Management of the research nurse in the informed consent process in clinical trials

Authors

Keywords:

consentimiento informado, enfermería, ensayos clínicos.

Abstract

Informed consent is a process that consists of a dialogue between researchers and the patient about a certain procedure related to their health. In clinical trials, informed consent has a special connotation because it is research in which the efficacy and safety of a new product can be sought. The bioethical principles of autonomy, justice and beneficence have their maximum expression in these studies. The health professional must inform the patient and respect the decision she makes, in accordance with her values and her life project, as a clear expression of her moral autonomy. Historically, the process is led by the medical researcher, however, research nurses can assume responsibility in the process, as long as they are well prepared and trained in the problem under investigation, in good clinical practices and in current laws and procedures. The research nurse can lead the informed consent, just as the clinical researcher does.

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Author Biography

Maura Tamayo Rodriguez, Centro Nacional de Toxicologia

Licenciada en Enfermeria. Master en Ensayos Clínicos. Enfermera investigadora de la sala de ensayos clinicos del Cenatox.

References

1. Vélez Vélez E. Investigación en Enfermería, fundamento de la disciplina. Rev de administración sanitaria siglo XXI. 2009 [acceso: 12/10/2019]; 7(2): 341-356. Disponible en: https://www.elsevier.es/es-revista-revista-administracion-sanitaria-siglo-xxi-261-pdf-13139769

2. Hereu P, Arnau JM. El consentimiento informado en los ensayos clínicos. En: Dal-Ré R, Carné X, Gracia D. Luces y sombras en la investigación clínica. Barcelona: Edit. Fundación Víctor Grífols i Lucas; 2015. [acceso: 13/08/2019]. Disponible en: https://www.fundaciogrifols.org/documents/4662337/4688901/cap5.pdf/e55c4c3f-87b6-4055-85bd-ed0cbd386d05

3. Grady C. The changing face of informed consent. Rev British Dental Journal. 2015[acceso: 13/05/2018];219(7):325-7. Disponible en: https://www.exodontia.info/files/BDJ_2015._The_Changing_Face_of_Informed_Consent.pdf

4. Villamaña E, Ruano M, Fernández-de Uzquiano E, Lavilla P, González D, Freire M, et al. Informed consent in clinical research: do patients understand what they have signed. Farm hosp. 2016 [acceso: 20/02/2019]; 40(3):209-218. Disponible en: https://scielo.isciii.es/scielo.php?script=arttext&pid=S113063432016000300006&1ng=es

5. Garay OE. Consentimiento informado: antecedentes éticos y jurídicos. Buenos Aires: DELS; 2017 [actualizado: 03/2017; acceso: 28/01/2019]. Disponible en: https://www.salud.gob.ar/dels/entradas/consentimiento-informado-antecedentes-eticos-y-juridicos

6. AMM. Declaración de Helsinki de la Asociación Médica Mundial. Principios éticos para las investigaciones médicas en seres humanos. Oslo: WMA; 2013. [actualizado: 21/03/2017; acceso: 13/03/2019]. Disponible en: https://www.wma.net/es/policies-post/declaracion-de-helsinki-de-la-amm-principios-eticos-para-las-investigaciones-medicas-en-seres-humanos/

7. Galende Domínguez I. Ética e investigación clínica: uso adecuado de la información genética. Responsabilidades de los biobancos. 2016 [acceso: 27/09/2019]; 7(2):12-18. Disponible en: https://www.endocrinologiapediatrica.org/revista/p1-E20-S943-A382.pdf

8. FDA. E6 (R2) Good Clinical Practice: integrated addendum to ICH E6 (R1) Guidance for Industry. New Hampshire: United States Department of Health and Human Services; 2018. [acceso: 25/06/2018]. Disponible en: https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf

9. OPS/CIOMS. Pautas éticas internacionales para la investigación biomédica en seres humanos. Washington: OPS/CIOMS; 2017. [acceso: 16/02/2018]. Disponible en: https://cioms.ch/wp-content/uploads/2017/12/CIOMS-EthicalGuideline_SP_INTERIOR-FINAL.pdf

10. Hernández-Medina GA. Historia del Consentimiento Informado. 2017. [actualizado: 06/09/2018; acceso: 16/05/2019]. Disponible en: https://eticapsicologica.org/index.php/info-investigacion/item/4-historia-del-consentimiento-informado?showall=1

11. Pinto Bustamante BJ, Gulfo Díaz R. Asentimiento y consentimiento informado en pediatría: aspectos bioéticos y jurídicos en el contexto colombiano. Revista Colombiana de Bioética. 2013 [acceso: 02/02/2019]; 8(1):[aprox. 15 p]. Disponible en: https://www.readalyc.org/pdf/1892/1892284290100000000000.pdf

12. Mentz RJ, Hernández AF, Berdan LG, Rorick T, O'Brien EC, Ibarra JC. Good clinical practice guidance and pragmatic clinical trials: balancing the best of both worlds. Circulation. 2016 [acceso: 3/03/2019]; 133(9):872-80. Disponible en: https://www.ncbi.nlm.nih.gov/pubmed/26927005

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Published

2020-10-06

How to Cite

1.
Tamayo Rodriguez M. Management of the research nurse in the informed consent process in clinical trials. Rev Cubana Med Milit [Internet]. 2020 Oct. 6 [cited 2025 Apr. 4];49(4):e0200527. Available from: https://revmedmilitar.sld.cu/index.php/mil/article/view/527

Issue

Vol. 49 No. 4 (2020): October - December

Section

Opinion Article

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