Literature DB >> 27145389

Informed consent in clinical research; Do patients understand what they have signed?

Elena Villamañán1, Margarita Ruano1, Enma Fernández-de Uzquiano2, Paz Lavilla2, Diana González3, Mercedes Freire1, Carmen Sobrino1, Alicia Herrero1.   

Abstract

Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

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Year:  2016        PMID: 27145389     DOI: 10.7399/fh.2016.40.3.10411

Source DB:  PubMed          Journal:  Farm Hosp        ISSN: 1130-6343


  4 in total

1.  Subject Retention in Prehospital Stroke Research Using a Telephone-Based Physician-Investigator Driven Enrollment Method.

Authors:  Bryant J Rosell; Kristina Shkirkova; Jeffrey L Saver; David S Liebeskind; Sidney Starkman; May Kim-Tenser; Marc Eckstein; Latisha Sharma; Robin Conwit; Scott Hamilton; Nerses Sanossian
Journal:  Cerebrovasc Dis Extra       Date:  2019-07-25

2.  Patients' knowledge about their involvement in clinical trials. A non-randomized controlled trial.

Authors:  Pablo Juan-Salvadores; Marcela Sánchez Michel Gómez; Víctor Alfonso Jiménez Díaz; Cristina Martínez Reglero; Andrés Iñiguez Romo
Journal:  Front Med (Lausanne)       Date:  2022-09-20

3.  Readability of patient information and consent documents in rheumatological studies.

Authors:  Bente Hamnes; Yvonne van Eijk-Hustings; Jette Primdahl
Journal:  BMC Med Ethics       Date:  2016-07-16       Impact factor: 2.652

4.  How informed are our subjects?

Authors:  Ravindra B Ghooi
Journal:  Perspect Clin Res       Date:  2016 Jul-Sep
  4 in total

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