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Current outlook of ethics in research with human subjects / Panorama atual da ética em pesquisa em seres humanos
Takahashi, Marystella Tomoe; Ramos, Henrique Faria; Pinheiro-Neto, Carlos Diógenes; Miziara, Ivan Dieb; Oliveira, Reynaldo Ayer de.
  • Takahashi, Marystella Tomoe; University of São Paulo. Medical School. University Hospital. Group of Voice ENT Division.
  • Ramos, Henrique Faria; University of São Paulo. Medical School. University Hospital. Department of Otorhinolaryngology.
  • Pinheiro-Neto, Carlos Diógenes; University of São Paulo. Medical School. University Hospital. Department of Otorhinolaryngology.
  • Miziara, Ivan Dieb; University of São Paulo. Medical School. University Hospital. Department of Otorhinolaryngology Stomatology Group.
  • Oliveira, Reynaldo Ayer de; University of São Paulo. Medical School. Department of Forensic Medicine, Medical Ethics, Social Medicine and Occupational Medicine.
Braz. j. otorhinolaryngol. (Impr.) ; 77(2): 263-266, Mar.-Apr. 2011.
Article in English | LILACS | ID: lil-583841
ABSTRACT
In the last decades, medical care has been increasingly permeated by the concept of evidence-based-medicine, in which clinical research plays a crucial role in establishing diagnostic and treatment. Following the improvements in clinical research, we have a growing concern and understanding that some ethical issues must be respected when the subjects are human beings. Research with human subjects relies on the principles of autonomy, beneficence, no maleficence and justice. Ordinance 196/96 from the National Health Board adds to the Brazilian legislation such renowned bioethical principles.

AIM:

Discuss the main ethical aspects involved in research with human subjects. MATERIALS AND

METHODS:

Critical analysis of Ordinance 196/96 and related literature.

CONCLUSION:

Ordinance 196/96 rules research with human subjects; nevertheless, it requires more in-depth discussions regarding the informed consent, use of placebo, research with vulnerable populations and research in developing countries.
RESUMO
Nas últimas décadas, a medicina tem sido cada vez mais permeada pelo conceito de medicina baseada em evidências, na qual a pesquisa clínica possui papel crucial no estabelecimento de diretrizes diagnósticas e terapêuticas. Com o avanço da pesquisa clínica, surgiu a preocupação e o entendimento que certos padrões éticos devam ser obedecidos quando o objeto de estudo é o ser humano. A pesquisa em seres humanos baseia-se nos princípios da autonomia, beneficência, não maleficência e justiça. A Resolução 196/96 do Conselho Nacional de Saúde incorpora à legislação brasileira tais princípios bioéticos consagrados.

OBJETIVO:

Discutir os principais aspectos éticos envolvidos na pesquisa em seres humanos. MATERIAL E

MÉTODO:

Análise crítica da Resolução 196/96 do CNS e literatura correlata.

CONCLUSÃO:

A Resolução 196/96 do Conselho Nacional de Saúde regulamenta a experimentação em seres humanos, no entanto necessita de discussões mais profundas no que diz respeito ao consentimento livre e esclarecido, ao uso de placebo, à participação de pessoas em situação de vulnerabilidade e à realização de pesquisas em países em desenvolvimento.
Subject(s)


Full text: Available Index: LILACS (Americas) Main subject: Ethics, Research / Human Experimentation Type of study: Controlled clinical trial / Practice guideline / Prognostic study / Qualitative research Limits: Humans Country/Region as subject: South America / Brazil Language: English Journal: Braz. j. otorhinolaryngol. (Impr.) Journal subject: Otolaryngology Year: 2011 Type: Article Affiliation country: Brazil

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Full text: Available Index: LILACS (Americas) Main subject: Ethics, Research / Human Experimentation Type of study: Controlled clinical trial / Practice guideline / Prognostic study / Qualitative research Limits: Humans Country/Region as subject: South America / Brazil Language: English Journal: Braz. j. otorhinolaryngol. (Impr.) Journal subject: Otolaryngology Year: 2011 Type: Article Affiliation country: Brazil