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Introduction: While pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co-infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without pregnancy-specific dosing data, pregnant people face risks of both toxicity and undertreatment; and delays in gathering evidence can limit access to beneficial next-generation drugs. Despite recognition of the need, numerous barriers and ethical complexities have limited progress. We describe the process, ethical foundations, recommendations and applications of guidance for advancing responsible inclusion of pregnant people in HIV/co-infections research. Discussion: The 26-member international and interdisciplinary Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Working Group was convened to develop ethics-centred guidance for advancing timely, responsible HIV/co-infections research with pregnant people. Deliberations over 3 years drew on extensive qualitative research, stakeholder engagement, expert consultation and a series of workshops. The guidance, initially issued in July 2020, highlights conceptual shifts needed in framing research with pregnant people, and articulates three ethical foundations to ground recommendations: equitable protection from drug-related risks, timely access to biomedical advances and equitable respect for pregnant people's health interests. The guidance advances 12 specific recommendations, actionable within the current regulatory environment, addressing multiple stakeholders across drug development and post-approval research, and organized around four themes: building capacity, supporting inclusion, achieving priority research and ensuring respect. The recommendations describe strategies towards ethically redressing the evidence gap for pregnant people around HIV and co-infections. The guidance has informed key efforts of leading organizations working to advance needed research, and identifies further opportunities for impact by a range of stakeholder groups. Conclusions: There are clear pathways towards ethical inclusion of pregnant people in the biomedical research agenda, and strong agreement across the HIV research community about the need for - and the promise of - advancing them. Those who fund, conduct, oversee and advocate for research can use the PHASES guidance to facilitate more, better and earlier evidence to optimize the health and well being of pregnant people and their children. Keywords: co-infections; ethics; HIV; pregnancy; prevention; research, 1 | INTRODUCTION Since the early 1990s, the management of pregnancy has been an important focus for HIV research. The urgent need to identify interventions to prevent perinatal transmission led [...]

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 COVID19-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. [phrase omitted] [phrase omitted] Pendant que les gouvernements se concentrent sur les profonds bouleversements que la maladie a coronavirus 2019 (COVID-19) engendre pour l'economie mondiale ainsi que sur l'urgence des recherches qui y sont consacrees, d'autres etudes sont touchees de plein fouet par la pandemie. Plusieurs travaux de recherche d'importance majeure, sans lien avec la COVID-19, ont considerablement ralenti ou ont ete totalement interrompus. Soit en raison des restrictions legales relatives a la COVID-19, soit a cause de problemes logistiques, operationnels ou d'effectifs. En ce moment, des milliards de personnes a travers le monde sont soumises a un confinement ou un couvrefeu. Comme la duree de telles mesures restrictives est inconnue et susceptible de changer, de nombreuses etudes sont actuellement en suspens et le bien-etre de dizaines de milliers de participants est menace. Ces circonstances particulieres ont entraine des defis ethiques complexes, qui requierent une attention immediate de la part des promoteurs, chercheurs et organismes de reglementation internationaux. Certains promoteurs et organismes de reglementation ont publie des directives sur la maniere de gerer les interruptions de recherches cliniques dues a la COVID-19. Elles offrent un bon point de depart pour negocier les ecueils au fil de l'evolution de la pandemie, mais elles ne s'appliquent qu'aux chercheurs finances ou administres par ces instances. Dans le present document, nous proposons donc des directives destinees a mieux gerer de telles interruptions, au-dela de ce cadre specifique. Nous soulignons quelques-uns des effets de la pandemie 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 maniere de garantir le bien-etre des participants aux etudes concernees. Enfin, nous parvenons a la conclusion que les legislateurs, promoteurs, chercheurs et organismes de reglementation doivent adopter une approche plus souple, afin d'assurer la securite des participants tout en preservant l'integrite des donnees et en respectant les bonnes pratiques cliniques. [phrase omitted] Mientras que los gobiernos se han centrado en la perturbacion sin precedentes de la economia 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 victimas de la pandemia. Las principales actividades de investigacion que no estan 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 logisticos, 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 esta en peligro debido a que se desconoce el calendario de esas medidas restrictivas y esta sujeto a cambios. Estas circunstancias han planteado desafios eticos complejos que merecen una atencion urgente por parte de los patrocinadores, los investigadores y los organismos reguladores internacionales. Algunos patrocinadores y organismos reguladores han publicado pautas sobre como se deben gestionar las perturbaciones relacionadas con la COVID-19 en la investigacion clinica. Aunque estas pautas constituyen un buen punto de partida para hacer frente a los desafios de la pandemia que esta 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 mas alla de estos entornos especificos. Se resaltan algunos de los efectos de la pandemia de la COVID-19 en otros proyectos de investigacion en curso que no estan relacionados con esta enfermedad y se proporcionan pautas practicas sobre como se debe gestionar el bienestar de los participantes afectados en el estudio. Se concluye que los responsables de formular las politicas, los patrocinadores, los investigadores y los organismos reguladores deben adoptar un enfoque mas flexible para garantizar la seguridad de los participantes, al tiempo que se mantiene la integridad de los datos y se cumplen las buenas practicas clinicas., Introduction Since the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Wuhan, China in November 2019, (1) and its designation by the World Health Organization (WHO) as a [...]

Pregnant and breastfeeding women (PBW) need new antiretroviral (ARV) agents and drug delivery technologies that are safe and effective for treatment and prevention of HIV. Perhaps unsurprisingly, this group is [...]

Author(s): Jerome Amir Singh [sup.1] [sup.2] , Sonali Kochhar [sup.3] [sup.4] , Jonathan Wolff [sup.5] , Caesar Atuire [sup.6] , Anant Bhan [sup.7] , Ezekiel Emanuel [sup.8] , Ruth Faden [...]

Surveillance for human immunodeficiency virus (HIV) in low- and middle-income countries started in the 1980s. However, the questions of whether the results of HIV tests should be given to participants, and if so how, has still not been resolved. In the absence of effective treatment, it was considered acceptable to withhold results from HIV-positive participants. However, when antiretroviral treatment is available, some argue for beneficence--that it is the researcher's duty to return the test results to all those who provide samples for surveillance. The corollary is that only participants who wish to receive their test results would be eligible to participate in surveys. Others argue for autonomy--that to obtain a more representative result for the general population, surveys should not exclude participants who do not wish to receive their test results. This round table discussion takes a closer look at those two arguments. We believe that the global community should work towards routine feed back of HIV surveillance while ensuring that participants receive and understand their test results. La surveillance du virus de l'immunodeficience humaine (VIH) dans les pays a revenu faible et intermediaire a commence dans les annees 1980. Les resultats des tests VIH doivent-ils etre communiques aux participants et si oui, comment ? En l'absence de traitement efficace, il avait ete juge acceptable de ne pas divulguer leur seropositivite aux participants infectes par le VIH. En revanche, des lors qu'un traitement antiretroviral est disponible, certains evoquent le principe de bienfaisance et estiment qu'il est du devoir du chercheur de communiquer les resultats des tests a tous ceux qui ont fourni des echantillons a des fins de surveillance. Mais le corollaire est que seuls les participants qui acceptent d'etre informes des resultats de leur test seraient alors eligibles pour participer a ce type d'enquetes. D'autres avancent le principe d'autonomie, en disant que pour obtenir un resultat plus representatif de la population generale, ces enquetes ne doivent pas exclure les participants qui ne souhaitent pas recevoir leurs resultats. Cette table ronde examine en detail ces deux positions. Nous pensons que la communaute internationale devrait oeuvrer pour une retroaction systematique autour de la surveillance du VIH, en veillant a ce que les participants recoivent et comprennent les resultats de leurs tests. El seguimiento del virus de la inmunodefidencia humana (VIH) en paises de ingresos bajos y medios empezo en los anos ochenta. ?Deberian proporcionarse los resultados de las pruebas del VIH a los participantes? Si es asi, ?de que modo? A falta de tratamiento efectivo, se considero aceptable retener los resultados de los participantes VIH-positlvos. Sin embargo, cuando se dispone de tratamiento antirretroviral, hay quien defiende la beneficencia, es decir, que es el deber del investigador informar de los resultados de las pruebas a todos aquellos que proporcionen muestras para el seguimiento. La consecuencia de esto es que solo los participantes que quieran recibir los resultados de sus pruebas reunirian los requisitos para participar en las encuestas. Otros defienden la autonomia, es decir, que para obtener un resultado mas representativo de la poblacion en general, las encuestas no deberian excluir a los participantes que no quieran recibir los resultados de sus pruebas. Este debate de mesa redonda analiza con mas detenimiento estos dos argumentos. Creemos que la comunidad mundial deberia trabajar por la informacion rutinaria del seguimiento del VIH, al mismo tiempo que garantiza que los participantes reciban y entiendan los resultados de sus pruebas., Introduction In the early stages of the human immunodeficiency virus (HIV) epidemic, surveillance presented various logistical and +ethical issues--including whether or not the results of HIV tests should be given [...]

Author(s): Jerome Amir Singh [sup.1] [sup.2], Sonali Kochhar [sup.3] [sup.4], Jonathan Wolff [sup.5], Caesar Atuire [sup.6], Anant Bhan [sup.7], Ezekiel Emanuel [sup.8], Ruth Faden [sup.9], Prakash Ghimire [sup.10], Dirceu Greco [...]

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Summary Points * Time-sensitive access to unapproved experimental interventions should be permitted on humanitarian grounds when patients or communities are facing death or irreversible disease progression and no other efficacious diagnostic, preventive, or therapeutic alternative exists. * Regulatory deficits could stymie time-sensitive efforts to contain public health threats when no efficacious curative, therapeutic, or preventive interventions exist to counter the threat in question. * United States regulatory mechanisms may provide useful guidance from a regulatory perspective to policy makers grappling with how to adequately prepare for, or respond to, potential or emerging public health emergencies. * Access to unapproved experimental interventions should be underpinned by a robust monitoring and evaluation component that will inform product development and licensure. * A global-level rapid-response governance framework for the employment of unapproved interventions in humanitarian contexts should be established as a matter of urgency., The rampant spread of the Ebola virus in West Africa has prompted the World Health Organization (WHO) to declare the outbreak there a public health emergency of international concern [1]. [...]

The threshold level of immunization coverage needed to confer population immunity for COVID-19 is not yet known, although some settings may require up to 85% of the population to be vaccinated for vaccine-induced population immunity to apply. Achieving such a goal may prompt some countries to contemplate mandating COVID-vaccination. However, attaining a threshold level of population immunity, even via vaccination mandates, is not necessarily a panacea. The emergence of variants that escape immune responses could also render a setting's previous attainment of population immunity meaningless. The extent to which immune responses protect against emerging variants is of increasing importance and speaks to the need for countries to urgently step up genomic surveillance for SARS-CoV-2 variants and openly share that data timeously. Emerging variants also underscore why COVID-19 candidate vaccines and antibody therapeutics should be trialled in diverse geographical settings. Such approaches will catalyse the development of effective next-generation COVID-19 vaccines and antibody therapeutics. [ABSTRACT FROM AUTHOR]

Competing Interests: Competing interests: None declared.

Although transgender women have been included in HIV prevention pre-exposure prophylaxis studies, no pre-exposure prophylaxis study has focused exclusively on transgender persons. Drawing on the cardinal principles of ethics espoused in the Belmont Report, this work highlights, among other issues, that (1) the principle of Justice requires the HIV prevention field to focus exclusively on transgender persons, (2) the disclosure of potential study-related risks to study participants demonstrates Respect for Persons, and (3) devising risk mitigation plans, optimizing a proposed study's standard of care, and the provision of ancillary care satisfy the principle of Beneficence.