"We are not the ethics police": The professionalization of clinical ethicists and the regulation of medical decision-making.

Clinical ethicists represent a growing profession in U.S. healthcare. This profession's aspirations include serving as a supportive resource to hospital staff, but also as an ethics "watchdog," ensuring that medical decision-making adheres to ethical standards. Drawing on 31 in-depth interviews conducted in 2021 of clinical ethicists working across the U.S., I evaluate the extent to which these watchdog aspirations have been achieved. I investigate ethicists' success in leveraging three strategies aspiring professions have used to secure their jurisdictional claims: acquiring professional expertise, securing administrative authority, and cultivating trusting relationships. I show that ethicists face barriers to leveraging each, which has consequences for how ethical dilemmas are resolved. Findings point to challenges aspiring professions must overcome in order to claim jurisdictions posing a threat to incumbent professions; the tensions that exist between legal risk management and clinical ethics; and the organizational strategies marginal actors leverage to advance their interests and influence the delivery of healthcare.

Views of IRB members regarding phase 1 pediatric oncology trials.

There is significant debate over whether phase 1 pediatric oncology trials are ethical and approvable. We thus surveyed IRB members to answer four questions. First, do IRB members think the potential medical benefits of average phase 1 pediatric oncology trials justify the risks? Second, do they think these trials are ethically appropriate? Third, do they think these trials are approvable? Fourth, how do the views of IRB members on the first two questions compare to the views of the US public? Of the 80 respondents who answered the test questions correctly, 18.8% stated that the potential medical benefits of average phase 1 pediatric oncology trials outweigh the risks, 32.5% stated that the potential medical benefits and risks are about equal, and 48.8% stated that the risks outweigh the potential medical benefits. Compared to the general public, IRB members were significantly more likely to think the risks outweigh the potential medical benefits (p = 0.01). Finally, 68.8% of IRB members indicated that average phase 1 pediatric oncology trials are approvable, and 56.3% indicated that these trials are appropriate in children. These findings suggest two-thirds of IRB members believe average phase 1 pediatric oncology trials are approvable. Yet, almost half regard the risks as outweighing the potential medical benefits and almost half think these trials are inappropriate. These findings raise important questions regarding why IRB members and the general public evaluate the same risk/benefit profile differently, and whether it is possible to reconcile the two perspectives.

COVID-19 Vaccine Rollouts and the Reproduction of Urban Spatial Inequality: Disparities Within Large US Cities in March and April 2021 by Racial/Ethnic and Socioeconomic Composition.

Rollouts of COVID-19 vaccines in the USA were opportunities to redress disparities that surfaced during the pandemic. Initial eligibility criteria, however, neglected geographic, racial/ethnic, and socioeconomic considerations. Marginalized populations may have faced barriers to then-scarce vaccines, reinforcing disparities. Inequalities may have subsided as eligibility expanded. Using spatial modeling, we investigate how strongly local vaccination levels were associated with socioeconomic and racial/ethnic composition as authorities first extended vaccine eligibility to all adults. We harmonize administrative, demographic, and geospatial data across postal codes in eight large US cities over 3 weeks in Spring 2021. We find that, although vaccines were free regardless of health insurance coverage, local vaccination levels in March and April were negatively associated with poverty, enrollment in means-tested public health insurance (e.g., Medicaid), and the uninsured population. By April, vaccination levels in Black and Hispanic communities were only beginning to reach those of Asian and White communities in March. Increases in vaccination were smaller in socioeconomically disadvantaged Black and Hispanic communities than in more affluent, Asian, and White communities. Our findings suggest vaccine rollouts contributed to cumulative disadvantage. Populations that were left most vulnerable to COVID-19 benefited least from early expansions in vaccine availability in large US cities.

Acceptable Risks in Pediatric Research: Views of the US Public.

BACKGROUND AND OBJECTIVES: Critics argue that it is unethical to expose children to research risks for the benefit of others, whereas many regulations permit "net-risk" pediatric research but only when the risks are minimal. In the present survey, we assessed whether the US public agrees with these views and whether the US public's views regarding the acceptability of net-risk pediatric research are influenced by its social value. METHODS: A 15-minute survey of a nationally representative sample of US adults. Participants were randomly assigned to 1 of 4 hypothetical scenarios involving procedures that pose increasing levels of risk. To assess whether respondents' views on the acceptability of the risks is influenced by the social value of the research, in each of the 4 scenarios we described the respective procedure being used in 3 studies with increasing levels of social value. RESULTS: A total 1658 of the 2508 individuals who were sent the survey link participated (response rate = 66.1%). Approximately 91% approved of a research blood draw in minors, and ∼69% approved of a research bone marrow biopsy. The proportion who indicated that the respective procedure was acceptable increased as the study's social value increased. This effect was significantly stronger for studies which pose greater risks compared with studies with lower risks (P < .001). CONCLUSIONS: The vast majority of the US public supports net-risk pediatric research that poses minimal risk, and a majority supports net-risk pediatric research that poses somewhat greater risks, provided it has high social value. These findings offer important information for assessing when it is acceptable to conduct net-risk pediatric research.

Exploring the motivations of research participants who chose not to learn medically actionable secondary genetic findings about themselves.

PURPOSE: Proposals to return medically actionable secondary genetic findings (SFs) in the clinical and research settings have generated controversy regarding whether to solicit individuals' preferences about their "right not to know" genetic information. This study contributes to the debate by surveying research participants who have actively decided whether to accept or refuse SFs. METHODS: Participants were drawn from a large National Institutes of Health (NIH) environmental health study. Participants who had accepted SFs (n = 148) or refused SFs (n = 83) were given more detailed information about the types of SFs researchers could return and were given an opportunity to revise their original decision. RESULTS: Forty-one of 83 initial refusers (49.4%) opted to receive SFs following the informational intervention. Nearly 75% of these "reversible refusers" thought they had originally accepted SFs. The 50.6% of initial refusers who continued to refuse ("persistent refusers") demonstrated high levels of understanding of which SFs would be returned postintervention. The most prominent reason for refusing was concern about becoming worried or sad (43.8%). CONCLUSION: This study demonstrates the need for a more robust informed consent process when soliciting research participants' preferences about receiving SFs. We also suggest that our data support implementing a default practice of returning SFs without actively soliciting preferences.

Do the Potential Medical Benefits of Phase 1 Pediatric Oncology Trials Justify the Risks? Views of the United States Public.

OBJECTIVES: To assess the US public's views on whether the potential medical benefits of phase 1 pediatric oncology trials justify the risks. STUDY DESIGN: Online survey of a nationally representative sample of US adults. Participants were presented with a hypothetical scenario in which they have a 10-year-old child with advanced cancer. They were then offered the option of giving their child supportive care or trying one more potential treatment, in the research or clinical care setting, which has the same risks and potential medical benefits as the average phase 1 pediatric oncology trial. We assessed what percentage of respondents thought the potential medical benefits justify the risks. RESULTS: In total, 1658 of the 2508 individuals who were sent the survey participated (response rate = 66.1%). Of those who passed all 3 test questions indicating understanding, 67.1% in the research scenario and 58.5% in the clinical care scenario regarded the potential medical benefits of an average phase 1 pediatric oncology trial as equal to or greater than the risks. In addition, 53.4% of respondents in the research scenario thought it was appropriate for researchers to conduct a study in children with these risks and potential medical benefits, and 46.9% stated they would enroll their own child in such a trial. CONCLUSIONS: A majority of the US public regards the potential medical benefits of average phase 1 pediatric oncology trials as justifying the risks. This finding suggests that these trials are ethically appropriate and approvable in patients who have no more effective treatment options. At the same time, a significant minority thought the potential medical benefits do not justify the risks, suggesting these trials should be approved only when they have significant social value. Moreover, approximately one-half of respondents regarded the trials as inappropriate and would not enroll their own child, underscoring the need for a rigorous informed consent process that accurately educates parents regarding the risks, potential medical benefits, and alternatives, so they can decide whether to enroll their child based on their own preferences and goals.

Re-examining the Ethics of Genetic Counselling in the Genomic Era.

Respect for patient autonomy has served as the dominant ethical principle of genetic counselling, but as we move into a genomic era, it is time to actively re-examine the role that this principle plays in genetic counselling practice. In this paper, we argue that the field of genetic counselling should move away from its emphasis on patient autonomy and toward the incorporation of a more balanced set of principles that allows counsellors to offer clear guidance about how best to obtain or use genetic information. We begin with a brief history of how respect for patient autonomy gained such emphasis in the field and how it has taken on various manifestations over time, including the problematic concept of nondirectiveness. After acknowledging the field's preliminary move away from nondirectiveness, we turn to a series of arguments about why the continued dominance of patient autonomy has become untenable given the arrival of the genomic era. To conclude, we describe how a more complete set of bioethical principles can be adapted and used by genetic counsellors to strengthen their practice without undermining patient autonomy.

Belmont in Context.

Given its outsized influence as a core document in bioethics, it is worth reminding ourselves of the historical context in which the Belmont Report came to be. This article examines the societal forces that helped bring about the Belmont Report and that shaped its conception of ethical research. A product of a public investigation that included many nonscientists and espoused philosophical principles, the Report internalized a growing call in the late 1960s for oversight over the research enterprise, which had long been the private realm of physician-investigators. Belmont helped bring about a regulatory and oversight apparatus to the research enterprise, as well as a language and discipline of bioethics that added a multidisciplinary set of voices and decision-makers to discussions of what constitutes ethical research. Because it reflected the spirit of protectionism engendered by events of the 1960s and 1970s, Belmont also helped emphasize the importance of informed consent and the protection of vulnerable populations. But because the Report was a product of its time, contingent on historical developments and highly publicized events, it is not necessarily responsive to new factors that now condition the research enterprise.

An ethical framework for genetic counseling in the genomic era.

The field of genetic counseling has grown and diversified since the profession emerged in the early 1970s. In the same period, genomic testing has become more complex, profitable, and widespread. With these developments, the scope of ethical considerations relevant to genetic counseling has expanded. In light of this, we find it helpful to revisit how ethical and relational variables are used to inform genetic counseling practice. Our specific focus is on whether, and to what extent, it is ethically acceptable for genetic counselors to make normative recommendations to patients. This article builds on prior literature that has critiqued nondirectiveness, a concept that has influenced and constrained the modern profession of genetic counseling since its origin. In it, we review scholarly efforts to move beyond nondirectiveness, which we believe privilege patient autonomy at the expense of other important values. We then argue that genetic counselors should favor a more explicit commitment to the principles of beneficence and non-maleficence, as well as a broader understanding of autonomy and the relational variables that impact genetic counseling. Finally, to translate our arguments into practice, we present a framework of six considerations that genetic counselors should take into account when deciding whether it is ethically acceptable, or even desirable, to make recommendations to patients in certain areas of their work.

Prevalence and predictors of alcohol and drug use among secondary school students in Botswana: a cross-sectional study.

BACKGROUND: Alcohol and illicit drug use has been recognized as a growing problem among adolescents in Botswana. Little is known about factors affecting alcohol and drug use among Botswana's secondary school students. To aid the design and implementation of effective public health interventions, we sought to determine the prevalence of alcohol and drug use in secondary school students in urban and peri-urban areas of Botswana, and to evaluate risk and protective factors for substance use. METHODS: We performed a 72-item cross-sectional survey of students in 17 public secondary schools in Gaborone, Lobatse, Molepolole and Mochudi, Botswana. The World Health Organization's (WHO) Alcohol Use Disorder Identification Test (AUDIT) was used to define hazardous drinking behavior. Using Jessor's Problem Behavior Theory (PBT) as our conceptual framework, we culturally-adapted items from previously validated tools to measure risk and protective factors for alcohol and drug use. Between-group differences of risk and protective factors were compared using univariate binomial and multinomial-ordinal logit analysis. Relative risks of alcohol and drug use by demographic, high risks and low protections were calculated. Multivariate ordinal-multinomial cumulative logit analysis, multivariate nominal-multinomial logit analysis, and binominal logit analysis were used to build models illustrating the relationship between risk and protective factors and student alcohol and illicit drug use. Clustered data was adjusted for in all analyses using Generalized Estimating Equations (GEE) methods. RESULTS: Of the 1936 students surveyed, 816 (42.1%) reported alcohol use, and 434 (22.4%) met criteria for hazardous alcohol use. Illicit drug use was reported by 324 students (16.7%), with motokwane (marijuana) being the most commonly used drug. Risk factors more strongly associated with alcohol and drug use were reported alcohol availability, individual and social vulnerability factors, and poor peer modeling. Individual and social controls protections appear to mitigate risk of student alcohol and drug use. CONCLUSIONS: Alcohol and illicit drug use is prevalent among secondary school students in Botswana. Our data suggest that interventions that reduce the availability of alcohol and drugs and that build greater support networks for adolescents may be most helpful in decreasing alcohol and drug use among secondary school students in Botswana.

Human Experimentation in Public Schools: How Schools Served as Sites of Vaccine Trials in the 20th Century.

Schools have long been critical partners for public health authorities in achieving widespread vaccination. In the mid-20th century, however, public schools also served as sites of large-scale experiments on novel vaccines. Through examining the experimental diphtheria, polio, and measles vaccine trials, I explored the implications of using schools in this manner, as well as the continuities and discontinuities among the three cases. Common to all of them was that the use of schools brought decision-making into the public sphere, subjecting parents to social pressures and the influences of school officials and community members. However, the effects of using schools varied as well, as their social and institutional significance interacted differently with the narratives surrounding each disease, the public's changing perception of medicine and science, and society's changing values. These insights show not only the power of public institutions to influence opinions and perceptions, but also the subtle forces that one's authority figures, peers, and community members may bring to a seemingly private decision-making process. These considerations are relevant to health interventions today, such as the complex debate over community consent in global health research. (Am J Public Health. 2018;108:1015-1022. doi: 10.2105/AJPH.2018.304423).