Journal article
The informed consent process in health research with under-served populations: a realist review protocol
- Abstract:
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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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Supplementary materials, pdf, 32.5KB, Terms of use)
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(Preview, Version of record, pdf, 602.2KB, Terms of use)
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- Publisher copy:
- 10.1186/s13643-021-01652-2
Authors
+ National Institute for Health and Care Research
More from this funder
- Funder identifier:
- https://ror.org/0187kwz08
- Publisher:
- BioMed Central
- Journal:
- Systematic Reviews More from this journal
- Volume:
- 10
- Issue:
- 1
- Article number:
- 103
- Publication date:
- 2021-04-09
- Acceptance date:
- 2021-03-29
- DOI:
- EISSN:
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2046-4053
- Language:
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English
- Keywords:
- Pubs id:
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2128989
- Local pid:
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pubs:2128989
- Deposit date:
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2025-06-09
- ARK identifier:
Terms of use
- Copyright holder:
- Hoverd et al.
- Copyright date:
- 2021
- Rights statement:
- © The Author(s). 2021 Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
- Licence:
- CC Attribution (CC BY)
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