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The author presents his views on the comments made by researchers Sissela Bok and Torbjörn Tännsjö for his article "Using informed consent to save trust" which published in a 2014 issues of the periodical. Topics discussed include the trust-based argument on utilitarianism, the role of trusts to promote social stability and the importance of commonsense morality to deny informed consent rights in patients who lack decisional capacity.

In human challenge trials (HCTs), volunteers are deliberately infected with an infectious agent. Such trials can be used to accelerate vaccine development and answer important scientific questions. Starting early in the COVID-19 pandemic, ethical concerns were raised about using HCTs to accelerate development and approval of a vaccine. Some of those concerns pertained to potential exploitation of and/or lack of truly informed consent from volunteers. Specific areas of concern arose around individuals who may be unusually risk-seeking or too economically vulnerable to refuse the payments these trials provide, as opposed to being motivated primarily by altruistic goals. This pre-registered study is the first large-scale survey to characterize people who, early in the pandemic, expressed interest and intention to volunteer to participate in COVID-19 HCTs. We found that individuals expressing interest in SARS-CoV-2 HCTs exhibit consistently altruistic motivations without any special indication of poor risk perception or economic vulnerability. In finding that, early in the pandemic, COVID-19 HCTs were able to attract volunteers whose values align with the nature of these trials, and who are not unusually vulnerable to exploitation, this study may allay some ethical concerns about the volunteers interested in participating in such trials. [ABSTRACT FROM AUTHOR]

Background: Participation in longitudinal research studies in resource-limited settings often involves frequent interactions with study staff and other participants, as well as receipt of incentives and transportation reimbursements. Social support—receipt of material and emotional resources from one's social network—has been linked to antiretroviral adherence in sub-Saharan Africa. The extent to which social support arises from study participation, its range and depth, and its implications for observational study conduct, have not been extensively described. Methods: We conducted individual open-ended and semi-structured interviews with participants in a longitudinal, observational antiretroviral therapy adherence monitoring study in Mbarara, Uganda. Participants were asked about their experiences in the longitudinal study and their interactions with research staff. We also interviewed study research assistants (RAs). Deductive and inductive coding were used to identify content related to the experience of study participation. Codes were organized into themes, and relationships between themes were used to develop overarching categories. Results: Sixty longitudinal study participants and 6 RAs were interviewed. Instrumental and emotional social support emerged as pervasive and valued aspects of longitudinal study participation. Instrumental support that participants received consisted of enhanced linkage to medical care, health education, and direct and indirect material benefits. Emotional support consisted of perceptions of feeling "cared for" and social interactions that permitted escape from HIV-related stigma. Both instrumental and emotional support often arose through the close relationships participants formed with research staff and with each other. Study-derived social support motivated some participants to adhere to antiretroviral therapy—an unanticipated effect potentially influencing the longitudinal study's primary observational outcome. Conclusions: Longitudinal study participation resulted in instrumental and emotional social support for participants. The depth of support participants experienced has implications for observational study design in resource-limited settings, including need to assess potential effects on study outcomes; consideration of social support during risk/benefit assessment in study ethics review and consent; and vigilance for consequences of social support loss when studies end. [ABSTRACT FROM AUTHOR]

A vaccine for COVID-19 is urgently needed. Several vaccine trial designs may significantly accelerate vaccine testing and approval, but also increase risks to human subjects. Concerns about whether the public would see such designs as ethical represent an important roadblock to their implementation; accordingly, both the World Health Organization and numerous scholars have called for consulting the public regarding them. We answered these calls by conducting a cross-national survey (n = 5920) in Australia, Canada, Hong Kong, New Zealand, South Africa, Singapore, the United Kingdom, and the United States. The survey explained key differences between traditional vaccine trials and two accelerated designs: a challenge trial or a trial integrating a Phase II safety and immunogenicity trial into a larger Phase III efficacy trial. Respondents' answers to comprehension questions indicate that they largely understood the key differences and ethical trade-offs between the designs from our descriptions. We asked respondents whether they would prefer scientists to conduct traditional trials or one of these two accelerated designs. We found broad majorities prefer for scientists to conduct challenge trials (75%) and integrated trials (63%) over standard trials. Even as respondents acknowledged the risks, they perceived both accelerated trials as similarly ethical to standard trial designs. This high support is consistent across every geography and demographic subgroup we examined, including vulnerable populations. These findings may help assuage some of the concerns surrounding accelerated designs. [ABSTRACT FROM AUTHOR]

Background: Microsurgery is a specialized procedure that necessitates well-trained and experienced surgeons and a skilled nursing care staff. This study presents our experience with a free flap service in a medium-sized hospital and its feasibility. Methods: This retrospective study included 91 patients who underwent breast and head and neck free tissue reconstruction between March 2010 and February 2018, by a single microsurgeon. Pre- and post-operative protocols were implemented. Data was retrospectively collected regarding age, gender, medical history, pre-oncological treatments, type of flaps, operation time, success, failure, re-exploration and salvage rates, minor and major complications, and hospitalization length. Results: Mean operation time was 12.5 h (range 4–26.8 h). Average hospital stay was 14 days (breast 11 days, head and neck 17 days), range 7–56 days. The overall flap success rate was 89% (breast 92.2%, head and neck 85.4%). Total complication rate was 60.6%. Minor complications 41.4% (breast 22.2%, head and neck 19.2%) and major complications 19.2% (breast 8.1%, head and neck 11.1%). Minor complications included seroma (breast 5.9%, head and neck 4.2%), infection/abscess (breast 2%, head and neck 10.4%), wound dehiscence (breast 3.9%, head and neck 8.3%), fistula (breast 0%, head and neck 8.3%), and fat necrosis (breast 21.5%, head and neck 0%). Major complications included flap necrosis (breast 9.8%, head and neck 8.3%) and venous thrombosis (breast 7.8%, head and neck 8.3%). Conclusions: This study demonstrated the probability of a reconstructive microsurgical service in a medium-sized hospital which achieves respectable results that meet international standards. Level of evidence: Level IV, therapeutic study. [ABSTRACT FROM AUTHOR]

Despite doing well on antiretroviral therapy, many people living with HIV have expressed a willingness to accept substantial risks for an HIV cure. To date, few studies have assessed the specific quantitative maximal risk that future participants might take; probed whether, according to future participants, the risk can be offset by the benefits; and examined whether taking substantial risk is a reasonable decision. In this qualitative study, we interviewed 22 people living with HIV and used standard gamble methodology to assess the maximum chance of death a person would risk for an HIV cure. We probed participants' reasoning behind their risk‐taking responses. Conventional inductive content analysis was used to categorize key themes regarding decision‐making. We found that some people would be willing to risk even death for an HIV cure, and some of their reasons were plausible and went far beyond the health‐related utility of an HIV cure. We contend that people's expressed willingness to take substantial risk for an HIV cure should not be dismissed out of hand. [ABSTRACT FROM AUTHOR]

Despite global progress in HIV stigma reduction, persistent HIV stigma thwarts effective HIV service delivery. Advances in HIV biomedical research toward a cure may shift perceptions of people living with HIV and HIV stigma. The purpose of this study was to examine how men who have sex with men (MSM) living with HIV in Guangzhou, China perceive HIV cure research and its potential impact on MSM and HIV stigma. We conducted in-depth interviews with 26 MSM living with HIV about their perceptions of HIV cure research and the potential impact of an HIV cure on their lives. Thematic coding was used to identify themes and structure the analysis. Two overarching themes emerged. First, participants stated that an HIV cure may have a limited impact on MSM-related stigma. Men noted that most stigma toward MSM was linked to stereotypes of promiscuity and high rates of sexual transmitted diseases in the MSM community and might persist even after a cure. Second, participants believed that an HIV cure could substantially reduce enacted, anticipated, and internalized stigma associated with HIV. These findings suggest that a biomedical cure alone would not remove the layered stigma facing MSM living with HIV. Comprehensive measures to reduce stigma are needed. [ABSTRACT FROM AUTHOR]

In a Policy Forum, Marc Lipsitch and colleagues discuss trial design issues in infectious disease outbreaks. [ABSTRACT FROM AUTHOR]

Studies suggest that inflammation is involved in the pathophysiology of depression. The present study examined the effects of the commonly used antidepressant escitalopram, in comparison with a novel herbal treatment (NHT) consisted of Crataegus pinnatifida , Triticum aestivum , Lilium brownii and Fructus Ziziphus jujuba , on cytokine and behavioral responses to an immune challenge. Escitalopram augmented lipopolysaccharide-induced tumor necrosis factor (TNF)-α peripheral secretion and induced a faster kinetics of interleukin-1β secretion, while marginally reducing sickness behavior. NHT, on the other hand, completely abolished lipopolysaccharide-induced interleukin-1β and TNFα peripheral secretion and diminished sickness behavior. These findings may have implications for the treatment of depressive symptoms associated with immune activation. [ABSTRACT FROM AUTHOR]

Problem District hospitals in Nepal struggle to provide essential services such as caesarean sections. Approach Retention of health workers is critical to the delivery of long-term, quality health-care services. To promote retention and enhance performance in rural public hospitals, the Government of Nepal and the Nick Simons Institute progressively implemented a rural staff support programme in remote hospitals. After competitive selection for a compulsory-service scholarship and training, family practice doctors who could do basic surgery, orthopaedics and obstetrics were hired under a binding three-year contract in each participating hospital. Comfortable living quarters and an Internet connection were provided for the resident doctors; in-service training for all staff and capacity development for each hospital's management committee were provided. Local setting Nepal's mountainous landscape, poverty and inequitable rural/urban distribution of health workers pose barriers to adequate health care. Relevant changes Between 2011 and 2015 family practice doctors were maintained in all seven programme hospitals. All hospitals became providers of comprehensive emergency obstetric care and served more patients. Compared with hospitals not within the programme, deliveries increased significantly (203% versus 71% increase, respectively; P = 0.002). The programme recently expanded to 14 hospitals. Lessons learnt A package of human resource supports can improve the retention of doctors and the use of remote hospitals. Factors contributing to the success of this programme were compulsory-service scholarship, central personnel management, performance-based incentives and the provision of comfortable living quarters. [ABSTRACT FROM AUTHOR]

Background: In the US, 1.2 million people live with HIV (PWH). Despite having near-normal life expectancies due to antiretroviral therapy (ART), many PWH seek an HIV cure, even if it means risking their lives. This willingness to take risks for a cure raises questions about "affective forecasting biases," where people tend to overestimate the positive impact of future events on their well-being. We conducted a study to test two interventions to mitigate affective forecasting in the decisions of PWH about taking HIV cure medication., Methods: We recruited PWH to complete a 30-minute survey about their current quality of life (QoL) and the QoL they anticipate after being cured of HIV, and assigned them to either no additional intervention, to one of two interventions intended to reduce affective forecasting bias, or to both interventions: (1) a defocusing intervention designed to broaden the number of life domains people consider when imagining life changes associated with new circumstances (e.g. HIV cure); and (2) an adaptation intervention to help them gauge fading of strong emotions over time. The study design included a 2 × 2 design: defocusing (yes/no) x adaptation (yes/no) intervention. We assessed PWH's willingness to take hypothetical HIV sterilizing cure medication using the Time Trade-Off (TTO) and their quality of life predictions with WHOQOL-HIV., Results: 296 PWH participated. Counter to what we had hypothesized, neither intervention significantly reduced PWH's willingness to trade time for a cure. Instead, the defocusing intervention increased their willingness to trade time (IRR 1.77, p = 0.03). Exploratory analysis revealed that PWH with lower current quality of life who received the defocusing intervention were more willing to trade time for a cure., Conclusion: These negative findings suggest that either these biases are difficult to overcome in the settings of HIV curative medication or other factors beyond affective forecasting biases influence willingness to participate in HIV curative studies, such as respondents' current quality of life., (© 2024. The Author(s).)

U.S. regulation of dual-use research of concern and of research with enhanced pathogens of pandemic potential may alter soon. Much has been written on the best form for that regulation to take. Less was written on a procedural question: whose voices should shape that regulation? This commentary addresses the latter, the procedural question, regarding the appropriate parties to the deliberations and decisions on this matter. It proposes to U.S. virologists that it would be in the interests of their discipline and only appropriate if that regulation were shaped by many voices from outside the discipline and from outside the United States., Competing Interests: The authors declare no conflict of interest.

Despite their clearly demonstrated safety and effectiveness, approved vaccines against COVID-19 are commonly mistrusted. Nations should find and implement effective ways to boost vaccine confidence. But the implications for ethical vaccine development are less straightforward than some have assumed. Opponents of COVID-19 vaccine challenge trials, in particular, made speculative or empirically implausible warnings on this matter, some of which, if applied consistently, would have ruled out most COVID-19 vaccine trials and many non-pharmaceutical responses., Competing Interests: Competing interests: NE serves on the Advisory Board of challenge trial volunteer organisation 1DaySooner (a non-profit promoting human challenge trials in COVID-19), an unpaid position., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Research with enhanced potential pandemic pathogens (ePPP) makes pathogens substantially more lethal, communicable, immunosuppressive or otherwise capable of triggering a pandemic. We briefly relay an existing argument that the benefits of ePPP research do not outweigh its risks and then consider why proponents of these arguments continue to confidently endorse them. We argue that these endorsements may well be the product of common cognitive biases-in which case they would provide no challenge to the argument against ePPP research. If the case against ePPP research is strong, the views of professional experts do little to move the needle in favour of ePPP research., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Sometimes, offering someone beneficial care is likely to thwart the similar or more serious medical needs of more people. For example, when acute shortage is strongly predicted to persist, providing the long period on scarce intensive care that a certain COVID-19 patient needs is sometimes projected to block several future COVID-19 patients from receiving the shorter periods on intensive care that they will need. Expected utility is typically higher if the former is denied intensive care. A tempting initial account of such cases is that consequentialism supports denying care to that patient and nonconsequentialism supports providing that care. This paper argues that the consequentialist case is more complicated than it may initially seem and that nonconsequentialism sides more readily with denial of the beneficial treatment. It also shows that when denying it would directly enhance public health by a lot, either ethical approach would normally recommend denying it. Practical implications are discussed, including how to address conscientious objection to this shared recommendation., (© 2023 The Authors. Bioethics published by John Wiley & Sons Ltd.)

In many countries, the COVID-19 pandemic varied starkly between different racial and ethnic groups. Before vaccines were approved, some considered assigning priority access to worse-hit racial groups. That debate can inform rationing in future pandemics and in some of the many areas outside COVID-19 that admit of racial health disparities. However, concerns were raised that "race-responsive" prioritizations would be ruled unlawful for allegedly constituting wrongful discrimination. This legal argument relies on an understanding of discrimination law as demanding color-blindness. We argue that a, color-blind understanding of discrimination would be hostile only to one of two rationales for prioritizing the relevant racial minorities in settings of racial health disparities. We also propose a method for incorporating appropriate race-responsive concerns that is in many ways ethically and legally superior to ones suggested thus far. That method turns artificial intelligence, thanks precisely to its artificial and "black box" nature (features that underlie recent concerns about artificial intelligence's discriminatory potential), into an instrument of social justice., (© 2023 The Authors. Bioethics published by John Wiley & Sons Ltd.)

Governments and non-governmental organisations are increasingly adopting a 'zero-suicide' goal, but what such a goal precisely involves is unclear. Ostensibly it strongly prioritises the prevention and elimination of all suicide. We argue that, so understood, a societal goal of zero suicide risks contravening several ethical principles. In terms of beneficence and non-maleficence, a 'zero-suicide' goal risks being inefficient and may burden or harm many people. Autonomy-wise, a blanket ban on all suicide is excessive. As regards social justice, zero suicide risks focusing on the symptoms of social malaise instead of the structures causing it. With respect to transparency, a 'zero' goal that cannot be met makes these authorities look detached and risks frustration, distrust and, worse, stigmatisation of suicide and of mental health conditions. Instead, we propose a middle path for suicide prevention, founded on harm reduction, 'soft group paternalism' and efforts directed at increased quality of life for disadvantaged groups. Although soft group paternalism respects autonomy, this approach permits coercive interferences in certain circumstances. We hope that the justificatory framework tying together these largely familiar elements is novel and sensible.

Background: WHO recommends mass drug administration (MDA) of the antibiotic azithromycin for children aged 1-11 months in areas with high rates of infant and child mortality. Notwithstanding the substantial potential benefits of lowering childhood mortality, MDA raises understandable concerns about exacerbating antibiotic resistance., Objectives: In this study, we aimed to evaluate the use of MDA using both quantitative and ethical considerations., Sources: We performed a series of literature searches between July 2019 and June 2022., Content: We first compared MDA with other uses of antibiotics using the standard metric of 'number needed to treat', and five additional criteria: (1) other widely accepted uses of anti-infectives (2) absolute use (i.e. total number), of antibiotics, (3) risk-benefit trade-off, (4) availability of short-term alternatives, and (5) the precedent for implementing similar interventions. We found that MDA falls well within a justifiable range when compared with widely accepted uses of antibiotics in terms of the number needed to treat. The other five criteria we considered provided further support for the use of MDA to prevent childhood mortality., Implications: Although better data on antibiotic use and resistance are needed, efforts to reduce antibiotic use and resistance should not start with halting MDA of azithromycin in the areas with the highest rates of childhood mortality. Improving data to inform this decision is critical. However, on the basis of the best evidence available, we believe that concerns regarding resistance should not thwart MDA; instead, MDA should be accompanied by robust plans to monitor its efficacy and changes in resistance levels. Similar considerations could be included in a framework for evaluating the benefits of antibiotics against the risk of resistance in other contexts., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

In high-income countries that were first to roll out coronavirus disease 2019 (COVID-19) vaccines, older adults have thus far usually been prioritized for these vaccines over younger adults. Age-based priority primarily resulted from interpreting evidence available at the time, which indicated that vaccinating the elderly first would minimize COVID-19 deaths and hospitalizations. The World Health Organization counsels a similar approach for all countries. This paper argues that some low- and middle-income countries that are short of COVID-19 vaccine doses might be justified in revising this approach and instead prioritizing certain younger persons when allocating current vaccines or future variant-specific vaccines., Competing Interests: Potential conflicts of interest. N. E. received payment or honoraria from Oxford University Press and held an unpaid, volunteer position with 1 Day Sooner. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Early into COVID, human challenge trials were considered, but usually as alternatives to conventional randomized controlled trials. Instead, assessment of authorized COVID vaccines, of further COVID vaccines, and of vaccines against future pandemics should combine both designs, in five different ways, including a wholly novel one that we elaborate, Viz., combining data from both designs to answer a single question., (© 2022 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.)

Proponents of the newly-developed "deliberative interview" argue that examining complex issues requires more dynamic and engaging interview exchanges. Unlike traditional qualitative interviews, deliberative interviewing champions opinion sharing, active debates and similar speaking times by both sides throughout the interview. Drawing on 20 interviews with health experts in Germany, we examined the process and outcome of deliberative versus conventional interviews on the topic of informed consent. The deliberative interview expedited clarity on the issue, led to more nuanced discussion and generated more knowledge overall, but was challenging because it broke the mold for traditional interviewing. Alignment in terms of gender, age, personality and professional background facilitated rapport, regardless of interview style. To manage expectations, we recommend a thorough, perhaps video-based explanation of the deliberative style prior to the interview. Deliberative interviews can bolster knowledge generation for complex issues and can be applied in public health and beyond., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2021 The Authors.)

HIV status disclosure remains one of the major challenges to effective HIV prevention. Given the complexities and low rates of disclosure, new innovative strategies are needed. Since electronic adherence monitoring (EAM) are unique mobile devices that light up when transmitting data, those who see them often want to know more about them, which can potentially result in HIV status disclosure. We conducted a qualitative study to explore patient experiences with EAM for antiretroviral therapy (ART) in Uganda with a goal of understanding potential ethical concerns, including disclosure. Unexpectedly, several participants reported intentionally using EAM to facilitate HIV status disclosure to others in order to get social support, encourage HIV testing, and create awareness about HIV. Although researchers and clinicians need to be mindful of the potential for unintended HIV status disclosure through the use of EAM, they should also recognize the potential of this approach to support intended disclosure.

Background: A vaccine trial with a conventional challenge design can be very fast once it starts, but it requires a long prior process, in part to grow and standardize challenge virus in the laboratory. This detracts somewhat from its overall promise for accelerated efficacy testing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine candidates, and from the ability of developing countries and small companies to conduct it., Aims: We set out to identify a challenge design that avoids this part of the long prior process., Sources: Literature in trial design (including a proof of concept flu challenge trial by B. Killingley et al.), vaccinology, medical ethics, and various aspects of COVID response., Content: A challenge design with deliberate natural viral exposure avoids the need to grow culture. This new design is described and compared both to a conventional challenge design and to a conventional phase III field trial. In comparison, the proposed design has ethical, scientific, and feasibility strengths., Implications: The proposed new design should be considered for future vaccine trials., (Copyright © 2021 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Many people living with HIV (PLWHIV) state that they would be willing to take significant risks to be "cured" of the virus. However, how they interpret the word "cure" in this context is not clear. We used a randomized survey to examine whether PLWHIV had a different willingness to take a hypothetical HIV medication if it causes flu-like symptoms, but provides: (a) cure, (b) remission that was labeled "cure", or (c) remission. PLWHIV (n = 454) were more willing to take a medication that provided a "cure" versus a "remission" if the side effects lasted less than 1 year. PLWHIV were more willing to take a medication that provided a remission that was labeled "cure" versus a "remission" (p = 0.01) if the side effects lasted 2 weeks. Clinicians and researchers should be aware of the impact of the word "cure" and ensure that PLWHIV fully understand the possible outcomes of their treatment options.

Ethical guidelines and recommendations for human subjects research typically focus on protecting the individuals who directly participate in that research. However, additional people, including sex partners of research participants, can also face harms and burdens from medical studies. In human immunodeficiency virus (HIV) cure-related research, a persistent ethical and practical challenge surrounds the use of analytical antiretroviral treatment interruptions. The challenge is usually discussed in relation to risks to study participants, but serious dangers accrue to nonparticipants, including sex partners of study participants. This multidisciplinary supplement relays the risks for nonparticipating sex partners in HIV cure-related studies and addresses the ethical dilemmas raised by these studies, with recommendations for researchers, advocates, sponsors, and oversight bodies., (© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.)

Many new technologies monitor patients' and study participants' medical adherence. Some have cautioned that these devices transgress personal autonomy and ethics. But do they? This qualitative study explored how Ugandan study participants perceive the effect of electronic monitoring of their adherence to antiretroviral therapy (ART) on their freedoms to be non-adherent and pursue other activities that monitoring may inadvertently expose. Between August 2014 and June 2015, we interviewed 60 Ugandans living with HIV and enrolled in the Uganda AIDS Rural Treatment Outcomes (UARTO) study, a longitudinal, observational study involving electronic adherence monitors (EAMs) to assess ART adherence. We also interviewed 6 UARTO research assistants. Both direct and indirect content analysis were used to interpret interview transcripts. We found that monitoring created a sense of pressure to adhere to ART, which some participants described as "forcing" them to adhere. However, even participants who felt that monitoring forced them to take medications perceived using the EAM as conducive to their fundamental goal of high ART adherence. Overall, even if monitoring may have limited participants' effective freedom to be non-adherent, participants welcomed any such effect. No participant rejected the EAM on the grounds that it would limit that effective freedom. Reports that monitoring altered behaviors unrelated to pill-taking were rare. Researchers should continue to be vigilant about the ways in which behavioral health monitoring affects autonomy, but should also recognize that even autonomy-limiting monitoring strategies may enable participants to achieve their own goals.

Purpose of Review: Several promising experimental pathways exist for long-term control of HIV in the absence of antiretroviral therapy (HIV 'remission') and are now being tested in early clinical studies. These studies can be invasive and pose a host of distinctive risks to participants, as well as to nonparticipants, especially to participants' fetuses, and sexual partners., Recent Findings: Ethical analyses of these studies have mainly focused on the risks to study participants. They recommend, and some investigators implement, procedures to mitigate risks for participants or to offset them with direct, indirect, and nonmedical benefits. They also suggest ways to keep participants' consent highly voluntary and informed. Rarely do ethicists propose keeping the social value of studies high. Of these recommended responses, only the latter, rarer proposals help address the risk to nonparticipants, as would some novel ways to address that risk., Summary: HIV remission studies pose a number of ethical dilemmas. Many current investigative approaches put the participant at significant risk, but well established guidelines exist for mitigating this risk. Ethical issues that are not being fully addressed include risk to nonparticipants and the need to consider the societal value of studies, for example, their prospective impact on the global HIV burden. VIDEO ABSTRACT.

Competing Interests: The authors declare no conflict of interest.

In this article, we provide a comprehensive analysis and a normative assessment of rationing through inconvenience as a form of rationing. By "rationing through inconvenience" in the health sphere, we refer to a nonfinancial burden (the inconvenience) that is either intended to cause or has the effect of causing patients or clinicians to choose an option for health-related consumption that is preferred by the health system for its fairness, efficiency, or other distributive desiderata beyond assisting the immediate patient. We argue that under certain conditions, rationing through inconvenience may turn out to serve as a legitimate and, compared to direct rationing, even a preferable tool for rationing; we propose a research agenda to identify more precisely when that might be the case and when, alternatively, rationing through inconvenience remains ethically undesirable. After defining and illustrating rationing through inconvenience, we turn to its moral advantages and disadvantages over other rationing methods. We take it as a starting assumption that rationing, understood as scarce-resource prioritization, is inevitable and, in a society that has goals beyond optimizing health care for individual patients-such as improving societal health care, education, or overall welfare-prudent and fair., (© 2018 The Hastings Center.)

Pressure necrosis which might be followed by skin necrosis and implant extrusion is a dreaded complication of breast reconstructive surgery. Over the years, several techniques have been introduced to address this challenging problem. We offer a novel surgical technique to confront this perplexing complication. By using the capsule of the implant as a turnover flap, the soft tissue coverage is enhanced thereby decreasing the pressure between the breast prosthesis and the over-laying skin. The technique is simply reproduced, requires no new incisions, and avoids further morbidity to the involved breast reconstructed patient.

We report a case of Takotsubo cardiomyopathy [TCM] occurrence in a 75-years-old female after surgical intervention for the treatment of bowel obstruction. Approximately 24 hours after the procedure, the hemodynamic and respiratory status of the patient deteriorated. Marked ECG ST segment elevation, and troponin levels were moderately elevated in a pattern suitable for ST elevation myocardial infarction [MI). Coronary angiogram showed no sign of coronary obstruction, and an angiography of the left ventricle, presented a template of apical ballooning highly suspicious of Takotsubo syndrome.