Process Factors Influencing Informed Consent For Clinical Research
Research type
Research Study
Full title
An exploratory study of service users' perspectives of the process of informed consent for participation in clinical research
IRAS ID
149566
Contact name
Nwanyieze N Nwali
Contact email
Sponsor organisation
Northumbria University
Duration of Study in the UK
1 years, 0 months, days
Research summary
Abstract
Research question: What is the perspective of service users on the process of informed consent for clinical research participation?
Background: Informed consent is identified as the “heart of ethical research”.
To ensure that prospective research participants are provided with well-balanced information on clinical research studies, a critical review must be carried out by the Research Ethics Committee (REC) in line with the Research Governance Framework (RGF), before an approval to proceed is given. This is a long standing requirement by the UK Department of Health (DOH) amongst other nations.However, despite the rigorous ethics review exercises, there is on-going concern that certain elements of the clinical research process is rather subjecting health research to unparalleled difficulties. One of these elements at the heart of ethical research is the process of informed consent for clinical research participation. Notwithstanding the challenging REC review process, Expert opinions claim that, most research participants remain unable to neither understand nor recall essential study information about studies in which they have signed to take part. It is unclear what component or combinations of components influence such non-operational outcome. This study seeks to explore the views of service users on the process of informed consent for clinical research participation.
Design: This study is a naturalistic inquiry using constructivist methodology.
Data collection & Analysis: Data will be collected by semi-structured one-to-one face-to-face interviews. Colaizzi Six Stage Model of Qualitative data analysis will be utilized to analyse data by content and thematic analysis.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1220
Date of REC Opinion
20 Oct 2014
REC opinion
Favourable Opinion