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)

The National Institutes of Health and other federal health agencies are considering establishing a national biobank to study the roles of genes and environment in human health. A preliminary public engagement study was conducted to assess public attitudes and concerns about the proposed biobank, including the expectations for return of individual research results. A total of 141 adults of different ages, incomes, genders, ethnicities, and races participated in 16 focus groups in six locations across the country. Focus group participants voiced (...) a strong desire to be able to access individual research results. Recognizing the wide range of possible research results from a large cohort study, they repeatedly and spontaneously suggested that cohort study participants be given ongoing choices as to which results they received. (shrink)

When there have been substantial failures by institutional leadership in their oversight responsibility to protect research integrity, the public should demand that these be recognized and addressed by the institution itself, or the funding bodies. This commentary discusses a case of research failures in developing genomic predictors for cancer risk assessment and treatment at a leading university. In its review of this case, the Office of Research Integrity, an agency within the US Department of Health and Human Services, focused their (...) report entirely on one individual faculty member and made no comment on the institution’s responsibility and its failure to provide adequate oversight and investigation. These actions missed an important opportunity to emphasize the institution’s critical responsibilities in oversight of research integrity and the importance of institutional transparency and accountability. (shrink)

Despite wide recognition of the importance of treating patients with respect and dignity, little is known about what constitutes treatment in this regard. The intensive care unit (ICU) is a unique setting that can pose specific threats to treatment with respect and dignity owing to the critical state of patients, stress and anxiety amongst patients and their family members, and the highly technical nature of the environment. In attempt to understand various stakeholders’ perspectives of treatment with respect and dignity, patients (...) and family members were interviewed, a wide range of health care professionals participated in focus groups, and third party observers took field notes of interactions in the ICU. This paper compares and contrasts the data that were generated using these different methods. Triangulating the data in this way contributes to a more complete and nuanced understanding of treatment with respect and dignity in the ICU. (shrink)

Respect and dignity are central to moral life, and have a particular importance in health care settings such as the intensive care unit (ICU). We conducted 15 semistructured interviews with 21 participants during an ICU admission to explore the definition of, and specific behaviors that demonstrate, respect and dignity during treatment in the ICU. We transcribed interviews and conducted thematic qualitative analysis. Seven themes emerged that focused on what it means to be treated with respect and/or dignity: treated as a (...) person; Golden Rule; acknowledgement; treated as family/friend; treated as an individual; treated as important/valuable; and treated as equal. Participants described particular behaviors or actions that were considered related to demonstrating treatment with respect and dignity: listening; honesty/giving information; attention to body/modesty/appearance; caring/bedside manner; patient and family as an information source; attention to pain; and responsiveness. These behaviors provide a framework for improving experiences with care in the ICU. (shrink)

The pandemic of SARS-CoV-2 has led to unprecedented changes to society, causing unique problems that call for extraordinary solutions. We consider one such extraordinary proposal: ‘safer infection sites’ that would offer individuals the opportunity to be intentionally infected with SARS-CoV-2, isolate, and receive medical care until they are no longer infectious. Safer infection could have value for various groups of workers and students. Health professionals place themselves at risk of infection daily and extend this risk to their family members and (...) community. Similarly, other essential workers who face workplace exposure must continue their work, even if have high-risk household members and live in fear of infecting. When schools are kept closed because of the fear that they will be sites of significant transmission, children and their families are harmed in multiple ways and college students who are living on campus, whether or not they are attending classes in person, are contributing to high rates of transmission and experiencing high rates of exposure. We consider whether offering safer infection sites to these groups could be ethically defensible and identify the empirical unknowns that would need to resolve before reaching definitive conclusions. This article is not an endorsement of intentional infection with the coronavirus, but rather is meant to spark conversation on the ethics of out-of-the-box proposals. Perhaps most meaningfully, our paper explores the value of control and peace of mind for those among us most impacted by the pandemic: those essential workers risking the most to keep us safe. (shrink)

Caring for critically ill and dying patients often triggers both professional and personal growth for physician trainees. In pediatrics, the neonatal intensive care unit is among the most distressing settings for trainees. We used longitudinal narrative writing to gain insight into how physician trainees are challenged by and make sense of repetitive, ongoing conflicts experienced as part of caring for very sick and dying babies. The study took place in a 45-bed, university-based NICU in an urban setting in the United (...) States. From November 2009 to June 2010 we enrolled pediatric residents and neonatology fellows at the beginning of their NICU rotations. Participants were asked to engage in individual, longitudinal narrative writing about their “experience in the NICU.” Thematic narrative analysis was performed. Thirty-seven physician trainees participated in the study. The mean number of narratives per trainee was 12; a total of 441 narratives were available for analysis. Conflict was the most pervasive theme in the narratives. Trainees experienced conflicts with families and conflicts with other clinicians. Trainees also described multiple conflicts of identity as members of the neonatology team, as members of the medical profession, as members of their own families, and as members of society. Physician trainees experience significant conflict and distress while learning to care for critically ill and dying infants. These conflicts often led them to question their own morals and their role in the medical profession. Physician trainees should be educated to expect various types of distress during intensive care rotations, encouraged to identify their own sources of distress, and supported in mitigating their effects. (shrink)

Little is known about health care professionals’ perceptions regarding what it means to treat patients and families with respect and dignity in the intensive care unit (ICU) setting. To address this gap, we conducted nine focus groups with different types of health care professionals (attending physicians, residents/fellows, nurses, social workers, pastoral care, etc.) working in either a medical or surgical ICU within the same academic health system. We identified three major thematic domains, namely, intrapersonal (attitudes and beliefs), interpersonal (behaviors), and (...) system (contextual) factors that influence treatment with respect and dignity. Participants suggested strategies for improving treatment of patients and families in the ICU with respect and dignity, as well as the related need for enhancing respect among the multidisciplinary team of clinicians. Implementing these strategies will require innovative educational interventions and leadership. Future research should focus on the design and evaluation of such interventions on the quality of care. (shrink)

Biomedical science is usually framed for the public in terms of its “promise.” When a breakthrough results from scientific inquiry, that promise is translated into a hope for a cure. The “promise” of such advances in biomedical research can have a paradoxical effect. In the case of pediatric neuromuscular disease, rather than reducing suffering, the expectation of cure can be a burden—both physically and emotionally—for affected children and their families. If a family expects a cure, it is likely to do (...) everything possible to help the child live as long as possible, in the hope that the child will eventually receive it. I am not arguing that the appropriate response to the paradox of promise is to impede scientific progress. What is needed, however, is a broader conception of hope—one that values hope for a good day, a good quality of life, good relationships, or even a good death—alongside the hope for a cure. (shrink)

Treating patients and their family members with respect and dignity is a broadly accepted goal of health care. The work presented in this article is part of a larger project aimed at better understanding what constitutes treatment with respect and dignity in the ICU to improve the care that patients and family members receive in this regard. Direct observation was selected as one of the methods to facilitate this understanding because it provides the opportunity to see and document what actually (...) occurs during encounters among patients, their families, and clinicians. This article reports seven major thematic domains and many subthemes that together create a detailed account of the interpersonal and environmental components of treatment with respect and dignity. Attention to these components might enhance the experience and treatment of patients and family members. (shrink)

Cancer susceptibility testing is likely to become routine in medical practice, despite many limitations and unanswered questions. These uncertainties greatly complicate the process of informed consent, creating an excellent opportunity to reconsider exactly how it should be conducted. Research with women's reactions to the availability of genetic susceptibility testing for breast cancer dramatically underscores that informed consent ought to be highly individualized, taking care to discern what patients believe about the disease and its causes and what role they want their (...) physician to play. (shrink)

Confidentiality is a cornerstone of the physician-patient relationship. Breaches of confidentiality in the context of genetic testing are of particular concern for a number of reasons. First, genetic testing reveals information not only about a particular patient, but also about his or her family members. Second,genetic testing can label healthy people as “at risk,” subjecting them to possible stigmatization or discrimination by third parties. Third, as genetic testing becomes more widespread and is incorporated into primary care, breaches of confidentiality might (...) inadvertently occur more frequently because primary care providers may not be trained to understand the uniqueness of genetic information. Until now, genetic services have been provided primarily by medical geneticists and genetic counselors. However, with the proliferation of new genetic presymptomatic and carrier tests, primary care physicians are going to become increasingly involved in genetic testing. Currently, little is known about physicians’ attitudes toward disclosure of confidential genetic information to third parties. (shrink)

Confidentiality is a cornerstone of the physician-patient relationship. Breaches of confidentiality in the context of genetic testing are of particular concern for a number of reasons. First, genetic testing reveals information not only about a particular patient, but also about his or her family members. Second,genetic testing can label healthy people as “at risk,” subjecting them to possible stigmatization or discrimination by third parties. Third, as genetic testing becomes more widespread and is incorporated into primary care, breaches of confidentiality might (...) inadvertently occur more frequently because primary care providers may not be trained to understand the uniqueness of genetic information. Until now, genetic services have been provided primarily by medical geneticists and genetic counselors. However, with the proliferation of new genetic presymptomatic and carrier tests, primary care physicians are going to become increasingly involved in genetic testing. Currently, little is known about physicians’ attitudes toward disclosure of confidential genetic information to third parties. (shrink)

Prenatal ultrasound use is skyrocketing despite limited evidence of improved outcomes. One factor driving this trend is the widely recognized psychological appeal of real-time fetal imaging. Meanwhile, considering imperfect safety evidence, U.S. professional guidelines dictate that prenatal ultrasound—a screening test—should be governed by expected clinical benefits—an opportunity for intervention. However, when women’s healthcare professionals themselves are pregnant, their access to ultrasound technology permits informal, personal use that may deviate from standard-of-care, e.g., for reassurance. Highlighting a poignant case wherein a pregnant (...) obstetrician’s personal ultrasound use had unforeseen negative consequences, we explore this issue within context of professional ethics and informal medical care. We discuss how women’s health professionals’ self-care may influence and inform prenatal care at large. We advocate curtailing informal prenatal ultrasound use, but also potentially broadening accepted indications for or relaxing proscriptions against ultrasounds for patients. Further research and updated, evidence-based, ethically-sound guidelines are needed. (shrink)

We have never been so aware of masks. They were in short supply in the early days of COVID-19, resulting in significant risk to health care workers. Now they are highly politicized with battles about mask-wearing protocols breaking out in public. Although masks have obtained a new urgency and ubiquity in the context of COVID-19, people have thought about both the literal and metaphorical role of masks in medicine for generations. In this paper, we discuss three such metaphors—the masks of (...) objectivity, of infallibility, and of benevolence—and their powerful role in medicine. These masks can be viewed as inflexible barriers to communication, contributing to the traditional authoritarian relationship between doctor and patient and concealing the authenticity and vulnerability of physicians. COVID masks, by contrast, offer a more nuanced and morally complex metaphor for thinking about protecting people from harm, authentic and trustworthy communication, and attention to potential inequities both in and beyond medical settings. We highlight the morally relevant challenges and opportunities that masks evoke and suggest that there is much to be gained from rethinking the mask metaphor in medicine. (shrink)

It is simple enough to claim that academic research institutions ought to be trustworthy. Building the culture and taking the steps necessary to earn and preserve institutional trust are, however, complex processes. The experience motivating this special report—a request for the Center for Talented Youth at Johns Hopkins University to collaborate on research regarding the genetics of intelligence—illustrates how ensuring institutional trustworthiness can be in tension with a commitment to fostering research. In this essay, we explore the historical context for (...) biomedical research institutions like Johns Hopkins that have worked to build local community trust. In so doing, we consider how the example under focus in this special report can lead to greater consideration of how research institutions balance fostering trust with their other commitments. (shrink)