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While many strategies for protecting personal privacy rely on regulatory frameworks, consent, and anonymizing data, they are not always effective. Terms and Conditions often lag behind advances in technology, software, and user behaviours, and consent to use data for a range of unclear purposes may be provided unwittingly. As the commercial market for (student) data expands, so does the number of brokers who move, share and sell data across continents and legislative environments. This paper reviews four Massive Open Online Course (MOOC) providers from different geopolitical and regulatory contexts. It explores how consent to collect and use data is described to potential users, and how that consent applies at micro, meso, and macro levels. This paper proposes a need for greater transparency around the implications of users granting consent at the point of registration. Further, it highlights that though MOOC providers have a responsibility to make clear the potential uses and sharing of user data, users themselves should also be more aware and consider how meaningful student agency can be achieved.

This article presents the findings of a systematic qualitative analysis of research in the ethics of digital trace data use in learning and education. From the resulting analysis of 77 peer-reviewed studies, we (1) map the characteristics of research by study type, academic community, institutional setting, and national context; (2) identify the primary ethical concerns and related responses; and (3) highlight the research gaps. Four areas of focus are identified in this emerging area: (1) privacy, informed consent, and data ownership; (2) validity and integrity; (3) ethical decision making; and (4) governance and accountability. We highlight the lack of evidence particularly for preschool and school-aged children and the disparate communities working in this domain, and we suggest a more cohesive approach, where the wider learning and educational ecosystem is recognized, explicit engagement with ethical theory is central, and mid- to long-term ethical issues are considered alongside immediate concerns.

The COVID-19 pandemic prompted an abrupt shift in the use of information and communication technology (ICT) in practice. The pre-pandemic use of informal ICT was already ubiquitous in social work practice. The purpose of this teaching note is to highlight that social work education must prepare students for practice using ICT during COVID-19 and beyond. Incorporated are findings from an international study on informal ICT use before COVID-19, which confirmed its ubiquity in social work, underscoring the need to educate and prepare social workers to use ICTs. Six knowledge areas important for social work education related to ICT use are discussed: integrating theoretical foundations; ethical considerations; confidentially and documentation; access and equity; risk assessment and management; and supervision and policy.

Considerations for conducting ethical research with human participants in languages other than English are addressed to some extent in regulatory and guiding statements for researchers, but in ways that are minimal or vague. In this article, I examine guiding documents for research ethics from four countries: the UK, Canada, Australia and the USA, with a view to analysing how the issue of research in other languages is addressed. Specific attention is paid to four key aspects of research as it relates to language. The first is informed consent. This includes a discussion of how written forms may not be the most appropriate method to ensure consent is informed. The second aspect of language is that of translation and interpretation, including budgetary implications for research. Third, the use of intermediaries such as (but not limited to) translators and local contacts is considered. Finally, considerations for knowledge mobilisation and dissemination of findings are explored. The article concludes with recommendations for researchers, graduate supervisors and research ethics boards.

Non-consensual sterilization is one of the characteristic historical abuses that took place mainly in the first half of the 20th century. People with intellectual disability (ID) were a prime target as part of the ideology of negative eugenics. In certain jurisdictions, laws were in force for several decades that permitted sterilization without the need for consent or with consent from third parties. The long-term adverse effects on those sterilized against their will have only more recently been recognized. In the latter half of the 20th century, human rights treaties were introduced and developed; they have, in the main, curbed sterilization abuses. Courts have developed more stringent criteria for making decisions on applications for sterilization, and nowadays there are mostly adequate safeguards in place to protect those with ID from non-consensual sterilization. The only exception should be the particular case in which, all medical and social factors having been taken into account, sterilization is overwhelmingly thought to be the right decision for the individual unable to give consent.

During the course of the last century, a number of historical instances of unethical human research have occurred, and risen to the forefront of the social imagination. The atrocities of the European and Pacific Holocausts, the tragic 1932-1972 United States Public Health Service Syphilis Studies at Tuskegee, concomitant with the 1946-48 unethical public health human research in Guatemala loom large. These high profile instances join with the Cold War pediatric experiments and other cases to draw the attention of culture to clear patterns of serious ethical deficiencies and regulatory non-compliance. The facts surrounding these historical events highlight the serious danger of moral objectification of human subjects in research. These cases carve in high relief the absolute necessity of one of the most critical areas of research administrator service, namely the ethical oversight of research involving human subjects. This article will explore the contemporary national concern over human subject protections, provide a brief synopsis of illustrative problematic cases, proceed to a reflection from a philosophical perspective upon the problem of moral objectification, and then further define the role research administrators should assume in assisting their institutions to learn a new grammar of service, namely an ethical "language" and perspective that transcends an all too elementary sense of regulatory compliance.

Dry needling (DN) uses a monofilament needle to reduce pain and is performed by various healthcare professions. Due to the invasive needle puncture, adverse events (AEs) have been associated with DN. It is unclear, which AEs should be included in a risk statement for Informed Consent (IC). The purpose of this study was to identify which AEs should be included in a risk statement for IC. A three-round e-Delphi study was undertaken using a panel of DN experts. Expert inclusion criteria included: (1) ≥5 years practice performing DN and one of the following secondary criteria: (A) certification in DN; (B) completion of a manual therapy fellowship that included DN training; or (C) ≥1 publication involving the use of DN. Participants rated their level of agreement using a 4-point Likert scale. Consensus was defined as either: 1) ≥80% agreement; or 2) ≥70% and <80% agreement with median ≥3, interquartile range ≤1, and standard deviation ≤1. A total of 14 (28%) AEs achieved final consensus in Round 3 for inclusion on IC. Kendall's Coefficient (w) of agreement for Round 2 was 0.213 and improved to 0.349 after Round 3. Wilcoxon rank tests revealed statistically significant changes for 12 of the 50 AEs. Consensus was attained for 14 AEs for inclusion on IC. The AEs identified can be used for the development of a shorter, more concise IC risk statement. A total of 93.6% of experts agreed on definitions for AE classification. [ABSTRACT FROM AUTHOR]

In recent years, the US has seen a significant rise in the rate of planned home births, with a 60 % increase from 2016 to 2023, reaching a total of 46,918. This trend positions the US as the leading developed country in terms of home birth prevalence. The American College of Obstetricians and Gynecologists (ACOG) suggests stringent criteria for selecting candidates for home births, but these guidelines have not been adopted by home birth midwives leading to poor outcomes including increased rates of neonatal morbidity and mortality. This paper explores the motivations behind choosing home births in the US despite the known risks. Studies highlight factors such as the desire for a more natural birth experience, previous negative hospital experiences, and the influence of the COVID-19 pandemic on perceptions of hospital safety. We provide new insights into why women choose home births by incorporating insights from Nobel laureate Daniel Kahneman's theories on decision-making, suggesting that cognitive biases may significantly influence these decisions. Kahneman's work provides a framework for understanding how biases and heuristics can lead to the underestimation of risks and overemphasis on personal birth experiences. We also provide recommendations ("nudges according to Richard Thaler") to help ensure women have access to clear, balanced information about home births. The development of this publication was assisted by OpenAI's ChatGPT-4, which facilitated the synthesis of literature, interpretation of data, and manuscript drafting. This collaboration underscores the potential of integrating advanced computational tools in academic research, enhancing the efficiency and depth of our analyses. [ABSTRACT FROM AUTHOR]

Background: Federal regulations allow exception from informed consent (EFIC) to study emergent conditions when obtaining prospective consent is not feasible. Little is known about public views on including children in EFIC studies. The Pediatric Dose Optimization for Seizures in EMS (PediDOSE) trial implements age‐based, standardized midazolam dosing for pediatric seizures. The primary objective of this study was to determine public support for and concerns about the PediDOSE EFIC trial. The secondary objective was to assess how support for PediDOSE varied by demographics. Methods: We conducted a mixed‐methods study in 20 U.S. communities. Participants reviewed information about PediDOSE before completing an online survey. Descriptive data were generated. Univariable and multivariable logistic regression analysis identified factors associated with support for PediDOSE. Reviewers identified themes from free‐text response data regarding participant concerns. Results: Of 2450 respondents, 79% were parents/guardians, and 20% had a child with previous seizures. A total of 96% of respondents supported PediDOSE being conducted, and 70% approved of children being enrolled without prior consent. Non‐Hispanic Black respondents were less likely than non‐Hispanic White respondents to support PediDOSE with an adjusted odds ratio (aOR) of 0.57 (95% CI 0.42–0.75). Health care providers were more likely to support PediDOSE, with strongest support among prehospital emergency medicine clinicians (aOR 5.82, 95% CI 3.19–10.62). Age, gender, parental status, and level of education were not associated with support of PediDOSE. Common concerns about PediDOSE included adverse effects, legal and ethical concerns about enrolling without consent, and potential racial bias. Conclusions: In communities where this study will occur, most respondents supported PediDOSE being conducted with EFIC and most approved of children being enrolled without prior consent. Support was lowest among non‐Hispanic Black respondents and highest among health care providers. Further research is needed to determine optimal ways to address the concerns of specific racial and ethnic groups when conducting EFIC trials. [ABSTRACT FROM AUTHOR]

Donation after circulatory determination of death (DCDD) is an accepted practice in the United States, but heart procurement under these circumstances has been debated. Although the practice is experiencing a resurgence due to the recently completed trials using ex vivo perfusion systems, interest in thoracoabdominal normothermic regional perfusion (TA-NRP), wherein the organs are reanimated in situ prior to procurement, has raised many ethical questions. We outline practical, ethical, and equity considerations to ensure transplant programs make well-informed decisions about TA-NRP. We present a multidisciplinary analysis of the relevant ethical issues arising from DCDD-NRP heart procurement, including application of the Dead Donor Rule and the Uniform Definition of Death Act, and provide recommendations to facilitate ethical analysis and input from all interested parties. We also recommend informed consent, as distinct from typical "authorization," for cadaveric organ donation using TA-NRP. [ABSTRACT FROM AUTHOR]

Patients and physicians do not know the cost of medical procedures. Opaque medical billing thus contributes to exorbitant, rising medical costs, burdening the healthcare system and individuals. After criticizing two proposed solutions to the problem of opaque medical billing, I argue that the Centers for Medicare and Medicaid Services should pursue a rule requiring that patients be informed by the physician of a reasonable out-of-pocket expense estimate for non-urgent procedures prior to services rendered. [ABSTRACT FROM AUTHOR]

Policies allowing some minors to consent to receive recommended vaccines are ethically defensible. However, a policy change at the federal level expanding minor consent for vaccinations nationwide risks triggering a political backlash. Such a move may be perceived as infringing on the rights of parents to make decisions about their children's health care. In the current post-COVID environment of heightened anti-vaccination activism, changes to minor consent laws may be unadvisable, and policy makers should proceed with caution. [ABSTRACT FROM AUTHOR]

In the United States, 98.3% of patients give birth in hospitals, 1.1% give birth at home, and 0.5% give birth in freestanding birth centers. This review investigated the impact of birth settings on birth outcomes in the United States. Presently, there are insufficient data to evaluate levels of maternal mortality and severe morbidity according to place of birth. Out-of-hospital births are associated with fewer interventions such as episiotomies, epidural anesthesia, operative deliveries, and cesarean deliveries. When compared with hospital births, there are increased rates of avoidable adverse perinatal outcomes in out-of-hospital births in the United States, both for those with and without risk factors. In one recent study, the neonatal mortality rates were significantly elevated for all planned home births: 13.66 per 10,000 live births (242/177,156; odds ratio, 4.19; 95% confidence interval, 3.62–4.84; P <.0001) vs 3.27 per 10,000 live births for in-hospital Certified Nurse-Midwife–attended births (745/2,280,044; odds ratio, 1). These differences increased further when patients were stratified by recognized risk factors such as breech presentation, multiple gestations, nulliparity, advanced maternal age, and postterm pregnancy. Causes of the increased perinatal morbidity and mortality include deliveries of patients with increased risks, absence of standardized criteria to exclude high-risk deliveries, and that most midwives attending out-of-hospital births in the United States do not meet the gold standard for midwifery regulation, the International Confederation of Midwives' Global Standards for Midwifery Education. As part of the informed consent process, pregnant patients interested in out-of-hospital births should be informed of its increased perinatal risks. Hospital births should be supported for all patients, especially those with increased risks. [ABSTRACT FROM AUTHOR]

The Covid‐19 pandemic has raised a range of complex challenges for the research community in the United States. This essay uses Covid‐19 as a model pandemic illness to consider two such issues that have yet to be fully explored in the ethics literature: first, whether the informed consent process should include a discussion of pandemic risks and, if so, how precisely these risks should be conveyed to potential research participants and, second, whether and under what circumstances vaccination status should be taken into consideration when enrolling subjects in non‐pandemic‐related studies during a pandemic. [ABSTRACT FROM AUTHOR]

Little is known regarding the outcomes and distinguishing characteristics of lawsuits related to endodontic procedures. This study used a verdict-based data from United States of America to analyze the factors associated with endodontic malpractice lawsuits and mitigate the risk of litigation. The LexisNexis legal database was used to search for endodontic malpractice cases from January 1, 2000 to December 31, 2021 using the terms "medical malpractice" and (I) "endodontist" (II) "endodontics" (III) "root canal" (IV) "dental pulp." Each case was reviewed for reported medical characteristics and litigation outcomes. A total of 650 cases were initially identified, and 97 cases were included in the final analysis. Eighty-four (86.6%) of the 97 defendants were general practitioners; 42 cases favored the plaintiff, 53 (54.6%) favored the defendant, 1 was partial win/loss, and 1 was settled. The annual case mean was 4.41 ± 2.17 (Mean ± SD). The major allegations favored for the patients involving paresthesia, root perforation, rubber dam not use, wrong tooth therapy, and infections. Plaintiffs who claimed with post-procedural reasons had a significantly higher winning rate than non-post-procedural reasons (P < 0.05). In the present study, 54.6% of endodontic litigation favored the dentists in the US. The authors recommend that general practitioners refer complicated cases to endodontists and treat carefully to avoid paresthesia, canal perforation and infections. Clinicians should always diagnose and treat correctly, shared decision making with the patient, use rubber dam routinely, and timely management to prevent malpractice claims. [ABSTRACT FROM AUTHOR]

Background: Drugs and high-risk medical devices are increasingly likely to receive Food and Drug Administration (FDA) approval through expedited pathways, which has implications for informed treatment consent (i.e., consent in clinical practice).Objective: To obtain expert opinion about the clinical and ethical implications of the increasing availability of new drugs and devices approved through expedited development and regulatory review pathways.Design: Qualitative study using individual semi-structured videoconference interviews.Participants: National leaders in medicine, ethics, and law (n=12) with expertise in medical product regulation, payor policymaking, bioethics, physician practice, patient advocacy, public health expertise/advocacy, clinical trials, the pharmaceutical and device industry, institutional review board oversight, and real-world evidence.Main Measures: Principal themes in 3 domains: expedited regulatory pathways, physician and patient understanding of and reliance on FDA approval, and informed treatment consent.Key Results: Respondents pointed out that more common use of expedited pathways translates to increased reliance on surrogate measures, some with uncertain clinical significance. While expedited development and review can have advantages, participants expressed worry that physicians were unaware when medical products were expedited and did not communicate about uncertainties in knowledge about new drug or device approvals effectively with patients. Many participants felt that informed treatment consent discussions about new drugs or devices should include some explanations of expedited pathways and use of surrogate measures.Conclusions: Experts identified advantages of expediting development and of FDA flexibility in applying its standards to new drugs and medical devices, but highlighted concerns that patients may not be adequately informed about the risks of shorter review times or about uncertainties in the evidence that result. There is a need to identify approaches to ensure effective clinical use of drugs and devices when approved through expedited pathways. [ABSTRACT FROM AUTHOR]

In the United States, Black, Indigenous, and People of Color (BIPOC) experience more adverse health outcomes and report mistreatment during pregnancy and birth care. The rights to bodily autonomy and consent are core components of high‐quality health care. To assess experiences of coercion and nonconsent for procedures during perinatal care among racialized service users in the United States, we analyzed data from the Giving Voice to Mothers (GVtM‐US) study. Methods: In a subset analysis of the full sample of 2700, we examined survey responses for participants who described the experience of pressure or nonconsented procedures or intervention during perinatal care. We conducted multivariable logistic regression analyses by racial and ethnic identity for the outcomes: pressure to have perinatal procedures (eg, induction, epidurals, episiotomy, fetal monitoring), nonconsented procedures performed during perinatal care, pressure to have a cesarean birth, and nonconsented procedures during vaginal births. Results: Among participants (n = 2490), 34% self‐identified as BIPOC, and 37% had a planned hospital birth. Overall, we found significant differences in pressure and nonconsented perinatal procedures by racial and ethnic identity. These inequities persisted even after controlling for contextual factors, such as birthplace, practitioner type, and prenatal care context. For example, more participants with Black racial identity experienced nonconsented procedures during perinatal care (AOR 1.89, 95% CI 1.35–2.64) and vaginal births (AOR 1.87, 95% CI 1.23–2.83) than those identifying as white. In addition, people who identified as other minoritized racial and ethnic identities reported experiencing more pressure to accept perinatal procedures (AOR 1.55, 95% CI 1.08–2.20) than those who were white. Discussion: There is a need to address human rights violations in perinatal care for all birthing people with particular attention to the needs of those identifying as BIPOC. By eliminating mistreatment in perinatal care, such as pressure to accept services and nonconsented procedures, we can help mitigate long‐standing inequities. [ABSTRACT FROM AUTHOR]

The author comments on tax liability associated with research payments. Topics discussed include ethical implications of taxing research-related income, financial risk associated with payment for research participation, and background of the study of M. Waltz and colleagues on financial compensation for research participants.

Due to the current organ shortage waitlist, alternatives to allotransplantation are necessary. Xenotransplantation is currently being pursued as one such alternative in adults in need of kidney or heart transplantation. Cardiac xenotransplantation of genetically modified pig hearts has been conducted twice in adults under the United States Food and Drug Administration (FDA) expanded access criteria. Because of the shortage of transplantable hearts for children as well as the lack of mechanical circulatory support in this population, pediatric researchers are exploring FDA expanded access in high-risk neonates and infants who lack alternative options for survival. The adult cardiac xenotransplantation experience with expanded access can provide lessons and highlight nuances for researchers preparing pediatric application. This includes aspects of informed consent, biosurveillance, and protection of bystanders from potential xenozoonoses., (© 2024 The Author(s). Pediatric Transplantation published by Wiley Periodicals LLC.)

Objective: To evaluate the impact of length of the Medicaid sterilization waiting period and postpartum permanent contraception fulfillment., Study Design: Simulations from a retrospective cohort study estimating the potential increase in permanent contraception within 365 days of delivery., Results: In our sample of 2076 patients, 61% achieved permanent contraception with the current waiting period of 30 days. With the waiting period hypothetically reduced to 15, 3, 1, and 0 days, 62.9%, 63.7%, 64.5%, and 75% patients, respectively, would have achieved permanent contraception., Conclusions: As potential Medicaid sterilization policy revisions are considered, understanding the impact on fulfillment rates is critical., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: In recognition of their status as a health disparities population, there is growing emphasis on conducting research inclusive of adults with intellectual disability to generate new knowledge and opportunities to improve health and equity. Yet they are often excluded from research, and human research participant protection experts and researchers lack agreement on effective consent protocols for their inclusion., Objective: We sought to identify approaches to consent in US-based social-behavioral research with adults with intellectual disability., Methods: We conducted a systematic review on approaches to self-consent with adults with intellectual disability published between 2009 and 2023, identified via searching eight databases and reference list hand searches. We identified 13 manuscripts and conducted a thematic analysis., Results: Our analysis identified themes related to guiding principles, strategies to enhance informed and voluntary consent, approaches to consent capacity, involving individuals subject to guardianship, and strategies for expressing decisions and enhancing ongoing decisions., Conclusions: Manuscripts largely reflected an emphasis on identifying approaches to consent that reflect disability rights principles to promote the right to be included and make one's own decisions based on assessment of relevant information, risks and benefits, and to employ reasonable modifications to achieve inclusion. To avoid the risks of exclusion and advance the responsible inclusion of adults with intellectual disability, we make recommendations to align consent approaches anchored in contemporary thinking about human research participant protections, including through integration with disability rights., Competing Interests: Declaration of competing interest The authors have no conflicts of interest to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Results from the Turnaway Study, conducted by Advancing New Standards in Reproductive Health (ANSRH), have widely been represented as definitive proof that women denied access to abortion will suffer severe injury to their health and economic wellbeing. Yet a careful examination reveals that the study is based on a non-random, non-representative sample of women that grossly underrepresents the experiences of the majority of women undergoing abortions. In addition, a reanalysis of its reported results reveal that the effect size of the outcomes observed have been grossly overstated, leading to conclusions that are not supported by the results. There also appears to be selective reporting and misrepresentation of results previously published. In addition, inconsistencies in ANSRH's published record strongly suggest that the credit history reports of the Turnaway Study participants were obtained without their informed consent., (Copyright © 2024 by the National Legal Center for the Medically Dependent and Disabled, Inc.)

Importance: Exception From Informed Consent (EFIC) research requires community consultation (CC) and public disclosure (PD). Traditional methods of conducting CC and PD are slow, expensive, and labor intensive., Objective: To describe the feasibility and reach of a novel interactive, media-based approach to CC and PD and to identify the similarities and differences between trial sites in website views, survey responses, online community forum attendance, and opt-out requests., Design, Setting, and Participants: This survey study analyzed the CC and PD campaigns conducted for the TAP trial (Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival), an EFIC trial of the early administration of prothrombin complex concentrate in patients with trauma. The CC and PD campaigns consisted of social media advertisements, linked websites, community surveys, and online community forums. These activities were coordinated from a central site and approved by a central institutional review board. This study focused on the first 52 of 91 TAP trial sites (level I trauma centers) in the US to have completed their CC and PD campaigns. Community members in the catchment areas of the participating trauma centers were targeted. Data analysis was conducted between October 2023 and February 2024., Exposure: Social media advertisements, surveys, and online community meetings conducted as part of the CC and PD campaign for the TAP trial., Main Outcomes and Measures: Social media campaign reach and engagement, web page views, survey results, online community forum attendance, and opt-out requests., Results: Fifty-two trial sites were approved for participant enrollment. Social media advertisements were displayed 92 million times, reaching 11.8 million individuals. The median (IQR) number of people reached in each location was 210 317 (172 068-276 968). Site-specific websites were viewed 144 197 times (median [IQR] viewings per site, 2984 [1267-4038]). A total of 17 206 fully or partly completed surveys were received, and survey respondents had a median (IQR) age of 40.1 (15-65) years and included 10 444 females (60.7%). Overall, 60.6% survey respondents said they would want to be entered into the trial even if they could not give consent, 87.7% agreed that emergency care research was necessary, and 88.0% agreed that the TAP trial should be conducted in their community. Online community forums were attended by a median (IQR) number of 38 (20-63) people. Four opt-out requests were received., Conclusions and Relevance: The interactive media-based approach to CC and PD for the ongoing TAP trial showed the feasibility and benefits of executing an efficient, coordinated, centrally run series of locally branded and geographically targeted CC and PD campaigns for a large EFIC study.

The Covid‐19 pandemic resulted in unprecedented restrictions on many public, private, and workplace activities throughout the United States and elsewhere. When restrictions were imposed, we were conducting a type III hybrid effectiveness‐implementation trial in 10 pediatric trauma centers. In response to several pandemic‐based restrictions, we had to develop procedures for engaging with potential research participants while limiting nonclinical, in‐person interactions. This manuscript describes the procedures and challenges of obtaining electronic informed consent and assent in a multisite trauma center‐based research study. We developed, tested, and trained staff to implement three options for obtaining informed consent. Twenty‐five participants were enrolled in the effectiveness‐implementation multisite trial during the first six months of utilization of the consent options, with eleven of these individuals enrolled using hybrid or electronic consent procedures. The challenges we identified involving electronic consent procedures included confusion over who would complete the electronic consent process and difficulties reconnecting with families. Lessons learned can strengthen electronic consent and assent procedures for future studies. More research is needed to further strengthen this process and increase its utilization. [ABSTRACT FROM AUTHOR]

Objective: The Medicaid consent policy has been identified as a major barrier to desired permanent contraception, particularly for low-income communities and communities of color. As each state may modify their state Medicaid sterilization consent form, variation in the form has been reported. This study aims to characterize state-level variation in Medicaid Title XIX consent form interpretation and application.Study Design: We aimed to collect primary data from Medicaid officials in all 50 United States from January to May 2020 via a 25-question electronic survey regarding state-level consent form implementation. Questions targeted consent form details and definitions, insurance and billing, clinician correspondence, and administrative processes. We used Qualtrics XM to collect survey responses. We performed descriptive statistics on the survey responses. There were no exclusion criteria.Results: We had 41 responses from 36/50 states (72% participation rate). Heterogeneity existed in the key definitions of "Premature Delivery" and "Emergency Abdominal Surgery." One in five respondents reported the consent form was only available in English. Variation among Current Procedural Terminology codes covered in each state's sterilization policy were noted. Nearly a quarter of respondents did not know how Medicaid informed healthcare providers of consent form denials. Most participants (90%) were unaware of differences between state sterilization policies.Conclusion: This study demonstrates variation in terms of consent form definitions, procedures covered, correspondence with clinicians, and administrative review processes among state Medicaid offices regarding the sterilization consent form. Greater transparency is necessary in order to reduce administrative barriers to desired permanent contraception.Implications: Inconsistent interpretation poses an administrative barrier to care, raises concern regarding appropriate clinician reimbursement, and can potentially lead to unnecessarily denying patients the contraceptive option of their choice. Permanent contraception policies should be equitable no matter insurance status, preserve reproductive autonomy and effectively protect vulnerable populations. [ABSTRACT FROM AUTHOR]

As emergency medicine physicians, we engage in informed consent, have conversations with patients leaving against medical advice, and screen them daily. Better understanding these concepts and processes can improve patient care., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Abstract: Since 2015, the Sudden Unexpected Infant Death (SUID) and Sudden Death in the Young (SDY) Case Registry has characterized sudden and unexpected deaths among young people (0-20 years). Families may provide informed consent to save biospecimens for banking and/or genomic research. We reviewed all consent-eligible cases to describe the frequency, time from death to consent, type (paper, phone, or electronic), and staffing method (Medical Examiner Office-based bereavement counselor vs outsourced genetic counselor). Of 5438 cases from January 2015 to January 2022, 3498 (64%) were eligible for consent and 391 (11%) were successfully consented. Half (54%) were obtained within 60 days of the death, 39% within 48 hours. Most were paper based (73%); 23% were obtained by phone, and 4% electronically. Consent rates varied by site from 3% to 66%. Higher consent rates were achieved within a Medical Examiner Office by a social worker or death investigator. Only 3% of consents attempted by a contracted genetic counselor were successful. Identified barriers include lack of available contact information, inability to reach family using the collected information, and lack of response when contacted. Consent rates were highest shortly after death when families were contacted by the Medical Examiner Office as part of bereavement outreach., Competing Interests: The authors report no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Pragmatic clinical trials of standard-of-care interventions compare the relative merits of medical treatments already in use. Traditional research informed consent processes pose significant obstacles to these trials, raising the question of whether they may be conducted with alteration or waiver of informed consent. However, to even be eligible, such a trial in the United States must have no more than minimal research risk. We argue that standard-of-care pragmatic clinical trials can be designed to ensure that they are minimal research risk if the random assignment of an intervention in a pragmatic clinical trial can accommodate individualized, clinically motivated decision-making for each participant. Such a design will ensure that the patient-participants are not exposed to any risks beyond the clinical risks of the interventions, and thus, the trial will have minimal research risk. We explain the logic of this view by comparing three scenarios of standard-of-care pragmatic clinical trials: one with informed consent, one without informed consent, and one recently proposed design called Decision Architecture Randomization Trial. We then conclude by briefly showing that our proposal suggests a natural way to determine when to use an alteration versus a waiver of informed consent., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Introduction: Emergency clinical research has played an important role in improving outcomes for acutely ill patients. This is due in part to regulatory measures that allow Exception From Informed Consent (EFIC) trials. The Food and Drug Administration (FDA) requires sponsor-investigators to engage in community consultation and public disclosure activities prior to initiating an Exception From Informed Consent trial. Various approaches to community consultation and public disclosure have been described and adapted to local contexts and Institutional Review Board (IRB) interpretations. The COVID-19 pandemic has precluded the ability to engage local communities through direct, in-person public venues, requiring research teams to find alternative ways to inform communities about emergency research., Methods: The PreVent and PreVent 2 studies were two Exception From Informed Consent trials of emergency endotracheal intubation, conducted in one geographic location for the PreVent Study and in two geographic locations for the PreVent 2 Study. During the period of the two studies, there was a substantial shift in the methodological approach spanning across the periods before and after the pandemic from telephone, to in-person, to virtual settings., Results: During the 10 years of implementation of Exception From Informed Consent activities for the two PreVent trials, there was overall favorable public support for the concept of Exception From Informed Consent trials and for the importance of emergency clinical research. Community concerns were few and also did not differ much by method of contact. Attendance was higher with the implementation of virtual technology to reach members of the community, and overall feedback was more positive compared with telephone contacts or in-person events. However, the proportion of survey responses received after completion of the remote, live event was substantially lower, with a greater proportion of respondents having higher education levels. This suggests less active engagement after completion of the synchronous activity and potentially higher selection bias among respondents. Importantly, we found that engagement with local community leaders was a key component to develop appropriate plans to connect with the public., Conclusion: The PreVent experience illustrated operational advantages and disadvantages to community consultation conducted primarily by telephone, in-person events, or online activities. Approaches to enhance community acceptance included partnering with community leaders to optimize the communication strategies and trust building with the involvement of Institutional Review Board representatives during community meetings. Researchers might need to pivot from in-person planning to virtual techniques while maintaining the ability to engage with the public with two-way communication approaches. Due to less active engagement, and potential for selection bias in the responders, further research is needed to address the costs and benefits of virtual community consultation and public disclosure activities compared to in-person events., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The increasing dementia prevalence worldwide is driving the testing of novel therapeutic approaches, such as invasive brain technologies, despite limited clinical evidence and the risk of accelerating cognitive decline. Our manuscript (a) reviews the NIH Clinicaltrials.gov database for deep brain stimulation, stem cell implantation, and gene therapy trials on people with dementia; (b) discusses issues on beneficence, nonmaleficence, and autonomy associated with these trials; and (c) proposes nine recommendations that build on elements from the Declaration of Helsinki. We found 49 preregistered high‐risk trials from nine countries planning to or involving 11,801 people with Alzheimer's or Lewy body dementia or dementia secondary to Parkinson's or Huntington's disease. Most of the people with Alzheimer's who are in these trials are from North America and East Asia. There is substantial heterogeneity in the enrolment criteria, even for trials recruiting only those with Alzheimer's disease. Although most trials enrol people in mild to moderate stages of Alzheimer's disease, trials in China enrol people who have severe Alzheimer's. Our findings highlight a pressing need to review and refine the enrolment criteria for invasive neural trials in people with dementia, considering risks, potential benefits, and capacity for informed consent. As a multidisciplinary team from Australia, the USA, Canada, and Germany with expertise in neurology, neuroscience, and ethics, we examine how it is essential to balance the risks of invasive neural research in a vulnerable population with limited capacity to provide informed consent to help advance the body of knowledge regarding a disease with limited therapeutic options. [ABSTRACT FROM AUTHOR]

Objective: Ketamine is contraindicated in pregnancy given the lack of knowledge about potential effects on a developing fetus. This study aimed to characterize current clinical practices specific to pregnancy and reproduction related to the use of ketamine for the treatment of psychiatric illness., Methods: Online surveys were sent to outpatient ketamine clinics across the United States inquiring about practices related to pregnancy. Responses were collected between September and November 2023. Additionally, a retrospective medical record review was conducted to ascertain the frequency of pregnancy testing and contraception use with ketamine treatments administered at a large academic health system. Online, publicly available informed consent documents were also reviewed for language related to pregnancy., Results: Fewer than half of survey respondents (n = 126) discuss specific risks related to pregnancy and fetal ketamine exposure during the informed consent process. Twenty percent of clinics require pregnancy tests prior to treatment, and 10.5% require subsequent testing during treatment; however, 22.9% of clinics do not have a standard process for testing. Only 13.7% of clinics specifically recommend or require use of contraception. Retrospective record review revealed that all patients who received intravenous ketamine for psychiatric indications in an academic medical center were pregnancy tested weekly, but only half were using contraception during treatment., Conclusion: Many women with the potential to become pregnant are treated with ketamine for psychiatric illness. Results of the present study reveal that risks of fetal ketamine exposure are often overlooked, indicating a need for increased awareness about reproductive concerns when prescribing ketamine for the treatment of psychiatric disorders., (© Copyright 2024 Physicians Postgraduate Press, Inc.)

Background: The VIVID (Videos for Addressing Racial Disparities in Implantable Cardioverter Defibrillator Therapy via Innovative Designs) study was a multicenter, randomized controlled trial aimed at evaluating the effectiveness of a video-based decision support tool in enhancing informed consent for implantable cardioverter defibrillator (ICD) implantation among Black patients who met guideline criteria for primary prevention ICDs. Within the broader VIVID randomized trial, a qualitative investigation was conducted to elucidate the decisional factors among Black individuals considering ICD implantation for the primary prevention of sudden cardiac arrest., Methods: Between October 2016 and July 2019, in-depth interviews were conducted at 2 time points from randomization, ≈7 days (time interval for the decision) and at 90 days; the time interval for determining ICD implantation. Interview findings were categorized by randomized groups, those assigned to 1 of the 2 encounter-based video decision support tools or standard care (without video). Interview participants were purposefully selected to ensure diversity across gender, age, educational background, research site, and randomization group; participants were sampled from 14 academic and community-based electrophysiology clinics in the United States. Data analysis employed applied thematic analysis techniques., Results: A diverse sample of Black individuals were interviewed at 1 week (n=59; female, 37.3%) and 90 days (n=48; female, 39.6%). The primary factors influencing the decisions of Black individuals considering a primary prevention ICD implantation were (1) their clinicians' recommendations for ICD implantation; (2) their perception of their cardiac health status; and (3) a desire to prolong their lives for the sake of their families., Conclusions: These findings offer valuable insights that may guide clinicians in their communication with Black patients during shared decision-making encounters related to ICD implantation., Competing Interests: Dr Jackson reports research grants from the National Institutes of Health, specifically the National Institute on Minority Health and Health Disparities, is currently supported by 1K01HL159041 from the National Heart, Lung and Blood Institute and the American Association under award number 851386. Dr Jackson serves as a consultant to Biosense Webster Inc, Johnson and Johnson, Sanofi, Bristol Myers Squibb, and Pfizer and receives honoraria from Zoll LifeVest, continuing medical education outfitters, Health Monitor, PRIME Education, and WebMD/Medscape. Dr Thomas reports on consulting with Biosense Webster Inc. The other authors report no conflicts.

Importance: Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials., Objective: To examine cancer clinical trial (CCT) participants' perceptions of informed consent processes and variations in perceptions by cancer type., Design and Setting and Participants: Cross-sectional survey from mixed-methods study at National Cancer Institute-designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic malignancies, lung cancer, and breast or gynecological cancer ( N  = 334)., Main Outcome Measures: Percentages satisfied with consent process and information provided; and assessing participation's perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type., Results: Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did-47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT., Conclusions and Relevance: Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making.

Human body donors play a crucial role in anatomical education, research, and clinical skills training, and those interested in anatomical donation may bequeath their bodies to body donation programs (BDPs). The purpose of this study was to evaluate the perspective of body donors on the donation process in order to make recommendations for improvement that align with donor values. A survey was administered via email to 2145 individuals that had enrolled in The Ohio State University's BDP and yielded a 40% response rate. Results showed that a majority of registered donors do not place high importance on detailed consent options during the enrollment process, but do value BDP oversight, such as through the use of an oversight committee to supervise the program. Only 9.1% of donors felt that their loved ones should be permitted to make changes to their consent forms after they have passed. Although 96.2% of participants would allow photos/videos to be taken of their donated bodies, females were significantly less likely to consent to this than males (p = 0.001), as well as less likely to allow their donations to be utilized for anatomy outreach (p = 0.023). Racial minorities were significantly less trusting of the university to treat their donation with dignity and respect compared to White registrants (p = 0.034). Suggestions for improving BDP protocols include the implementation of an annual newsletter for registrants, improving methods to spread awareness about donation, increasing transparency during the consent process, and creating resources for donors' families., (© 2024 The Authors. Anatomical Sciences Education published by Wiley Periodicals LLC on behalf of American Association for Anatomy.)

Introduction: The concealment of suicidal ideation (SI) constitutes a significant barrier to reducing veteran deaths by suicide and is associated with fear of negative consequences (e.g., involuntary hospitalization). This study examined whether augmenting informed consent with psychoeducation aimed to help patients achieve a more realistic risk appraisal of consequences associated with disclosure of SI, decreased hesitancy to disclose SI, and related risk behaviors among U.S. veterans., Method: Participants (N = 133) were recruited from combat veteran social media groups and were randomly assigned to a video simulated treatment-as-usual informed consent (control) or to one of two psychoeducation-enhanced informed consent conditions (psychoed, psychoed + trust)., Results: Compared with the control group, participants in both psychoeducation and enhanced informed consent conditions reported lower hesitancy to disclose SI, firearm access, and problems with drugs/thoughts of harming others, as well as greater trust and respect for the simulated clinician., Conclusions: These findings suggest that brief psychoeducation regarding common factors that affect hesitancy to disclose SI may be beneficial for increasing trust in providers during the informed consent process and decreasing concealment of SI and firearm access among veterans., (© 2024 American Association of Suicidology.)

From a legal perspective, before a physician engages in a serious medical intervention they must obtain informed consent. In this paper, we argue that there are serious deficits in our processes of obtaining informed consent; it is often seen as just a bureaucratic hurdle, and people agree to interventions without being in an appropriate epistemic state. We explore some possible reasons for this, including ignorance, trust in physicians' authority, and the minimal time physicians spend with patients. We trace many of these issues to one central cause, which is that in the United States obtaining informed consent is the purview of physicians. We argue that a simple shift in how we obtain informed consent can help to ameliorate these issues. Specifically, we argue that obtaining informed consent should be the responsibility of nurses rather than physicians. While there are several reasons for this, the central ideas are that (1) since nurses are the ones who know the patient, they will be in better position to tell when patients are genuinely informed, and (2) patients will be more comfortable asking questions and admitting ignorance to nurses rather than physicians. While we focus on US law, our conclusions are more broadly applicable. [ABSTRACT FROM AUTHOR]

The authors surveyed hospitals across the country on their policies regarding overlapping surgery, and found large variation between hospitals in how this practice is regulated. Specifically, institutions chose to define "critical portions" in a variety of ways, ultimately affecting not only surgical efficiency but also the autonomy of surgical trainees and patient experiences at these different hospitals. [ABSTRACT FROM AUTHOR]

Obtaining parental consent for youth to participate in research is a standard requirement in the United States. However, the assumption that involving parents is the best way to protect youth research participants is untenable for some populations. This study draws on interviews with 19 LGBTQ+ mixed-race participants to examine lay views of parental consent requirements for LGBTQ+ youth research participants. Qualitative data analysis found concerns about potentially outing LGBTQ+ youth to intolerant parents. Interviewees also asserted that adolescents aged 16 and older are competent enough and should have the autonomy to consent themselves. Finally, interviewees raised several methodological concerns regarding the biased research that may result from parental consent requirements. We agree with others that U.S. Institutional Review Boards should end uncritical requirements for parental consent for older adolescents and should routinize the use and study of alternative protective measures. [ABSTRACT FROM AUTHOR]

Background: Informed consent for surgery is a complex process particularly in paediatrics. Complexity increases with procedures such as CHD surgery. Regulatory agencies outline informed consent contents for surgery. We assessed and described CHD surgical informed consent contents through survey dissemination to paediatric CHD centres across United States of America., Methods: Publicly available email addresses for 125 paediatric cardiac clinicians at 70 CHD surgical centres were obtained. Nine-item de-identified survey assessing adherence to The Joint Commission informed consent standards was created and distributed via RedCap® 14 March, 2023. A follow-up email was sent 29 March, 2023. Survey link was closed 18 April, 2023., Results: Thirty-seven surveys were completed. Results showed informed consent documents were available in both paper (25, 68%) and electronic (3, 8%) format. When both (9, 24%) formats were available, decision on which format to use was based on centre protocols (1, 11%), clinician personal preference (3, 33%), procedure being performed (1, 11%), or other (4, 45%). Five (13%) centres' informed consent documents were available only in English, with 32 (87%) centres also having a Spanish version. Review of informed consent documents demonstrated missing The Joint Commission elements including procedure specific risks, benefits, treatment alternatives, and expected outcomes., Conclusions: Informed consent for CHD surgery is a complex process with multiple factors involved. Majority of paediatric CHD surgical centres in the United States of America used a generic informed consent document which did not uniformly contain The Joint Commission specified information nor reflect time spent in discussion with families. Further research is needed on parental comprehension during the informed consent process.

Kink practitioners are marginalized and experience adverse health and social outcomes, which are exacerbated by consent violations. This study aims to understand experiences of reporting consent violations within a kink context. Kink practitioners ( N  = 2,888) completed a survey focused on consent violations, reporting, and recommendations, with 767 (25.56%) of them reporting consent violations in the kink context. The type of consent violation (sexual assault or kink-related behaviors), disclosure, and reporting significantly differed based on gender, sexual orientation, and injury status, but not age. Additionally, recommended steps included avoidance of police and others in positions of power and increased accountability., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: To characterize malpractice trends related to active surveillance (AS) as a treatment strategy across cancers., Background: Active surveillance is increasingly considered a viable management strategy for low-risk cancers. Since a subset of AS cases will progress, metastasize, or exhibit cancer-related mortality, a significant barrier to implementation is the perceived risk of litigation from missing the window for cure. Data on malpractice trends across cancers are lacking., Methods: Westlaw Edge and LexisNexis Advance databases were searched from 1990 to 2022 for malpractice cases involving active surveillance in conjunction with thyroid cancer, prostate cancer, kidney cancer, breast cancer, or lymphoma. Queries included unpublished cases, trial orders, jury verdicts, and administrative decisions. Data were compiled on legal allegations, procedures performed, and verdicts or settlements rendered., Results: Five prostate cancer cases were identified that pertained to active surveillance. Two cases involved alleged deliberate indifference from AS as a management strategy but were ruled as following the appropriate standard of care. In contrast, 3 cases involved alleged physician negligence for not explicitly recommending AS as a treatment option after complications from surgery occurred. All cases showed documented informed consent for AS, leading to defense verdicts in favor of the physicians. No cases of AS-related malpractice were identified for other cancer types., Conclusions: To date, no evidence of successful malpractice litigation for active surveillance in cancer has been identified. Given the legal precedent detailed in the identified cases and increasing support across national guidelines, active surveillance represents a sound management option in appropriate low-risk cancers, with no increased risk of medicolegal exposure., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

This case explores the legal and ethical considerations for pediatricians surrounding gestational carrier pregnancies in the United States. Because of high success rates for assisted reproduction, state laws supporting same-sex adoption and surrogacy, and established legal precedents, gestational carrier pregnancies are increasingly common. The case presented involves a gestational carrier in preterm labor at 30 weeks' gestation with malpositioned twins who declines a cesarean delivery. Three commentaries are presented. The first highlights the importance of understanding the ethical implications of gestational carrier pregnancies in prenatal counseling. The second commentary emphasizes the pregnant person's right to autonomy and bodily integrity, and discusses considerations in surrogacy pregnancies, including the authority to authorize a cesarean delivery, valid informed consent, and decision-making for neonates. The third commentary discusses autonomy, emphasizing the importance of contracts in surrogacy pregnancies, and suggests that, in the case of a conflict between the gestational carrier and the intended parent(s), the gestational carrier's preference should be decisive regarding medical care during pregnancy. These discussions highlight key concepts for ethically informed and family-centered care in gestational carrier pregnancies and deliveries., (Copyright © 2024 by the American Academy of Pediatrics.)

Background: Few studies have investigated malpractice broadly in the field of plastic surgery. The purpose of this analysis was to characterize plastic surgery malpractice cases and examine factors influencing malpractice case outcomes, thereby identifying areas of patient safety concern., Methods: The Candello database, which catalogs approximately 30% of all paid and unpaid malpractice claims in the United States, was used to obtain cases involving plastic surgery closed between 2009 and 2018. A total of 2674 cases were identified. A multivariable regression model was developed to analyze factors associated with a malpractice case closing with indemnity payment., Results: A total of 716 claims (26.8%) resulted in an indemnity payment. The clinical severity was determined to be high in 229 cases (8.6%). Emotional trauma [ n = 558 (20.9%)] was the most frequently cited injury category. Major differences between procedure groups were not observed, with consistent severity of injury across categories. Poor surgical technique, problems with communication among providers, inadequate informed consent, and deficient documentation were significant factors predictive of malpractice cases closing with payment. Issues with technical performance resulting in a known complication and patient factors were protective against paid claims., Conclusions: The financial and clinical severity of malpractice claims in plastic surgery were relatively low overall. Multiple factors were found to be associated with a case closing with an indemnity payment. These data highlight the importance of the informed consent process and managing expectations in the clinical care of surgical patients., (Copyright © 2023 by the American Society of Plastic Surgeons.)

A first therapeutic target of somatic genome editing (SGE) is sickle cell disease (SCD), the most commonly inherited blood disorders, affecting more than 100,000 individuals in the United States. Advancement of SGE is contingent on patient participation in first in human clinical trials. However, seriously ill patients may be vulnerable to overestimating the benefits of early phase studies while underestimating the risks. Therefore, ensuring potential clinical trial participants are fully informed prior to participating in a SGE clinical trial is critical. Methods: We conducted a mixed-methods study of adults with SCD as well as parents and physicians of individuals with SCD. Participants were asked to complete a genetic literacy survey, watch an educational video about genome editing, complete a two-part survey, and take part in focus group discussions. Focus groups addressed topics on clinical trials, ethics of gene editing, and what is not understood regarding gene editing. All focus groups were audio-recorded, transcribed, and analyzed using conventional content analysis techniques to identify major themes. Results: Our study examined the views of SCD stakeholders regarding what they want and need to know about genome editing to make an informed decision to participate in a SGE clinical trial. Prominent themes included stakeholders' desire to understand treatment side effects, mechanism of action of SGE, trial qualification criteria, and the impact of SGE on quality of life. In addition, some physicians expressed concerns about the extent to which their patients would understand concepts related to SGE; however, individuals with SCD demonstrated higher levels of genetic literacy than estimated by physicians. Conclusions: Designing ethically robust genome editing clinical trials for the SCD population will require, at a minimum, addressing the expressed information needs of the community through culturally sensitive engagement, so that they can make informed decisions to consider participation in clinical trials. [ABSTRACT FROM AUTHOR]

Background: Medical malpractice occurs when a hospital or health-care provider through negligent act or omission results in an injury to a patient. More than 50% of otolaryngologists have faced at least 1 claim, with rhinology being the most litigated subspecialty. This study aims to analyze medical litigation trends in Rhinology from 2000 to 2017 in the United States. Methods: The Westlaw database was reviewed from 2000 to 2017. Data were compiled on the demographics of the plaintiffs, procedures, nature of damages, legal allegations, and the use of expert witnesses, physician demographics/practice characteristics, verdicts, indemnities, and county/state of case. Results: There were 75 cases that met inclusion criteria after review of 125 cases. Majority of cases went to trial over settlement (80%) and were found in the Northeast region of the United States (36%). Most common cited legal allegations were improper performance and failure to follow standard of care. The most common nature of injuries were eye injury (29%) and intracranial complications (27%). The highest payouts were for progression of disease followed by intracranial injury. Of the 75 total cases analyzed, 37 (49.3%) used expert witnesses. When an expert witness was used at trial, the verdict statistically favored the defendant (62.5%). Conclusions: Our analysis reveals the importance of meticulous surgical techniques and thorough preoperative evaluations. [ABSTRACT FROM AUTHOR]

Background: Novel rationales for randomizing clusters rather than individuals appear to be emerging from the push for more pragmatic trials, for example, to facilitate trial recruitment, reduce the costs of research, and improve external validity. Such rationales may be driven by a mistaken perception that choosing cluster randomization lessens the need for informed consent. We reviewed a random sample of published cluster randomized trials involving only individual-level health care interventions to determine (a) the prevalence of reporting a rationale for the choice of cluster randomization; (b) the types of explicit, or if absent, apparent rationales for the use of cluster randomization; (c) the prevalence of reporting patient informed consent for study interventions; and (d) the types of justifications provided for waivers of consent. We considered cluster randomized trials for evaluating exclusively the individual-level health care interventions to focus on clinical trials where individual randomization is only theoretically possible and where there is a general expectation of informed consent. Methods: A random sample of 40 cluster randomized trials were identified by implementing a validated electronic search filter in two electronic databases (Ovid MEDLINE and Embase), with two reviewers independently extracting information from each trial. Inclusion criteria were the following: primary report of a cluster randomized trial, evaluating exclusively an individual-level health care intervention, published between 2007 and 2016, and conducted in Canada, the United States, European Union, Australia, or low- and middle-income country settings. Results: Twenty-five trials (62.5%, 95% confidence interval = 47.5%–77.5%) reported an explicit rationale for the use of cluster randomization. The most commonly reported rationales were those with logistical or administrative convenience (15 trials, 60%) and those that need to avoid contamination (13 trials, 52%); five trials (20%) were cited rationales related to the push for more pragmatic trials. Twenty-one trials (52.5%, 95% confidence interval = 37%–68%) reported written informed consent for the intervention, two (5%) reported verbal consent, and eight (20%) reported waivers of consent, while in nine trials (22.5%) consent was unclear or not mentioned. Reported justifications for waivers of consent included that study interventions were already used in clinical practice, patients were not randomized individually, and the need to facilitate the pragmatic nature of the trial. Only one trial reported an explicit and appropriate justification for waiver of consent based on minimum criteria in international research ethics guidelines, namely, infeasibility and minimal risk. Conclusion: Rationales for adopting cluster over individual randomization and for adopting consent waivers are emerging, related to the need to facilitate pragmatic trials. Greater attention to clear reporting of study design rationales, informed consent procedures, as well as justification for waivers is needed to ensure that such trials meet appropriate ethical standards. [ABSTRACT FROM AUTHOR]