The ethical value of consulting community members in non-emergency trials conducted with waivers of informed consent for research.

There is growing interest in using embedded research methods, particularly pragmatic clinical trials, to address well-known evidentiary shortcomings afflicting the health care system. Reviews of pragmatic clinical trials published between 2014 and 2019 found that 8.8% were conducted with waivers of informed consent; furthermore, the number of trials where consent is not obtained is increasing with time. From a regulatory perspective, waivers of informed consent are permissible when certain conditions are met, including that the study involves no more than minimal risk, that it could not practicably be carried out without a waiver, and that waiving consent does not violate participants' rights and welfare. Nevertheless, when research is conducted with a waiver of consent, several ethical challenges arise. We must consider how to: address empirical evidence showing that patients and members of the public generally prefer prospective consent, demonstrate respect for persons using tools other than consent, promote public trust and investigator integrity, and ensure an adequate level of participant protections. In this article, we use examples drawn from real pragmatic clinical trials to argue that prospective consultation with representatives of the target study population can address, or at least mitigate, many of the ethical challenges posed by waivers of informed consent. We also consider what consultation might involve to illustrate its feasibility and address potential objections.

Hormonal Contraceptive Side Effects and Nonhormonal Alternatives on TikTok: A Content Analysis.

The use of hormonal contraceptives is decreasing in the United States alongside a growing interest in nonhormonal contraceptive options. Social media messaging may be contributing to this trend. TikTok thus offers a novel opportunity to understand how people share information about risks and alternatives for pregnancy prevention. To describe the availability and content of information about hormonal contraceptive side effects and nonhormonal contraceptive options on TikTok, we conducted a content analysis of 100 videos using the hashtags #birthcontrolsideeffects and #nonhormonalcontraception. We found that these videos were popular and often framed hormonal contraceptives and patient-provider interactions negatively, with users frequently discussing discontinuation of hormonal contraception and no plans for uptake of another contraceptive. When uptake of a new contraceptive method is mentioned, creators typically mention a fertility awareness-based method, which requires specialized knowledge to use safely and effectively. The risks and side effects of hormonal options were often overemphasized compared with the possible risks and side effects of nonhormonal options. This framing may suggest opportunities for providers and health educators to reassess how they counsel about contraceptive options. We conclude with recommendations for future research on TikTok and consider the policy implications of these findings.

Think Pragmatically: Investigators' Obligations to Patient-Subjects When Research is Embedded in Care.

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.

Do Clinicians Have a Duty to Participate in Pragmatic Clinical Trials?

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.

Researching the future: scenarios to explore the future of human genome editing.

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.

A Pregnant Pause: System-Level Barriers to Perinatal Mental Health Care.

Perinatal mood and anxiety disorders, defined as mood and anxiety disorders during pregnancy and the year following birth, affect one in five pregnant and postpartum individuals in the United States and are associated with substantial morbidity and mortality for both pregnant individuals and their infants. Despite this tremendous prevalence and associated disease burden, the overwhelming majority of those affected do not receive treatment. Although prior research has identified several patient-level barriers to effective treatment, the contributions of system-level factors have been underappreciated. We present a pilot study using a simulated patient approach to describe the accessibility and affordability of mental health care through the 18 clinics affiliated with U.S. reproductive psychiatry fellowship programs. Based on our experience, a prospective patient seeking care from these 18 clinics without a prior referral would only have been successful half of the time-and even then may have to wait as long as 2 months for an initial appointment. These data underscore the need for clinicians, public health professionals, and institutions to address system-level barriers that undermine effective referrals for care, including implementing "warm-handoffs" to mental health providers and ending practices that restrict appointments to existing patients within a health care system. They also reinforce the importance of contemporary federal policy efforts to address maternal health, particularly among low-income and racially minoritized communities. Key policies include expanding postpartum insurance coverage, which plays a critical role in reducing insurance disruptions that can undermine the accessibility of mental health care and other vital health services.

Patients' Reactions to Letters Communicating Collateral Findings of Pragmatic Clinical Trials: a National Web-Based Survey.

BACKGROUND: Collateral findings in pragmatic clinical trials are findings that may have implications for patients' health but were not generated to address a trial's primary research questions. It is uncertain how best to communicate these collateral findings to patients. OBJECTIVES: To determine how reactions to a letter communicating collateral findings relate to who signed the letter, the type of finding, or whether the letter specified that the finding arose from a pragmatic clinical trial. RESEARCH DESIGN: Web-based survey experiment using a between-subjects design in which respondents were randomly assigned within education strata to view and respond to 1 of 16 hypothetical scenarios. SUBJECTS: Adults recruited from an online panel constructed from a probability sample of US-based postal addresses. MEASURES: The primary outcomes were the action the respondent would take next (i.e., contact a doctor immediately or something else) and the respondent's emotional reactions (i.e., all positive, all negative, mixed, or none). RESULTS: A total of 4080 respondents had analyzable data. Although some effects were statistically significant (P < .05), none exceeded a prespecified threshold for policy relevance (15 or more percentage points). Ratings of letter clarity and level of understanding were lower for letters that included a description of the clinical trial. CONCLUSIONS: Signatory and level of detail about collateral findings did not substantially affect people's intentions to take the recommended action of contacting their doctor. Deciding whether to include a description of the pragmatic clinical trial requires a trade-off between transparency and more difficulty understanding the contents of the letter.

Paid Leave for Fathers: Policy, Practice, and Reform.

Policy Points Government policies that secure paid leave for all parents, regardless of gender, can reduce structural inequalities, while promoting fathers' engagement in parenting. Such policies are likely to be most effective when they secure full, or almost full wage replacement, and when they provide incentives for fathers to take leave. Organizations must also participate in the culture shift, providing workplaces that encourage paternity leave rather than reinforcing the "male breadwinner" stigma.

Ethics challenges in sharing data from pragmatic clinical trials.

Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trials data, and trial sponsors and journals are increasingly requiring it. However, data sharing in pragmatic clinical trials presents ethical challenges related to the use of waivers or alterations of informed consent for some pragmatic clinical trials and corresponding limitations of informed consent to guide sharing decisions; the potential for data sharing in pragmatic clinical trials to present risks not only for individual patient-subjects, but also for health systems and the clinicians within them; sharing of data from electronic health records instead of data newly collected for research purposes; and researchers' limited capacity to control sensitive data within an electronic health record and potential implications of such limits for meeting obligations inherent to Certificates of Confidentiality. These challenges raise questions about the extent to which traditional research ethics governance structures are capable of guiding decisions about pragmatic clinical trial data sharing. This article identifies and examines these ethical challenges for pragmatic clinical trial data sharing. We suggest several areas for future empirical scholarship, including the need to identify patient and public attitudes regarding pragmatic clinical trial data sharing as well as to assess the demand for pragmatic clinical trial data and the correspondingly likely benefit of such sharing. Further conceptual work is also needed to explore how requirements to respect patient-subjects about whom data are shared in the context of pragmatic clinical trials should be understood, particularly in the absence of informed consent for initial research activities, and the appropriate balance between promoting the generation of socially valuable knowledge and respecting autonomy.

Intention to Receive COVID-19 Vaccine during Pregnancy: A Systematic Review and Meta-analysis.

OBJECTIVE: This meta-analysis aimed to assess the level of intent to receive coronavirus disease 2019 (COVID-19) vaccination and demographical factors influencing vaccine uptake among pregnant individuals. STUDY DESIGN: PubMed, Scopus, and archive/pre-print servers were searched up to May 22nd, 2021. Cross sectional surveys reporting the percentage of the pregnant individuals intending to get a COVID-19 vaccine were considered eligible for meta-analysis. This review was registered with PROSPERO (CRD42021254484). The primary outcome was to estimate the prevalence of COVID-19 vaccination intent among pregnant population. The secondary outcome was to evaluate the factors influencing the intention for vaccination. RESULTS: Twelve studies sourcing data of 16,926 individuals who were identified as pregnant were eligible. The estimated intention for the receipt of COVID-19 vaccine among women who were pregnant was 47% (95% CI: 38-57%), with the lowest prevalence in Africa 19% (95% CI: 17-21%) and the highest in Oceania 48.0% (95% CI: 44.0-51.0%). Uptake of other vaccines (influenza and/or TdaP) during pregnancy was associated with higher rate of intent to receive the COVID-19 vaccine (OR = 3.03; 95% CI: 1.37-6.73; p = 0.006). CONCLUSION: The intent to receive COVID-19 vaccine is relatively low among women who are pregnant and substantially varies based on the country of residence. In our meta-analysis, intent of women who were pregnant to receive the COVID-19 vaccine was significantly associated with the history of receiving influenza or TdaP vaccine during pregnancy. Given that in every country only a minority of gravidae have received the COVID-19 vaccine, despite known risks of maternal morbidity and mortality with no evidence of risks of vaccination, it highlights the importance of revised approaches at shared decision making and focused public health messaging by national and international advisories. KEY POINTS: · The estimated global intention for COVID-19 vaccination among pregnant women was 47%.. · The lowest intention was in Africa and the highest in Oceania.. · These findings highlight the importance of public health messaging by by different agencies..

Sex Education on TikTok: A Content Analysis of Themes.

Leading medical and public health societies endorse comprehensive sex education, but only 20 states and Washington, D.C., currently require information about contraception when sex education is taught, and even fewer require the inclusion of topics such as gender diversity or consent. At the same time, social media use, especially the video-sharing app TikTok, is increasing among teens. TikTok, therefore, offers a novel opportunity to make up for shortcomings in sex education and convey sexual health information to adolescents. To describe the availability and content of sexual education on TikTok, we conducted a content analysis of themes for 100 sex education-focused videos. We found that female anatomy was the most frequently addressed topic. Sexual pleasure was the second most common theme, within which discussions of the female orgasm and arousal constituted the most common subtheme. Other common themes include contraception and sexual health. These sought-after topics may be incongruent with those presented in standard school- or home-based sex education or interactions with health care providers, and this disconnect suggests opportunities for health care providers and educators to initiate conversations or offer resources on these themes as part of routine interaction. We conclude with recommendations for future research to consider the factual accuracy of sex education on TikTok and determine how exposure to this content affects adolescents' understanding of the risks and benefits of intercourse, sexual practices, age- and gender-based sexual norms, and other health behaviors.

Using the Delphi method to identify clinicians' perceived importance of pediatric exome sequencing results.

PURPOSE: Information obtained from clinical exome sequencing (ES) may impact clinical care or other aspects of a patient's life. Little is known about clinicians' perceptions regarding either the value of ES results or which among various outcomes are most relevant to determine value. This study aims to assess clinicians' opinions of the importance of ES results for medical decision making and identify a set of outcomes to be measured in future ES evaluations. METHODS: Expert opinion regarding the value of remarkable (diagnostic/positive) and unremarkable (nondiagnostic/negative) ES results was elicited via the Delphi method, consisting of two survey rounds and a teleconference. Participants had expertise in caring for clinically diverse infants and children with suspected underlying genetic etiologies. Descriptive statistics and (dis)agreement were calculated for each survey item. RESULTS: Remarkable ES results were considered important for 17 outcome domains. Unremarkable ES results were also perceived as important in terms of psychological impact and ability to inform follow-up diagnostic test decisions. CONCLUSION: Clinicians regard remarkable ES results as more important in many ways than findings from other diagnostic modalities. Unremarkable ES results were not considered unimportant for decision making, but rather uncertain in most outcome domains.

Patients' Views About the Disclosure of Collateral Findings in Pragmatic Clinical Trials: a Focus Group Study.

BACKGROUND: Pragmatic clinical trials (PCTs) are increasingly being conducted to efficiently generate evidence to inform healthcare decision-making. Despite their growing acceptance, PCTs may involve a variety of ethical issues, including the management of pragmatic clinical trial-collateral findings (PCT-CFs), that is, information that emerges in PCTs that is unrelated to the primary research questions but may have implications for patients, clinicians, and health systems. OBJECTIVE: We sought to understand patients' views about PCT-CF disclosure, including how, by whom, and the nature and extent of information provided. DESIGN: Prospective, qualitative focus group study. PARTICIPANTS: Focus groups were conducted in Baltimore, MD; Houston, TX; and Seattle, WA (overall N = 66), during July and August 2019. APPROACH: All groups discussed a hypothetical scenario involving the detection of a PCT-CF of contraindicated medications. Participants were asked about their reactions to the PCT-CF and issues related to its disclosure. KEY RESULTS: Reactions to learning about the PCT-CF were mixed, ranging from fear of a significant health problem, anger that the contraindicated medications had gone unnoticed and/or for being included in research without their permission, to gratitude for the information. Preferences for how such disclosures are made varied but were driven by several consistent desires, namely minimizing patient harm and anxiety and demonstrating trust and respect. Many wanted their treating clinician to be informed of the PCT-CF so that they would be prepared to answer patients' questions and to discuss treatment options. CONCLUSIONS: The detection of PCT-CFs is likely to increase with further expansion of PCTs. As such, clinicians will undoubtedly become involved in the management of PCT-CFs. Our data illustrate some of the challenges clinicians may face when their patients are informed of a PCT-CF and the need to develop guidance for disclosing PCT-CFs in ways that align with patients' preferences and values.

Ethical allocation of future COVID-19 vaccines.

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.

Ethics and Collateral Findings in Pragmatic Clinical Trials.

Pragmatic clinical trials (PCTs) 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(s), 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.

Readability and Accessibility of Terms of Service and Privacy Policies for Menstruation-Tracking Smartphone Applications.

Over 100 million women track their menstruation using mobile applications (apps). In addition to comparatively unremarkable personal information such as height and weight, these apps collect intimate data like characteristics of vaginal discharge and cervical position. In exchange, many apps claim to predict the timing and duration of menstruation and windows of fertility. From this information, users may modify their sexual behavior based on their reproductive intentions. Though these apps are popular, news reports and prior studies reveal that user expectations about privacy and accuracy often do not align with the content of terms of service and privacy policies. In this article, we analyzed the readability and accessibility of terms of service and privacy policies for 15 popular menstruation-tracking apps. We found that information about data-sharing practices and accuracy is often neither easily accessible nor understandable. As a result, terms of service and privacy policies likely obscure material information about privacy and accuracy, posing safety and reproductive health risks to users. To date, no regulatory body oversees or approves the vast majority of menstruation trackers, leaving the market open to apps that vary widely in quality, accuracy, and levels of protection. We encourage health care professionals to ask their patients and clients about app use and understanding, encourage them to review relevant app-specific information, and discourage use as contraception when indicated. We conclude with recommendations for future research to establish the appropriate standards of disclosure that should govern these and similar types of smartphone-based consumer health technologies.

Ethical Acceptability of Reducing the Legal Blood Alcohol Concentration Limit to 0.05.

Twenty-nine Americans die in alcohol-impaired driving crashes daily. The National Academies of Sciences, Engineering, and Medicine released a report that identified strategies to reduce alcohol-impaired driving deaths. One strategy suggests amending state laws to reduce the legal blood alcohol concentration (BAC) limit from 0.08 to 0.05. Although BAC 0.05 laws would likely reduce alcohol-related deaths, they are also controversial. Critics object to these laws because they restrict individual liberty and fail to consider that individuals value social drinking. We explored the ethical acceptability of BAC 0.05 laws. We made an ethical argument in support of BAC 0.05 laws, which include preventing harm to both drinking drivers and to others. We then considered and rejected liberty-based objections to BAC 0.05 laws. We concluded that BAC 0.05 laws are not only ethically defensible but desirable. States and Congress should work to promote them.

Parental Leave, Lactation, and Childcare Policies at Top US Schools of Public Health.

OBJECTIVES: To describe policies related to parental leave, breastfeeding, and childcare for faculty and staff at top schools of public health in the United States. METHODS: We identified the top 25 schools of public health from the US News and World Report rankings. We reviewed each institutional Web site to identify publicly available policies as of July 2018. RESULTS: For birth mothers, 80% (20/25) of the schools provided paid childbearing leave to faculty (mean = 8.2 weeks), and 48% (12/25) provided paid childbearing leave for staff (mean = 5.0 weeks). For nonbirth parents, 68% (17/25) provided paid parental leave for faculty and 52% (13/25) for staff (range = 1-15 weeks). We found that 64% (16/25) of the schools had publicly available lactation policies, and 72% (18/25) of the schools had at least 1 university-run on-campus childcare center. CONCLUSIONS: The majority of top US schools of public health provide paid leave to faculty birth mothers. However, most schools fall short of the 14 weeks recommended by the American Public Health Association.

Time to pull the trigger? Examining the ethical permissibility of minimum age restrictions for gun ownership and use.

A series of prominent mass shootings in the United States (US) has prompted renewed interest in revising gun policy. One proposal that has gained political traction is raising the minimum age for purchase and possession of guns to 21. While some commentators have suggested that the public mood may be shifting on gun policy, proposals to raise the minimum age have nevertheless provoked controversy. In this manuscript, we examine the ethical acceptability of raising the minimum age of purchase and possession of guns to 21. First, we examine the nature of the rights claim at issue. Second, we examine liberty-based objections to minimum age laws, and offer counter-arguments to these claims. Then, we examine the nature of the harm to be prevented via minimum age laws. We conclude that gun ownership is an important right, but one that nevertheless is ethical to regulate. We argue that liberty-based objections to minimum age laws are not as strong as critics of these laws claim. While we acknowledge the data limitations on assessing their likely success in reducing gun-related harms, we argue that minimum age laws are an ethically permissible policy strategy. We conclude with several recommendations for further research and policy responses to addressing the toll of gun-related morbidity and mortality.

When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients?

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.