ABSTRACT

Background: Conducting Patient and Public Involvement (PPI) in health research is a way of building knowledge that incorporates the experience of service users, adds research impact, and helps avoid wasting resources on findings that have little relevance to people or cannot be implemented. We argue that there is a need to extend ethical considerations currently focused on research participants with aphasia to encompass and guide expectations of involvement in partnerships with people with aphasia across the research lifecycle.

Method: We use the 2018 revision of the Australian National Statement on Ethical Conduct in Human Research as the framework for this article. The National Statement is underpinned by values based on respect for human beings, research merit and integrity, justice, and beneficence. While the National Statement outlines the ethical standards for conducting human research with research participants in Australia, the ideas and principles within it draw on international norms. Building on the seven elements of the research process introduced in Chapter 3 of the National Statement, we develop a model for examining ethics and PPI across the research lifecycle. This model revolves around an extra phase, Element Zero, required for the preparation of PPI for both researchers and research partners with aphasia.

Results: There are many ethical considerations when involving patients and members of the public across the research lifecycle. Ethical questions that arise in relation to patients and the public as partners (whether in a role of consultant, advisor, collaborator or within user-controlled projects) may differ from those associated with participants. The nature of the relationships built through the PPI process requires a clear extension of the remit for research ethics to encompass ethical reflection both before the design of a project and after a project has ended as represented by the Ethics and PPI Research Lifecycle Model.

Conclusion: The role of people with aphasia as partners in research recognises their expertise and potential to improve the relevance and impact of research endeavours. Reflecting on the ethical implications of this is crucial, protecting, empowering and enabling both researchers and partners with aphasia to engage with each other through respectful and positive research relationships.

摘要

背景：进行健康研究中的患者和公众参与（PPI）是一种积累知识的方法，该方法吸收服务用户的经验，增加研究影响，并有助于避免将资源浪费在与人无关或无法实施的研究结果上。我们认为，有必要扩展目前针对失语症研究参与者的道德考量，以涵盖和指导在整个研究生命周期中参与与失语症患者建立伙伴关系的期望。

方法：我们使用2018年修订的《澳大利亚国家人类研究道德行为国家声明》作为本文的框架。《国家声明》的基础是尊重人类，研究功绩和正直，正义与仁慈的价值观。尽管《国家声明》概述了与澳大利亚研究人员进行人类研究的道德标准，但其中的思想和原则借鉴了国际规范。以《国家声明》第3章中介绍的研究过程的七个要素为基础，我们开发了一个用于在整个研究生命周期中检查道德和PPI的模型。该模型围绕着一个额外的阶段，即零元素，这是为失语症的研究人员和研究伙伴准备PPI所必需的。

结果：在整个研究生命周期中，让患者和公众参与时，有许多道德方面的考虑。关于患者和公众作为合作伙伴的道德问题（无论是作为顾问，顾问，合作者还是在用户控制的项目中）可能与参与者有关。通过PPI流程建立的关系的性质要求将研究伦理的职权范围明确扩展，以涵盖在伦理设计和 PPI研究生命周期模型所代表的项目设计之前和项目结束之后的伦理反思。

结论：失语症患者作为研究合作伙伴的角色认识到他们的专业知识和潜力，可以改善研究工作的相关性和影响力。反思这种伦理意义至关重要，保护，授权和使失语症的研究人员和合作伙伴能够通过相互尊重和积极的研究关系相互参与。