Asunto(s)
Betacoronavirus/aislamiento & purificación , Ensayos Clínicos como Asunto , Infecciones por Coronavirus , Ética en Investigación , Pandemias/prevención & control , Neumonía Viral , Investigación , COVID-19 , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/métodos , Ensayos Clínicos como Asunto/organización & administración , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/prevención & control , Infecciones por Coronavirus/terapia , Salud Global/ética , Humanos , Evaluación de Necesidades , Selección de Paciente/ética , Neumonía Viral/epidemiología , Neumonía Viral/prevención & control , Neumonía Viral/terapia , Investigación/organización & administración , Investigación/normas , SARS-CoV-2RESUMEN
The precision health era is likely to reduce and respond to antimicrobial resistance (AMR). Our stewardship and precision efforts share terminology, seeking to deliver the "right drug, at the right dose, at the right time." Already, rapid diagnostic testing, phylogenetic surveillance, and real-time outbreak response provide just a few examples of molecular advances we dub "precision stewardship." However, the AMR causal factors range from the molecular to that of global health policy. Mirroring the cross-sectoral nature of AMR science, the research addressing the ethical, legal and social implications (ELSI) of AMR ranges across academic scholarship. As the rise of AMR is accompanied by an escalating sense of its moral and social significance, what is needed is a parallel field of study. In this paper, we offer a gap analysis of this terrain, or an agenda for "the ELSI of precision stewardship." In the first section, we discuss the accomplishments of a multi-decade U.S. national investment in ELSI research attending to the advances in human genetics. In the next section, we provide an overview of distinct ELSI topics pertinent to AMR. The distinctiveness of an ELSI agenda for precision stewardship suggests new opportunities for collaboration to build the stewardship teams of the future.
RESUMEN
Biospecimen research is a prominent investigative strategy that aims to provide novel insights into coronavirus disease 2019 (COVID-19), inform clinical trials, and develop effective, life-saving treatments. However, COVID-19 biospecimen research raises accompanying ethical concerns and practical challenges for investigators and participants. In this special article, we discuss the ethical issues that are associated with autonomy, beneficence, and justice in COVID-19 biospecimen research and describe strategies to manage the practical challenges, with an emphasis on protecting the rights and welfare of human research participants during a pandemic response. Appropriate institutional review board oversight and bioethics guidance for COVID-19 biospecimen research must maintain their focus on protecting the rights and welfare of research participants, despite the urgent need for more knowledge about the virus and the threat it poses to communities and nations.