The report by Barbara Bierer and Mark Barnes highlights the complexities experienced by institutions that conduct Public Health Service‐funded research involving human subjects and that need to negotiate the requirements of two sets of federal regulations: 45 C.F.R. 46, covering protections for human research subjects, and 42 C.F.R. 93, the PHS policies on research misconduct. As the nation's single largest sponsor of biomedical and behavioral research, the National Institutes of Health seeks to exemplify and promote human research protections and the (...) highest level of scientific integrity, public accountability, and social responsibility in the conduct of science. The NIH is committed to protecting the rights and welfare of research participants and to upholding integrity standards for research supported with public funds. However, human subjects protections must always take priority. (shrink)

The COVID-19 pandemic has raised a host of ethical challenges, but key among these has been the possibility that health care systems might need to ration scarce critical care resources. Rationing p...

Background Medical Assistance in Dying in Canada came into effect in 2016 with the passing of Bill C-14. As patient interest and requests for MAID continue to evolve in Canada, it is important to understand the attitudes of future providers and the factors that may influence their participation. Attitudes towards physician hastened death in general and the specific provision of MAID are unknown among Canadian residents. This study examined residents’ attitudes towards PHD and MAID, and identified factors that may influence (...) their decision to participate in PHD and provide MAID. Methods A cross-sectional survey was adapted from prior established surveys on MAID to reflect the Canadian setting. All Canadian family medicine programs were invited to participate. The survey was distributed between December 2016 and April 2017. Analysis of the results included descriptive statistics to characterize the survey participants and multivariable logistic regressions to identify factors that may influence residents’ attitudes towards PHD and MAID. Results Overall, 247 residents from 6 family medicine training programs in Canada participated. While residents were most willing to participate in treatment withdrawal, active participation in PHD and MAID by prescription of a lethal drug and lethal injection were less acceptable. Logistic regressions identified religion as a consistent and significant factor impacting residents’ willingness to participate in PHD and MAID. Residents who were not strictly practicing a religion were more likely to be willing to participate in PHD and MAID. Increased clinical exposure to death and dying crudely correlated with increased willingness to participate in PHD and MAID, but when examined in multivariable models, only a few activities had a statistically significant association. Other significant factors included the residents’ sex and location of training. Conclusions Residents are hesitant to provide MAID themselves, with religious faith being a major factor impacting their decision. (shrink)

We propose a new picture of nature in which there are only two fundamental universal constantsè ē (≡e/c) andh(≡ħ/c). Our theory is developed within the framework of a new four-dimensional symmetry which is constructed on the basis of the Poincaré-Einstein principle of relativity for the laws of physics and the Newtonian concept of time. We obtain a new space-light transformation law, a velocity-addition law, and so on. In this symmetry scheme, the speed of light is constant and is completely relative. (...) The new theory is logically self-consistent, and it moreover is in agreement with all previously established experimental facts, such as the “lifetime dilatation” of unstable particles, the Michelson-Morley experiment, etc. There is a difference relative to the usual theory, though, in that our theory predicts a new law for the Dopplerfrequency shift, which can be tested experimentally by measuring the second-order frequency shift. (shrink)

We discuss quantum electrodynamics within the framework of a new four-dimensional symmetry in which the concept of time, the propagation of light, and the transformation property of many physical quantities are drastically different from those in special relativity. However, they are consistent with experiments. The new framework allows for natural developments of additional concepts. Observers in different frames may use the same grid of clocks, located in any one of the frames, and hence have a universal time.

A 2011 National Academies of Sciences report called for an “Information Commons” and a “Knowledge Network” to revolutionize biomedical research and clinical care. We interviewed 41 expert stakeholders to examine governance, access, data collection, and privacy in the context of a medical information commons. Stakeholders' attitudes about MICs align with the NAS vision of an Information Commons; however, differences of opinion regarding clinical use and access warrant further research to explore policy and technological solutions.

The structures of space and time associated with various four-dimensional symmetries are constructed and examined. It is interesting that some of these four-dimensional symmetries are compatible with the existence of an aether in the Einstein sense. There are two classes of infinitely many four-dimensional symmetries that cannot be ruled out by previous experiments. We discuss some laser experiments that test these two classes of four-dimensional symmetries. An interesting connection between the nonclassical aether and gravity through the equality of inertial and (...) gravitational mass is explored. (shrink)

A new theory of four-dimensional symmetry introduced by Hsu has been criticized as logically inconsistent. We answer the criticisms that have been raised and show that in fact this theory is not logically inconsistent.

This study investigates: the changes in three major health-related factors—physical activity, non-physical-activity health behavior, and depressive symptoms, and how changes in physical activity were associated with changes in one’s depressive symptoms among young adults, middle-aged adults, and older adults while controlling non-physical-activity health behavior and sociodemographic characteristics among young, middle-aged, and older adults before and after the COVID-19 outbreak lockdown in the United States. A total of 695 participants completed an online questionnaire via MTurk, and participants were asked to recall (...) their physical activity, depressive symptoms, and non-physical-activity health behavior status in January and May of 2020. The IPAQ-SF was used to evaluate individuals’ physical activity, while the CES-D-10 was used to assess depressive symptoms. Covariates included non-physical-activity health behavior and sociodemographic factors. A Bayesian significance testing of changes was used to examine significant changes in physical activity, non-physical-activity behavior, and depressive symptoms in each age group while Bayesian regression analysis was employed to examine how the changes in physical activity were associated with respondents’ depressive symptoms while controlling for individual NHB and sociodemographic characteristics. The results showed that the participants tended to maintain their physical activity levels after the lockdown despite significant increases in sitting time among young and older adults. Decreases in moderate physical activity frequency were associated with a higher level of depressive symptoms. Although young and middle-aged cohorts experienced fewer differences in depressive symptoms compared to their counterparts in the older group, we found no significant heterogeneity effects in the relationships of interest across all age groups. Considering different influences of physical activity on depressive symptoms depending on different levels of activity and ages, more randomized clinical trials with program-based intervention studies should be conducted with different physical activity programs for different age populations. (shrink)

We explore the mathematical structure and the physical implications of a general four-dimensional symmetry framework which is consistent with the Poincaré—Einstein principle of relativity for physical laws and with experiments. In particular, we discuss a four-dimensional framework in which all observers in different frames use one and the same grid of clocks. The general framework includes special relativity and a recently proposed new four-dimensional symmetry with a nonuniversal light speed as two special simple cases. The connection between the properties of (...) light propagation and the convention concerning clock systems is also discussed, and is seen to be nonunique within the four-dimensional framework. (shrink)

A collection of personal narratives and essays, Living Professionalism is designed to help medical students and residents understand and internalize various aspects of professionalism. These essays are meant for personal reflection and above all, for thoughtful discussion with mentors, with peers, with others throughout the health care provider community who care about acting professionally.

Following the ideas of Poincaré, Reichenbach, and Grunbaum concerning the convention of setting up clock systems, we analyze clock systems and light propagation within the framework of four-dimensional symmetry. It is possible to construct a new four-dimensional symmetry framework incorporatingcommon time: observers in different inertial frames of reference use one and the same clock system, which is located in any one of the frames. Consequently, simultaneity has a meaning independent of position and independent of frame of reference. A further consequence (...) is that the two-way speeds of light alone are isotropic in any frame. By the choice of clock system there will be one frame in which the one-way speed of light is isotropic. This frame can be arbitrarily chosen. The difference between one-way speeds and two-way speeds of light signals is considered in detail. (shrink)

We study the magnetic monopoles in non-Abelian gauge theories. The exact static, spherically symmetric solutions of the magnetic monopoles in both Yang-Mills and unified gauge theories are obtained. The energyE of the static system is calculable and it is either zero or infinite. The existence of the magnetic monopole solution is a consequence of symmetry rather than dynamics. We propose a new definition of the electromagnetic field tensor, which relates the static solution of gauge fields and the magnetic monopole solution. (...) Experimental implications are discussed. (shrink)

We discuss the symmetry basis of unified field theories, i.e., the generalized concept of local gauge symmetry, and its physical implications. The generalized Ward-Takahashi identities and the explicit constraints among renormalization constants are derived by using the path integral in a specific model. These constraints are confirmed at the one-loop level.

The observable phase factor is taken as a basic concept for the description of electromagnetism. Generalization of this concept toSU(2) andSU(2) × U(1) groups is carried out in such a way that the monopoles with quantized charges appear naturally and that the symmetry between the electric and magnetic phenomena is preserved. Some physical implications are discussed.

It is demonstrated on the basis of the Dirac equation that quarks cannot be confined by a vector gluon potential of the form(r/r 0)a or[ln(r/r 0]a, a>0, if the quark-gluon interaction conserves parity. In order to confine quarks with the parity-conserving interaction, the effective gluon potential must be a pseudovector or a scalar. These are shown in a simple Yang-Mills field with theSU(2) group.

Clinical ethics consultations exist to support patients, families and clinicians who are facing ethical or moral challenges related to patient care. They provide a forum for open communication, where all stakeholders are encouraged to express their concerns and articulate their viewpoints. Ethics consultations can be requested by patients, caregivers or members of a patient’s clinical or supportive team. Althoughpatientsand by extension their families (especially in cases of decisional incapacity) are the common denominators in most ethics consultations, these constituents are theleastlikely (...) to request them. At many healthcare organisations in the USA, ethics consultations are overwhelmingly requested by physicians and other clinicians. We believe it is vital that healthcare institutions bridge the knowledge gaps and power imbalances over access to ethics consultation services through augmented policies, procedures and infrastructure. With enhanced education and support, patients and families may use ethics consultation to elevate their voices and prioritise their unique characteristics and preferences in the delivery of their healthcare. Empowering patients and families to request ethics consultation can only strengthen the patient/family–clinician relationship, enhance the shared decision-making model of care and ultimately lead to improved patient-centred care. (shrink)

Life education, also known as life and death education, is an important subject in Taiwan with institutions offering degree programs and courses that focus on quality learning and implementation of life education. What is interesting from the perspective of Taiwanese Education is that the teaching of life education also incorporates a number of Eastern-derived and conceptualized tenets, for example, Buddhist teaching and the importance of spiritual wisdom. This premise contends then that life education in Taiwan, in general, is concerned with (...) the promotion, fulfillment, and cherishing of quality life experiences (e.g., personal contentment, happiness). One example of life education, which resonates with other spiritual beliefs and religious faiths (e.g., Hinduism), is related to spiritual cultivation and the enlightenment of life wisdom. Our own teaching of the subject, likewise, places emphasis on the goal of teaching students to seek meaningful understanding of and appreciation for three major, interrelated components of life education: life wisdom, life practice, and life care. Life education is a beneficial subject as its theoretical understanding may help individuals cope with pathologies and negative life experiences. One negative life experience, in this case, is the ultimate fate of humankind: death. Approaching death and/or the onset of grief is something that we all have to experience. How does one approach death? It is not easy feat and, of course, grief for a loved one is personal and some of us struggle with this. We contend that spiritual cultivation and enlightenment, arising from life education, may assist us with the coping of death (e.g., the possibility of transcendence beyond the realm of life). Forming the premise of the present article, we propose that a person’s ‘spiritual and enlightened self’, reflecting the convergence of three major aspects of life education (i.e., Philosophical reflection, Enrichment of personal well-being, and Spiritual cultivation), would result in the initiation and creation of a number of virtues and positive characteristics – for example: having a positive outlook in life, showing compassion, forgiveness, etc. These virtues and quality characteristics, from our philosophical reasoning, are equivalent to those qualities that positive psychology advocates for. (shrink)

The identity of lesbian-mother combines a marginalized identity with one of the most revered mainstream identities. With data collected through exploratory in-depth interviews from nine lesbian-mothers, the authors use symbolic interaction framework to explore the strategies that lesbian birth mothers and comothers employ to gain acceptance for their marginal-mainstream identities in their family networks. Respondents experienced varying levels of resistance from their social networks, with comothers being especially vulnerable due to their lack of both biological and legal substantiation. The authors (...) explore the process of identity negotiation in three realms of everyday experience: in relationships with extended families, in relations within the nuclear family, and in lesbian relationships that have ended. (shrink)

The expansion of research on deep brain stimulation (DBS) and adaptive DBS (aDBS) raises important neuroethics and policy questions related to data sharing. However, there has been little empirical research on the perspectives of experts developing these technologies. We conducted semi-structured, open-ended interviews with aDBS researchers regarding their data sharing practices and their perspectives on ethical and policy issues related to sharing. Researchers expressed support for and a commitment to sharing, with most saying that they were either sharing their data (...) or would share in the future and that doing so was important for advancing the field. However, those who are sharing reported a variety of sharing partners, suggesting heterogeneity in sharing practices and lack of the broad sharing that would reflect principles of open science. Researchers described several concerns and barriers related to sharing, including privacy and confidentiality, the usability of shared data by others, ownership and control of data (including potential commercialization), and limited resources for sharing. They also suggested potential solutions to these challenges, including additional safeguards to address privacy issues, standardization and transparency in analysis to address issues of data usability, professional norms and heightened cooperation to address issues of ownership and control, and streamlining of data transmission to address resource limitations. Researchers also offered a range of views on the sensitivity of neural activity data (NAD) and data related to mental health in the context of sharing. These findings are an important input to deliberations by researchers, policymakers, neuroethicists, and other stakeholders as they navigate ethics and policy questions related to aDBS research. (shrink)

Institutional Review Boards have expressed concern that research into sensitive topics such as mental disorder will cause participants undue distress. This study investigated the emotional responses of 5,220 Australians to a survey on mental-health-related discrimination. Participants were interviewed about their mental health and experiences of discrimination across 10 life domains and then the emotional impacts of the survey. Results suggested that a minority experienced a negative reaction in contrast to 88% reporting positive experiences. A mental health problem was associated with (...) both negative and positive reactions. (shrink)

This paper advocates for the inclusion of patient perspectives in the diagnosis and treatment of eating disorders (EDs) for ethical, epistemological, and pragmatic reasons. We build upon the ideas of a recent editorial published in this journal. Using EDs as their example, the authors argue against dominant DSM-oriented approaches in favor of an increased focus on understanding patients’ subjective experiences. We argue that their analysis stops too soon for the development of practical—and actionable—insights into how to effect the integration of (...) first-person and third-person accounts of EDs. Methods Contextual analysis was used to make the case for patient perspectives. (shrink)

Time is analyzed by considering the actual setup of clock system within the four-dimensional framework. We find that both relativistic time and universal time can be embedded in such a symmetry framework. Although Poincaré and Einstein both understood the meaning of Lorentz's local time in terms of sending light signals to calibrate clocks, they differed on a basic point: Einstein believed local time to be the necessary and unique time, while Poincaré admitted flexibility in the definitions of time and regarded (...) local time as only a convention. The results of our analysis shed light on Poincaré's original idea concerning conventions of time and provide the conceptual basis for the formulation of a new four-dimensional symmetry with a universal time. We demonstrate that the one-way speeds of light measured by stable atomic clocks in rockets may not be isotropic, in contrast to the two-way speeds of light. Furthermore, atomic clocks can be used to set up a clock system which reads a universal (but not absolute) time. (shrink)

BackgroundThe Public Health Service Increased Risk designation identified organ donors at increased risk of transmitting hepatitis B, hepatitis C, and human immunodeficiency virus. Despite clear data demonstrating a low absolute risk of disease transmission from these donors, patients are hesitant to consent to receiving organs from these donors. We hypothesize that patients who consent to receiving offers from these donors have decreased time to transplant and decreased waitlist mortality.MethodsWe performed a single-center retrospective review of all-comers waitlisted for liver transplant from (...) 2013 to 2019. The three competing risk events (transplant, death, and removal from transplant list) were analyzed. 1603 patients were included, of which 1244 (77.6%) consented to offers from increased risk donors.ResultsCompared to those who did not consent, those who did had 2.3 times the rate of transplant (SHR 2.29, 95% CI 1.88–2.79, p < 0.0001), with a median time to transplant of 11 months versus 14 months (p < 0.0001), as well as a 44% decrease in the rate of death on the waitlist (SHR 0.56, 95% CI 0.42–0.74, p < 0.0001). All findings remained significant after controlling for the recipient age, race, gender, blood type, and MELD. Of those who did not consent, 63/359 (17.5%) received a transplant, all of which were from standard criteria donors, and of those who did consent, 615/1244 (49.4%) received a transplant, of which 183/615 (29.8%) were from increased risk donors.ConclusionsThe findings of decreased rates of transplantation and increased risk of death on the waiting list by patients who were unwilling to accept risks of viral transmission of 1/300–1/1000 in the worst case scenarios suggests that this consent process may be harmful especially when involving “trigger” words such as HIV. The rigor of the consent process for the use of these organs was recently changed but a broader discussion about informed consent in similar situations is important. (shrink)

BackgroundIn the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort, participants underwent magnetic resonance imaging (MRI) of the brain, heart, and abdomen, that generated incidental findings (IFs). The approach to managing these unexpected results remain a complex issue. Our objectives were to describe the CAHHM policy for the management of IFs, to understand the impact of disclosing IFs to healthy research participants, and to reflect on the ethical obligations of researchers in future MRI studies.MethodsBetween 2013 and 2019, 8252 participants (...) (mean age 58 ± 9 years, 54% women) were recruited with a follow-up questionnaire administered to 909 participants (40% response rate) at 1-year. The CAHHM policy followed a restricted approach, whereby routine feedback on IFs was not provided. Only IFs of severe structural abnormalities were reported.ResultsSevere structural abnormalities occurred in 8.3% (95% confidence interval 7.7–8.9%) of participants, with the highest proportions found in the brain (4.2%) and abdomen (3.1%). The majority of participants (97%) informed of an IF reported no change in quality of life, with 3% of participants reporting that the knowledge of an IF negatively impacted their quality of life. Furthermore, 50% reported increased stress in learning about an IF, and in 95%, the discovery of an IF did not adversely impact his/her life insurance policy. Most participants (90%) would enrol in the study again and perceived the MRI scan to be beneficial, regardless of whether they were informed of IFs. While the implications of a restricted approach to IF management was perceived to be mostly positive, a degree of diagnostic misconception was present amongst participants, indicating the importance of a more thorough consent process to support participant autonomy.ConclusionThe management of IFs from research MRI scans remain a challenging issue, as participants may experience stress and a reduced quality of life when IFs are disclosed. The restricted approach to IF management in CAHHM demonstrated a fair fulfillment of the overarching ethical principles of respect for autonomy, concern for wellbeing, and justice. The approach outlined in the CAHHM policy may serve as a framework for future research studies.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/nct02220582. (shrink)

In a healthcare setting, a multitude of ethical and moral challenges are often present when patients and families direct uncivil behavior toward clinicians and staff. These negative interactions may elicit strong social and emotional reactions among staff, other patients, and visitors; and they may impede the normal functioning of an institution. Ethics Committees and Clinical Ethics Consultation Services (CECSs) can meaningfully contribute to organizational efforts to effectively manage incivility through two distinct, yet inter-related channels. First, given their responsibility to promote (...) a humane, respectful, and professional climate, many CECSs and Ethics Committees may assist institutional leadership in evaluating and monitoring incivility policies and procedures. Second, when confronted with individual incidents of patient/family incivility, Ethics Consultants can and often do work with all stakeholders to address and mitigate potentially deleterious impacts. This manuscript presents an overview of the multifaceted ethical implications of incivility in the healthcare environment, discusses the inherent qualifications of Ethics Consultants for assisting in the management of incivility, and proposes specific mitigating actions within the purview of CECSs and Ethics Committees. We also invite healthcare organizations to harness the skills and reputation of their CECSs and Ethics Committees in confronting incivility through comprehensive policies, procedures, and training. (shrink)

The progress of electronic health technologies and biobanks holds enormous promise for efficient research. Evidence shows that studies based on sharing and secondary use of data/samples have the potential to significantly advance medical knowledge. However, sharing of such resources for international collaboration is hampered by the lack of clarity about ethical and legal requirements for transfer of data and samples across international borders. Here, the International Clinical Trial Center Network reports the legal and ethical requirements governing data and sample exchange (...) across four continents. The most recurring requirement is ethical approval, whereas only in specific conditions approval of national health authorities is required. Informed consent is not required in all sharing situations. However, waiver of informed consent is only allowed in certain countries/regions and under certain circumstances. The current legal and ethical landscape appears to be very complex and under constant evolution. Regulations differ between countries/regions and are often incomplete, leading to uncertainty. With this work, ICN illuminates the unmet need for a single international collaborative framework to facilitate DSE. Harmonising requirements for global DSE will reduce inefficiency and waste in research. There are many challenges to realising this ambitious vision, including inconsistent terminology and definitions, and heterogeneous and dynamic legal constraints. Here, we identify areas of agreement and significant difference as a necessary first step towards facilitating international collaboration. We propose the establishment of a working group to continue the comparison across jurisdictions, create a standardised glossary and define a set of basic principles and fundamental requirements for DSE. (shrink)

The capacity of next-generation closed-loop or adaptive deep brain stimulation devices to read and write shows great potential to effectively manage movement, seizure, and psychiatric disorders, and also raises the possibility of using aDBS to electively modulate mood, cognition, and prosociality. What separates aDBS from most neurotechnologies currently used for enhancement is that aDBS remains an invasive, surgically-implanted technology with a risk-benefit ratio significantly different when applied to diseased versus non-diseased individuals. Despite a large discourse about the ethics of enhancement, (...) no empirical studies yet examine perspectives on enhancement from within the aDBS research community. We interviewed 23 aDBS researchers about their attitudes toward expanding aDBS use for enhancement. A thematic content analysis revealed that researchers share ethical concerns related to safety and security; enhancement as unnecessary, unnatural or aberrant; and fairness, equality, and distributive justice. Most researchers felt that enhancement applications for DBS will eventually be technically feasible and that attempts to develop such applications for DBS are already happening. However, researchers unanimously felt that DBS ideally should not be considered for enhancement until researchers better understand brain target localization and functioning. While many researchers acknowledged controversies highlighted by scholars and ethicists, such as potential impacts on personhood, authenticity, autonomy and privacy, their ethical concerns reflect considerations of both gravity and perceived near-term likelihood. (shrink)

This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human‐nonhuman chimeric research. Led by bioethics researchers working closely with an (...) interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human‐nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics’ previous focus on human‐centered questions about the ethics of “humanization” and this research's potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less‐siloed governance and oversight and more‐comprehensive public communication. (shrink)

Working parents in are struggling to balance the demands of their occupation with those of childcare and homeschooling during the COVID-19 pandemic. Moreover, studies show that women are shouldering more of the burden and reporting greater levels of psychological distress, anxiety, and depression relative to men. However, research has yet to show that increases in psychological symptoms are linked to changes in stress during the pandemic. Herein, we conduct a small-N study to explore the associations between stress and psychological symptoms (...) during the pandemic among mothers using structural equation modeling, namely latent change score models. Thirty-three mothers completed questionnaires reporting current anxious and depressive symptoms, as well as stressful life experiences prior to-versus during the pandemic. Women endorsed significantly more stressful events during the pandemic, relative to the pre-pandemic period. Additionally, 58% of mothers scored as moderate-to-high risk for developing a stress-related physical illness in the near future because of their pandemic-level stress. Depressive symptoms were associated with the degree of change in life stress, whereas anxiety symptoms were more related to pre-pandemic levels of stress. The present study preliminarily sheds light on the nuanced antecedents to mothers’ experiences of anxious and depressive symptoms during the COVID-19 pandemic. Although further work is needed in larger, more diverse samples of mothers, this study highlights the potential need for appropriate policies, and prevention and intervention programs to ameliorate the effects of pandemics on mothers’ mental health. (shrink)