Advances in life-saving technologies in the past few decades have challenged our traditional understandings of death. Traditionally, death was understood to occur when a person stops breathing, their heart stops beating and they are cold to the touch. Today, physicians determine death by relying on a diagnosis of ‘total brain failure’ or by waiting a short while after circulation stops. Evidence has emerged, however, that the conceptual bases for these approaches to determining death are fundamentally flawed and depart substantially from (...) the established biological conception of death. We argue that the current approach to determining death consists of two different types of unacknowledged legal fictions. These legal fictions were developed for practices that are largely ethically legitimate but need to be reconciled with the law. The considerable debate over the determination of death in the medical and scientific literature has not informed the public that vital organs are being procured from still-living donors and it seems unlikely that this information can remain hidden for long. Given the instability of the status quo and the difficulty of making the substantial legal changes required by complete transparency, we argue for a second-best policy solution: acknowledging the legal fictions involved in determining death to move in the direction of greater transparency. This may someday result in more substantial legal change to directly confront the challenges raised by life-sustaining and life-preserving technologies without the need for fictions. (shrink)

The Declaration of Helsinki and the Council of the International Organization of Medical Sciences provide guidance on standards of care and prevention in clinical trials. In the current and increasingly challenging research environment, the ethical status of a trial design depends not only on protection of participants, but also on social value, feasibility, and scientific validity. Using the example of a study assessing efficacy of a vaccine to prevent human papilloma virus in HIV-1 infected adolescent girls in low resource countries (...) without access to the vaccine, we compare several trial designs which rank lower on some criteria and higher on others, giving rise to difficult trade-offs. This case demonstrates the need for developing more nuanced guidance documents to help researchers balance these often conflicting criteria. (shrink)

The proposed study would be a single-arm interventional trial in a community where HIV is endemic. The proposed observational design can provide confirmatory data for the initial clinical observation, data that would be necessary before considering whether a randomized controlled trial is appropriate. A previous ethical analysis has argued for conducting such a study in a country with limited resources and with higher HIV prevalence, and to recruit those with the highest risk of transmission. The primary rationale was to address (...) the scientific question in the most efficient timeframe and to expose the smallest number of infants to the uncertain benefits and risks of the study. However, there are.. (shrink)

A published case report of an infant who inadvertently developed remission of HIV viral expression has prompted research to determine if this observation is reproducible and can offer a potentially novel clinical approach to inducing sustained viral remission of HIV.Typically HIV-infected mothers receive antiretroviral therapy before delivery and infants receive between one and three drugs at “low doses” for prevention. In the case report, the mother delivered before she could receive ART. The infant was placed on a three-drug approach with (...) “higher” doses by her doctor than are typically used for treatment. When HIV infection was confirmed, the three-drug regimen was continued. For most.. (shrink)

Lower plasma levels of high-density lipoproteins in adolescents with type 2 diabetes have been associated with a higher pulse wave velocity, a marker of arterial stiffness. Evidence suggests that HDL proteins or particle subspecies are altered in T2D and these may drive these relationships. In this work, we set out to reveal any specific proteins and subspecies that are related to arterial stiffness in youth with T2D from proteomics data. Plasma and PWV measurements were previously acquired from lean and T2D (...) adolescents. Each plasma sample was separated into 18 fractions and evaluated by mass spectrometry. Then, we applied a validated network-based computational approach to reveal HDL subspecies associated with PWV. Among 68 detected phospholipid-associated proteins, we found that seven were negatively correlated with PWV, indicating that they may be atheroprotective. Conversely, nine proteins show positive correlation with PWV, suggesting that they may be related to arterial stiffness. Intriguingly, our results demonstrate that apoA-I and histidine-rich glycoprotein may reverse their protective roles and become antagonistic in the setting of T2D. Furthermore, we revealed two arterial stiffness-associated HDL subspecies, each of which contains multiple PWV-related proteins. Correlation and disease association analyses suggest that these HDL subspecies might link T2D to its cardiovascular-related complications. (shrink)

The “dead-donor rule” states that, in any case of vital organ donation, the potential donor should be determined to be dead before transplantation occurs. In many countries around the world, neurological criteria can be used to legally determine death (also referred to as brain death). Nevertheless, there is considerable controversy in the bioethics literature over whether brain death is the equivalent of biological death. This international legal review demonstrates that there is considerable variability in how different jurisdictions have evolved to (...) justify the legal status of brain death and its relationship to the dead-donor rule.In this article, we chose to review approaches that are representative of many different jurisdictions—the United States takes an approach similar to that of many European countries; the United Kingdom’s approach is followed by Canada, India, and influences many other Commonwealth countries; Islamic jurisprudence is applicable to several different national laws; the Israeli approach is similar to many Western countries, but incorporates noteworthy modifications; and Japan’s relatively idiosyncratic approach has received some attention in the literature. Illuminating these different justifications may help develop respectful policies regarding organ donation within countries with diverse populations and allow for more informed debate about brain death and the deaddonor rule. (shrink)

Imagine a study in which HIV-infected pregnant women are given antiretroviral treatment to determine how effectively it will prevent HIV transmission during childbirth. Each mother’s involvement in this study ends with the birth of her child, at which time her access to antiretrovirals provided by the study also ceases. At the outset of the study, the investigator and sponsor agree that after the child’s birth, they will refer mothers who require treatment for their HIV to a national program that provides (...) antiretroviral treatment and care. Assuming the Institutional Review Board raises no objections to this plan, should the research team consider their ethical obligations to participants fulfilled? If the investigator and sponsor were to consult the Common Rule, they would find little to suggest that there are any further ethical issues to address. (shrink)

In many regions around the world, those at highest risk for acquiring HIV are young adults and adolescents. Young men who have sex with men in the USA are the group at greatest risk for HIV acquisition, particularly if they are part of a racial or ethnic minority group.1 Adolescent girls and young women have the highest incidence rates of any demographic subgroup in sub-Saharan Africa.2 To reverse the global AIDS pandemic’s toll on these high-risk groups, it is important to (...) deploy the most effective HIV prevention tools to young MSM in the USA, to adolescent girls and young women in sub-Saharan Africa, and to any other adolescents and young adults at high risk for HIV as products are proven to be safe and efficacious. Although prevention interventions with proven efficacy, such as oral pre-exposure prophylaxis, are available,3–8 they have not been sufficient to stem the tide and an expanded prevention toolkit is urgently needed to serve these populations. The field of HIV prevention continues to identify promising leads in the development of new biomedical prevention products, either delivering antiviral drug topically or systemically. The dapivirine ring has been shown to provide modest protection and is currently being tested in open label studies while injectable cabotegravir is being tested in a large efficacy trial for preventing HIV acquisition. Advances in the field of HIV prevention mean that scientists and regulators must plan for how they will bring prevention tools to populations at high risk for HIV as they conduct efficacy and effectiveness trials. For instance, safety data from younger age groups can also be used in combination with efficacy data from adult studies, where appropriate, as bridging studies to expand labelling to younger ages. If these …. (shrink)

The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants in English or Spanish (...) about their experiences with respect in the study and perceptions of how researchers in a hypothetical observational study could convey respect or a lack thereof. Most interviewees were female, identified as Hispanic/Latino or non-Hispanic white, reported annual household income under US$60 000 and did not have a Bachelor’s degree ; 30% had limited health literacy. We identified four key domains for demonstrating respect: personal study team interactions, with an emphasis on empathy, appreciation and non-judgment; study communication processes, including following up and sharing results with participants; inclusion, particularly ensuring materials are understandable and procedures are accessible; and consent and authorisation, including providing a neutral informed consent and keeping promises regarding privacy protections. While the experience of respect is inherently subjective, these findings highlight four key domains that may meaningfully demonstrate respect to potential and current research participants. Further empirical and normative work is needed to substantiate these domains and evaluate how best to incorporate them into the practice of research. (shrink)

Using medical advances to enhance human athletic, aesthetic, and cognitive performance, rather than to treat disease, has been controversial. Little is known about physicians? experiences, views, and attitudes in this regard. We surveyed a national sample of physicians to determine how often they prescribe enhancements, their views on using medicine for enhancement, and whether they would be willing to prescribe a series of potential interventions that might be considered enhancements. We find that many physicians occasionally prescribe enhancements, but doctors hold (...) nuanced and ambiguous views of these issues. Most express concerns about the potential effects of enhancements on social equity, yet many also believe specific enhancements that are safe and effective should be available but not covered by insurance. These apparently contradictory views might reflect inherent tensions between the values of equity and liberty, which could make crafting coherent social policies on medical enhancements challenging. [Supplementary materials are available for this article. Go to the publisher's online edition of American Journal of Bioethics for the following free supplemental resource(s): An additional table (Table 5) referred to on p. 5]. (shrink)

This essay exposes how recent attempts at lethal injection reform have involved unethical and illegal research on prisoners. States are varying the doses and types of drugs used, developing methods designed for non-medical professionals to administer medical procedures, and gathering data or making provisions for the gathering of data to learn from executions gone wrong. When individual prisoners are executed under these conditions, states are conducting research on them. Conducting research or experimentation on prisoners in the process of reform is (...) problematic because it violates ethical frameworks and state laws. The Supreme Court has recently taken up the challenge of elucidating the standard for determining the constitutionality of lethal injection. If the Court suggests an approach to lethal injection reform that is akin to some of the more thoughtful and cautious approaches other courts have proposed, the Court's decision may also contravene state laws or ethical precepts regarding research with prisoners. Thus, this paper provides important limitations on the kinds of reform that may be permissible and outlines the open questions that must be addressed before it can be determined whether the risks and uncertainties involved in lethal injection can be remedied. (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)

Shaḥrūr, Muḥammad; Islamic philosophy; Qurʼan; hermeneutics; criticism, interpretation, etc.

ABSTRACT Controlled human infection (CHI) models have been developed for numerous pathogens in order to better understand disease processes and accelerate drug and vaccine testing. In the past, some researchers conducted highly controversial CHIs with vulnerable populations, including children. Ethical frameworks for CHIs now recommend vulnerable populations be excluded because they cannot consent to high risk research. In this paper we argue that CHI studies span a wide spectrum of benefit and risk, and that some CHI studies may involve minimal (...) risk. The categorical exclusion of children from CHIs therefore departs from the standard approach to evaluating research risks, as international regulations and ethical guidance for pediatric research generally permit non‐beneficial research with low risks. The paradigm in research ethics has also shifted from focusing on protecting vulnerable participants to recognizing that inclusion can be important as a matter of justice, providing new reasons to question this default exclusion of children from CHIs. Recognizing that pediatric CHIs can raise complex ethical issues and are easy to sensationalize in ways that may threaten the public’s trust in research and sponsor institutions, we conclude by describing additional complexities that must be addressed before pediatric CHIs beyond licensed vaccine studies might be ethically acceptable. (shrink)

The U.S. FDA has issued emergency use authorizations for monoclonal antibodies for non-hospitalized patients with mild or moderate COVID-19 disease and for individuals exposed to COVID-19 as post-exposure prophylaxis. One EUA for an oral antiviral drug, molnupiravir, has also been recommended by FDA’s Antimicrobial Drugs Advisory Committee, and others appear likely in the near future. Due to increased demand because of the Delta variant, the federal government resumed control over the supply and asked states to ration doses. As future variants (...) with increased infectivity and/or severity emerge, further rationing may be required. We identify relevant ethical principles and priority groups for access to therapies based on an integrated approach to population health and medical factors. Using priority categories to allocate scarce therapies effectively operationalizes important ethical values. This strategy is preferable to the current approach of categorical rules based on vaccination, immunocompromise status, or older age, or the ad hoc consideration of clinical risk factors. (shrink)

Background Standard interpretations of the ethical principle of respect for persons have not incorporated the views and values of patients, especially patients from groups underrepresented in research. This limits the ability of research ethics scholarship, guidance, and oversight to support inclusive, patient-centered research. This study aimed to identify the practical approaches that patients in community-based settings value most for conveying respect in genomics research. Methods We conducted a 3-round, web-based survey using the modified Delphi technique to identify areas of agreement (...) among English-speaking patients at primary care clinics in Washington State and Idaho who had a personal or family history of cancer. In Round 1, respondents rated the importance of 17 items, identified in prior qualitative work, for feeling respected. In Round 2, respondents re-rated each item after reviewing overall group ratings. In Round 3, respondents ranked a subset of the 8 most highly rated items. We calculated each item’s mean and median rankings in Round 3 to identify which approaches were most important for feeling respected in research. Results Forty-one patients consented to the survey, 21 (51%) completed Round 1, and 18 (86% of Round 1) completed each of Rounds 2 and 3. Two sets of rankings were excluded from analysis as speed of response suggested they had not completed the Round 3 ranking task. Respondents prioritized provision of study information to support decision-making (mean ranking 2.6 out of 8; median ranking 1.5) and interactions with research staff characterized by kindness, patience, and a lack of judgment (mean ranking 2.8; median ranking 2) as the most important approaches for conveying respect. Conclusions Informed consent and interpersonal interactions are key ways that research participants experience respect. These can be supported by other approaches to respecting participants, especially when consent and/or direct interactions are infeasible. Future work should continue to engage with patients in community-based settings to identify best practices for research without consent and examine unique perspectives across clinical and demographic groups in different types of research. (shrink)

Tom has mounting evidence that he has incurable cancer, but he also believes that he would be happier, regardless of the truth, were he to believe that he is healthy. W.K.Clifford, who famously claimed, “It is wrong, always, everywhere, and for anyone, to believe anything upon insufficient evidence,” would, depending upon the sufficiency of Tom’s evidence, direct him to believe that he has incurable cancer, no matter the results for his happiness. The legendary pragmatist William James, on the other hand, (...) might deem this one of those situations in which it is permissible to follow one’s passions, and therefore might advise Tom to trust in his health in the face of the evidence to the contrary. Which one is right: the evidentialist or the pragmatist? The core of my research to date has aimed at resolving this central debate in the ethics of belief. (shrink)

Security has become one of the important factors for any network communication and transmission of data packets. An organization with an optimal security system can lead to a successful business and can earn huge profit on the business they are doing. Different network devices are linked to route, compute, monitor, and communicate various real-time developments. The hackers are trying to attack the network and want to draw the organization’s significant information for its own profits. During the communication, if an intrusion (...) or eavesdropping occurs, it will lead to a severe disfigurement of the whole communication network, and the data will be controlled by wrong malicious users. Identification of attack is a way to identify the security violations and analyze the measures in a computer network. An identification system, which is effective and accurate, can add security to the existing system for secure and smooth communication among end to end nodes and can work efficiently in the identification of attack on data packets. The role of information security is to design and protect the entire data of networks and maintain its confidentiality, integrity, and availability for their right users. Therefore, there is a need for end to end security management, which will ensure the security and privacy of the network and will save the data inside networks from malicious users. As the network devices are growing, so the level of threats is also increasing for these devices. The proposed research is an endeavor toward the detection of data packets attack by using the rough set theory for a secure end to end communication. The experimental work was performed by the RSES tool. The accuracy of the K-NN was 88% for the total objects of 8459. For cross validation purposes, the decision rules and decomposition tree algorithms were used. The DR algorithm showed accuracy of 59.1%, while the DT showed accuracy of 61.5%. The experimental results of the proposed study show that the research is capable of detecting data packets attack. (shrink)

What drives organisations to engage in socially responsible purchasing initiatives? To investigate this important question, this article uses a case-study approach to examine the context within which supplier diversity programmes have emerged in both the U.S. and U.K. The analysis identifies legislative and policy developments, economic imperatives, stakeholder pressures and ethical influences as forces shaping organisational responses. It reveals important contextual differences between U.K. and U.S. experience and offers an empirical and theoretical explanation of corporate behaviour.

The present commentary on it greatly contributes to the understanding of thisvery important work. In fact, it is a good expositary commentary, lucidly explaning the knotty points. It evinces deep study and understanding of Navya-Nyaya and its methodology.yhus, the sukhabodhika Tippanika represents a positive and distinctive contribution to the vast commercial literature on the Tattvacimtamani.

The paper highlights the alienation and separation produced by science—technology between man and nature, and between man and man. The principal thesis in this paper is that such separative mentality is the root cause of the deterioration in ethics even in unexpected quarters. Warnings about this were foreseen by a number of Indian livers (those who live the thought) and thinkers during the early twentieth century. Their prophecies seem to be unfortunately coming true. After sharing this sample of opinions, several (...) recent cases of vicious unethicalities all over the world have been presented. This is followed by a brief survey of Western thought over the past six decades which too was mature enough to caution us about the blind onslaught of technology. The paper concludes by arguing for a complete overhaul of the vocabulary of modern discourse from the objective to the subjective. (shrink)

This paper is an adventure of ideas which draws on the 'magic—magician' metaphor of medieval India to define the current existential predicament of the world. The author sets an agenda for reprioritization for restoring the imbalance in the fragmented human consciousness. This, the paper suggests, can be done by a gradual return to the subjective causal source of all our problems. The waning of the Objective Age created by science-technology-industrialism has led to a 'mutilating assimilative im balance' in this world. (...) The author urges the readers to strive for a subjective metanoia to counteract the objective paranoia of our times. (shrink)

This volume is a collection of S.K. Chakraborty's papers on the east-west distinction in worldviews. The essays are reflective and deliberate upon philosophical diferences and attitudes of thinkers that have shaped the behavior of the common man, both in and out of the workplace.