Design and validation of 2 instruments to analyze and evaluate the formal quality in the informed consent process of clinical trials with medicinal products. / Diseño y validación de 2 instrumentos para analizar y evaluar la calidad formal en el proceso de consentimiento informado de ensayos clínicos con medicamentos.
Farm Hosp
; 47(2): 64-68, 2023.
Article
em En, Es
| MEDLINE
| ID: mdl-37000781
ABSTRACT
OBJECTIVE:
The activity of sponsors and Ethics Committees for Research with medicines has increased in recent years. The objective was to design and validate 2 instruments to analyze and evaluate the formal quality of the patient information sheet and the informed consent form of clinical trials with drugs, in accordance with the legislation.METHOD:
Design (Guideline for good clinical practice and European and Spanish regulations); validation (Delphi method and expert consensus concordance ≥ 80%); reliability (inter-observer method, Kappa index). 40 patient information sheets/informed consent forms were evaluated.RESULTS:
Very good concordance was obtained in both checklists (k ≥ 0.81, p < 0.001). The final versions consisted of checklist-patient information sheet 5 sections, 16 items and 46 sub-items; and checklist-informed consent form 11 items.CONCLUSION:
The instruments developed are valid, reliable and facilitate the analysis, evaluation, and decision-making on the patient information sheets/informed consent forms of clinical trials with drugs.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Consentimento Livre e Esclarecido
Tipo de estudo:
Guideline
/
Prognostic_studies
Aspecto:
Ethics
Limite:
Humans
Idioma:
En
/
Es
Revista:
Farm Hosp
Ano de publicação:
2023
Tipo de documento:
Article