Requerimientos normativos¿Qué pasos tengo que seguir antes de iniciar un estudio de investigación biomédica?

  1. P.M. López Vázquez 1
  2. S. Cinza Sanjurjo 13
  3. M. Portela Romero 12
  1. 1 Servicio Galego de Saúde, Santiago de Compostela (A Coruña), España
  2. 2 Centro de Concepción Arenal, Santiago de Compostela (A Coruña), España
  3. 3 Centro de Salud de Porto do Son, Santiago de Compostela (A Coruña), España
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Revista:
Semergen: revista española de medicina de familia

ISSN: 1138-3593

Ano de publicación: 2019

Número: 2

Páxinas: 134-140

Tipo: Artigo

DOI: 10.1016/J.SEMERG.2018.06.005 DIALNET GOOGLE SCHOLAR

Outras publicacións en: Semergen: revista española de medicina de familia

Obxectivos de Desenvolvemento Sustentable

Resumo

Studies of research with human beings, their biological specimens, or their personal data in the field of biomedicine have been subject to regulation since the middle of the last century. Initially a regulation based on recommendations such as the Nuremberg Code, the Belmont Report or the first versions of the Declaration of Helsinki. All of them documents in which the principles (autonomy, beneficence, non-maleficence, and justice) were conceptualized, and that all researchers had to follow in the development of their research. This first phase is known as a period of self-regulation, because it is considered that the researchers themselves could, by following these recommendations, carry out their investigations without further control. Subsequently, it went through a clearly regulatory period in which the premises of these recommendations were progressively incorporated into the legal system of the different countries, and with this, arose the external control of the investigation by the administrations and other bodies, such as the Research Ethics Committees. The purpose of this article is to serve as a guide to professionals whose main activity is care in the field of Primary Care and who, in turn, are interested in initiating research studies to respond to uncertainties in the context of their daily activity that may arise.

Referencias bibliográficas

  • L. Palomo Ensayos clínicos en atención primaria, o la investigación a ras de suelo Semergen., 27 (2001), pp. 466-468 ArticleDownload PDFGoogle Scholar
  • E.I. García Criado Investigación en atención primaria Semergen, 27 (2001), pp. 190-211 ArticleDownload PDFGoogle Scholar
  • T. Seoane, E. Martín-Sánchez, J.L.R. Martín, S. Lurueña-Segovia, F.J. Alonso Moreno Curso de introducción a la investigación clínica. Capítulo 3: La investigación a partir de la observación. Estudios descriptivos. Estudios analíticos Semergen, 33 (2007), pp. 250-256 ArticleDownload PDFView Record in ScopusGoogle Scholar
  • E. Martín-Sánchez, J.L.R. Martín, T. Seoane, S. Lurueña-Segovia, F.J. Alonso Moreno Curso de introducción a la investigación clínica. Capítulo 4: El ensayo clínico. Metodología de calidad y bioética Semergen, 33 (2007), pp. 296-304 ArticleDownload PDFView Record in ScopusGoogle Scholar
  • N. Riba, G. Calvo Pruebas invasivas en investigación clínica: ¿suponen siempre un incremento del riesgo? ICB digital. (Noviembre 2015) [consultado 23 Feb 2018]. Disponible en: https://se-fc.org/gestor/images/icbdigital/93aarticulo.pdf Google Scholar
Fonte de datos: Dialnet