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Restrictive measures imposed because of the coronavirus disease 2019 (COVID-19) pandemic have resulted in severe social, economic and health effects. Some countries have considered the use of immunity certification as a strategy to relax these measures for people who have recovered from the infection by issuing these individuals a document, commonly called an immunity passport. This document certifies them as having protective immunity against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19. The World Health Organization has advised against the implementation of immunity certification at present because of uncertainty about whether long-term immunity truly exists for those who have recovered from COVID-19 and concerns over the reliability of the proposed serological test method for determining immunity. Immunity certification can only be considered if scientific thresholds for assuring immunity are met, whether based on antibodies or other criteria. However, even if immunity certification became well supported by science, it has many ethical issues in terms of different restrictions on individual liberties and its implementation process. We examine the main considerations for the ethical acceptability of immunity certification to exempt individuals from restrictive measures during the COVID-19 pandemic. As well as needing to meet robust scientific criteria, the ethical acceptability of immunity certification depends on its uses and policy objectives and the measures in place to reduce potential harms, and prevent disproportionate burdens on non-certified individuals and violation of individual liberties and rights. [phrase omitted] Les restrictions imposees dans le cadre de la lutte contre la pandemie de maladie a coronavirus 2019 (COVID-19) ont eu de lourdes consequences economiques, sociales et sanitaires. Certains pays ont envisage la mise en place d'une strategie visant a alleger ces restrictions pour les individus gueris en leur octroyant un document communement appele <>. Ce document atteste qu'ils ont developpe une immunite protectrice contre le coronavirus 2 du syndrome respiratoire aigu severe (SARS-CoV-2), le virus a l'origine de la COVID-19. LOrganisation mondiale de la Sante a deconseille l'usage du certificat d'immunite pour l'instant, car l'incertitude demeure quant a l'existence reelle d'une immunite a long terme pour ceux qui se sont remis de la COVID-19. En outre, la fiabilite des tests serologiques censes determiner si l'individu est immunise n'est pas averee. Un tel certificat ne peut etre instaure que si les seuils scientifiques en matiere d'immunite sont respectes, qu'ils soient fondes sur les anticorps ou sur d'autres criteres. Neanmoins, meme si le certificat d'immunite est desormais bien accepte par la science, il s'accompagne de nombreuses questions d'ordre ethique en ce qui concerne la limitation des libertes individuelles et la mise en reuvre. Dans le present document, nous examinons les principales considerations a prendre en compte pour garantir l'acceptabilite ethique du certificat d'immunite visant a lever les mesures de restriction pour certaines personnes durant la pandemie de COVID-19. Cette acceptabilite ethique depend non seulement de son degre de conformite a des criteres scientifiques stricts, mais aussi de son usage, des objectifs politiques ainsi que des mesures mises en place pour attenuer les prejudices potentiels et eviter d'imposer une charge disproportionnee sur les individus depourvus de certificat, ou de bafouer les droits et libertes de tout un chacun. [phrase omitted] Las medidas restrictivas impuestas a causa de la pandemia de la enfermedad coronavirus de 2019 (COVID-19) han tenido graves efectos sociales, economicos y sanitarios. Algunos paises han considerado la posibilidad de utilizar la certificacion de inmunidad como estrategia para flexibilizar dichas medidas para las personas que se han recuperado de la infeccion mediante la expedicion a dichas personas de un documento, comunmente denominado pasaporte de inmunidad. Este documento certifica que han desarrollado inmunidad protectora contra el coronavirus-2 del sindrome respiratorio agudo severo (SARS-CoV-2), el virus que causa la COVID-19. La Organizacion Mundial de la Salud ha desaconsejado la aplicacion de la certificacion de la inmunidad en la actualidad debido a la incertidumbre sobre si existe realmente una inmunidad a largo plazo para quienes se han recuperado de la COVID-19 y a las preocupaciones sobre la fiabilidad del metodo de prueba serologica propuesto para determinar la inmunidad. La certificacion de la inmunidad solo puede considerarse si se cumplen los umbrales cientificos para asegurar la inmunidad, ya sea que se basen en anticuerpos o en otros criterios. Sin embargo, incluso si la certificacion de la inmunidad llegara a estar bien respaldada por la ciencia, tiene muchas cuestiones eticas en cuanto a las diferentes restricciones de las libertades individuales y su proceso de aplicacion. Examinamos las principales consideraciones sobre la aceptabilidad etica de la certificacion de la inmunidad para eximir a los individuos de las medidas restrictivas durante la pandemia de la COVID-19. Ademas de necesitar cumplir criterios cientificos solidos, la aceptabilidad etica de la certificacion de inmunidad depende de sus usos y objetivos de politica y de las medidas que se apliquen para reducir los posibles danos y evitar que se impongan cargas desproporcionadas a las personas que no cuenten con dicha certificacion y se violen las libertades y derechos individuales., Introduction Most countries have adopted restrictive public health measures to control the coronavirus disease 2019 (COVID-19) epidemic caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). These measures include physical distancing, [...]

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 [...]

In February 2016, the World Health Organization (WHO) declared the Zika virus-related cluster of microcephaly cases and other neurological disorders reported in Brazil, a Public Health Emergency of International Concern [...]

Gene drive technology has been recognized for its potential to provide durable and cost-effective solutions for previously intractable problems in public health, conservation, and agriculture. In recognition of the rapid advances in this field, in 2016 the U.S. National Academies of Sciences, Engineering, and Medicine issued a report making several recommendations aimed at researchers, funders, and policymakers for the safe and responsible research and development of gene drive technology. Subsequently, in 2017 sixteen global organizations self-identifying as sponsors and supporters of gene drive research became public signatories committed to the 'Principles for Gene Drive Research' which were inspired by the report's recommendations. Herein we reflect on the progress of gene drive research in relation to the ethical principles laid out and committed to by the signatories to the Principles. Our analysis indicates high levels of alignment with the Principles in the field of gene drive research. The manuscript also discusses the Gene Drive Research Forum, which had its genesis in the publication of the Principles. Discussions between participants at the latest meeting of the Forum point to the work that lies ahead for gene drive research in line with the Principles. Going forward the gene drive research community can productively focus on: i) safety and efficacy criteria for open release, ii) risk assessment frameworks and methods, iii) more downstream technical, regulatory and policy considerations for field evaluations and implementation, iv) continued transparency and developing mechanisms of accountability, and v) strengthening capacity in locales of potential release and expected drive spread., Competing Interests: No competing interests were disclosed., (Copyright: © 2024 Roberts AJ et al.)

In the past decade, there has been an increase in genomic research and biobanking activities in Africa. Research initiatives such as the Human Heredity and Health in Africa (H3Africa) Consortium are contributing to the development of scientific capacity and infrastructure to support these studies on the continent. Despite this growth, genomic research and biobanking have raised important ethical challenges for key research stakeholders, including members of research ethics committees. One of these is the limited ethical and regulatory frameworks to guide the review and conduct of genomic studies, particularly in Africa. This paper is a reflection on a series of consultative activities with research ethics committees in Africa which informed the development of an ethics and governance framework for best practices in genomic research and biobanking in Africa. The paper highlights the engagement process and the lessoned learned.

On the 5th of November 2015, the Inserm Ethics Committee, Fondation Mérieux and the Global Forum on Bioethics in Research (GFBR), organized a workshop at Les Pensières, Annecy, France, bringing together more than thirty scientists and ethicists, from twenty countries around the world, to debate the way to ensure better sharing of data and biological samples collected during trials in countries with limited resources.Propositions were made to improve the practices of different stakeholders of scientific research (researchers, members of ethics committees, key community representatives) and policy makers (ministers, funding agencies), on the following issues :How to foster equitable scientific collaborations in international research projects ?How to protect the interests of the study participants when sharing data and biological samples ?How to ensure appropriate information and obtain informed consent from individuals with different cultures and levels of education ?In this publication on the use of ?big data? in health, this report from the workshop of November 5, focuses on the aspects related to the sharing of research data.