Hastings Center Report, Volume 51, Issue 5, Page 53-55, September‐October 2021.

Hastings Center Report, Volume 51, Issue 5, Page 30-41, September‐October 2021.

This article outlines current safe harbors in the law for healthcare practitioners who work in a disaster setting. It reviews available legal protection in crisis situations with respect to the Emergency Medical Treatment and Labor Act (EMTALA), criminal liability, and licensure.

We propose six guideposts that states and hospitals should follow to respect disability rights when designing policies for the allocation of scarce, lifesaving medical treatments. Four relate to criteria for decisions. First, do not use categorical exclusions, especially ones based on disability or diagnosis. Second, do not use perceived quality of life. Third, use hospital survival and near-term prognosis (e.g., death expected within a few years despite treatment) but not long-term life expectancy. Fourth, when patients who use ventilators in their (...) daily lives (e.g., home ventilation) present to acute care hospitals, their personal ventilators should not be reallocated to other patients. Fifth, designate triage officers to assess patients individually on the basis of objective medical evidence, not stereotypes or assumptions. Sixth, include disability rights advocates in policy development and dissemination. (shrink)

In this essay, we suggest practical ways to shift the framing of crisis standards of care toward disability justice. We elaborate on the vision statement provided in the 2010 Institute of Medicine (National Academy of Medicine) “Summary of Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations,” which emphasizes fairness; equitable processes; community and provider engagement, education, and communication; and the rule of law. We argue that interpreting these elements through disability (...) justice entails a commitment to both distributive and recognitive justice. The disability rights movement's demand “Nothing about us, without us” requires substantive inclusion of disabled people in decision‐making related to their interests, including in crisis planning before, during, and after a pandemic like Covid‐19. (shrink)

During public health crises including the COVID-19 pandemic, resource scarcity and contagion risks may require health systems to shift—to some degree—from a usual clinical ethic, focused on the well-being of individual patients, to a public health ethic, focused on population health. Many triage policies exist that fall under the legal protections afforded by “crisis standards of care,” but they have key differences. We critically appraise one of the most fundamental differences among policies, namely the use of criteria (...) to categorically exclude certain patients from eligibility for otherwise standard medical services. We examine these categorical exclusion criteria from ethical, legal, disability, and implementation perspectives. Focusing our analysis on the most common type of exclusion criteria, which are disease-specific, we conclude that optimal policies for critical care resource allocation and the use of cardiopulmonary resuscitation (CPR) should not use categorical exclusions. We argue that the avoidance of categorical exclusions is often practically feasible, consistent with public health norms, and mitigates discrimination against persons with disabilities. (shrink)

Extracorporeal membrane oxygenation (ECMO) is a form of life support for cardiac and/or pulmonary failure with unique ethical challenges compared to other forms of life support. Ethical challenges with ECMO exist when conventional standards of care apply, and are exacerbated during periods of absolute ECMO scarcity when “crisis standards of care” are instituted. When conventional standards of care apply, we propose that it is ethically permissible to withhold placing patients on ECMO for reasons (...) of technical futility or when patients have terminal, short-term prognoses that are untreatable by ECMO. Under crisis standards of care, it is ethically permissible to broaden exclusionary criteria to also withhold ECMO from patients who have a low likelihood of recovery, to maximize the overall number of lives saved. Unilateral withdrawal of ECMO against a patient’s preferences is unethical under conventional standards of care, but is ethical under crisis standards of care to increase access to ECMO to others in society. ECMO should only be rationed when true scarcity exists, and allocation protocols should be transparent to the public. When rationing must occur under crisis standards of care, it is imperative that oversight bodies assess for inequities in the allocation of ECMO and make frequent changes to improve any inequities. (shrink)

Some argue that it is ethically justifiable to unilaterally withdraw life‐sustaining treatment during crisis standards of care without the patient's consent in order to reallocate it to another patient with a better chance of survival. This justification has been supported by two lines of argument: the equivalence thesis and the rule of the double effect. We argue that there are theoretical issues with the first and practical ones with the second, as supported by an experiment aimed at (...) exploring whether the Knobe effect, which affects the folk concept of intention, applies to situations of unilateral withdrawal. Fifty‐two critical care physicians from one university were asked to ascribe intention in two hypothetical scenarios A and B in which outcomes differ—the patient from whom life‐sustaining treatment is withdrawn dies in scenario A but survives in scenario B—but the intention, to save the other patient regardless of the outcome of the other, is the same. The survey was administered via a web‐based survey and all answers were anonymous. A paired proportion test was used to compare responses to both questions. All 52 surveyed individuals responded in scenario A and 30 (57.7%) ascribed intention when outcomes were unfavorable, whereas 50 responded in scenario B and 8 (16%) ascribed intention when outcomes were favorable, a difference that was statistically significant (p < 0.001). There are theoretical and practical issues with the arguments proposed to justify the unilateral withdrawal of life‐sustaining treatment based on the equivalence thesis and the rule of double effect. (shrink)

Public health emergencies invariably entail difficult decisions among medical and emergency first responders about how to allocate essential, scarce resources. To the extent that these critical choices can profoundly impact community and individual health outcomes, achieving consistency in how these decisions are executed is valuable. Since the terrorist attacks on September 11, 2001, however, public and private sector allocation plans and decisions have followed uncertain paths. Lacking empirical evidence and national input, various entities and actors have proffered multifarious approaches on (...) how best to allocate scarce resources to protect the public's health. Though beneficial in some jurisdictions, these approaches fail to clarify how the type and amount of care delivered in major emergencies might be curtailed. This is due, in part, to a lack of meaningful guidance on shifting standards of care in major emergencies. (shrink)

Lowering the standard of care in a pandemic is a recipe for inferior care and discrimination. Wealthy white patients will continue to get “standard of care” medicine, while the poor and racial mino...

The Nuclear Threat Initiative focuses on preventing catastrophes related to weapons of mass destruction, with a wide range of attacks including nuclear, biologic, radiologic, chemical and cyb...

Hastings Center Report, Volume 51, Issue 5, Page 2-2, September‐October 2021.

ABSTRACT:It may be too late to avoid the climate crisis, likely to be humanity's most expensive, widespread, and enduring catastrophe. This is a qualitatively different kind of catastrophe, in which increased costs, decreased revenue, and no possibility of bailout force communities to harshly cut budgets, especially in health care. Little is known about making such brutal cuts fair or efficient, nor how to help the public accept them. The crisis presents an opportunity for bioethicists to play a (...) crucial role, but one for which traditional approaches are inherently inadequate. Although often dismissed as heartless, Garrett Hardin's "lifeboat ethics" started a conversation about making ethical choices in global disasters—where all options are painful and unacceptable—and may provide guidance. Bioethics during the climate crisis must focus on communities rather than individuals and help survivors grieve the terrible consequences. Because today's choices will affect many generations, with the burdens falling most heavily on poor communities, we have to construct a radical bioethics to help tomorrow's health care become green, efficient, and fair. (shrink)

Volume 20, Issue 7, July 2020, Page 156-158.

Volume 20, Issue 7, July 2020, Page 167-169.

The Director-General of the WHO has suggested that China’s approach to the COVID-19 crisis could be the standard of care for global epidemics. However, as remarkable as the Chinese strategy might be, it cannot be replicated in other countries and certainly not in Europe. In Europe, there is a distribution of power between the European Union and its member states. In contrast, China’s political power is concentrated in the central government. This enables it to take immediate measures that (...) affect the entire country, such as massive quarantines or closing borders. Moreover, the Chinese legal framework includes restrictions on privacy and other human rights that are unknown in Europe. In addition, China has the technological power to easily impose such restrictions. In most European countries, that would be science fiction. These conditions have enabled China to combat epidemics like no other country can. However, the WHO might have been overoptimistic. The Chinese standard of care for treating COVID-19 also raises problematic issues for human rights, and the real consequences of these actions remain to be seen. (shrink)

The current outbreak of Ebola virus infection in West Africa continues to spread. Several patients have now been treated in the United States and preparations are being made for more. Because of the strict isolation required for their care, questions have been raised about what diagnostic and therapeutic interventions should be available. I discuss the ethical challenges associated with caring for patients in strict isolation and personnel wearing bulky protective gear with reduced dexterity and flexibility, the limitations this may (...) place on available treatments and the permissibility of consequent departures from the standards of care. Restricting access to some interventions such as surgery requiring an operating room, advanced imaging, etc. is reasonable due to concern for protecting other patients, visitors and staff. Cardiopulmonary resuscitation is a special case and the implications for withholding this intervention in situations where it may be desired is discussed, especially with respect to those patients who have suspected, but not proven, infection. These same restrictions are also considered under conditions where there are scarce resources and thus limited numbers of patients may receive care. While it is to be hoped that there is only limited and sporadic infection with Ebola virus in the US, careful thought must be given to the care of these patients under the unusual circumstances demanded by their isolation. I argue that an altered standard of care is reasonable and ethically acceptable under certain conditions. (shrink)

Although telepsychiatry consultations have been tried and tested for several years, at least in relatively limited numbers and settings, the current COVID-19 pandemic has caused an exponential increase in their application. Even as lockdown restrictions were lifted and a return to face-to-face consultations was possible, many practitioners and patients decided to uphold teleconsultations for some or a large part of their interactions. This was mostly driven by the exceptional circumstances of the pandemic, as ongoing safety concerns, the need for PPE (...) use and uncertainty around whether face-to-face meetings could go ahead continued to form barriers to usual care practices. Frittgen and Haltaufderheide aptly hypothesise that extensive changes in online communication behaviour will also impact ethical aspects of the therapeutic relationship.1 After considering how the use of technology may affect the therapeutic relationship in video-based consultations, they provide an ethical analysis of this impact along four dimensions: respect for autonomy, lucidity, fidelity and humanity.1 In this commentary I will have a look at the difference between crisis standards of care and usual care, the need to consider specific patient needs in teleconsultation use, the importance of justice understood as equity and access to technology, and a major challenge ahead. Throughout history, crisis situations have often been major catalysts of technological and other progress. Under challenging …. (shrink)

The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular institutional role. (...) I examine two types of institutional contexts: (1) public research agencies – agencies or departments of states that fund or conduct clinical research in the public interest; and (2) private-for-profit corporations. I argue that investigators who are employed or have their research sponsored by the former have a distinctive institutional obligation to conduct their research in a way that is consistent with the state's duty of distributive justice to provide its citizens with access to basic health care, and its duty to aid citizens of lower income countries. By contrast, I argue that investigators who are employed or have their research sponsored by private-for-profit corporations do not possess this obligation nor any other institutional obligation that is directly relevant to the ethics of RCTs. My account of the institutional obligations of investigators aims to contribute to the development of a reasonable, distributive justice-based account of standard of care. (shrink)

With an estimated 12.1% of children aged 2–5 years already obese, prevention efforts must target our youngest children. One of the best places to reach young children for such efforts is the early care and education setting. More than 11 million U.S. children spend an average of 30 hours per week in ECE facilities. Increased attention at the national, state, and community level on the ECE setting for early obesity prevention efforts has sparked a range of innovative efforts. To (...) assist these efforts, CDC developed a technical assistance and training framework – the Spectrum of Opportunities for Obesity Prevention in the ECE setting – which also served as the organizing framework for the Weight of the Nation ECE track. Participants highlighted their efforts at national, state, and local levels pursuing opportunities on the Spectrum, the standards and best practices that had been the emphasis of their efforts, and common steps for developing, implementing, and evaluating initiatives. Strong leadership and collaboration among a broad group of stakeholders; systematic assessment of needs, opportunities and resources; funding sources; and training and professional development were reported to be integral for successful implementation of standards and best practices, and sustainability. (shrink)

The World Medical Association’s revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors (...) show that there is also consensus regarding the broad conditions under which this is acceptable. (shrink)

The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular institutional role. (...) I examine two types of institutional contexts: (1) public research agencies – agencies or departments of states that fund or conduct clinical research in the public interest; and (2) private‐for‐profit corporations. I argue that investigators who are employed or have their research sponsored by the former have a distinctive institutional obligation to conduct their research in a way that is consistent with the state's duty of distributive justice to provide its citizens with access to basic health care, and its duty to aid citizens of lower income countries. By contrast, I argue that investigators who are employed or have their research sponsored by private‐for‐profit corporations do not possess this obligation nor any other institutional obligation that is directly relevant to the ethics of RCTs. My account of the institutional obligations of investigators aims to contribute to the development of a reasonable, distributive justice‐based account of standard of care. (shrink)

The pandemic creates unprecedented challenges to society and to health care systems around the world. Like all crises, these provide a unique opportunity to rethink the fundamental limiting assumptions and institutional inertia of our established systems. These inertial assumptions have obscured deeply rooted problems in health care and deflected attempts to address them. As hospitals begin to welcome all patients back, they should resist the temptation to go back to business as usual. Instead, they should retain the more (...) deliberative, explicit, and transparent ways of thinking that have informed the development of crisis standards of care. The key lesson to be learned from those exercises in rational deliberation is that justice must be the ethical foundation of all standards of care. Justice demands that hospitals take a safety‐net approach to providing services that prioritizes the most vulnerable segments of society, continue to expand telemedicine in ways that improve access without exacerbating disparities, invest in community‐based care, and fully staff hospitals and clinics on nights and weekends. (shrink)

ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that (...) additional dimensions of the standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

It is argued by Lie et al in the current issue of the Journal of Medical Ethics that an international consensus opinion has formed on the issue of standards of care in clinical trials undertaken in developing countries. This opinion, so they argue, rejects the Declaration of Helsinki’s traditional view on this matter. They propose furthermore that the Declaration of Helsinki has lost its moral authority in the controversy in research ethics. Although the latter conclusion is supported by (...) this author, it will be demonstrated in this paper that there is not such a thing as an international consensus opinion, and that the authorities used by Lie et al as evidence in support of their claim should not be relied upon as authorities or final arbiters in this debate. Furthermore, it will be shown that arguments advanced substantively to show that lower standards of care are ethically acceptable in the developing world, conflate scientific with economic reasons, and ultimately fail to bolster the case they are designed to support. (shrink)

The law has therefore had two conflicting impacts on medical ethics: the positive effect of eroding paternalism and replacing it with a patient-centered ethic; and the negative effect of encouraging physicians to be more concerned with avoiding litigation than doing the "right" thing.

ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that (...) additional dimensions of the standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

Law wrangles with setting and applying standards for the practice of medicine in many different arenas. One of the most prominent is medical malpractice litigation in which the trial process examines a physician's performance and measures it against the standard of care. The profession's prevailing custom, with some substantial tolerance for “respectable minority” views, has been the gold standard for scrutinizing physician practice and treatment decisions in the malpractice context. Using the profession's custom as the measure against which (...) a physician's performance is judged defers to the expertise of medicine. Deference to the medical profession is attractive as a tool for reining in law. Reliance on customary practice is criticized, however, for driving physicians to the relative safety of the middle of the herd. Creating such a strong incentive for compliance with customary practice can dampen medical innovation and the diffusion of new clinical knowledge. The safety of the herd can also deprive individual patients of the best care in their particular circumstances.Several current trends are strengthening claims that professional practice patterns are an inappropriate tool for distinguishing between high‐quality and substandard care. In particular, advocacy for evidence‐based medicine aggressively asserts that the traditional way of making medical treatment decisions is largely untethered from scientific method or data, rendering professional judgment, even in the aggregate, suspect. (shrink)

Historically, the standard of care in medical negligence provided considerable scope for external evaluation of clinical judgment. Under the Bolam test, however, determining the standard was seen by the courts as essentially a matter for the medical profession, to be resolved by expert testimony with minimal court scrutiny. In recent years, courts have become more willing to probe such testimony and challenge the credibility of medical experts, although they would very rarely override clinical judgment. The House of Lords' decision (...) in Bolitho may be construed as inviting courts to reach their own conclusions on the reasonableness of clinical conduct, along standard risk–benefit lines, after having made their own assessment of the expert opinion. Closer scrutiny of such opinion is the more welcome in the light of current concerns about partisanship in expert testimony. (shrink)

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a novel antiviral medicine aimed (...) at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of Molnupiravir through the large-scale PANORAMIC randomised control trial. By analysing the ways in which the authorisation and clinical use of Molnupiravir complicate standard approaches to clinical equipoise, standard of care, and participant consent in the PANORAMIC randomised control trial we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

A central feature of experimental development economics is the use of randomized controlled trials (RCTs) to evaluate the effectiveness of prospective socioeconomic interventions. The use of RCTs in development economics raises a host of ethical issues which are just beginning to be explored. In this article, I address one ethical issue in particular: the routine use of the status quo as a control when designing and conducting a development RCT. Drawing on the literature on the principle of standard care (...) in medical research ethics, as well as considerations of distributive justice in non-ideal circumstances, I argue that the practice of using the status quo as a control is ethically justifiable. However, I add an important qualification based on the natural duty of rescue to address the concern that my account is overly permissive. (shrink)

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of molnupiravir, a novel antiviral medicine aimed (...) at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of molnupiravir through the large-scale Platform Adaptive trial of Novel antiviRals for eArly treatMent of COVID-19 In the Community randomised control trial. By analysing the ways in which the authorisation and clinical use of molnupiravir complicate standard approaches to clinical equipoise, standard of care and participant consent in the PANORAMIC randomised control trial, we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

In this essay the ethical issues related to the ‘standard of care’ are discussed together with the implications for the treatment of the control group in transnational clinical trials. It is argued that the human right to health and the duty of justice formulate the moral basis on which this case should be debated.

While the entire “wish-list” of expected benefits from nanotechnology has received little scrutiny in the U.S. with regard to issues of social justice, ethics specialists and social scientists are beginning to focus on the responsible conduct of actual nano research and development (R&D) in government, commercial, and academic institutions. In view of the current rush to commercialization, the rush by universities to “get aboard,” and the importance of public trust, it is essential to investigate strategies to promote responsible conduct in (...) the nano area. As this paper discusses, public engagement is one strategy; another is the formulation and implementation of standards of care that are the outcome of inclusive, deliberative processes. (shrink)

Govind Persad and Ezekiel Emanuel's article “The Case for Resource Sensitivity: Why It Is Ethical to Provide Cheaper, Less Effective Treatments in Global Health,” in this issue of the Hastings Center Report, is a reminder of the debates around resources for health care that raged during the years immediately preceding and following the fifth revision of the Declaration of Helsinki, in 2000. In global health, it is a common expectation for rich countries to assist poor countries in resolving health (...) challenges, yet global health involves not only the governments of rich and poor nations but also nongovernmental organizations, pharmaceutical companies, the World Health Organization, philanthropic organizations, and other parties—all of whom take roles in ensuring that health interventions become available to poor countries, including deciding which types of interventions to make available. The question whether it is ethical to provide cheaper, less effective interventions to poor countries is perhaps relevant only in wealthy nations, where there really is a choice to be made. (shrink)

The Office for Human Research Protections was correct in determining that the consent forms for the National Institutes of Health -sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: how risks and benefits should be described in informed consent documents; the meaning and application of the concept of “standard of care” in the context of research; and the proper role of OHRP. Examination of the consent (...) forms reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of “standard of care” may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements. (shrink)

BackgroundThe prevention of HIV remains an ongoing global concern. The safety and welfare of participants in these trials are imperative. Research Ethics Committees (RECs) review all reports of serious adverse events, adverse events and social harms arising in the course of such trials. There is little guidance for RECs on how to respond appropriately to social harm reports.MethodologyThis paper reviews the literature on social harms in HIV prevention trials and offers suggestions for RECs on how to respond appropriately to such (...) reports.ResultsThis review confirms that social harms are reported in clinical trials in South Africa and that specific guidance on managing these is minimal.ConclusionSocial harms in South African HIV prevention trials need to be more systematically researched so that ethical evidence‐based prevention, care and treatment strategies can be developed. This review makes specific suggestions for further research on social harms that can inform further consultations to develop more specific guidance for stakeholders on appropriate responses to such social harms. Such future work may also inform future versions of relevant local and international ethics guidance on HIV prevention trials. (shrink)

This article briefly reviews the discussion over changes to the Declaration of Helsinki. It suggests that the final product the World Medical Association has adopted as its guiding research ethics document is superior to the version it has replaced, but falls short of what would be ethically desirable.