I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

Focus on shareholders’ interests at the cost of other stakeholders’ interests and the ecosystem has brought into prominence the need for responsible leadership. This study builds a five-level framework for responsible leadership drawing on leadership styles from case studies presented at a National Convention on Responsible Leadership. For each of the five levels, the study further identifies the necessary condition and the sufficient conditions of the leader to develop responsible organization. This comprehensive framework combines levels identified by two earlier studies. (...) Implications for developing responsible leadership are suggested. (shrink)

Bizarre delusions are not specific to schizophrenia and can be found in other psychotic disorders. However, to date, there are no studies investigating socio-demographic and clinical characteristics associated with BizD across the psychosis spectrum. In this study 819 subjects with a diagnosis of SZ, schizoaffective disorder and bipolar I disorder were included. Patients with history of BizD and with no BizD were compared with respect to socidemographic and clinical variables, and predictors of BizD were explored. Patients with BizD were less (...) educated, less likely to be married, had higher Positive and Negative Syndrome Scale negative scores and lower Young Mania Rating Scale scores. Younger age, SZ and SZA diagnoses, higher PANSS positive scores, presence of reference delusions, tactile and olfactory hallucinations were predictors. Our results indicate that BizD are associated with higher illness severity, lower functionality and specific set of symptoms. (shrink)

Although the teaching of medical ethics and law in medical education is an old story that has been told many times in medical literature, recent studies show that medical students and physicians lack confidence when faced with ethical dilemmas and medico-legal issues. The adverse events rates and medical lawsuits are on the rise whereas many medical errors are mostly due to negligence or malpractices which are preventable. While it is true that many medical schools teach their students medical law and (...) ethics, there are wide variations in what is being taught because there is no universally agreed syllabus. Yet the knowledge of medical law and ethics is closely relevant to the medical profession and that failure in abiding the law may result in serious civil or even criminal consequences. While this paper does not propose to lay detailed analysis of the relevant areas of law or ethics, it proposes to cover some legal areas so as to highlight and bring to attention the need for a medical law and ethics course. This article also considers the problems faced and recommendation as to future directions to be taken with respect to teaching medical law and ethics. It concludes with a suggested course outline for the teaching of medical law and ethics. (shrink)

I have gathered and studied these Sanskrit and Telugu writings by South Indian poets, and I’ve thought about them, and researched them for a few years. My highest priority in this piece is not to make the most simple literal word-for-word translation. I am trying not only to be faithful to the original texts, but to find a way in English to tell the detailed century-old stories more naturally, conveying them in a way that gives them a flow and literary (...) charm. I want to make a new attempt to convey these century-old stories which suggest the rich feelings of human life, in refreshing ways. I hope people who are not professional Indologists, but who are humanists, can enjoy the nuances of the topic. So this article based on translations is literary and frankly experimental; it is about natural experiences told in natural language. Often, translations from centuries ago seem stilted, dry and archaic, literally correct and academically adequate, but lacking such touchstones of basic humanity’s life as inner feelings and visceral intuitive sensations. I am exercising a hope of offering a fresh telling, and a chance to provide some imaginative reflections on this topic I have chosen. The theme is sweat—and other natural human responses. Why explore sweat? This is a pertinent question. For one thing, I’ve been struck by how the experience of sweat meant something different centuries ago in India, in comparison with what it means to many people today. As reflected in Sanskrit literature, it had associations with desirable feelings—thrills, soulful exertions, arousal, passionate intensity. It is distinctive, and I seek to know what it might tell us about life, both to Hindus and non-Hindus. It offers a chance to contemplatively play around with beauty, too. It is an aesthetic exploration, an artistic challenge, an alluring human mood, of loving joy. The longer texts I am working with are Tirumalamba’s Sanskrit text Varadambika Parinaya Campu and Pingali Surana’s Telugu text Kalapurnodayam. Shorter texts I refer to include a verse from the Sanskrit Bhagavad Gita, and Jayadeva’s Sanskrit Gita Govinda, and a Telugu song by Annamacharya. (shrink)

This work presents results of improvement in the productivity of Arthrospira platensis in a company dedicated to its production. The six sigma methodology was applied in production processes that require the use of bioreactors. Starting from the analysis of the current state, aspects, physical and chemical variables that directly influence the productivity achieved were identified. Various culture media were tested and subsequently scaled for industrial production. In addition, the incorporation of carbon into the culture medium was controlled, optimizing the range (...) of potential hydrogen pH. The identified parameters were measured and six sigma methodology strategies were assigned. An improvement in productivity corresponding to 66% was verified with the same quality of final product. Keywords: Six sigma, Bioreactors, Productivity, Arthrospira platensis. References [1]E. Ariawan and A. Makalew, “Smart Micro Farm: Sustainable Algae Spirulina Growth Monitoring System” in 10th International Conference on Information Technology and Electrical Engineering, Bali, 2018, pp.1-4. [2]L. Socconini and C. Reato, Lean six sigma: sistema de gestión para liderar empresas. Primera edición. Barcelona: Marge Books, 2019. [3]H. Gutiérrez, Calidad and productividad. Cuarta edición. México D.F.: McGraw-Hill Interamericana, 2014. [4]G. Usharani, P. Saranraj and D. Kanchana, “Spirulina Cultivation: A Review” in International Journal of Pharmaceutical & Biological Archives, vol. 3, no. 6, pp. 1327-1336, December 2012. [5]J. Udin, O. Gani, A. Mahato, I. Sakib and M. Rakiuzzaman, SPIRULINA PRODUCTION IN DIFFERENT PHOTOBIOREACTORS ON ROOFTOP, International Journal of Business, Social and Scientific Research, vol. 8, no. 1, pp. 15-19, January 2020. [6]M. Arredondo, Contabilidad y análisis de costos. Primera edición. México D.F.: Grupo Editorial Patria, 2015. [7]J. García, Contabilidad de costos. Cuarta edición. México D.F.: McGraw-Hill Interamericana, 2014. [8]L. Socconini, Certificación Lean Six Sigma Green Belt para la excelencia en los negocios. Primera edición. Barcelona: Marge Books, 2015. [9]A. Vian, Introducción a la Química Industrial. Segunda edición. Buenos Aires: Reverté, 2012. [10]S. Milton, Estadística para Biología y Ciencias de la Salud. Tercera edición. Madrid: McGraw-Hill Interamericana, 2014. (shrink)