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.

The role of community engagement in the adoption of new agricultural biotechnologies by farmers: the case of the Africa harvest tissue-culture banana in Kenya.

BACKGROUND: The tissue culture banana (TCB) is a biotechnological agricultural innovation that has been adopted widely in commercial banana production. In 2003, Africa Harvest Biotech Foundation International (AH) initiated a TCB program that was explicitly developed for smallholder farmers in Kenya to help them adopt the TCB as a scalable agricultural business opportunity. At the heart of the challenge of encouraging more widespread adoption of the TCB is the question: what is the best way to introduce the TCB technology, and all its attendant practices and opportunities, to smallholder farmers. In essence, a challenge of community or stakeholder engagement (CE). RESULTS: In this paper, we report the results of a case study of the CE strategies employed by AH to introduce TCB agricultural practices to small-hold farmers in Kenya, and their impact on the uptake of the TCB, and on the nature of the relationship between AH and the relevant community of farmers and other stakeholders. We identified six specific features of CE in the AH TCB project that were critical to its effectiveness: (1) adopting an empirical, "evidence-based" approach; (2) building on existing social networks; (3) facilitating farmer-to-farmer engagement; (4) focusing engagement on farmer groups; (5) strengthening relationships of trust through collaborative experiential learning; and (6) helping farmers to "learn the marketing game". We discuss the implications of AH's "values-based" approach to engagement, and how these guiding values functioned as "design constraints" for the key features of their CE strategy. And we highlight the importance of attention to the human dimensions of complex partnerships as a key determinant of successful CE. CONCLUSION: Our findings suggest new ways of conceptualizing the relationship between CE and the design and delivery of new technologies for global health and global development.

Considering risk contexts in explaining the paradoxical HIV increase among female sex workers in Mumbai and Thane, India.

BACKGROUND: The period 2006-2009 saw intensive scale-up of HIV prevention efforts and an increase in reported safer sex among brothel and street-based sex workers in Mumbai and Thane (Maharashtra, India). Yet during the same period, the prevalence of HIV increased in these groups. A better understanding of sex workers' risk environment is needed to explain this paradox. METHODS: In this qualitative study we conducted 36 individual interviews, 9 joint interviews, and 10 focus group discussions with people associated with HIV interventions between March and May 2012. RESULTS: Dramatic changes in Mumbai's urban landscape dominated participants' accounts, with dwindling sex worker numbers in traditional brothel areas attributed to urban restructuring. Gentrification and anti-trafficking efforts explained an escalation in police raids. This contributed to dispersal of sex work with the sex-trade management adapting by becoming more hidden and mobile, leading to increased vulnerability. Affordable mobile phone technology enabled independent sex workers to trade in more hidden ways and there was an increased dependence on lovers for support. The risk context has become ever more challenging, with animosity against sex work amplified since the scale up of targeted interventions. Focus on condom use with sex workers inadvertently contributed to the diversification of the sex trade as clients seek out women who are less visible. Sex workers and other marginalised women who sell sex all strictly prioritise anonymity. Power structures in the sex trade continue to pose insurmountable barriers to reaching young and new sex workers. Economic vulnerability shaped women's decisions to compromise on condom use. Surveys monitoring HIV prevalence among 'visible' street and brothel-bases sex workers are increasingly un-representative of all women selling sex and self-reported condom use is no longer a valid measure of risk reduction. CONCLUSIONS: Targeted harm reduction programmes with sex workers fail when implemented in complex urban environments that favour abolition. Increased stigmatisation and dispersal of risk can no longer be considered as unexpected. Reaching the increasing proportion of sex workers who intentionally avoid HIV prevention programmes has become the main challenge. Future evaluations need to incorporate building 'dark logic' models to predict potential harms.

Law Commission of India report on the age of consent: Denying justice and autonomy to adolescents.

The 22nd Law Commission of India (henceforth, the Commission) [1], in its recent 283rd report, offered its recommendation on the question of age of consent (AoC) to sexual activity. Two High Courts which have seen several cases of non-exploitative consensual sex involving adolescent girls, filed by the police under "sexual assault", had referred this issue to the Commission. The substantive matter before the Commission was whether to lower the AoC to prevent unnecessary prosecutions and resolve the contradictions in sexual violence laws. In this regard, we find the report rather disappointing. It is a lost opportunity to decriminalise adolescent sexuality, to restore the autonomy of adolescent girls over their bodies, uphold their sexual and reproductive rights, and respect their evolving capacity to exercise their sexuality. The Commission has also let go of a chance to undo a highly protectionist clause in the Protection of Children from Sexual Offences Act (POCSO), 2012 [2] which renders all sexual activity of individuals under the age of 18 an offence. It failed to reiterate the progressive recommendations made by the Justice Verma Committee Report in 2013 [3] in this regard, which had come after extensive deliberations and were widely welcomed by stakeholders.

Understanding structural inequities in Covid-19 vaccine access and uptake among disability, transgender and gender-diverse communities in India.

INTRODUCTION: Undervaccination and vaccination-related anxieties among marginalised communities like the transgender and gender-diverse (TGD) and disability communities are underexplored in the Indian context. Our study seeks to understand the role of structural and historical inequities in shaping COVID-19 vaccine access for the two communities in India. METHODS: Using a participatory qualitative research approach, TGD and disabled individuals were involved in and consulted throughout the research process. We interviewed 45 individuals for our study, hailing from the two communities and other key stakeholders and health system representatives involved in vaccination roll-out in India. We conducted an inductive thematic analysis guided by the socio-ecological model and intersectionality approach. RESULTS: Despite intent to get vaccinated among most participants, several structural barriers shaped COVID-19 vaccine access for people from the TGD and disability community. This included information and communication gaps with respect to the specific health needs of the two communities, barriers related to vaccine registration, data collection, transport, infrastructure and actual or anticipated mistreatment at vaccine centres. Each emergent structural gap in vaccination had parallels in past health systems experiences, pointing to the longstanding and pervasive inequities within health and allied systems which impact how communities perceive and respond to new health system interventions. CONCLUSION: This study uncovers the structural inequities within health systems that have permeated the planning, design and outreach of COVID-19 vaccination programs in India. Moving beyond notions of vaccine hesitancy among the TGD and disability community, we underscore the importance of socio-historical contexts of marginalisation and advocate for systems to recognise these contexts and respond equitably to the vaccination and health needs of the two communities. While some challenges among the two communities were distinct, the study explores how a shared experience of exclusion from public systems can provide avenues for cross-movement advocacy and solidarity, and help inform health system reforms.

COVID-19 Vaccine decision-making: trust among the transgender and disability communities in India.

BACKGROUND: Historical marginalisation and ongoing trust deficits in health and government systems shape present-day vaccine perceptions among marginalised communities. This paper sought to understand the role of trust in decision-making about COVID-19 vaccine uptake in the transgender and disability communities in India. METHODS: Using a participatory approach we interviewed 24 community representatives, identifying themselves as transgender individuals or as persons with disability, and 21 key informants such as vaccine programme managers, vaccine providers, and community advocates. We undertook an inductive thematic analysis of the data using a socio-ecological model. RESULTS: Fear of side effects in relation to specific needs of the two communities and mistrust of systems involved in vaccination shaped four different pathways for vaccine decision-making. Mistrust of systems was influenced by past negative experiences with the health system, creating contexts in which information and misinformation are shared and interpreted. Participants negotiated their doubts about safety and mistrust of systems by interacting with different sources of influence showing patterns of decision-making that are dynamic, context-dependent, and intersectional. CONCLUSION: These findings will help in determining the content, strategies and approaches to equitable vaccine communication for these two communities. The two communities ought to be included in vaccine trials. Vaccine information must respond to the specific needs of these two communities which could be enabled by collaboration and engagement with community members and influencers. Finally, long-term investment towards the needs of marginalised communities is vital to dismantle cycles of marginalisation and distrust and in turn improve vaccine acceptance and uptake.

Aligning community engagement with traditional authority structures in global health research: a case study from northern Ghana.

Despite the recognition of its importance, guidance on community engagement practices for researchers remains underdeveloped, and there is little empirical evidence of what makes community engagement effective in biomedical research. We chose to study the Navrongo Health Research Centre in northern Ghana because of its well-established community engagement practices and because of the opportunity it afforded to examine community engagement in a traditional African setting. Our findings suggest that specific preexisting features of the community have greatly facilitated community engagement and that using traditional community engagement mechanisms limits the social disruption associated with research conducted by outsiders. Finally, even in seemingly ideal, small, and homogeneous communities, cultural issues exist, such as gender inequities, that may not be effectively addressed by traditional practices alone.

The origins of a research community in the Majengo Observational Cohort Study, Nairobi, Kenya.

BACKGROUND: Since the 1980s the Majengo Observational Cohort Study (MOCS) has examined sexually transmitted infections, in particular HIV/AIDS, in a cohort of sex workers in Majengo, an impoverished urban village in Nairobi, Kenya. The MOCS investigators have faced criticism since the women have remained in the sex trade for the duration of their participation in the study, prompting concerns about exploitation. Yet despite these concerns, the cohort has survived for almost 30 years. METHODS: In this retrospective qualitative case study, we examine the community engagement practices of the MOCS and explore the factors that account for its durability. RESULTS: Women in sex work in Kenya were a highly stigmatized and disfranchised community. As a result, there was no natural 'community' of sex workers either in Nairobi or in the Majengo village. The Majengo clinic aimed to reduce the barriers to health care the women experienced at the STC clinic by bringing the services closer to them and by providing a non-discriminatory environment. The women acknowledged the fact they had hoped their participation in the MOCS would have helped them find a path out of the sex trade. But our findings also add another dimension to this debate, since every cohort member we interviewed expressed her gratitude for the deep impact the MOCS has had on her life, much of it beyond the improved health status made possible by access to quality healthcare services. Participation in the MOCS has improved and enriched their lives. The CE activities have played a central role in creating a community that did not exist independently of the MOCS. CONCLUSIONS: Our case study identified 3 distinct phases of community engagement in the MOCS: (1) reaching out: mobilization, dialogue and education; (2) foundations of trust through relationships of care; and (3) leveraging existing social capital to form a cohort community. The findings demonstrate the importance of some of the less obvious benefits of participation in research, namely the evolving experience of community and the accompanying gains in personal security and solidarity that have kept the women in the cohort, some for 20 years or more.

'Relief of oppression': an organizing principle for researchers' obligations to participants in observational studies in the developing world.

BACKGROUND: A central question in the debate about exploitation in international research is whether investigators and sponsors from high-income countries (HIC) have obligations to address background conditions of injustice in the communities in which they conduct their research, beyond the healthcare and other research-related needs of participants, to aspects of their basic life circumstances. DISCUSSION: In this paper, we describe the Majengo sexually transmitted disease (STD) Cohort study, a long-term prospective, observational cohort of sex workers in Nairobi, Kenya. Despite important scientific contributions and a wide range of benefits to the women of the cohort, most of the women have remained in the sex trade during their long-standing participation in the cohort, prompting allegations of exploitation. The Majengo STD cohort case extends the debate about justice in international research ethics beyond clinical trials into long-term observational research. We sketch the basic features of a new approach to understanding and operationalizing obligations of observational researchers, which we call 'relief of oppression'. 'Relief of oppression' is an organizing principle, analogous to the principle of harm reduction that is now widely applied in public health practice. Relief of oppression aims to help observational researchers working in conditions of injustice and deprivation to clarify their ethical obligations to participants. It aims to bridge the gap between a narrow, transaction-oriented account of avoiding exploitation and a broad account emphasizing obligations of reparation for historic injustices. We propose that relief of oppression might focus researchers' consideration of benefits on those that have some relevance to background conditions of injustice, and so elevate the priority of these benefits, in relation to others that might be considered and negotiated with participants, according to the degree to which the participating communities are constrained in their realization of fundamental freedoms. SUMMARY: The over-arching aim of relief of oppression is that, within the range of benefits negotiated over time with the local communities and organizations, an increasing proportion reflects a shared interest in improving participants' fundamental freedoms. We describe how harm reduction serves as a useful analogy for how we envision relief of oppression functioning in international research.

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.

Addressing diversity and complexity in the community engagement literature: The rationale for a realist review.

In this research note we reflect on our failed attempt to synthesize the community engagement literature through a standard systematic review and explain our rationale for now embarking on a realist synthesis of community engagement in global health research. We believe this paper will be helpful for many who grapple with the lack of clarity about community engagement's core elements and mechanisms.

Sex, gender, and health biotechnology: points to consider.

BACKGROUND: Reproductive technologies have been extensively debated in the literature. As well, feminist economists, environmentalists, and agriculturalists have generated substantial debate and literature on gender. However, the implications for women of health biotechnologies have received relatively less attention. Surprisingly, while gender based frameworks have been proposed in the context of public health policy, practice, health research, and epidemiological research, we could identify no systematic framework for gender analysis of health biotechnology in the developing world. DISCUSSION: We propose sex and gender considerations at five critical stages of health biotechnology research and development: priority setting; technology design; clinical trials; commercialization, and health services delivery. SUMMARY: Applying a systematic sex and gender framework to five key process stages of health biotechnology research and development could be a first step towards unlocking the opportunities of this promising science for women in the developing world.

Bringing solidarity, justice and equity to the centre of the bioethics discourse: Overview of proceedings of the joint 14th World Congress of Bioethics and the 7th National Bioethics Conference, 2018.

Forum for Medical Ethics Society (FMES), Mumbai; St. John's National Academy of Health Sciences (SJNAHS), Bengaluru; Society for Community Health Awareness Research and Action (SOCHARA,) Bengaluru and SAMA Resource Group for Women and Health, New Delhi co-hosted the joint 14th World Congress of Bioethics (WCB) and the 7th National Bioethics Conference (NBC) in Bengaluru. The theme of the Congress was, "Health for all in an unequal world: Obligations of Global Bioethics". The conference was held at an opportune time when we also commemorate 70 years of the Declaration of Human Rights of 1948 and 40 years of the Alma Ata Declaration of 1978. Both declarations affirmed Health as a fundamental Human Right. We have discussed earlier the significance of the congress theme in the year 2018.

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.

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).

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.