ETHICAL CHALLENGES OF BIOMEDICAL RESEARCH IN TIMES OF COVID-19: OUTLOOK IN ARGENTINA
DOI:
https://doi.org/10.22481/rbba.v1i02.7797Keywords:
COVID-19, Ethics of Research with Human Beings, Biomedical research, Research in infectious disease outbreaks, Accelerated ethics review, PandemicAbstract
After a brief introduction about the COVID-19 pandemic, this article makes a detailed and convenient review of the regulation and the main international documents that refer to the distinctive issues of research with human beings in the context of health emergencies. Then, with reference to Argentina, it addresses the lack of adequate regulation, mentioning the existing regulations at the national level that apply to clinical trials and highlighting the creation of a specific National Committee. Finally the contribution pursues to reflect on the response given in the country to the current pandemic with regard to research specifically, analyzing and commenting - briefly but critically-, the coincidences, successes and deficiencies of Resolution N° 908/20, issued by the Ministry of Health of the Nation, particularly on the ethical guidelines that regulate the research carried out in the country during the emergency.
Downloads
References
ANMAT. Medidas y recomendaciones en los estudios de farmacología clínica durante la pandemia COVID19, 2020 [en línea]. Disponible en: https://www.argentina.gob.ar/noticias/medidas-y-recomendaciones-en-los-estudios-de-farmacologia-clinica-durante-la-pandemia-covid [Consulta: 16 junio 2020].
ANNAS, G.J. Globalized Clinical Trials and Informed Consent. The New England Journal of Medicine, v. 360, p. 2050-2053, 2009. [en línea]. Disponible en: https://www.nejm.org/doi/full/10.1056/nejmp0901474 [Consulta: 15 junio 2020].
BEIGEL, J.H., TOMASHEK, K.M., DODD, L.E., MEHTA, A.K., ZINGMAN, B.S., KALIL, A. C. LANE, H.C. Remdesivir for the Treatment of Covid-19 -Preliminary Report. The New England Journal of Medicine, p. 1-12, 2020. [en línea]. Disponible en: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2007764?articleTools=true [Consulta: 15 junio 2020].
CAPUTTO, M.C. La investigación con seres humanos: una novedosa y saludable introducción del artículo 58 del Código Civil y Comercial de la Nación. Revista La Ley, ADLA v. 10, 59, 2017.
COMITÉ NACIONAL DE ÉTICA EN LA CIENCIA Y LA TECNOLOGÍA (CECTE). Análisis y recomendaciones para una ética en las prácticas de la investigación, 2005 [en línea]. Disponible en: www.cecte.gov.ar/str/etica/ [Consulta: 15 junio 2020].
GREIN, J., OHMAGARI, N., SHIN, D., DIAZ, G., ASPERGES, E., CASTAGNA, A. FLANIGAN, T. Compassionate Use of Remdesivir for Patients with Severe Covid-19. The New England Journal of Medicine, v. 382, p. 2327-2336, 2020. [en línea]. Disponible en: https://www.nejm.org/doi/10.1056/NEJMoa2007016 [Consulta: 15 junio 2020].
JAMROZIK, E. Y SELGELID, M.J. COVID-19 human challenge studies: ethical issues. [en línea]. The Lancet Infectious Diseases, p. 1-6, 2020. [en línea]. Disponible en: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30438-2/fulltext#back-bib8 [Consulta: 19 junio 2020].
LONDON, A.J. Y JONATHAN KIMMELMAN, J. Against pandemic research exceptionalism. Science, v. 368, n. 6490, p. 476-477, 2020. [en línea]. Disponible en: https://science.sciencemag.org/content/368/6490/476 [Consulta: 22 junio 2020].
MEHRA, M.R., DESAI, S.S., KUY, S.R., HENRY, T.D. Y PATEL, A.N. Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. The New England Journal of Medicine, 382: e102, p. 1-7, 2020. [en línea]. Disponible en: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2007621 [Consulta: 19 junio 2020].
MEHRA, M.R., DESAI, S.S., RUSCHITZKA, F. Y PATEL, A.N. Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. The Lancet, p. 1-10, 2020. [en línea]. Disponible en: https://doi.org/10.1016/S0140-6736(20)31180-6 [Consulta: 22 junio 2020].
MEHRA, M.R., DESAI, S.S., KUY, S.R., HENRY, T.D. Y PATEL, A.N. Retraction: Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. N Engl J Med. DOI: 10.1056/NEJMoa2007621. The New England Journal of Medicine, v. 382, p.2582, 2020. [en línea]. Disponible en: https://www.nejm.org/doi/full/10.1056/NEJMc2021225 [Consulta: 19 junio 2020].
ORGANIZACIÓN PANAMERICANA DE LA SALUD. Orientación ética sobre cuestiones planteadas por la pandemia del nuevo coronavirus (COVID-19), 2020. [en línea]. Disponible en: https://www.paho.org/es/documentos/orientacion-etica-sobre-cuestiones-planteadas-por-pandemia-nuevo-coronavirus-covid-19 [Consulta: 21 junio 2020].
PERALTA, V. Ensayos clínicos, industria farmacéutica y práctica clínica. Boletín de Información Farmacoterapéutica de Navarra, v. 13, n. 4, p. 30-34, 2005.
RUBIN, E.J. Expression of Concern: Mehra MR et al. Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. N Engl J Med. DOI: 10.1056/NEJMoa2007621 (Editorial). The New England Journal of Medicine, v. 382, p. 2464, 2020. [en línea]. Disponible en: https://www.nejm.org/doi/full/10.1056/NEJMe2020822 [Consulta: 19 junio 2020].
SHAH, S.K., MILLER, F.G., DARTON, T.C., DUENAS, D., EMERSON, C., FERNANDEZ LYNCH, H.,…RID, A. Ethics of controlled human infection to address COVID-19. Science, v. 368, n. 6493, p. 832-834, 2020. [en línea]. Disponible en: https://science.sciencemag.org/content/368/6493/832 [Consulta: 22 junio 2020].
TEALDI, J.C. (COORD.), PFEIFFER, M.L., SAVOY, A. Y BLANCO, L.G. Consulta Pública Para un Sistema Nacional de Ética y Derechos Humanos en las Investigaciones Biomédicas. Informe Final, 2006. [en línea]. Disponible en: https://www.psi.uba.ar/academica/carrerasdegrado/psicologia/sitios_catedras/obligatorias/723_etica2/material/noticias/consulta_publica_senado_nacion.pdf [Consulta: 16 junio 2020].
WANG, M., CAO, R., ZHANG, L., YANG, X., LIU, J., XU, M.,…XIAO, G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res, v. 30, p. 269–271, 2020. [en línea]. Disponible en: https://doi.org/10.1038/s41422-020-0282-0 [Consulta: 15 junio 2020].
WANG, Y., ZHANG, D., DU, G., DU, R., ZHAO, J., JIN, Y.,… WANG, C. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. The Lancet, v. 395, p. 1569–78, 2020. [en línea]. Disponible en: https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(20)31022-9.pdf [Consulta: 15 junio 2020].
WORLD HEALTH ORGANIZATION. Human Challenge Trials for Vaccine Development: regulatory considerations, 2016. [en línea]. Disponible en: https://www.who.int/biologicals/expert_committee/Human_challenge_Trials_IK_final.pdf [Consulta: 19 junio 2020].
WORLD HEALTH ORGANIZATION. Ethical standards for research during public health emergencies: Distilling existing guidance to support COVID-19 R&D, 2020a. [en línea]. Disponible en: https://www.who.int/publications/i/item/WHO-RFH-20.1 [Consulta: 21 junio 2020].
WORLD HEALTH ORGANIZATION. Key criteria for the ethical acceptability of COVID-19 human challenge studies, 2020b. [en línea]. Disponible en: https://www.who.int/ethics/publications/key-criteria-ethical-acceptability-of-covid-19-human-challenge/en/ [Consulta: 22 junio 2020].
WORLD HEALTH ORGANIZATION. Guidance for research ethics committees for rapid review of research during public health emergencies, 2020c. [en línea]. Disponible en: https://www.who.int/publications/i/item/9789240006218 [Consulta: 21 junio 2020].