The impact of the COVID-19 pandemic response on other health research.

While governments have been focusing on the unprecedented disruption to the global economy caused by coronavirus disease 2019 (COVID-19) and the urgent need for COVID-19 research, other health research has become a casualty of the pandemic. Major research operations that are unrelated to COVID-19 have been significantly diminished or suspended entirely because of either COVID-19-related legal restrictions or logistical, staffing or operational concerns. Billions of people globally are currently affected by lockdowns or curfews. Since the timescale of such restrictive measures is unknown and subject to change, many studies are now in limbo and the welfare of tens of thousands of study participants is at risk. These circumstances have introduced complex ethical challenges that merit urgent attention from international sponsors, researchers and regulators. Certain sponsors and regulators have published guidelines on how the COVID-19-related disruptions to clinical research should be managed. Although these guidelines provide a good starting point in navigating the challenges of the evolving pandemic, they only apply to those researchers funded or governed by these bodies. Here, we provide guidelines on managing such disruptions that apply beyond these specific settings. We highlight some of the effects of the COVID-19 pandemic on other ongoing research projects that are unrelated to COVID-19 and provide practical guidance on how the welfare of affected study participants should be managed. We conclude that policy-makers, sponsors, researchers and regulators must adopt a more flexible approach to ensure participant safety, while maintaining data integrity and complying with good clinical practices.

Pendant que les gouvernements se concentrent sur les profonds bouleversements que la maladie à coronavirus 2019 (COVID-19) engendre pour l'économie mondiale ainsi que sur l'urgence des recherches qui y sont consacrées, d'autres études sont touchées de plein fouet par la pandémie. Plusieurs travaux de recherche d'importance majeure, sans lien avec la COVID-19, ont considérablement ralenti ou ont été totalement interrompus. Soit en raison des restrictions légales relatives à la COVID-19, soit à cause de problèmes logistiques, opérationnels ou d'effectifs. En ce moment, des milliards de personnes à travers le monde sont soumises à un confinement ou un couvre-feu. Comme la durée de telles mesures restrictives est inconnue et susceptible de changer, de nombreuses études sont actuellement en suspens et le bien-être de dizaines de milliers de participants est menacé. Ces circonstances particulières ont entraîné des défis éthiques complexes, qui requièrent une attention immédiate de la part des promoteurs, chercheurs et organismes de réglementation internationaux. Certains promoteurs et organismes de réglementation ont publié des directives sur la manière de gérer les interruptions de recherches cliniques dues à la COVID-19. Elles offrent un bon point de départ pour négocier les écueils au fil de l'évolution de la pandémie, mais elles ne s'appliquent qu'aux chercheurs financés ou administrés par ces instances. Dans le présent document, nous proposons donc des directives destinées à mieux gérer de telles interruptions, au-delà de ce cadre spécifique. Nous soulignons quelques-uns des effets de la pandémie de COVID-19 sur d'autres projets de recherche en cours qui n'ont aucun rapport avec la maladie, et nous donnons des conseils pratiques sur la manière de garantir le bien-être des participants aux études concernées. Enfin, nous parvenons à la conclusion que les législateurs, promoteurs, chercheurs et organismes de réglementation doivent adopter une approche plus souple, afin d'assurer la sécurité des participants tout en préservant l'intégrité des données et en respectant les bonnes pratiques cliniques.

Mientras que los gobiernos se han centrado en la perturbación sin precedentes de la economía global que la enfermedad del coronavirus 2019 (COVID-19) ha causado y en la urgente necesidad de investigar sobre esta enfermedad, otras investigaciones sanitarias se han convertido en víctimas de la pandemia. Las principales actividades de investigación que no están relacionadas con la COVID-19 se han reducido de manera significativa o se han suspendido por completo debido a las restricciones legales relacionadas con la COVID-19 o a los problemas logísticos, de personal u operativos. En la actualidad, el confinamiento o los toques de queda afectan a miles de millones de personas en todo el mundo. Muchos estudios se encuentran ahora en el limbo y el bienestar de decenas de miles de sus participantes está en peligro debido a que se desconoce el calendario de esas medidas restrictivas y está sujeto a cambios. Estas circunstancias han planteado desafíos éticos complejos que merecen una atención urgente por parte de los patrocinadores, los investigadores y los organismos reguladores internacionales. Algunos patrocinadores y organismos reguladores han publicado pautas sobre cómo se deben gestionar las perturbaciones relacionadas con la COVID-19 en la investigación clínica. Aunque estas pautas constituyen un buen punto de partida para hacer frente a los desafíos de la pandemia que está evolucionando, solo se aplican a los investigadores que son financiados o gestionados por estos organismos. En este documento, se ofrecen pautas para gestionar esas perturbaciones que se extienden más allá de estos entornos específicos. Se resaltan algunos de los efectos de la pandemia de la COVID-19 en otros proyectos de investigación en curso que no están relacionados con esta enfermedad y se proporcionan pautas prácticas sobre cómo se debe gestionar el bienestar de los participantes afectados en el estudio. Se concluye que los responsables de formular las políticas, los patrocinadores, los investigadores y los organismos reguladores deben adoptar un enfoque más flexible para garantizar la seguridad de los participantes, al tiempo que se mantiene la integridad de los datos y se cumplen las buenas prácticas clínicas.

Public narrative on "instant justice": A slippery slope.

The brutal gang rape and murder of a young veterinarian (now known as the 'Disha' case) on Nov 27, 2019 in Hyderabad (2), was followed by the encounter deaths of the four suspects at the hands of the Hyderabad police, on Dec 6, 2019 (2). The rape-murder, the police killings, and the public jubilation after the killings are all not only extremely disturbing, but very intriguing.

The Supreme Court of India on euthanasia: Too little, too late.

On Friday, March 9, 2018 the five-judge Constitution Bench (CB) of the Supreme Court of India (SCI) chaired by Dipak Misra, the Chief Justice of India, pronounced its judgment (1) (henceforth CC judgment) granting, for the first time in India, legal recognition to "advanced medical directives" or "living wills", ie, a person's decision communicated in advance on withdrawal of life-saving treatment under certain conditions, which should be respected by the treating doctor/s and the hospital. It also reiterates the legal recognition of the right to "passive euthanasia"; and draws upon Article 21 - the right to life - of the Constitution of India (henceforth Constitution) (2) interpreting robustly that the "right to life" includes the "right to die with dignity". Justices Misra and Khanwilkar disposed of the writ petition filed in 2005 by Common Cause (3) (henceforth CC petition) saying, "The directive and guidelines shall remain in force till the Parliament brings a legislation in the field" (1:p 192).

Five years post Nirbhaya: Critical insights into the status of response to sexual assault.

It is five years since the fatal gang rape of Jyothi Singh (Nirbhaya), a physiotherapy student, on December 16, 2012, in New Delhi, the capital of India. The legal and policy reforms triggered by the Nirbhaya case will remain a watershed moment in the history of efforts towards seeking justice for survivors of gender-based violence in India. The Criminal Law (Amendment) Act, 2013 and the "Guidelines and protocols: Medico-legal care for survivors/victims of sexual violence" issued by the Ministry of Health and Family Welfare in March 2014 are two landmark reforms. March 2018 marks four years since the issuance of these Guidelines and five years since the Criminal Law (Amendment) Act, 2013. Any reasonable tribute to Nirbhaya would constitute fair implementation of legal reforms, efforts to strengthen multi-sectoral response and sincere attempts to reduce crimes against women, gender and sexual minorities, and children. This paper reviews the issue, through a close study of recent cases of rape, police responses, court judgements, studies, news reporting and field-based observations. It brings forth the gaps in implementation that persist, and constitute a major obstacle in making these progressive policies and reforms effective. Given the fact that the reforms are intersectoral in nature, implementation has been particularly challenging. Lack of efficient implementation of such policies and reforms amounts to denying survivors their right to justice.

Health for all in an unequal world: Obligations of global bioethics.

The theme of the joint 14th World Congress of Bioethics and 7th National Bioethics Conference Congress "Health for all in an unequal world: Obligations of global bioethics" is of critical relevance in the present global context. Although the world is better off in terms of improved health status of people by many measures than before, there exist colossal gaps across and within populations. Much needs to be done to respond to the lack of access to healthcare, poor quality of living and working conditions, and deteriorating quality of overall environment which affects more adversely the already deprived. We take this opportunity to make a few observations about the current status of affairs on this front, and offer brief analytical insights into the complex origins of the global health scenario characterised by disparities. We revisit the original conception of bioethics and suggest that it is well placed to respond to the current global crisis of inexorably widening disparities in health and wealth, and that global bioethics has an obligation to engage with this crisis.

Access to controlled medicines for palliative care in India: gains and challenges.

It was in the early 1990s that an appeal was made, both in India and globally, for access to palliative care to be treated as a human rights issue. Over the past few years, India has witnessed robust advocacy efforts which push for the consideration of palliative care and pain management as a human right. Central to this paper is India's Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985: its genesis, its critique, and the amendments aimed at enhancing access to the NDPS for medical care and research. I refer to the advocacy efforts in India, particularly the most recent ones, which led to the amendments to the NDPS Act, 1985 in February 2014; and the contribution of the global and local human rights discourse on palliative care to these efforts. This I situate in the overall status of palliative care in India. Towards the end, I briefly set out the agenda that should be pursued in the coming years to enhance access to controlled medicines for pain management and palliative care.