Abstract
BackgroundThe 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.MethodsIn 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.DiscussionFindings 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.
Highlights
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
Following involvement from a range of stakeholder groups as part of the project, it is recommended that the term under-served is preferred when describing the many groups of people whom are often not represented in health research, such as ethnic minority groups [8]
It is unclear from the wider literature as to what a suitable definition of under-served groups is, as this varies according to setting and perspective, but they are often those groups whom are met with difficulties in accessing and utilising resources [9]
Summary
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. Following involvement from a range of stakeholder groups as part of the project, it is recommended that the term under-served is preferred when describing the many groups of people whom are often not represented in health research, such as ethnic minority groups [8] It is unclear from the wider literature as to what a suitable definition of under-served groups is, as this varies according to setting and perspective, but they are often those groups whom are met with difficulties in accessing and utilising resources [9]. A suitable working definition will be proposed by the stakeholder groups for the purpose of this review
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