The ethics of encouraging employees to get the COVID-19 vaccination.

The coronavirus pandemic continues to hinder the ability of businesses to operate at full capacity. Vaccination offers a path for employees to return to work, and for businesses to resume full capacity, while protecting themselves, their fellow workers, and customers. Many employers reluctant to mandate vaccination for their employees are considering other ways to increase employee vaccination rates. Because much has been written about the ethics of vaccine mandates, we examine a related and less discussed topic: the ethics of encouragement strategies aimed at overcoming vaccine reluctance (which can be due to resistance, hesitance, misinformation, or inertia) to facilitate voluntary employee vaccination. While employment-based vaccine encouragement may raise privacy and autonomy concerns, and though some employers might hesitate to encourage employees to get vaccinated, our analysis suggests ethically acceptable ways to inform, encourage, strongly encourage, incentivize, and even subtly pressure employees to get vaccinated.

The Claims of Biospecimen Donors to Credit and Compensation.

The biorights movement argues that current treatment of biospecimen donors is unfair. To evaluate this claim, the present Science & Society article identifies the standards used to determine credit and compensation in research, and applies them to donors. This analysis suggests most donors deserve credit and, contrary to current practice, some deserve compensation.

Adolescent Barriers to HIV Prevention Research: Are Parental Consent Requirements the Biggest Obstacle?

PURPOSE: One third of people newly living with HIV/AIDS are adolescents. Research on adolescent HIV prevention is critical owing to differences between adolescents and adults. Parental permission requirements are often considered a barrier to adolescent enrollment in research, but whether adolescents view this barrier as the most important one is unclear. METHODS: Adolescents were approached in schools in KwaZulu-Natal, South Africa, and at a sexually transmitted infection clinic at the Children's Hospital of Aurora, Colorado. Surveys with a hypothetical vignette about participation in a pre-exposure prophylaxis trial were conducted on smartphones or tablets with 75 adolescents at each site. We calculated descriptive statistics for all variables, using 2-sample tests for equality of proportions with continuity correction. Statistical significance was calculated at p < 0.05. Multivariate analyses were also conducted. RESULTS: Most adolescents thought side effects (77%) and parental consent requirements (69%) were very important barriers to research participation. When asked to rank barriers, adolescents did not agree on a single barrier as most important, but the largest group of adolescents ranked parental consent requirements as most important (29.5%). Parental consent was seen as more of a barrier for adolescents in South Africa than in the United States. Concerns about being experimented on or researchers' mandatory reporting to authorities were ranked much lower. Finally, most (71%, n = 106) adolescents said they would want to extra support from another adult if parental permission was not required. CONCLUSION: Adolescents consider both parental permission requirements and side effects important barriers to their enrollment in HIV prevention research. Legal reform and better communication strategies may help address these barriers.

Racial/Ethnic Differences in Comprehension of Biospecimen Collection: a Nationwide University of Rochester Cancer Center NCI Community Oncology Research Program Study.

To examine whether (a) non-minority participants differed from racial minority participants in the understanding of biospecimens collected for research purposes, (b) patients differed from comparison group in their understanding of the ways their biospecimens could be used by researchers, and (c) participants received adequate information before consenting to donate blood for research studies. We analyzed cross-sectional data from female breast cancer patients scheduled to receive chemotherapy at the National Cancer Institute (NCI) Community Oncology Research Program (NCORP) clinical sites and a healthy comparison group. After reading a consent form related to biospecimens and consenting to participate in a clinical trial, participants' understanding of biospecimen collection was evaluated. Linear models were used to compare scores between non-minority and racial minority participants as well as cancer and non-cancer comparisons adjusting for possible confounding factors. A total of 650 participants provided evaluable data; 592 were non-minority (Caucasian) and 58 participants were a racial minority (71% Black and 29% other). There were 427 cancer patients and 223 comparisons. Non-minority participants scored higher than racial minorities on relevance-to-care items (diff. = 0.48, CI 0.13-0.80, p = 0.001). Comparison group scored higher than cancer patients on relevance-to-care items (diff. = 0.58, CI 0.37-0.78). A moderate number of the participants exhibited a poor understanding of biospecimen collection across all racial/ethnic backgrounds, but racial minority participants' scores remained lower in the relevance-to-care subscale even after adjusting for education and reading level. Differences were also noted among the patients and comparison group. Researchers should facilitate comprehension of biospecimen collection for all study participants, especially racial minority participants.

The Ethics of Research in Lower Income Countries: Double Standards Are Not the Problem.

Discussion of the ethics of clinical trials in lower income countries has been dominated by concern over double standards. Most prominently, clinical trials of interventions that are less effective than the worldwide best treatment methods typically are not permitted in higher income countries. Commentators conclude that permitting such trials in lower income countries involves an ethical double standard. Despite significant attention to this concern, and its influence over prominent guidelines for research in lower income countries, there has been little analysis of what constitutes an ethical double standard in clinical research. The present article attempts to address this gap in the literature. This analysis finds that ethical double standards involve a kind of disrespect, and yields a three-step decision procedure for evaluating when trials of less than the worldwide best methods raise this concern. Application of this procedure reveals that permitting these trials in lower income countries rarely involves an ethical double standard. Instead, the real challenge is determining when clinical trials of interventions that are less effective than the worldwide best represent a permissible and effective response to differences in access to healthcare between higher income and lower income countries. To protect research subjects, without blocking clinical trials that have the potential to improve health in lower income countries, research review committees and other stakeholders should focus on this issue, not on ethical double standards.

Defining pathways for development of disease-modifying therapies in children with type 1 diabetes: a consensus report.

Emerging data suggest that type 1 diabetes is a more aggressive disease in children than in adults, with important differences in pathophysiology and clinical course. Therefore, the efficacy of disease-modifying therapies may be different in the two populations. Understanding the developmental and regulatory pathways for type 1 diabetes-modifying therapies in children will enable industry, academia, funders, advocacy groups, and regulators to translate new science to clinical care. This consensus report characterizes the fundamental differences in type 1 diabetes between children and adults and proposes a thoughtful approach to better understand the development and regulatory pathways for type 1 diabetes therapies.

Genetic research on biospecimens poses minimal risk.

Genetic research on human biospecimens is increasingly common. However, debate continues over the level of risk that this research poses to sample donors. Some argue that genetic research on biospecimens poses minimal risk; others argue that it poses greater than minimal risk and therefore needs additional requirements and limitations. This debate raises concern that some donors are not receiving appropriate protection or, conversely, that valuable research is being subject to unnecessary requirements and limitations. The present paper attempts to resolve this debate using the widely-endorsed 'risks of daily life' standard. The three extant versions of this standard all suggest that, with proper measures in place to protect confidentiality, most genetic research on human biospecimens poses minimal risk to donors.

Research into a functional cure for HIV in neonates: the need for ethical foresight.

In 2013, researchers announced that a newborn child from Mississippi, USA might have been functionally cured of HIV by being given combination antiretroviral therapy within hours of birth. Public and media attention has since been captured by the possibility of finding a cure for HIV transmitted from mother to child. Research into the strategy used for the Mississippi patient is crucially important to establish whether it can be replicated and shown to work in diverse populations. At the same time, any ethical issues likely to arise in such studies should be addressed and not ignored in the pursuit of a functional cure. In this Personal View we identify ethical issues that could arise in research towards achievment of a functional cure for HIV in neonates, including difficult trade-offs associated with choosing the study population and questions about the broader social implications of the research, and propose ways to resolve them.

Problems with the consensus definition of the therapeutic misconception.

In a previous article,' I attempted to assess the likely impact of the most prominent versions of the therapeutic misconception (TM) on research subjects' informed consent. I concluded that the TM is not nearly as significant a concern as is commonly thought, and that focusing on it is more likely to undermine than promote research subjects' informed consent. A recent commentary rejects these conclusions, as least as they pertain to the "consensus" definition of the TM.2 The authors of the commentary argue that work on the TM remains central to ensuring the appropriateness of research subjects' consent and, by implication, the ethical acceptability of clinical research. The present work evaluates the arguments offered in support of these claims. This analysis reveals that the authors offer few substantive responses to my arguments, and the responses they do offer fail to undermine my prior conclusions. Furthermore, consideration of an additional issue-the emergence of learning healthcare systems-suggests that the TM is likely to be even less significant in the future, hence, focusing on it may be even more problematic than I argued previously.

Time to stop worrying about the therapeutic misconception.

Work on the therapeutic misconception suggests that investigators should ensure that potential research subjects understand the fundamental differences between clinical research and clinical care. Yet, what potential research subjects should understand depends on their circumstances and the study in question. This analysis implies that researchers and review committees should stop attempting to define, measure, and dispel the therapeutic misconception, and instead should focus on what potential subjects should understand to participate in individual studies.

Performing nondiagnostic research biopsies in irradiated tissue: a review of scientific, clinical, and ethical considerations.

PURPOSE: Recent development of drugs that target specific pathways in tumors has increased scientific interest in studying drug effects on tumor tissue. As a result, biopsies have become an important part of many early-phase clinical trials. Performing nondiagnostic tumor biopsies raises technical and ethical concerns mostly related to the use of a potentially harmful procedure with no potential benefit to the patient. This issue is complicated by uncertainty about whether performing biopsies in irradiated fields adds significant risk. This article reviews the clinical, scientific, and ethical considerations involved in performing nondiagnostic tumor biopsies in competent adults for research purposes, with a focus on biopsies performed in the setting of therapeutic irradiation. METHODS: Clinical trials that performed biopsies during or within 4 months of the completion of radiotherapy were identified with a literature review. RESULTS: Twenty-nine studies with 2,160 patients were identified. Sixteen of 29 studies reported adverse events (AEs) but did not report active evaluation for biopsy complications. Ten studies did not mention AEs within the study report. At least three studies actively evaluated patients for biopsy complications. Taking this into consideration, 17 (>1%) of 2,160 patients were reported to have biopsy complications, although reporting of AEs was suboptimal in most studies. CONCLUSION: Limited data suggest that biopsies can be performed in irradiated tissues without clinically significant excess risk. Ongoing and future trials including nondiagnostic research biopsies should record and report AEs related to this procedure to provide additional data on safety and toxicity.