Ethical problems in research with human subjects during the COVID-19 pandemic: integrative literature review

Authors

DOI:

https://doi.org/10.33448/rsd-v9i12.10802

Keywords:

Ethics; Bioethics; COVID-19; Pandemics.

Abstract

Objective: To analyze publications that address ethical problems in research with human beings carried out during the COVID-19 pandemic. Method: an integrative review in order to answer the following guiding question: which publications address ethical problems in research with human beings during the COVID-19 pandemic? National and international publications, published from 01/01/2020 to 05/14/2020, in Portuguese, English or Spanish, were consulted in the MedLine/Pubmed databases, using the standardized descriptors MesH, Ethics, Research and COVID-19, combined using the Boolean operator AND. Results: 43 articles were found that met the selection criteria, of which 10 articles were selected based on the title and online summary with subsequent full reading, presented in two synoptic tables: one containing the title of the article, journal and year of publication and objective; and the other containing the challenges presented for research with human beings. The articles were grouped into three categories: Respect for the autonomy of research participants; Equity in allocating treatments to research participants and; Balancing the risks and benefits of studies in the pandemic period. Conclusion: Ethical issues referred to conflicts regarding the principles of biomedical ethics: autonomy, involving the difficult decision on the part of the participants between withdrawing or remaining in studies, as well as obtaining free and informed consent by the researcher in the context of the pandemic; and beneficence/non-maleficence, challenging in terms of management complexity in the sense of designing ethically and methodologically high-level studies that manage to minimize risks and maximize benefits in a timely manner.

Author Biographies

Sandra Pinto, Universidade Federal de Mato Grosso do Sul

Nurse. Master's student in Nursing from the Federal University of Mato Grosso do Sul / UFMS. Três Lagoas (MS), Brazil.

Juliana Dias Reis Pessalacia, Universidade Federal de Mato Grosso do Sul

Nurse, Post-doctorate in Nursing, Associate Professor at the Federal University of Mato Grosso do Sul Foundation, Campus Três Lagoas, Três Lagoas (MS), Brazil.

Lucas Gazarini, Universidade Federal de Mato Grosso do Sul

Pharmacist, PhD in Pharmacology, Associate Professor at the Federal University of Mato Grosso do Sul Foundation, Campus Três Lagoas, Três Lagoas (MS), Brazil

Priscila Kelly da Silva Neto, Universidade Federal de Mato Grosso do Sul

Formação: Enfermeira. Mestranda em Enfermagem pela Universidade Federal de Mato Grosso do Sul, MS, Brasil. Instituição de origem: Universidade Federal de Mato Grosso do Sul, MS, Brasil.

Adailson da Silva Moreira, Universidade Federal de Mato Grosso do Sul

Graduated in Law and Psychology, PhD in Psychology, and professor at UFMS - Federal University of Mato Grosso do Sul, Três Lagoas campus - MS.

Elton Fogaça da Costa, Universidade Federal de Mato Grosso do Sul

Graduated in Law and Specialist in Bioethics, Adjunct Professor in the Law Course at the Federal University of Mato Grosso do Sul, Campus of Três Lagoas - UFMS / CPTL.

References

Amorim, K. P. C. (2019). Ética em pesquisa no sistema CEP-CONEP brasileiro: reflexões necessárias. Ciência e saúde coletiva, 24(3), 1033-1040.

Bardin, L. (2011). Análise de conteúdo [Content analysis]. São Paulo, Brasil: Edições 70.

Barrow, J. M., Brannan, G. D, & Khandhar, P. B. (2020). Research Ethics. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. Recuperado de: https://www.ncbi.nlm.nih.gov/books/NBK459281/

Beauchamp, T. L, & Childress, J. F. (2002). Princípios de ética biomédica. Tradução Luciana Pudenzi. (4ª ed). São Paulo: Edições Loyola.

Boletim Epidemiológico Especial – COE-COVID-19 (2020), (36). Brasil: Ministério da Saúde. Secretaria de Vigilância em Saúde. Recuperado de: https://www.gov.br/saude/pt-br/media/pdf/2020/outubro/23/boletim_epidemiologico_covid_36_final.pdf

Campos, A, & Oliveira, D. R. (2017). A relação entre o princípio da autonomia e o princípio da beneficência (e não-maleficência) na bioética médica. Revista Brasileira de Estudos Políticos, 115. Doi: 10.9732/P.0034-7191.2017V115P13.

Cadernos de Ética em Pesquisa (1). (1998). Conselho Nacional de Saúde. Comissão Nacional de Ética em Pesquisa. Brasília, DF: CONEP.

Orientações para condução de pesquisas e atividade dos cep durante a pandemia provocada pelo coronavírus sars-cov-2 (covid-19). Ministério da Saúde Secretaria-Executiva do Conselho Nacional de Saúde. Brasília, DF: CONEP.

COVID-19, Painel Coronavírus Brasil. Ministério da Saúde. Secretaria de Vigilância em Saúde. Recuperado de: https://Covid.saude.gov.br/.

Dawson, A., Lignou, S, & Siriwardhana, C. (2019). Why research ethics should add retrospective review. BMC Medical Ethics, 20(68). Recuperado de: https://doi.org/10.1186/s12910-019-0399-1

De Panfilis L., Merlo, D. F., Satolli, R., Perin, M., Ghirotto, L, & Costantini, M. (2019). Clinical ethics consultation among Italian ethics committee: A mixed method study. PLoS One, 14(12): e0226710. doi: 10.1371/journal.pone.0226710.

Dwyer, J, & Sambath, V. (2019). Power, pollution, and ethics. Indian J Med Ethics. 4(3), 203-206. doi: 10.20529/IJME.209.045.

Gallasch, C., Cunha, M, Pereira, L, & Silva-Junior, J. (2020). Prevenção relacionada à exposição ocupacional do profissional de saúde no cenário de COVID-19 [Prevention related to the occupational exposure of health professionals workers in the COVID-19 scenario]. Revista Enfermagem UERJ, 28, e49596. doi: https://doi.org/10.12957/reuerj.2020.49596

Garrafa, V., Cunha, T. R, & Manchola-Castillo, C. (2020). Ensino da ética global: uma proposta teórica a partir da Bioética de Intervenção. Interface - Comunicação, Saúde, Educação, 24, e190029. doi: https://doi.org/10.1590/interface.190029

Hellmann, F., Williams-Jones, B, & Garrafa, V. (2020). COVID-19 and Moral Imperialism in Multinational Clinical Research. Archives of medical research, 51(6), 572–573. https://doi.org/10.1016/j.arcmed.2020.04.017

London, A. J., & Kimmelman, J. (2020). Against pandemic research exceptionalism. Science (New York, N.Y.), 368(6490), 476–477. doi: https://doi.org/10.1126/science.abc1731

Luo, Q, & Qin, T. (2020). Managing clinical trials for covid-19: the importance of ethics committees. BMJ (Clinical research ed.), 369, m1369. doi: https://doi.org/10.1136/bmj.m1369

Organização Panamericana de Saúde - OPAS. (2020). Folha informativa – COVID-19 (doença causada pelo novo coronavírus). Recuperado de: https://www.pah o.org/bra/index.php?option=com_content&view=article&id=6101:Covid19&Itemid=875

Padala, P. R., Jendro, A. M, & Padala, K. P. (2020). Conducting Clinical Research During the COVID-19 Pandemic: Investigator and Participant Perspectives. JMIR public health and surveillance, 6(2), e18887. doi: https://doi.org/10.2196/18887

Passini, R., Pinheiro, M, & Montagner, M. (1). (2018). Declaração de Helsinque: flexibilização do uso do placebo, um interesse do mercado farmacêutico. Revista Brasileira De Bioética, 14, 1-20. doi: https://doi.org/10.26512/rbb.v14i0.14687

Pompeo, D. A., Rossi, L. A, & Galvão, C. M. (2009). Revisão integrativa: etapa inicial do processo de validação de diagnóstico de enfermagem. Acta Paulista de Enfermagem, 22(4), 434-438. doi: https://doi.org/10.1590/S0103-21002009000400014

Reis, H. T. S. (2007). A Ética Principialista como modelo na assistência à saúde humana. (Dissertação de mestrado em Filosofia, Universidade Federal de Santa Catarina, Florianópolis, Brasil).

Resolução 466/2012 de 10 de outubro de 2012. Trata das diretrizes e normas regulamentadoras de pesquisa envolvendo seres humanos. Diário Oficial da União, 12 de dezembro de 2012. Brasília: Conselho Nacional de Saúde.

Retsas, S. (2020). Clinical trials and the COVID-19 pandemic. Hellenic journal of nuclear medicine, 23(1), 4–5. doi: https://doi.org/10.1967/s002449912014

Schramm, F. R., Palácios, M, & Rego, S. (2008). O modelo bioético principialista para a análise da moralidade da pesquisa científica envolvendo seres humanos ainda é satisfatório? Ciência & Saúde Coletiva, 13(2), 361-370. doi: https://doi.org/10.1590/S1413-81232008000200011

Shojaei, A, & Salari, P. COVID-19 and off label use of drugs: an ethical viewpoint. DARU J Pharm Sci (2020). doi: https://doi.org/10.1007/s40199-020-00351-y

Shuman, A. G, & Pentz, R. D. (2020). Cancer Research Ethics and COVID-19. The oncologist, 25(6), 458–459. doi: https://doi.org/10.1634/theoncologist.2020-0221

Souza, M. T., Silva, M. D, & Carvalho, R. (2010). Revisão integrativa: o que é e como fazer. Einstein (São Paulo), 8(1), 102-106. doi: https://doi.org/10.1590/s1679-45082010rw1134

Spector-Bagdady, K., Higgins, P, & Lok, A. S. (2020). COVID-19 Clinical Trial Oversight at a Major Academic Medical Center: Approach of the Michigan Medicine COVID-19 Clinical Trial Committees. Clinical infectious diseases: an official publication of the Infectious Diseases Society of America, ciaa560. Advance online publication. https://doi.org/10.1093/cid/ciaa560

Thakur, S, & Lahiry, S. (2019). Research ethics in the modern era. Indian journal of dermatology, venereology and leprology, 85(4), 351–354. https://doi.org/10.4103/ijdvl.IJDVL_499_18

Townsend, E., Nielsen, E., Allister, R, & Cassidy, S. A. (2020). Key ethical questions for research during the COVID-19 pandemic. The lancet. Psychiatry, 7(5), 381–383. https://doi.org/10.1016/S2215-0366(20)30150-4

World Health Organization. Rolling updates on coronavirus disease (COVID-19). Recuperado de: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen.

World Medical Association. (2013). Declaration of Helsinki. Ethical principles for medical research involving human subjects. Recuperado de: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

Zhang, H., Shao, F., Gu, J., Li, L, & Wang, Y. (2020). Ethics Committee Reviews of Applications for Research Studies at 1 Hospital in China During the 2019 Novel Coronavirus Epidemic. JAMA, 323(18), 1844–1846. https://doi.org/10.1001/jama.2020.4362

Published

26/12/2020

How to Cite

PINTO, S.; PESSALACIA, J. D. R.; GAZARINI, L.; SILVA NETO, P. K. da; MOREIRA, A. da S.; COSTA, E. F. da. Ethical problems in research with human subjects during the COVID-19 pandemic: integrative literature review. Research, Society and Development, [S. l.], v. 9, n. 12, p. e32291210802, 2020. DOI: 10.33448/rsd-v9i12.10802. Disponível em: https://rsdjournal.org/index.php/rsd/article/view/10802. Acesso em: 28 apr. 2024.

Issue

Section

Health Sciences