Protecting Privacy of Pregnant and LGBTQ+ Research Participants.

This Viewpoint summarizes existing federal regulations aimed at protecting research data, describes the challenges of enforcing these regulations, and discusses how evolving privacy technologies could be used to reduce health disparities and advance health equity among pregnant and LGBTQ+ research participants.

Consideraciones bioéticas para la investigación sobre los programas de residencias médicas / Consideracions bioètiques per a la investigació sobre els programes de residències mediques / Bioethical considerations for research on medical residents

El presente artículo argumenta que es necesaria la investigación sobre los programas de residencias médicas para mejorar el entorno laboral y académico que viven los médicos y médicas en su formación como especialistas. Por lo que se proponen algunas consideraciones para garantizar una investigación ética. Para ello, el artículo sigue la estructura de dos premisas y una conclusión, donde cada premisa se fundamenta analíticamente. La primera premisa es que los factores estructurales de los programas de residencias médicas conducen a una condición de vulnerabilidad, se sustenta la primera premisa al explorar los factores estructurales que contribuyen a su vulnerabilidad desde el análisis del contexto mexicano y el marco teórico de la interseccionalidad. Así, se presentan algunas de las características que se entrecruzan y determinan la forma en la que los y las residentes experimentan en sus espacios sociales y ambientes de desarrollo. La segunda premisa es que la investigación de un grupo vulnerable conduce al desarrollo de estrategias para el cambio. El artículo reconoce la necesidad de investigar y desarrollar intervenciones para los grupos sociales vulnerables con el fin de mejorar su situación y proporcionar un entorno más seguro.(AU)

L'article actual argumenta que és necessària la investigació sobre els programes de residències mèdiques per millorar l'entorn laboral i acadèmic que viuen els metges en la seva formació com a especialistes. Per això, es proposen algunes consideracions per garantir una investigació ètica. L'article segueix l'estructura de dues premisses i una conclusió, on cada premissa es fonamenta analíticament. La primera premissa és que els factors estructurals dels programes de residències mèdiques porten a una condició de vulnerabilitat. Aquesta primera premissa es fonamenta explorant els factors estructurals que contribueixen a la seva vulnerabilitat des de l'anàlisi del context mexicà i el marc teòric de la interseccionalitat. Així, es presenten algunes de les característiques que es creuen i determinen la forma en què els residents experimenten en els seus espais socials i entorns de desenvolupament. La segona premissa és que la investigació d'un grup vulnerable condueix al desenvolupament d'estratègies per al canvi. L'article reconeix la necessitat d'investigar i desenvolupar intervencions per als grups socials vulnerables amb l'objectiu de millorar la seva situació i proporcionar un entorn més segur.(AU)

This paper argues that research on medical residency programs is necessary to improve the work and academic environment that physicians experience in their training as specialists. Therefore, some considerations are proposed to ensure ethical research. on medical residents. For this purpose, the paper follows the structure of two premises and a conclusion, where each premise is analytically supported. The first premise is that the structural factors of medical residency programs lead to a condition of vulnerability. The first premise is supported by exploring the structural factors that contribute to their vulnerability from the analysis ofthe Mexican context and the theoretical framework of intersectionality. Thus, some of the characteristics that intersect and determine the way in which residents experience their social spaces and development environments are presented. The second premiseis that researching a vulnerable group leads to the development of strategies for change. The article recognizes the need to research and develop interventions for vulnerable social groups to improve their situation and provide a safer environment.(AU)

Ética en investigación: de los principios a los aspectos prácticos / Research ethics: From principles to practical aspects

La realización de cualquier investigación con seres humanos o sus muestras biológicas requiere una valoración ética previa con el fin de evitar riesgos y problemas a todos los actores del proceso. La legislación al respecto es muy amplia, y hace hincapié en la preservación de los derechos de los pacientes en relación con los principios universales de autonomía, beneficencia y justicia. En este manuscrito se revisan las normativas sobre ensayos clínicos, estudios observacionales con medicamentos, proyectos de biobanco o cualquier otro tipo de estudio que se pueda realizar en el ámbito de la salud. Así mismo se analiza el papel de los comités de ética en investigación, la protección de datos y las bases de la integridad científica. (AU)

Any research conducted on human beings or human biological samples requires a prior ethical assessment to avoid risks and problems for all involved parties. The legislation in this regard is very broad and emphasizes the safeguarding of patient rights in relation to the universal principles of autonomy, beneficence and justice. The present article reviews the regulations applicable to clinical trials, observational studies with drugs, biobank projects or any other type of study that may be conducted in the health care field. It also addresses the role of research ethics committees, data protection and the foundations of scientific integrity. (AU)

Applicability and usefulness of the Declaration of Helsinki for forensic research with human cadavers and remains.

Bodies of deceased persons and human remains and their specimens (i.e., organs, bones, tissues, or biological samples) are essential in forensic research but ad hoc worldwide-recognized ethical standards for their use are still lacking. Such standards are needed both to avoid possible unethical practices and to sustain research in the forensic field. Pending consensus within the forensic science community regarding this topic, with this article we aim to stimulate a debate as to the applicability and usefulness of the Declaration of Helsinki in the field of forensic research involving human cadavers and remains. Considering the fundamental differences compared to clinical research involving human beings and the different moral obligations involved, we focus on the risks, burdens, and benefits of research, ethics committee approval, and informed consent requirements. The Declaration of Helsinki framework allows forensic researchers to focus on substantial ethical principles promoting the consistency, integrity, and quality of research. Consensus regarding ethical standards and the adoption of national and supranational laws that clearly regulate the use of human cadavers and remains, including those from autopsies, continues to be of primary importance for the forensic science community.

Normative decentralization of the food and nutrition security agenda: descriptive study of legislation published in Brazilian capitals / Descentralização normativa da agenda de segurança alimentar e nutricional: estudo descritivo das legislações publicadas nas capitais brasileiras

ABSTRACT Objective This study aimed to identify and characterize the legislation published in Brazilian capitals regarding food and nutritional security. Methods This is a descriptive, exploratory, and documentary research, with a survey on public and free access websites to legislation published until July 2021 in the 26 Brazilian state capitals. Document characterization information was extracted, systematized, and systematically analyzed. Results Of the 1,390 legislations found, 307 were included in the analysis, 31% from the South region of Brazil and 23% from the Southeast region. The legislation mainly referred to the Structuring of the Brazilian System of Food and Nutritional Security (76.5%) and the Promotion of Universal Access to Adequate Food (17.3%). The categories less present were Evaluation and Monitoring of the Brazilian System of Food and Nutritional Security and Food and Nutritional Security (1.9%), Food and Nutrition Actions Aimed at Quilombolas and Traditional Communities (1.3%) and Universal Access to Water (0.7%), with 17 capitals (65.4%) having no localized legislation for these three themes. Conclusion The results point to the need for qualification of transparency mechanisms in public management and good governance, and demonstrate an incipient process of implementing the government food and nutrition security agenda in Brazilian capitals, with low incidence on different government sectors and other public policies

RESUMO Objetivo O estudo teve o objetivo de identificar e caracterizar as legislações relacionadas à segurança alimentar e nutricional publicadas nas capitais brasileiras. Métodos Trata-se de uma pesquisa descritiva, exploratória e documental, com levantamento em sites públicos e de acesso livre de legislações publicadas até julho de 2021 nas 26 capitais dos estados brasileiros. Informações de caracterização dos documentos foram extraídas, sistematizadas e analisadas de forma sistemática. Resultados Das 1.390 legislações localizadas, 307 foram incluídas na análise, sendo 31% da região Sul e 23% da região Sudeste. As legislações referiam-se principalmente à Estruturação do Sistema Naiconal de Segurança Alimentar e Nutricional (76,5%) e à Promoção do Acesso Universal à Alimentação Adequada (17,3%). As categorias menos presentes nas legislações foram Avaliação e Monitoramento do Sistema Nacional de Segurança Alimentar e Nutricional e de Segurança Alimentar e Nutricional (1,9%), Ações de Alimentação e Nutrição Voltadas para Quilombolas e Comunidades Tradicionais (1,3%) e Acesso Universal à Água (0,7%), sendo que 17 capitais (65,4%) não tiveram legislações localizadas para o conjunto destes três temas. Conclusão Os resultados apontam para a necessidade de qualificação dos mecanismos de transparência na gestão pública e de boa governança, e demonstram um processo incipiente de implementação da agenda governamental de segurança alimentar e nutricional nas capitais brasileiras, com baixa incidência sobre os diferentes setores de governo e demais políticas públicas.

An international policy on returning genomic research results.

The Global Alliance for Genomics and Health has approved a policy for the return of clinically actionable genomic research results, the first such policy approved by an international body. The policy acknowledges the potential medical benefits to millions of individuals who are participating in genomics research. It ties the pace of implementation to each country's clinical standards, including for the return of secondary findings, and urges funders to set aside resources to support responsible return.

Scientific research and product development in the United States to address injuries from a radiation public health emergency.

The USA has experienced one large-scale nuclear incident in its history. Lessons learned during the Three-Mile Island nuclear accident provided government planners with insight into property damage resulting from a low-level release of radiation, and an awareness concerning how to prepare for future occurrences. However, if there is an incident resulting from detonation of an improvised nuclear device or state-sponsored device/weapon, resulting casualties and the need for medical treatment could overwhelm the nation's public health system. After the Cold War ended, government investments in radiation preparedness declined; however, the attacks on 9/11 led to re-establishment of research programs to plan for the possibility of a nuclear incident. Funding began in earnest in 2004, to address unmet research needs for radiation biomarkers, devices and products to triage and treat potentially large numbers of injured civilians. There are many biodosimetry approaches and medical countermeasures (MCMs) under study and in advanced development, including those to address radiation-induced injuries to organ systems including bone marrow, the gastrointestinal (GI) tract, lungs, skin, vasculature and kidneys. Biomarkers of interest in determining level of radiation exposure and susceptibility of injury include cytogenetic changes, 'omics' technologies and other approaches. Four drugs have been approved by the US Food and Drug Administration (FDA) for the treatment of acute radiation syndrome (ARS), with other licensures being sought; however, there are still no cleared devices to identify radiation-exposed individuals in need of treatment. Although many breakthroughs have been made in the efforts to expand availability of medical products, there is still work to be done.

Ethical, legal and social implications of human genome studies in radiation research: a workshop report for studies on atomic bomb survivors at the Radiation Effects Research Foundation.

The Radiation Effects Research Foundation (RERF) is the primary organization in Japan dedicated to studying the health consequences of the Hiroshima and Nagasaki atomic bombings in World War II. In December 2020, RERF held a virtual international workshop on the ethical, legal and social implications (ELSI) of genome studies. In this workshop, the ELSI considerations of future human genome studies on radiation research including atomic bomb survivors and their families were discussed. Since genome sequencing (GS) is now practical and affordable, RERF now plans GS of parents/child trios to examine genetic effects of atomic bomb radiation. As such studies may engender some novel risks and benefits, ethics review and engagement with families (including consent) need to be considered. These include protection of individual privacy, use of samples from deceased prior participants, return of results to the participants, public sharing of genome data and advance science and social welfare. Specifically with regard to social welfare, the results of such studies may have implications for public and government decision-making regarding social benefits of victims and other important questions. Based on these broad-ranging discussions we have developed the following concepts to guide this work: "trust," "compromise" and "relationship building," inclusive of the concerned stakeholders, scientific aims and Japanese society at large. We conclude that in order to realize, establish and maintain these concepts, it is essential to put procedures into place to ensure the successful, consensus-based implementation of the RERF studies.

International transfers of personal data for health research following Schrems II: a problem in need of a solution.

On 16 July 2020, the Court of Justice of the European Union issued their decision in the Schrems II case concerning Facebook's transfers of personal data from the EU to the US. The decision may have significant effects on the legitimate transfer of personal data for health research purposes from the EU. This article aims: (i) to outline the consequences of the Schrems II decision for the sharing of personal data for health research between the EU and third countries, particularly in the context of the COVID-19 pandemic; and, (ii) to consider certain options available to address the consequences of the decision and to facilitate international data exchange for health research moving forward.