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Feb 17, 2017

BTS 2017

A qualitative analysis and review of the informed consent process for recruiting deceased donor kidney transplant recipients to research in the EMPIRIKAL Study

;

N.N. Johnson;

T. Kassimatis;

Laura Nichols;

N. Hare;

K. Williams;

J. Olsburgh;

M. Drage

informed consent

research

empirikal

participant information

Abstract

Abstract

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Keywords

informed consent

research

empirikal

participant information

Abstract

Introduction: The EMPIRIKAL study aims to evaluate the efficacy of Mirococept in reducing the incidence of delayed graft function in deceased donor renal transplantation. Voluntary informed consent is fundamental to research participation (RCN 2011). For consent to be valid, participants need to understand important information about the study (e.g. purpose of the research, what participation involves, potential risks and benefits). Adequate time for reading research information and answering questions is required. This is challenged by the nature of organ availability, timing of admission and conflicting priorities in preparing the patient. Methods: Review of current practice; questions frequently asked during the consent process and received patient feedback was undertaken. Results were used to guide future practice and improve the consent process. Results: Feedback from recruited participants indicated some faced difficulties in digesting information amid anxieties about surgery. Some wanted more time to consider the research. Questions during consent included drug safety information, number of participants enrolled to date and what side effects were expected. Discussion: This review highlights that providing patients with research information and allowing time for questions prior to admission for surgery is essential to the consent process and may improve comprehension of research material. An invitation letter and study participation information is posted to patients on the deceased donor register. This is now followed up with a telephone call to confirm receipt and answer questions. Coordination between admission and research teams maximises opportunities for patients to better understand consent to research studies and may enhance recruitment. RCN (2011) Informed consent in health and social care: RCN Guidance for Nurses. Royal College of Nursing: London

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© Copyright 2019 Morressier GmbH.
All rights reserved.