Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms (...) enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)

BackgroundStudies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent.MethodsParents of children participating in a trial of nutritional supplementation were (...) randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents.ResultsA total of 128 parents were recruited and follow up was established with 118 (90.2%) for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm.ConclusionsThe results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials.Trial RegistrationClinical Trial Registry - India (CTRI): CTRI/2009/091/000612. (shrink)

In developed economies, powerful legislative and regulatory frameworks, for people with disability over the last five decades, have provided major motivation for business compliance with disability in the workplaces. However, developing economy like India is marked by emergent disability legislation, weak institutional enforcement and an evolving disability rights movement. In the absence of strong institutional expectations, the private sector’s role in mainstreaming the disability agenda has been largely an act of voluntary participation. Drawing upon an in-depth, multilevel, cross-functional qualitative study (...) of four Indian information technology sector companies, this paper explores why these companies engage in pro-social corporate behaviour in favour of disability. The study locates itself in the context of conceptualization of PWD as employee stakeholders and the literature on strategic CSR. The findings reveal that strategic factors promote voluntary business engagement with disability at workplaces and contribute to understanding of workplace integration of minority employees. (shrink)

The objective of this paper is to examine the ‘Code of Ethics Quality’ (CEQ) in the largest companies of Australia, Canada and the United States. For this purpose, a proposed CEQ construct has been applied. It appears from the empirical findings that while Australia, Canada and the United States are extremely similar in their economic and social development, there may well be distinct cultural mores and issues that are forming their business ethics practices. A research implication derived from the performed (...) research is that the construct provides a selection of observable and measurable elements in the context of CEQ. The construct of CEQ consists of nine measures divided into two dimensions (i.e. staff support and regulation). They should not be seen as a complete list. On the contrary, it is encouraged that others propose and elaborate revisions and extensions. A practical implication of this paper is a structure of what and how to examine the CEQ in a managerial setting. It may assist companies in their efforts to establish, maintain and improve their ethical culture, norms and beliefs within the organization and supporting them in their ethical business practices with different stakeholders in the marketplace and society. The dimensions and measures of the construct may be used as a frame of reference for further research. They may be useful and applicable across contexts and over time using similar samples when it comes to large companies, as small‐ or medium‐sized ones may not have considered all areas nor have the elements in place. This is a research limitation, but it provides an opportunity for further research. (shrink)

The issue of ‘mandatory publications’ has generated serious flak about its usefulness among the various stakeholders. A lot of debate centers around the question of ‘lack of will’ or ‘lack of skill’ as a reason for the diminishing research interests among the medical faculty in India. In our view, it is the lack of will to publish good quality research which is to be blamed rather than the lack of skill to do good quality research.

Kireet Joshi, b. 1931, Indian philosopher and educationist; contributed articles.

The stability of the power grid is concernment due to the high demand and supply to smart cities, homes, factories, and so on. Different machine learning and deep learning models can be used to tackle the problem of stability prediction for the energy grid. This study elaborates on the necessity of IoT technology to make energy grid networks smart. Different prediction models, namely, logistic regression, naïve Bayes, decision tree, support vector machine, random forest, XGBoost, k-nearest neighbor, and optimized artificial neural (...) network, have been applied on openly available smart energy grid datasets to predict their stability. The present article uses metrics such as accuracy, precision, recall, f1-score, and ROC curve to compare different predictive models. Data augmentation and feature scaling have been applied to the dataset to get better results. The augmented dataset provides better results as compared with the normal dataset. This study concludes that the deep learning predictive model ANN optimized with Adam optimizer provides better results than other predictive models. The ANN model provides 97.27% accuracy, 96.79% precision, 95.67% recall, and 96.22% F1 score. (shrink)

Research suggests that sedentary behavior is negatively associated with cognitive outcomes. Interrupting prolonged sitting has been shown to improve cognitive functions, including executive functioning, which is important for academic performance. No research has been conducted on the effect of standing on EF in VET students, who make up a large proportion of the adolescent population and who are known to sit more than other students of this age. In this study, we investigated the acute effects of reducing SB by short (...) time standing on EF in vocational education and training students. In a randomized crossover study, 165 VET students were first taught for 15 min in seated position. After this, they performed while seated the Letter Memory Test for updating, and the Color Shape Test for shifting and inhibition. Students were randomly assigned to a sitting or standing condition. All students were taught again for 15 min and then took the same tests in the condition they were allocated to, respectively, standing or seated. After 1 week, the test procedure was repeated, in which students switched conditions. Mixed model analyses showed no significant effect of sitting or standing on updating, shifting, or inhibition. Also, no significant differences were found for the order of condition on updating, shifting, or inhibition. Our results suggest that 40 min of standing does not significantly influence EF among VET students. (shrink)

BackgroundDiagnostic ultrasound has long been a part of a physician’s armamentarium, but transcranial focused ultrasound (FUS) is an emerging treatment of neurological disorders. Consequently, the literature in this field is increasing at a rapid pace.ObjectiveThis analysis was aimed to identify the top-cited articles on FUS to discern their origin, spread, current trends highlighting future impact of this novel neurosurgical intervention.MethodsWe searched the Web of Science database on 28th May 2021 and identified the top 100 cited articles. These articles were analyzed (...) with various scientometric parameters like the authors, corresponding authors, country of corresponding author, journal of publication, year of publication. Citation based parameters including total citations, mean citations per article and mean citations, citation count, and the citation per year, citations per year and co-authors per document were studied as well in addition to Hirsch h-index, g-index, m-index, Bradford’s Law, Lotka’s law and Collaboration index.ResultsThe 100 top-cited articles were published between 1998 and 2019 in 45 different journals. The average citations per document and citations per document per year were 97.78 and 12.47, respectively. The most prolific authors were Hynynen K (Medical Biophysics—Toronto), Elias WJ (Neurosurgery—Virginia), Zadicario (InSightec). The Journal of Neurosurgery published the most top-cited articles (n = 11), and most articles originated from the United States, followed by Canada. Among individual institutions, the University of Toronto was the most productive.ConclusionFUS is an emerging treatment of neurological disorders. With its increasing application, the FUS literature is increasing rapidly. Eleven countries contributed to the top 100 cited articles, with the top 2 countries (the United States and Canada) contributing to more than half of these articles. (shrink)

Precision medicine (PM) aims to revolutionise healthcare, but little is known about the role religion and spirituality might play in the ethical discourse about PM. This Perspective reports the outcomes of a knowledge exchange fora with religious authorities in Singapore about data sharing for PM. While the exchange did not identify any foundational religious objections to PM, ethical concerns were raised about the possibility for private industry to profiteer from social resources and the potential for genetic discrimination by private health (...) insurers. According to religious authorities in Singapore, sharing PM data with private industry will require a clear public benefit and robust data governance that incorporates principles of transparency, accountability and oversight. (shrink)

Our concern in this paper lies with a common argument from racial discrimination to realism about races: some people are discriminated against for being members of a particular race (i.e., racial discrimination exists), so some people must be members of that race (i.e., races exist). Error theorists have long responded that we can explain racial discrimination in terms of racial attitudes alone, so we need not explain it in terms of race itself. But to date there has been little detailed (...) discussion of whether it is better to explain racial discrimination in terms of race or in terms of racial attitudes alone. Our goal is to offer a novel and detailed argument in defense of explaining racial discrimination in terms of racial attitudes alone, by attending to the neglected phenomenon of misperception discrimination, which involves differential treatment due to misperceived race. We argue that the discriminatory action in misperception cases must be explained in the same way as cases where (according to the realist) the victim’s race is accurately perceived. Thus, the victim’s actual race cannot provide the best explanation. The main upshot of our argument is that explanatory arguments from racial discrimination to realism about race fail. (shrink)

Comprises articles on Sikh faith and philosophy.

Bhakti is a remarkable existential tendency that shows itself in the rich expanse of the tradition originating from the Vedas. Recognized as a prize possession of the religions, philosophies, and culture of India, it has often won fascination and admiration from students of Eastern heritage. However, its nature, role, and history remain misunderstood and have not received all the attention they deserve. Its role as a gatherer of life, love, thought, and the divine is missed in its partial characterizations as (...) “Hindu devotion” or “divine love” or “theism implicit in polytheism.” Its status as a perennial thematic concept of the Indian civilization is missed when its pervasiveness is overlooked by the cultural historians preoccupied primarily with its periodic eruptions. Furthermore, the philosophical role of bhakti is missed when it is deemed as an alternative to jnana (knowledge) rather than “the living of jnana.”. (shrink)