Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory (...) protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research. (shrink)

Jecker makes three major points in her article, “A Broader View of Justice” (2008). First, she argues that justice in healthcare relates to justice in the broader social conditions of society as th...

Growing interest in embedded research approaches—where research is incorporated into clinical care—has spurred numerous studies to generate knowledge relevant to the real-world needs of patients and other stakeholders. However, it also has presented ethical challenges. An emerging challenge is how to understand the nature and extent of investigators’ obligations to patient-subjects. Prior scholarship on investigator duties has generally been grounded upon the premise that research and clinical care are distinct activities, bearing distinct duties. Yet this premise—and its corresponding implications—are challenged (...) when research and clinical care are deliberately integrated. After presenting three case studies from recent pragmatic clinical trials, we identify six differences between explanatory trials and embedded research that limit the application of existing scholarship for ascertaining investigator duties. We suggest that these limitations indicate a need to account for the implications of usual care and to move beyond a narrow focus on the investigator-subject dyad, one that better reflects the team- and institution-based nature of contemporary health systems. (shrink)

Classic statements of research ethics advise against permitting physician-investigators to obtain consent for research participation from patients with whom they have preexisting treatment relationships. Reluctance about “dual-role” consent reflects the view that distinct normative commitments govern physician–patient and investigator–participant relationships, and that blurring the research–care boundary could lead to ethical transgressions. However, several features of contemporary research demand reconsideration of the ethics of dual-role consent. Here, we examine three arguments advanced against dual-role consent: that it creates role conflict for the (...) physician-investigator; that it can compromise the voluntariness of the patient-participant’s consent; and that it promotes therapeutic misconceptions. Although these concerns have merit in some circumstances, they are not dispositive in all cases. Rather, their force—and the ethical acceptability of dual-role consent—varies with features of the particular study. As research participation more closely approximates usual care, it becomes increasingly acceptable, or even preferable, for physicians to seek consent for research from their own patients. It is time for a more nuanced approach to dual-role consent. (shrink)

Pragmatic clinical trials offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question, yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as?pragmatic clinical trial collateral findings,? (...) or?PCT-CFs?. In this article, we explore the ethical considerations associated with the identification, assessment, and management of PCT-CFs, and how these considerations may vary based upon the attributes of a specific PCT. Our purpose is to map the terrain of PCT-CFs to serve as a foundation for future scholarship as well as policy-making and to facilitate careful deliberation about actual cases as they occur in practice. (shrink)

Hastings Center Report, Volume 52, Issue 3, Page 9-17, May–June 2022.

Research that is integrated into ongoing clinical activities holds the potential to accelerate the generation of knowledge to improve the health of individuals and populations. Yet integrating research into clinical care presents difficult ethical and regulatory challenges, including how or whether to obtain informed consent. Multiple empirical studies have explored patients' and the public's attitudes toward approaches to consent for pragmatic research. Questions remain, however, about how to use the resulting empirical data in resolving normative and policy debates and what (...) kind of data warrants the most consideration. We recommend prioritizing data about what people consider acceptable with respect to consent for pragmatic research and data about people's informed, rather than initial, preferences on this subject. In addition, we advise caution regarding the weight given to majority viewpoints and identify circumstances when empirical data can be overridden. We argue that empirical data bolster normative arguments that alterations of consent should be the default in pragmatic research; waivers are appropriate only when the pragmatic research would otherwise be impracticable and has sufficiently high social value. (shrink)

This chapter is part of a project to collect David Lewis's correspondence explicitly on topics in the philosophy of religion and arrange major threads by topic, tying the correspondence to his published work. The chapter confines itself to only few letters on only a few topics. David's metaphysics sometimes takes the form of philosophical theology, especially in his correspondence about the free will theodicy. It presents selections of David's correspondence on topics in the philosophy of religion: a letter on evil, (...) specifically on the possibility of divine evil, evil perpetrated by God a letter on evil. The chapter concludes with a discussion of the place which, according to the author, God must have in David's logical space and also of the success of the many‐worlds theodicy that David briefly discusses. (shrink)

In recent years, a robust body of scholarship has emerged that examines ethical challenges facing the learning health organization model. In “Bystander Ethics and Good Samaritanism,” James Sabin and colleagues make a valuable addition to this scholarship, identifying and exploring the important question of what researchers' obligations are to patients receiving “usual care” if “that care is seen as suboptimal.” The central issue that Sabin et al. faced was whether it would be acceptable for researchers to identify patients with untreated (...) atrial fibrillation but then assign them to a control group that would not receive education about the importance of oral anticoagulation. The authors present this challenge as an issue of “bystander ethics.” To avoid being “bystanders” to identified instances of suboptimal care, the research team decided to instead identify a “delayed intervention” group for which they would not determine the members' anticoagulation status, thereby preventing them from knowing that specific patients met the criteria for oral anticoagulants but were not using them. This “workaround” approach strikes me as disingenuous. (shrink)

Volume 19, Issue 5, May 2019, Page W3-W4.

This essay examines how disability interacts with gender in public discourse about sexual violence by investigating the ableist implications of two popular labels commonly applied to people who have experienced rape or sexual assault: survivors and liars. Using a rhetorical approach in conjunction with disability theory, I analyze how discourses of compulsory survivorship ask people who experience sexual assault to overcome disability and appear nondisabled, whereas rape‐hoax narratives frame others as mentally ill, mad, or irrational. Taken together, I argue, these (...) frameworks form a discursive paradox for people who experience sexual assault, specifically marking their mental fitness and placing them in a rhetorically impossible situation when attempting to disclose sexual assault. Demonstrating how these frameworks silence articulations of pain and the realities of mental illness that can result from sexual trauma brings debates about mental disability and pain more centrally into disability studies through a feminist lens. (shrink)

This chapter exhibits elements of the origins of David Lewis, philosopher and human being, and whose works we know. It describes important influences on David as a child, as an adolescent, and young man. The chapter begins with the last, and most important, of the forces that shaped the adult David, and made him the philosopher that he was. The chapter dealing with childhood and early adolescence draws partly on Lewis family myth and folklore, but primarily on an autobiography he (...) wrote, at the age of 14, in his next‐to‐last year of high school. David also showed early signs of the high‐mindedness that characterized him for his entire life. The chapter also looks at David's early life. What Australia, and the Australians, did for him was to take him out of himself and make him into a member of community. (shrink)

Engaging patients in research has come to be viewed as a vital component of high‐quality research, and funders now regard engaging patients and other stakeholders as a core criterion for funding decisions. In response, numerous empirical and conceptual papers have emerged to guide the process of engagement. However, as Emily Largent and colleagues rightly note, the inquiry of whom to engage has received less attention. While several teams have suggested that the selection of patients for engagement is an important consideration, (...) researchers generally have little guidance on how to undertake this process. To that end, Largent and colleagues offer an important contribution to the literature. I agree with their argument regarding the centrality of critically examining which patients to engage in research and with their recommendations to maximize the positive goals of patient engagement. However, three issues warrant further consideration. (shrink)

The conflicts of interest that may arise in relationships between academic researchers and industry continue to prompt controversy. The bulk of attention has focused on financial aspects of these relationships, but conflicts may also arise in the legal obligations that faculty acquire through consulting contracts. However, oversight of faculty members' consulting agreements is far less vigorous than for financial conflicts, creating the potential for faculty to knowingly or unwittingly contract away important rights and freedoms. Increased regulation could prevent this, but (...) it is unclear what forms of oversight universities view as feasible and effective. In this article, we report on a Delphi study to evaluate several approaches for oversight of consulting agreements by medical schools. The panel was comprised of 11 senior administrators with responsibility for oversight of faculty consulting relationships. We found broad agreement among panelists regarding the importance of institutional oversight to protect universities' interests. There was strong support for two specific approaches: providing educational resources to faculty and submitting consulting agreements for institutional review. Notwithstanding the complexities of asserting authority to regulate private consulting agreements between faculty members and companies, medical school administrators reached consensus that several approaches to improving institutional oversight are feasible and useful. (shrink)

Breastfeeding and human milk are the normative standards for infant feeding and nutrition. Given the documented short- and long-term medical and neurodevelopment advantages of breastfeeding, infant nutrition should be considered a public health issue and not only a lifestyle choice.In a letter sent out to 2600 hospitals across the country they [Public Citizen] demand that healthcare facilities “immediately discontinue the distribution of commercial infant formula manufacturer discharge bags,” claiming it undermines women’s success at breastfeeding. What they failed to explain is (...) why a woman’s decision regarding her own tits is anyone’s fucking business but her own.Clearly, policies to promote breast-feeding.. (shrink)

While the human papillomavirus vaccine is medically indicated to reduce the risk of genital warts and certain types of cancer, rates of HPV vaccination repeatedly fall short of public health goals. Individual-level factors contributing to low vaccination rates are well documented. However, system-level barriers, particularly the need for parental consent, have been less explored. To date, there is no legal or ethical consensus in the USA regarding whether adolescents might permissibly self-consent to the HPV vaccine. Consequently, there is considerable variability (...) in medical practice at the provider and state level. In this essay, we explore the ethical acceptability of vaccinating adolescents for HPV without parental consent. We argue that the same ethical considerations that justify permitting minors to consent to treatment for sexual and reproductive health care—namely, public health benefit and adolescents’ developing autonomy—similarly justify permitting minors to consent to HPV vaccination. Based on this analysis, we conclude that allowing adolescents to self-consent to the HPV vaccine is ethically justifiable and should be reflected in US state policies. (shrink)

The COVID-19 pandemic will likely recede only through development and distribution of an effective vaccine. Although there are many unknowns surrounding COVID-19 vaccine development, vaccine demand will likely outstrip early supply, making prospective planning for vaccine allocation critical for ensuring the ethical distribution of COVID-19 vaccines. Here, we propose three central goals for COVID-19 vaccination campaigns: to reduce morbidity and mortality, to minimise additional economic and societal burdens related to the pandemic and to narrow unjust health inequalities. We evaluate five (...) prioritisation approaches, assess their likely impact on advancing the three goals of vaccine allocation and identify open scientific questions that may alter their outcomes. We argue that no single prioritisation approach will advance all three goals. Instead, we propose a multipronged approach that considers the risk of serious COVID-19 illness, instrumental value and the risk of transmission, and is guided by future research on COVID-19-specific clinical and vaccine characteristics. While we focus this assessment on the USA, our analysis can inform allocation in other contexts. (shrink)

Interest in the use of medical data for health research is increasing. Yet, as Elizabeth Ford and colleagues rightly note, there are open questions about the suitability of existing ethical and regulatory oversight frameworks for these research approaches. In their feature article, ‘Should free text data in electronic medical records be shared for research? A citizen’s jury study in the United Kingdom’, Ford et al report the results of a deliberative engagement study in which 18 members of the public were (...) asked whether and under what conditions free text data from medical records should be shared for research purposes. The authors’ explicit aim was to inform national policy on sharing medical text. Public attitudes—stated otherwise, the attitudes of patients whose medical information will ultimately be used under any data sharing policy—are a necessary input into ethical and regulatory decision-making about use of medical data for health research. Though public attitudes will rarely be determinative, they must be weighed in order to uphold the ethical principle of respect for persons.1 Ford et al ’s article is, therefore, an important contribution to …. (shrink)

While provisions of youth sports concussion laws are very similar, little is known as to how they are being implemented, factors that promote or impede implementation, or the level of compliance in each jurisdiction. We aimed to describe state experiences with implementation in order to inform ongoing efforts to reduce the harm of sports-related traumatic brain injury and to guide future evaluations of the laws’ impacts and the development of future public health laws. We conducted key-informant interviews in 35 states (...) with recently enacted concussion legislation. States varied considerably in their readiness and capacity for implementation. Factors facilitating implementation included existing partnerships, procedures, and resources; centralized implementation authority; prior related efforts; and involvement in the policymaking process by those now charged with implementation. Inhibitors included ambiguous statutory language, unclear delegation of authority, and compliance difficulties. Ongoing challenges persist, including primary prevention; determining which providers are qualified to make return-to-play assessments and contents of those assessments; compliance difficulties in rural and under-served areas; and unclear responsibility for enforcement. Despite the similarity of youth sports concussion laws, early evidence suggests there is considerable variation in their implementation. These findings are critical for ongoing empirical investigations to accurately evaluate the laws’ provisions and to identify successful legal approaches to protecting young athletes. (shrink)

Over the past decade, a flurry of media stories devoted to sports-related concussions have drawn attention to the previously “silent epidemic” of traumatic brain injury in athletes. From 2001 to 2009, the annual number of sports-related TBI emergency department visits in individuals age 19 and under climbed from 153,375 to 248,414, an increase of increase of 62 percent. Multiple head injuries place youth athletes at risk for serious health conditions, including cerebral swelling, brain herniation, and even death — postconcussive conditions (...) that have collectively been referred to as “second impact syndrome.” Studies have shown that children and teens — and girls, in particular — are more likely to sustain a concussion and have a longer recovery time than adults. Recent research also suggests that even subconcussive hits in children and adolescents may result in longer-term health effects such as decreased cognitive functioning, increased rates of depression, memory problems, and mild cognitive impairment. (shrink)

Berger and Miller raise important considerations regarding the ongoing relevance and use of cultural competency in medical education. In particular, the authors critique the United States’ L...

There has been extensive discussion in research ethics literature surrounding the appropriate form of informed consent for biobanking, whether with adapted content, or adapted forms such as broad or tiered consent. These discussions presuppose that it is possible to disclose adequate information at the outset to facilitate an informed choice to donate to a biobank. I will argue that informed consent cannot be achieved because in the biobanking context, we are either consenting to an enterprise that is not research or (...) to future research. Nor is the solution to abandon the idea that informed consent ethically requires the disclosure of a certain minimal amount of information to make an informed choice by misleadingly identifying broad, blanket or even tiered consent as forms of ‘informed’ consent. Rather, we should abandon the idea that informed consent for research can be adapted to the type of endeavor that biobanking is, and understand the goal as to develop alternatives not as alternative forms of informed consent, but rather alternatives to informed consent. (shrink)

An estimated 6,500 undocumented immigrants in the United States have been diagnosed with end-stage renal disease. These individuals are ineligible for the federal insurance program that covers dialysis and/or transplantation for citizens, and consequently are subject to local or state policies regarding the provision of healthcare. In 76% of states, undocumented immigrants are ineligible to receive scheduled outpatient dialysis treatments, and typically receive dialysis only when presenting to the emergency center with severe life-threatening symptoms. ‘Emergency-only hemodialysis’ is associated with higher (...) healthcare costs, higher mortality, and longer hospitalizations. In this paper, we present an ethical critique of existing federal policy. We argue that EOHD represents a failure of fiduciary and professional obligations, contributes to moral distress, and undermines physician obligations to be good stewards of medical resources. We then explore potential avenues for reform based upon policies introduced at the state level. We argue that, while reform at the federal level would ultimately be a more sustainable longterm solution, state-based policy reforms can help mitigate the ethical shortcomings of EOHD. (shrink)

Surrogate (proxy) decision makers must make research decisions for people with dementia who lack decision-making capacity. Proxies’ decision-making processes are minimally understood. We randomly assigned 82 proxies of AD patients to informed consent for one of three hypothetical protocols with differing levels of risk and benefit. Proxies answered questions about potential benefits of the described research to the patient and society, as well as about whether they would enroll their relative and why or why not. Proxies interested in enrolling their (...) relative cited the potential for direct benefit to their relative, altruism, and trust in researchers. Those declining cited risks, inconvenience, and stage of illness. Proxies weighed numerous factors, incorporating both substituted judgment and best interests standards in their decision-making processes. Although further empirical work is needed to understand the influences on and adequacy of proxies’ decision making regarding research, these findings can help inform policy regarding surrogate consent. (shrink)

Early versions of satellite and radiosonde datasets suggested that the tropical surface had warmed more than the troposphere, while climate models consistently showed tropospheric amplification of surface warming in response to human-caused increases in greenhouse gases. We revisit such comparisons here using new observational estimates of surface and tropospheric temperature changes. We find that there is no longer a serious discrepancy between modeled and observed trends in the tropics. Our results contradict a recent claim that all simulated temperature trends in (...) the tropical troposphere are inconsistent with observations. This claim was based on the use of older radiosonde and satellite datasets and on two methodological errors: the neglect of observational trend uncertainties introduced by interannual climate variability and application of an inappropriate statistical “consistency test”.This emerging reconciliation of models and observations has two primary explanations. First, because of changes in the treatment of buoy and satellite information, new surface temperature datasets yield slightly reduced tropical warming relative to earlier versions. Second, recently developed satellite and radiosonde datasets now show larger warming of the tropical lower troposphere. In the case of a new satellite dataset from remote sensing systems, enhancedRSS warming is due to an improved procedure of adjusting for inter-satellite biases. When the RSS-derived tropospheric temperature trend is compared with four different observed estimates of surface temperature change, the surface warming is invariably amplified in the tropical troposphere, consistent with model results. Even if we use data from a second satellite dataset with smaller tropospheric warming than in remote sensing systems RSS, observed tropical lapse rates are not significantly different from those in all model simulations.Our results contradict a recent claim that all simulated temperature trends in the tropical troposphere and in tropical lapse rates are inconsistent with observations. This claim was based on the use of older radiosonde and satellite datasets and on two methodological errors: the neglect of observational trend uncertainties introduced by interannual climate variability and application of an inappropriate statistical “consistency test”. (shrink)

Volume 19, Issue 5, May 2019, Page 41-42.

Interest in the ethics of research on human subjects, stimulated by atrocious human experimentation during WWII and the resultant Nuremberg Code, has been sustained by examples of unethical research in many countries and by proliferation of codes and guidelines. Such interest has intensified in recent years in association with expanding international collaborative research endeavors. The ongoing controversy in international research ethics takes place at two levels. At the practical level it is about the competing concerns of those predominantly interested in (...) doing research to advance knowledge and those who, while supporting the need for research, are more acutely aware of the potential to exploit vulnerable participants, especially in developing countries. At the level of theory the controversy pits ethical universalism against moral relativism.In her recent review of agreements and controversies in international research ethics, Ruth Macklin has concluded that, despite seeming agreement on several issues, many different viewpoints persist. In her view it is unlikely that these will be resolved easily. (shrink)

Interest in the ethics of research on human subjects, stimulated by atrocious human experimentation during WWII and the resultant Nuremberg Code, has been sustained by examples of unethical research in many countries and by proliferation of codes and guidelines. Such interest has intensified in recent years in association with expanding international collaborative research endeavors. The ongoing controversy in international research ethics takes place at two levels. At the practical level it is about the competing concerns of those predominantly interested in (...) doing research to advance knowledge and those who, while supporting the need for research, are more acutely aware of the potential to exploit vulnerable participants, especially in developing countries. At the level of theory the controversy pits ethical universalism against moral relativism.In her recent review of agreements and controversies in international research ethics, Ruth Macklin has concluded that, despite seeming agreement on several issues, many different viewpoints persist. In her view it is unlikely that these will be resolved easily. (shrink)

Medical practitioners have traditionally seen themselves as part of an international community with shared and unifying scientific and ethical goals in the treatment of disease, the promotion of health, and the protection of life. This shared mission is underpinned by explicit acceptance of traditional concepts of medical morality, and by an implied link between individual human rights and the ethics of medical practice long enshrined in a range of World Medical Association (WMA) and other medical codes. These have been powerful (...) instruments exhorting individual practitioners to promote health and to defend universal principles in order to protect their patients and the physician-patient relationship even in the face of authoritarian state coercion and imposed national ideologies and policies. There has been widespread support for this approach and this should be intensified. (shrink)

Widening disparities in health within and between nations reflect a trajectory of ‘progress’ that has ‘run its course’ and needs to be significantly modified if progress is to be sustainable. Values and a value system that have enabled progress are now being distorted to the point where they undermine the future of global health by generating multiple crises that perpetuate injustice. Reliance on philanthropy for rectification, while necessary in the short and medium terms, is insufficient to address the challenge of (...) economic and other systems spinning out of control. Innovative approaches are required and it is suggested that these could best emerge from in-depth multidisciplinary research supported by endeavours to promote a ‘global mind-set.’. (shrink)

Intense scientific work on HIV/AIDS has led to the development of effective combination drug therapies and there is hope that effective vaccines will soon be produced. However, the majority of people with HIV/AIDS in the world are not benefiting from such advances because of extreme poverty. This article focuses on the pandemic as a reflection of a complex trajectory of social and economic forces that create widening global disparities in wealth and health and concomitant ecological niches for the emergence of (...) new infectious diseases. While the biomedical approach to HIV/AIDS is necessary, has prolonged the lives of many individuals and could offer much at the level of population health, it cannot, in isolation, improve the health of populations. To achieve the latter will require understanding and addressing the deeper social causes of pandemics. Broadening the discourse on ethics to include public health ethics and the ethics of international relations could contribute to reducing the impact of the pandemic and to preventing the emergence of new infectious diseases in the future. (shrink)