CRN West Midlands Primary Care/Unit of Academic Primary Care, Warwick Medical School, Warwick University, Gibbet Hill Rd, Coventry, CV4 7AL, England.
Warwick Research in Nursing, Warwick Medical School, Warwick University, Coventry, England.
Syst Rev. 2021 Apr 9;10(1):103. doi: 10.1186/s13643-021-01652-2.
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.
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.
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.
知情同意过程旨在向潜在参与者提供有关健康研究的信息，使他们能够就是否选择参与做出明智的决定。然而，对于在健康研究中服务不足的人群，该过程是否有效仍不清楚。扩大参与健康研究的人群多样性是健康研究中的一个关键问题。英国国家卫生研究院（NIHR）承诺支持平等、多样性和包容性，积极为所有符合条件的公民创造参与健康研究的机会。
为了了解健康研究中服务不足人群的知情同意过程是如何运作的，在什么情况下以及在哪些方面，将采用现实主义审查方法。将使用电子数据库（EMBASE、MEDLINE、Web of Science 和 PsycINFO）以及选定的网站和灰色文献进行搜索。初始粗略方案理论的开发将导致更精细的方案理论，该理论将提供对背景、机制和结果的解释。NIHR（公众）研究冠军、卫生专业人员和临床学者的利益相关者参与将提供有关概念和方案理论的专家意见。
这项现实主义审查的结果将强调健康研究中的知情同意过程如何影响服务不足人群的潜在参与者的体验和决策过程。它们将按照 RAMESES 指南进行编写，并通过同行评审的出版物、演讲和讨论分发给患者和公众、健康研究人员、卫生专业人员和政策制定者。该审查将有助于我们了解在健康研究中经常代表性不足的人群的知情同意过程中导致积极和消极结果的机制，为政策、研究设计和实施提供信息。
