Clinicians have good moral and professional reasons to contribute to pragmatic clinical trials (PCTs). We argue that clinicians have a defeasible duty to participate in this research that takes place in usual care settings and does not involve substantive deviation from their ordinary care practices. However, a variety of countervailing reasons may excuse clinicians from this duty in particular cases. Yet because there is a moral default in favor of participating, clinicians who wish to opt out of this research must (...) justify their refusal. Reasons to refuse include that the trial is badly designed in some way, that the trial activities will violate the clinician’s conscience, or that the trial will impose excessive burdens on the clinician. (shrink)

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)

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)

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)

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)

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)

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)

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

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)

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)

In recent years, various obesity-related policy strategies have fostered rigorous debate in both the academic and popular literature: should a city restrict soda size to reduce obesity rates? Should low-income individuals receiving government food assistance through the Supplemental Nutritional Assistance Program be prohibited from using such funds to purchase soda or other “junk foods?” Should schools undertake screening and surveillance of student body mass index? These strategies pose a central challenge for public health regulation: what is the role of government (...) in responding to rising obesity rates? Specifically, to what degree can the state restrict individual freedom to reduce the burden of.. (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)

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)

Background Forward-looking, democratically oriented governance is needed to ensure that human genome editing serves rather than undercuts public values. Scientific, policy, and ethics communities have recognized this necessity but have demonstrated limited understanding of how to fulfill it. The field of bioethics has long attempted to grapple with the unintended consequences of emerging technologies, but too often such foresight has lacked adequate scientific grounding, overemphasized regulation to the exclusion of examining underlying values, and failed to adequately engage the public. Methods (...) This research investigates the application of scenario planning, a tool developed in the high-stakes, uncertainty-ridden world of corporate strategy, for the equally high-stakes and uncertain world of the governance of emerging technologies. The scenario planning methodology is non-predictive, looking instead at a spread of plausible futures which diverge in their implications for different communities’ needs, cares, and desires. Results In this article we share how the scenario development process can further understandings of the complex and dynamic systems which generate and shape new biomedical technologies and provide opportunities to re-examine and re-think questions of governance, ethics and values. We detail the results of a year-long scenario planning study that engaged experts from the biological sciences, bioethics, social sciences, law, policy, private industry, and civic organizations to articulate alternative futures of human genome editing. Conclusions Through sharing and critiquing our methodological approach and results of this study, we advance understandings of anticipatory methods deployed in bioethics, demonstrating how this approach provides unique insights and helps to derive better research questions and policy strategies. (shrink)

We very much appreciate the helpful and generous commentaries in response to “Do Clinicians have a Duty to Participate in Pragmatic Clinical Trials?” (Garland, Morain, and Sugarman 2023). In that a...

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

Aim: Streamlining consent for low-risk comparative effectiveness research (CER) could facilitate research, while safeguarding patients' rights. Materials & methods: 2618 adults were randomized to one of seven consent approaches (six streamlined and one traditional) for a hypothetical, low-risk CER study. A survey measured understanding, voluntariness, and feelings of respect. Results: Participants in all arms had a high understanding of the trial and positive attitudes toward the consent interaction. Highest satisfaction was with a streamlined approach showing a video before the medical (...) appointment. Participants in streamlined were more likely to mistakenly think a signature was required. Conclusion: Streamlined consent was no less acceptable than traditional, signed consent. Streamlined and traditional approaches achieved similar levels of understanding, voluntariness and a feeling that the doctor–patient interaction was respectful. (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...

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)