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Open Access 01-12-2021 | Protocol

The informed consent process in health research with under-served populations: a realist review protocol

Authors: Eleanor Hoverd, Sophie Staniszewska, Jeremy Dale

Published in: Systematic Reviews | Issue 1/2021

Abstract

Background

The informed consent process aims to provide potential participants with information about health research that enables them to make an informed decision as to whether they choose to participate, or not. However, it remains unclear as to whether the process is effective for those who are under-served in health research. It is a pivotal issue within health research that the diversity of people who participate is broadened. The National Institute for Health Research (NIHR) pledges to support equality, diversity and inclusion, actively creating opportunities for all citizens whom are eligible, to take part in health research.

Methods

In order to understand how the informed consent process for under-served populations in health research works, under what circumstances and in what respects, a realist review approach will be undertaken. Searches will be carried out using electronic databases (EMBASE, MEDLINE, Web of Science and PsycINFO), along with selected websites and grey literature. Development of initial rough programme theory(ies) will lead to a more refined programme theory that will provide an explanation of context, mechanism and outcomes. Stakeholder involvement by NIHR (Public) Research Champions, health professionals and clinical academics will provide expert opinion about concepts and programme theory.

Discussion

Findings of this realist review will highlight how the informed consent process in health research affects the experience and decision-making process of potential participants from under-served populations. They will be written up in accordance with RAMESES guidelines and disseminated to patients and the public, health researchers, health professionals and policymakers through peer-reviewed publication, presentations and discussions. The review will contribute to our understanding of the mechanisms that cause both positive and negative outcomes in the informed consent process for those whom are often under-represented in health research to inform policy, study design and delivery.

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Title: The informed consent process in health research with under-served populations: a realist review protocol
Authors: Eleanor Hoverd
Sophie Staniszewska
Jeremy Dale
Publication date: 01-12-2021
Publisher: BioMed Central
Published in: Systematic Reviews / Issue 1/2021
Electronic ISSN: 2046-4053
DOI: https://doi.org/10.1186/s13643-021-01652-2

At a glance: The STEP trials

Springer Medicine

The informed consent process in health research with under-served populations: a realist review protocol

Abstract

Background

Methods

Discussion

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Discussion

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