is appropriate? In this essay, I will develop a framework for thinking about the ethics of knowledge and apply it to the H5N1 controversy, focusing on issues related to publication. I will argue that redacted publication would have been a reasonable response to the dilemmas posed by the H5N1 papers if not for practical and legal problems with this option. Given these problems, full publication seems appropriate.

If Shaming Reduced Obesity, There Would Be No Fat People

Abstract: One of six commentaries on “Obesity: Chasing an Elusive Epidemic,” by Daniel Callahan, from the January-February 2013 issue.

Bloomberg's Health Legacy: Urban Innovator or Meddling Nanny?

Abstract: Michael Bloomberg assumed office as the 108th mayor of New York City on January 1, 2002. As he leaves the mayoralty—having won re—election twice-his public health legacy is bitterly contested. The public health community views him as an urban innovator—a rare political and business leader willing to fight for a built environment conducive to healthier, safer lifestyles. To his detractors, Bloomberg epitomizes a meddling nanny—an elitist dictating to largely poor and working—class people about how they ought to lead their lives. His policies have sparked intense public, corporate, and political ire—critical of sweeping mayoral power to socially engineer the city and its inhabitants. Here, I seek to show how Bloomberg has fundamentally changed public health policy and discourse. He has used the engine of government to make New York City a laboratory for innovation-raising the visibility of public health, testing policy effectiveness, and probing the boundaries of state power. Even though the courts have blocked some of his boldest initiatives, he has offered a paradigm for the “new public health”—reaching beyond infectious diseases to upstream risk factors in everyday life and the human habitat. I also critically probe various arguments designed to derail his policies, along with the overarching charge of unjustified paternalism.

Ethical Oversight of Research on Patient Care

Abstract: The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. There has been progress in realizing the IOM's vision, but also many challenges. One of these challenges has been lingering uncertainty about whether the data collection and monitoring central to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems. Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void.

Voluntary sterilization for childfree women: understanding patient profiles, evaluating accessibility, examining legislation.

Abstract: Approximately 47 percent of women ages fifteen to forty-four are currently without children, and slightly more than 20 percent of white women in America will never bear children, the highest percentage in modern history. Many fertile women who are childless are voluntarily so. Although any competent person twenty-one years or older is legally eligible for voluntary sterilization, many doctors refuse to sterilize childfree women. This essay explores various reasons a woman would want to continue in her childfree lifestyle, evaluates the accessibility of sterilization for women who are childfree by examining the reported reasons for denial of sterilization-both from the woman's and the physician's perspective-and assesses the legal status of voluntary sterilization for nonparous women. The essay also urges physicians to follow recommended guidelines for counseling women who, regardless of parity, desire sterilization and to provide this contraception if, after careful consideration, there are no outstanding health or other reasons that the procedure should not be performed.

The Ethics of Advocacy for Undocumented Patients

Abstract: Approximately 11.2 million undocumented immigrants have settled in the United States. Providing health care to these residents is an everyday concern for the clinicians and health care organizations who serve them. Uncertain how to proceed in the face of severe financial constraints, clinicians may improvise remedies–a strategy that allows our society to avoid confronting the clinical and organizational implications of public policy gaps. There is no simple solution-no quick fix-that will work across organizations (in particular, hospitals with emergency departments) in states with different concentrations of undocumented immigrants, varying public and private resources for safety-net health care, and differing approaches to law and policy concerning the rights of immigrants. However, every hospital can help its clinicians by addressing access to health care for undocumented immigrants as an ethical issue. We offer some recommendations for doing this in a structured, fair, and transparent way. We also describe the problems that may result when clinicians are forced to grapple with this issue on their own.

Casting Light and Doubt on Uncontrolled DCDD Protocols

Abstract: The ever-increasing demand for organs led Spain, France, and other European countries to promote uncontrolled donation after circulatory determination of death (uDCDD). For the same reason, New York City has recently developed its own uDCDD protocol, which differs from European programs in some key ways. The New York protocol incorporates a series of technical and management improvements that address some practical problems identified in response to European uDCDD protocols. However, the more fundamental issue of whether uDCDD donors are dead when organs are procured remains problematic for the New York City protocol and, indeed, for all uDCDD protocols. In the United States, two amendments to the legal criteria of death have been suggested to avoid a formal violation of the dead donor rule in DCDD protocols: first, replacing the requirement “irreversible” with the weaker term “permanent,” and second, using the term “circulatory” instead of “cardiac” to identify the key function that must be lost to declare death. While intended to facilitate controlled DCDD, these modifications create a problem for uDCDD protocols: if extracorporeal membrane oxygenation is introduced to preserve the organs, then circulation is restored after death is declared. In this issue of the Hastings Center Report, Kevin Munjal and colleagues call for a new ethical construct and policy so that uncontrolled and controlled DCDD can coexist.

A rationale in support of uncontrolled donation after circulatory determination of death.

Abstract: Most donated organs in the United States come from brain dead donors, while a small percentage come from patients who die in “controlled,” or expected, circumstances, typically after the family or surrogate makes a decision to withdraw life support. The number of organs available for transplant could be substantially if donations were permitted in “uncontrolled” circumstances–that is, from people who die unexpectedly, often outside the hospital. According to projections from the Institute of Medicine, establishing programs permitting “uncontrolled donation after circulatory determination of death,” or uDCDD, throughout the United States has the potential to provide 22,000 more donation opportunities annually. In contrast, U.S. controlled donation after circulatory determination of death, or cDCDD, cases have increased progressively over the past decade from 87 to 848 donors, but currently account for only 10.6 percent of all deceased donors. Following the IOM recommendations, several projects exploring the feasibility of uDCDD were funded by the federal government, including a grant from the Health Resources and Services Administration that supported a pilot project in New York City in which the authors of this article participated. A key feature of our protocol, and indeed of many uDCDD protocols, is the initiation of preservation methods such as chest compressions and extracorporeal membrane oxygenation shortly after death in order to perfuse and preserve the donor's organs. Critics of uDCDD argue that the means of determining death deviates from generally ascribed principles. They assert that reinstituting circulation in order to preserve organs has the effect of “undoing” the prior determination of death. The result is that cDCDD is widely accepted and practiced routinely even though it only marginally increases the number of organs available for transplantation, and uDCDD is widely considered unacceptable despite being ethically embraced and proven to significantly increase organ donation opportunities in other countries. This article explores the evolution of this counterintuitive state of affairs and calls for a policy that, in line with the IOM report, allows for both cDCDD and uDCDD protocols.

A prescription for ethical learning

Abstract: We argued last year in this journal that extensive integration of research and care is a worthy goal of health system design, and we second the call from Ruth Faden and colleagues to move toward learning health care systems. As they recognize, learning health care systems demand the coordination of research and medical ethics—two sets of normative commitments that have long been considered distinct. In offering a novel ethics framework for such systems, Faden et al. advance the scholarly debate about how best to do this and challenge us to think more deeply about its practical implications. However, we believe that at least three issues they raise require additional attention. First, the research-care distinction has more normative bite than they are willing to concede. Second, the role for independent oversight requires clarification. Finally, they neglect the concept of stewardship as a guiding obligation of learning health care systems.

Obesity Stigma: A Failed and Ethically Dubious Strategy

Abstract: One of six commentaries on “Obesity: Chasing an Elusive Epidemic,” by Daniel Callahan, from the January-February 2013 issue.

Ethical Oversight: Serving the Best Interests of Patients

Abstract: The papers by Nancy Kass, Ruth Faden, and colleagues describe an ethical imperative to study clinical care as it is being delivered. The goal of learning from each patient is attractive, but integrating research and clinical practice is not easy. The authors suggest that the bioethical framework in use for the past forty years to oversee clinical research may be as much an impediment to the development of a learning health care system as a means of protecting the interests of patients. This framework draws a bright line between clinical research and clinical care activities, subjecting clinical research to institutional review and ongoing oversight while assuming that clinical care is conducted primarily in the interests of patients and not in need of additional ethical oversight. The authors identify five characteristics that have been used to distinguish the two activities, and they conclude that none succeed. The practical implications of this conclusion are left unspecified, however. Should ethical oversight simply be eliminated for these kinds of research activities on the grounds that oversight is not mandated for clinical care and the two cannot be distinguished?

Manipulation in the enrollment of research participants.

Abstract: Recruitment is a challenge for many biomedical research studies with human participants. Strategies to increase the speed and ease of recruitment are therefore valuable. One way to improve these strategies is to design them so as to make use of other factors that play a role in potential participants’ decisions. In this paper, we analyze the noncoercive ways in which researchers can use knowledge about the decision-making tendencies of potential participants in order to motivate them to consent to research enrollment. We identify which modes of influence preserve respect for participants’ autonomy and which disrespect autonomy, applying the umbrella term “manipulation” to the latter. We then apply our analysis to a series of cases adapted from the experiences of clinical researchers in order to develop a framework for thinking through the ethics of manipulating people into research participation. All manipulation disrespects autonomy and is therefore pro tanto wrong. However, only deceptive manipulation invalidates the consent that results from it. Use of the other forms of manipulation can be permissible, but only if the outcome of using manipulation is sufficiently good, and the research cannot be carried out using ethically preferable means to obtain consent.

Found your DNA on the web: reconciling privacy and progress.

Abstract: An article by Melissa Gymrek and colleagues, published this January in Science, described how the researchers used surname inferences from commercial genealogy databases and Internet searches to deduce the identity of nearly fifty research participants whose supposedly private data were stored in large, publicly available datasets. This news comes just months after the Presidential Commission for the Study of Bioethical Issues published a report that expressed serious concerns about personal privacy and security in whole genome sequencing. The bioethics commission (on which we serve as chair and vice-chair) highlighted the importance of reconciling the enormous public benefits anticipated from research in this area with the potential risks to individuals’ privacy, and it offered several policy proposals to help balance the potential of scientific progress with privacy and respect for persons. The human subjects research protections laid out in the federal regulations are triggered by the identifiability of data. The participants in the Gymrek et al. study were not “readily identifiable”; however, the data proved far more easily identifiable than expected. With rapidly evolving technology, a precise definition of that notion may be impossible. But if we move the debate from the rhetoric of identifiability to the ethical principles of public beneficence and the centrality of respecting all persons, we find that the real ethical focus must be on promoting generalizable progress while at all times respecting individual privacy.

Why we should all pay for fertility treatment: an argument from ethics and policy.

Abstract: Since 1980, the number of twin births in the United States has increased 76 percent, and the number of triplets or higher-order multiples has increased over 400 percent. These increases are due in part to increased maternal age, which is associated with spontaneous twinning. But the primary reason for these increases is that more and more people are undergoing fertility treatment. Despite an emerging (but not absolute) consensus in the medical literature that multiples, including twins, should be a far less frequent outcome of fertility treatment, American clinicians currently practice fertility medicine in ways likely to result in twins and, occasionally, triplets—often, they tell us, at the request of their patients. At first blush, one might conclude that these practice patterns show that patients and their doctors have weighed the risks associated with twins against the benefits of swiftly completing their families and decided that the risks are worth taking. That is, their requests for twins must represent their free and informed choices. But there are reasons to be skeptical of this interpretation, including that the preferences of many patients seem to be very strongly shaped, if not sometimes completely constrained, by concerns about costs—costs that mainly result from the routine exclusion of in vitro fertilization from health insurance coverage. It is quite possible, we believe, that these cost concerns actually undermine the autonomy of fertility patients, pushing many of them to take risks with their health and the health of their hoped-for future children.

Making the transition to a learning health care system

Abstract: 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.

Evaluation as Part of Operations: Reconciling the Common Rule and Continuous Improvement

Abstract: Understanding the components of clinical care that work best is a cornerstone of improving health care. And yet, the more we improve the quality of quality improvement and move to continuous learning about clinical care more broadly, the more we find ourselves in a regulatory environment that makes evaluation more difficult, expensive, and, in some situations, impossible. In their paper on the ethical underpinnings of the distinction between research and treatment, Ruth Faden and colleagues raise important implications for a wide array of situations. These points give reason to rethink the definition of routine clinical operations to include evaluation of the processes and outcomes of care and dissemination of findings. We concur with the assertion by Faden and colleagues, and with previous work from The Hastings Center, that conducting continuous improvement activities such as these is an obligation of health systems and clinicians. We believe that rigorous, systematic evaluation should be considered part of normal, expected operations, rather than exceptional behavior that requires extraordinary regulatory control.

The Unbelievable Rightness of Being in Clinical Trials

Abstract: Much of what Ruth Faden and colleagues say squarely meshes with the ideas of the U.S. Department of Health and Human Services about reforming the system for protecting research subjects. Having said that, I want to turn to a very different part of the research universe, the elephant in the room, as it were: the world of interventional randomized clinical trials. Under the current regulatory system, these research subjects receive substantial protections. Most importantly, they are generally enrolled only after they give their informed consent. The rationale for this approach is that research subjects are denied the core ethical protection provided to patients: there is no requirement that everything done to them be in their best interests. Faden and colleagues appear to be proposing to eliminate this informed consent requirement for a significant range of such trials.

Reform within the Common Rule

Abstract: In their papers in this supplement, Ruth Faden and colleagues conclude that research ethics and regulation must change to accommodate a changed and changing health care environment. The reality, however, is that the widely understood and accepted ethical framework embedded in the regulatory requirements known as the Common Rule, and recent proposals to modify the Common Rule have become stalled, at least for the foreseeable future, if not permanently. Meaningful systemic modernization of the Common Rule is not likely to occur any time soon. All the same, modernization of the Common Rule is desperately needed. In the short term, the agencies responsible for implementing it must be willing to develop practical guidance for implementing the current regulatory requirements in a way that promotes clarity and understanding and allocates human and fiscal resources based on the level of risk to subjects. To this end, the Veterans Health Administration recently implemented policy to address the research-practice distinction—a distinction that is especially relevant to VHA's current challenges and that the authors of the “ethical framework” articles have identified as particularly outmoded.

Avoiding a “Death Panel” Redux

Abstract: If engaging in end of life conversations and advance care planning not only is desired by many Americans but also might significantly improve patient care at the end of life, then why was a provision that provided reimbursement for physicians to engage in end of life planning through Medicare removed from legislation? If, as some researchers have suggested, reimbursements under Medicare “would have been a start” for encouraging these conversations, then why was the Advance Care Planning Consultation provision in the 2008 health reform effort so vehemently opposed by politicians and citizens alike? The heated and misleading rhetoric employed against the ACPC undoubtedly contributed to intractable polarization surrounding this portion of the health reform bill and assured its failure. But the ACPC's emphasis on “checklists” and regulation may also have served as fodder for these fiery critiques. If that's right, legislation that focuses squarely on the broader and more fundamental goals of end of life consultations and deemphasizes administrative and documentary concerns may have a greater chance for success in years to come, as health reform is implemented and the battle over the ACPC fades from memory.

Googling a Patient

Abstract: The twenty-six-year-old patient requested a prophylactic bilateral mastectomy with reconstruction because of an extensive family history of cancer. She reported that she had developed melanoma at twenty-five; that her mother, sister, aunts, and a cousin all had breast cancer; that a cousin had ovarian cancer at nineteen; and that a brother was treated for esophageal cancer at fifteen. The treating team was skeptical about this history, and they could find no documentation of the patient's reported melanoma. The surgeon wrote the patient's primary care physician, explaining that he had seen the patient and planned to proceed with the bilateral mastectomy and reconstruction. The primary care physician responded that he was unable to substantiate several of the patient's claims; some of his colleagues believed the family history to be fabricated. Trying to make sense of the discrepancies, the genetic counselor called a counselor colleague who had met with this patient. The colleague suggested that the in-house genetic counselor “google” the patient. The search revealed two Facebook pages linked to the patient. In one, apparently a personal profile, the patient stated that in addition to battling stage four melanoma, she had recently been diagnosed with breast cancer. She provided a link to a site where she solicited donations to attend a summit for young cancer patients. The other Facebook page featured numerous pictures of her with a bald head, as though she has been through chemotherapy. The genetic counselor showed the Facebook pages to the surgeon, who then decided not to operate. Should health care professionals “google” their patients?

The Death Debates: A Call for Public Deliberation

Abstract: Since the early 1980s, James Bernat has played a leading role in shaping both scholarly discourse and policy-mak-ing about death determination and organ procurement. His scientific contributions may be indirectly responsible for having extended the life expectancy and the quality of life of thousands of people around the world. However, the conceptual reformulations he and others have pro-posed have had intellectual and practical costs. Critics ar-gue that linguistic gerrymandering, semantic contortions, and legal fictions reveal more concern for pragmatic goals than for truth.