Review of the 2016 Statement on Consumer and Community Involvement in Health and Medical Research

• There is a lack of consistency from research funders in terms of consumer involvement in research. We would prefer a single statement/guidance or consistency from funders
• The terms “consumers” and “community” do not reflect the role of all stakeholders with lived experience who are involved in research activities. Some people in these roles have expressed their inability to speak as a representative for a community or a consumer group. The preference is for flexibility in the terms used to allow the person to choose how they identify in their role.
• The current statement emphasises the importance of promoting consumer and community involvement through their representation within research project teams and organisations, which is undoubtedly a critical aspect of reflecting their voices. Additionally, the statement could explicitly recognise the value of using various research methods traditionally utilised in health service and implementation research (e.g. focus groups, co-design workshops, Delphi studies) to engage a wide range of consumers in determining research and practice priorities, identifying gap areas, and developing implementation strategies. These methods can provide effective mechanisms to ensure a wide range of consumer voices are represented, especially those who may not have the resources or time to engage in research on a consistent base. The initiative, as well as the call for research “by consumers”, is not clearly supported by funding structures such as NHMRC and this responsibility is left to researchers and research institutions to co-ordinate and fund. This is an additional burden.
• There is also a lack of guidance on budget and funding for consumer involvement. Consumers can feel uncomfortable being asked what remuneration they expect.
• In the current statement, the onus on building consumer capacity is on the researcher and the research institution. This is a significant responsibility and requires adequate resourcing and funding. The researchers and research institutions should certainly be involved in these activities, and this could be supported by NHMRC through funding to specialised organisations and/or within grant funding required to be dedicated to consumer involvement in research.
• The statement calls for “appropriate consumer involvement in research”. The statement could be amended to include possible interpretations of “appropriate” in this context as a guide for research institutions and researchers.
• There is no recommended central place to access consumer research training, resources & support. There needs to be consistency and a central point to address consumer needs.
• Some researchers leaving consumer involvement to last minute with little true engagement in project design or development of data collection tools.

o Our Centre’s position on consumer and community involvement in research embraces the value of public participation, recognising the contribution user-inspired research makes to the community.
o Consumers bring a diversity of age, gender, culture, and ability. Their experience and perspectives can lead to improved relevance, quality, and outcomes from research projects.
o Consumer representatives play an important role in research as they are involved in concept development, contribute to grant applications, review and provide feedback on lay summaries, patient information, and consent forms as well as co-designing research. They also provide a mechanism for advice on clinical trial design, recruitment, and communication strategies to support the dissemination of research findings to the community. These can enable consumer to become equal partners in the research.
o A consumer perspective can also influence changes to research design and treatment decisions as well as informing researchers of the impact of the research on the patient & their family members.
o The heart of the value in involving consumers in research is in improving transparency and accountability in research.

o We are cognisant that consumer involvement in research is increasingly common and becoming a necessary requirement in health settings. Funding and policy contexts are shifting towards consumer engagement and involvement. As a Centre, we aim to integrate the consumer voice through our actions in research and the establishment of a Consumer Involvement in Research Panel. The Panel will contribute to the strategic direction of the Centre and support the integration and systematisation of consumer involvement in all aspects of our research.
o Our Panel members represent people who can’t speak for themselves, and may be too ill to be involved in research projects. They would like to influence where funds are spent to ensure cost-effectiveness and maximal benefit to those impacted by cancer. The community provides the funds so they should have a voice in how the research funds are spent.

The values proposed in the later question cover the main additions that are warranted in the value statement:
• Accountability: all parties involved in research activities hold some accountability to ensure ethical conduct, trust, and meaningful engagement in health research. This ultimately leads to research that is of higher quality, relevance, and impact for all.
• Transparency: transparency fosters a culture of openness, trust, and collaboration in health research, empowering consumers to actively participate in the research process.
• Collaboration and partnership: By working together as partners, researchers, research institutions and consumers can co-create knowledge, drive positive change, and improve health outcomes for all.
• Equity: A value of equity ensures fair and inclusive participation, addresses systemic barriers, and promotes justice in the distribution of research benefits and outcomes, ultimately leading to research that is representative, responsive, and equitable for all communities involved.
• Diversity and inclusiveness: this builds on the equity value by broadening the focus to include diverse perspectives, experiences, and needs within the research process, fostering innovation, relevance, and responsiveness to the varied needs of all communities involved.
• Advocacy: this allows for the consumer involvement to have an outlet which could potentially influence change at a higher level and improve outcomes for more than just themselves or the community but for all Australians.
• Integrity: this promotes working with respect, being open, transparent & honest

o The statement can be strengthened and improved by including the additional values raised above as well as including further and stronger emphasis on diversity, especially around gender, age, ethnicity and regional representation.
o The values from the 2016 statement should be maintained. In relation to the current values, the emphasis on mutual respect. This should focus on respect for the lived experiences, perspectives & expertise of consumers and community members. Shared understanding may also need to be expanded or defined to ensure consistent application & interpretation. Commitment could be further clarified to “commitment to meaningful collaboration & inclusion”.

yes to all

The better practice principles can be strengthened and improved by including the additional values raised above. They should also include further emphasis on:
• Recruiting consumers with the aim to recruit the right person, for the right role, at the right time
• A commitment to supporting effective partnerships between the community, researchers and the research institutions, and
• A requirement for consumer involvement activities to be planned and implemented in all types of research.
The revised Consumer Statement should ideally build on the Principles for Consumer Involvement in Research Funded by the Medical Research Future Fund issued in 2023 (available at: https://www.health.gov.au/sites/default/files/2023-03/principles-for-consumer-involvement-in-research-funded-by-the-medical-research-future-fund.pdf).

We have taken time to consider consumer and researcher expectations. Based on this work, we suggest that the in addition and extension of the above:
• Consumers should undergo the necessary training to participate effectively as consumer/community member representatives.
• Consumers should be able to see beyond their personal experience, offering a balanced perspective to enhance outcomes for individuals affected by cancer broadly.
• Consumers can facilitate the dissemination of research findings relevant to the community and relay feedback through established community connections.
• Consumers can build the capability to offer insightful and practical perspectives to contribute to research design and activities, ensuring participation has a meaningful impact on outcomes.
• Consumers should have a commitment to improving their own health literacy and understanding of the research cycle.

We have taken time to consider consumer and researcher expectations. Based on this work, we suggest that the in addition and extension of the above:
• Researchers should initiate consumer and community involvement early in the research process by building relationships and understanding community research priorities.
• Researchers should make every effort to incorporate consumer and community perspectives from the outset when formulating research aims, design, and budget development.
• Researchers must communicate study findings to consumers and community members and engage in a feedback loop to identify subsequent research needs.
• Researchers must recognise the intellectual contributions of consumers and community members.
• Researchers have a responsibility to ensure research delivers clear scientific and practical value to the community through strategic planning, including clear dissemination and implementation strategies developed in collaboration with consumers.
• Researchers must participate in training to acquire skills and knowledge in effective and respectful consumer and community engagement practices in research.
• Researchers should secure appropriate remuneration to support consumer and community involvement in their research
• Research should display a willingness to undertake training on how to better engage & include consumers in research
• Researchers must make an attempt to reach out to an appropriately diverse range of consumers and community members to ensure the most effective involvement strategies are developed and implemented
• Researchers must use accessible language that avoids the use of certain expressions, words, acronyms or jargon that might be considered to exclude particular groups of people
• Researchers should plan for a co-design process to enable consumers to become equal partners

Yes – as eventual beneficiaries of the research outcomes, the involvement of consumers and community members can enhance research application and viability as well as ensuring patient safety and improved outcomes.

Involving consumers and community representatives in research is ethically imperative as it supports the principles of respect, transparency and equity. It ensures individuals have a voice in work that may eventually influence their health and access to health care. It also enhances the relevance and quality of research, and addresses disparities in access and representation, promoting equity and fairness in research endeavours.

o Research institutions have a responsibility to create an inclusive and supportive environment for both researchers and consumers and community that gives value to diverse perspectives and promotes meaningful involvement from consumers and community in their research. Research institutions face some challenges in supporting this involvement, including cultural barriers, resource limitations, lack of expertise, resistance to change, ethical considerations, and issues of diversity and representation. Overcoming these challenges requires institutions to prioritise consumer engagement. This should include the allocation of resources, provision of training and support (preferably accredited) that focuses on improving communication and engagement with consumers, and ongoing fostering of a culture of collaboration and inclusivity. Institutions also require support, including financial, training, infrastructure, partnership development, evaluation frameworks, and leadership, to effectively facilitate consumer involvement in research.
o We also believe that this should build on the best practice consumer involvement by research organisations outlined in the MRFF statement from 2023 (available from: https://www.health.gov.au/sites/default/files/2023-03/principles-for-consumer-involvement-in-research-funded-by-the-medical-research-future-fund.pdf)

o Research funders largely provide statements, principles and guidelines, such as this national statement. These are essential starting points and worthy activities. The funding bodies should also consider more concrete guidance for consumer funding requirements in their grant calls and emphasise the involvement of consumers from the beginning of the process. For example, personnel salary package type guidance for including consumers in grant budget could be provided and consideration for consumer involvement should be systematically included in grant assessment scoring. There should also be stronger reporting requirements, beyond a tick box, on consumer involvement through the process and also in the final reporting of project outcomes.
o More funding opportunities, specifically for consumer remuneration during the conceptualisation and research design phase of the research cycle, should also be considered.

Many funding bodies already do this but can have diverse requirements. Given its critical role, consumer and community involvement is already a standard requirement and mandating or formalising this will strengthen its importance from the top down. Some researchers will still choose not to involve consumers if this is not mandatory, or only involve consumers in a tokenistic manner.

o Researchers should focus on a holistic approach to consumer involvement in their research. That is, they can involve consumer representatives in their research area, rather than solely by project, and build a relationship with these representatives over time. In this way, as specific projects and funding opportunities arise, researchers can build from this established relationship to enable the best research outcomes.
o Research institutions may benefit from the approach taken by our Centre and many other organisations. This is the formation of a Consumer Involvement in Research Panel: a standing committee of consumer and/or community members. This Panel has been established to provide strategic direction to the Centre in terms of the integration of consumer and community involvement as well as advice on research projects. In this way, researchers can seek feedback from Panel members at different stages of the research pathway, including (but not limited to) generation of research ideas and input into the design, conduct, analysis and interpretation of research studies, and dissemination of findings.
o Researchers should also utilise organisations that provide a service that matches researchers with trained & appropriate consumers e.g. Cancer Voices, NSW Regional Health Partners. This should be encouraged through research institutions and funders.
o Consumer representatives play a vital role in the provision of advice and feedback on research activities, such as clinical trials, from a community perspective. They are involved in concept development, contribute to grant applications, and review and provide feedback on lay summaries, patient information, and consent forms. They also provide a mechanism for advice on trial design and conduct, recruitment, and two-way communication strategies to support the dissemination of research findings back to the community.

The key implementation issues for a Consumer Statement would cover:
• Mechanisms for sharing, disseminating and evaluating the effectiveness and utility of the statement,
• centralised support for capacity building. This is especially important as the pool of consumer and community representatives can be small and these willing participants are often overextended in their commitment to supporting research. There needs to be additional efforts to provide opportunities to expand this pool,
• clear communication strategies, especially around expectations for all parties involved,
• centralised guidance on resource allocation, and
• quality assurance including evaluation frameworks.