Mark Israel, Deborah Hersh and Ciara Shiggins

Advocates in health research of Consumer and Community Involvement – a concept better known in the United Kingdom as Patient and Public Involvement (PPI) – argue that it offers a way of building knowledge that incorporates the experiences and perspectives of a range of stakeholders, including patients and members of the public. Such involvement can improve the experience for research participants, enhance the process of informed consent, aid research impact and dissemination. It might also avoid the waste of resources on findings that have little relevance to end users or that cannot be implemented. Adopting consumer and community involvement focuses on justice, both procedural in relation to fair treatment during the research, and distributive in terms of fair allocation of the benefits and possible burdens of research. This position has found favour among consumer advocates, researchers, editors and research funders. As a result, consumer and community involvement is increasingly expected and is a bureaucratic prerequisite for research to occur in some countries. For example, within the United Kingdom evidence of patient and public involvement is essential for those seeking National Institute for Health Research funding. Similarly, in Australia, the National Health and Medical Research Council (NHMRC) and the Consumer Health Forum of Australia have developed the Statement on Consumer and Community Involvement in Health and Medical Research (2016).

Consumer and community involvement and Research Ethics

However, our guidelines on research ethics have not kept up. Human research ethics statements traditionally focus on the relationship between researchers and research participants, particularly on protecting participant rights, and ensuring that they are treated properly. Consumer and community involvement requires new thinking because of the shift in that relationship. When patients and members of the public are partners, the ethical questions and choices that arise in relation to a study will diverge from those associated with individuals who are research participants. We suggest consumer and community involvement extends the remit for research ethics – raising ethical questions early, even before the design of a project, and having effects on the public long after a project has ended. We also argue that the shift towards acceptance and expectation of consumer and community involvement demands an equivalent shift in ethical considerations right across the research process.

In a recent article focused on consumer and community involvement with people who have aphasia (Hersh et al., 2021), we used the 2018 revision of the Australian National Statement on Ethical Conduct in Human Research (2007) as a framework to guide an in-depth consideration of the ethics associated with consumers and members of the community as research partners. We examined the need to stretch ethical thinking to a point before Element 1 in the National Statement to prepare both researchers and partners for their collaboration, roles, and relationship.

Ethics and Element Zero

Genuine consumer and community involvement occurs from the very start of a research initiative, when research aims and questions are identified, issues are prioritised and funding is sought. However, this can be difficult to achieve. If a research team is submitting a grant application, is that application based on discussions with partners? If so, in that early stage how might these partners have been prepared, invited, involved and perhaps paid for their time considering the grant application itself was still in preparation? These partners may have additional requirements that need to be understood, acknowledged, and accommodated to ensure an inclusive and accessible process. This is the case when working with people with aphasia, a language disorder acquired after brain damage (such as stroke) that can affect spoken language, understanding, reading, or writing. Preparation is required for researchers to enable a real partnership and to avoid tokenism, a superficial involvement simply to satisfy expectations of funders, editors or research ethics committees. In our work (Hersh et al., 2021), we argue that the National Statement needs to be amended to consider what happens before Element 1. We call this stage Element Zero.

We assert that groundwork is required to prepare both researchers and potential research partners to understand and take full advantage of consumer and community involvement. Partners need to be fully informed about what research projects entail so that they can exercise their autonomy, share their expertise to benefit others, take part in shaping the research agenda, and are neither exploited nor unfairly advantaged in the distribution of resources that might flow from projects.

Research teams should consider what they mean by consumer and community involvement and what roles different people might play within it; they should also reflect on their motivations for conducting it. They could consider different possible levels of involvement for consumers and community members – if their research benefits from consultation (asking for views and opinions), collaboration (working together as co-researchers more deeply embedded in the project over time), or a user-controlled approach (where a community sets an agenda and also enrols researchers to work with it) (Health Research Authority/INVOLVE, 2016). Potential roles and responsibilities should be established in the early stages of developing ideas about research projects, prior to applications for funding. If left until later, the research questions, design, timeframe, and budget may no longer be negotiable. Underpinning these efforts is the understanding that they permit a truly respectful research partnership and relationship, two-way learning, and mutual benefit. This includes encouraging researchers to educate themselves about how to accommodate partners with physical, sensory, cognitive, or communication needs.

Element Zero is not simply about preparing individuals but also considers preparation for, and with, community groups or organisations. This work should enable greater collective confidence for community members to act as representatives and advocates on projects. Empowering people to have a say and be prepared to take roles in research respects their autonomy and human right to have a positive impact on service provision and life quality. It is also relevant to community-based participatory research (Hacker, 2013) outside the health area. When research is conducted on this basis it might contribute to a broader political agenda of decolonising methodologies (Smith, 2012; AIATSIS, 2020), a stimulus for critiquing how dominant cultures shape what and who are deemed worthy of research and funding, what knowledges are privileged, what relationships between researcher and researched are acceptable, and to whom researchers and their institutions should be accountable.

Element Zero supports merit and integrity, and a genuine rationale for involving consumers and communities as research partners. It gives attention to the need for research teams to discuss expectations, attitudes, benefits, and challenges in relation to consumer and community involvement and choices within potential research studies. Element Zero also offers a challenge to those who draft ethics guidelines to acknowledge what is missing from the Australian National Statement and how this can be rectified.

Conflicts of Interest: The authors have no conflicts of interest to declare.

References

Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS) (2020) AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research. https://aiatsis.gov.au/sites/default/files/2020-10/aiatsis-code-ethics.pdf

Hacker, K A (2013) Community-Based Participatory Research. London: SAGE.

Health Research Authority/INVOLVE (2016) Impact of public involvement on ethical aspects of research. https://www.invo.org.uk/posttypepublication/public-involvement-in-researchimpact-on-ethical-aspects-of-research

Hersh D, Israel M & Shiggins C (2021) The ethics of Patient and Public Involvement across the research process: Towards partnership with people with aphasia. Aphasiology DOI: 10.1080/02687038.2021.1896870

National Health and Medical Research Council (2007, updated 2018). National Statement on Ethical Conduct in Human Research. https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018

National Health and Medical Research Council (2016). Statement on Consumer and Community involvement in Health and Medical Research. Consumers Health Forum of Australia. https://www.nhmrc.gov.au/about-us/publications/statement-consumer-and-community-involvement-health-and-medical-research

National Institute for Health Research (NIHR) (2015) Going the extra mile: Improving the nation’s health and wellbeing through public involvement in research. http://www.nihr.ac.uk/news/going-the-extra-mile-a-strategic-review-of-74/8*9-+public-involvement-in-the-nationalinstitute-for-health-research/2739.

Smith, L T (2012) Decolonizing methodologies. Research and indigenous peoples (2nd ed.). Zed Books.

Acknowledgements

This article draws on our work (Hersh et al., 2021) published in the Special Issue of Aphasiology on the topic of Patient and Public Involvement. Figure One is reproduced from that article and is published here with permission from Taylor & Francis Ltd. We thank Lauren Wilson and Melissa Green for their help designing the Figure.

This post may be cited as:
Israel, M., Hersh, D. & Shiggins, C. (28 April) Element Zero: What’s missing from the National Statement to support Consumer and Community Involvement in health research? Research Ethics Monthly. Retrieved from: https://ahrecs.com/element-zero-whats-missing-from-the-national-statement-to-support-consumer-and-community-involvement-in-health-research/