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

We are the Consumer and Community Engagement Committee from Monash University’s School of Public Health and Preventive Medicine. Our Committee brings together researchers and professional staff from across a range of research areas, including clinical trials, registries, implementation science and more. We all have experience and/or an interest in Consumer and Community Involvement (CCI) in research, and our work focuses on driving a capacity and capability uplift for staff across the School to ensure all CCI work is high quality and reflects best practice.

The current statement offers a fair and reasonable exploration of Consumer and Community Involvement as it was conceived and practiced in 2016. It offers helpful guidance regarding the roles/responsibilities of different stakeholders (e.g. consumers, institutions, researchers, etc). Since 2016, the value and benefit of CCI, as well as expectations from funders, consumers, communities and other researchers have undergone accelerated growth. However, this has not been met by similarly-paced developments to ensure practices are meaningful and equitable. As a result, we have observed increasing numbers of researchers developing and delivering CCI projects without having undergone proper skill development, and without supportive infrastructure (e.g. policies, processes, organisational culture), leading to many risks.

We also note that the Statement has a narrow focus in the following areas:
- A focus on consumer involvement (e.g. individualised consultation) and inadequate direction on community involvement (e.g. group- and community-based) which has greater meaning for collectivist (e.g. multicultural and First Nations) groups where sense-making is done together.
- Limited acknowledgement of First Nations communities, in particular their ways of knowing, being and doing. The Statement doesn’t encourage readers to identify, recognise and respect these practices and to work with First Nations peoples (including other researchers, consumers and community members) in designing and delivering projects that are culturally appropriate and meaningful.
- We recognise the Statement does not intend to provide prescriptive advice around how to operationalise various values and principles, and we understand this is based on the diversity of research and engagement approaches. However, greater support for researchers and institutions in operationalising the values and principles is required. This could be achieved through linking more effectively to existing practical resources or developing additional ones.

At the School of Public Health and Preventive Medicine (SPHPM) at Monash University, we believe the contributions of people, organisations and groups with diverse experiences strengthen our work. These might be members of the general public, people who use or benefit from the knowledge we generate, people who use health and/or other services or other professionals. Bringing together different perspectives helps ensure our work is fit-for-purpose, has maximum impact, and reaches those who need it most.

At the School of Public Health and Preventive Medicine (SPHPM) at Monash University, we believe the contributions of people, organisations and groups with diverse experiences strengthen our work. These might be members of the general public, people who use or benefit from the knowledge we generate, people who use health and/or other services or other professionals. Bringing together different perspectives helps ensure our work is fit-for-purpose, has maximum impact, and reaches those who need it most.

While values are an important inclusion and help to set the tone of a resource like this Statement, we find that the more abstract and conceptual the value, the harder it is for people to operationalise. This is a risk with the current statement. We suggest moving away from a focus on the values in favour of the principles. These are typically more action-oriented, objective and can be assessed which will make it clearer for people what is expected of them. These can still be linked to or paired with values, and should provide some examples that reduce the risk of abstract confusion. For example, the value of collaboration could be the following principle: We recognise and listen to the collective wisdom and diverse thinking of our consumers by collaborating across the research cycle.

While values are an important inclusion and help to set the tone of a resource like this Statement, we find that the more abstract and conceptual the value, the harder it is for people to operationalise. This is a risk with the current statement. We suggest moving away from a focus on the values in favour of the principles. These are typically more action-oriented, objective and can be assessed which will make it clearer for people what is expected of them. These can still be linked to or paired with values, and should provide some examples that reduce the risk of abstract confusion. For example, the value of collaboration could be the following principle: We recognise and listen to the collective wisdom and diverse thinking of our consumers by collaborating across the research cycle.

Considering our response above we think principles would be a more objective operational approach. However, if values are preferred, we think these are sound but could be condensed so that they are recalled more easily:
1. Relational and collaborative
2. Accountable and transparent
3. Inclusive and equitable
4. Safe and rights-based
Following from our point above, rather than including them as stand-alone values, it would be helpful to have some sense of what this might look like in practice, or how to embody the values.

Governance principles, such as those that integrate CCI into the structures, practices, processes, systems and resources require the greatest attention. The voices of consumers and community members should be meaningfully involved in all aspects of the design and delivery of research, and not just on individual projects. This could be through participation on Steering Committees or other initiatives where they contribute to decision-making, priority setting and planning as well as implementation.
In considering end-to-end involvement, there is a need to better articulate the role (governance or other) that collectives (e.g. populations/groups) play. They stand to be impacted by research and therefore should have some involvement in setting the agenda (e.g. needs assessment processes, issue prioritisation). They may not be considered ‘consumers’ on the projects that eventuate but may contribute valuable insights that help researchers and institutions develop a birds-eye view of population issues and challenges more broadly.

The roles and responsibilities currently outlined in the Statement are good. We suggest making it clear to consumers and community members that they have a right and responsibility to report poor conduct by researchers, for example, tokenistic engagement and exploitation.

We note that there is inconsistency in language throughout the Statement, which may lead to unintended consequences in this section given the audience it is directed at. Specifically, there is regular mention of research ‘stages’, ‘phases’ and ‘levels’. We suggest ensuring this is deliberate and consistent. In regards to the term ‘level’, we feel this should be reserved for describing the degrees to which consumers/communities are involved (e.g. the IAP2 spectrum of participation). This should be couched in discussion about the fact that different projects, and even each stage/phase of each project, will need different levels of engagement, , and that the highest level of engagement is not always the most appropriate or desirable level.

In addition to the roles and responsibilities already mentioned, we suggest adding that researchers have a role to play in identifying opportunities to upskill themselves and their colleagues to do CCI better. Researchers supervising PhD, Masters and Honours students should demonstrate pathways where upskilling is promoted where appropriate.

We believe CCI can enhance almost all research projects. However, we also recognise that:
a. some research projects (for example some laboratory research ) may not benefit from CCI and forcing these researchers to involve consumers/community members would be a misappropriate use of time and resources for little gain - and possibly even some harm.
b. not all researchers have the capabilities and/or are not working within structures that scaffold, resource and support high-quality CCI. As such, forcing them to do CCI attracts the risks associated with poor quality, tokenistic and/or exploitative interactions with consumers and communities.
We believe some sort of caveat to this effect is important to include in the Statement.

As described earlier, we have observed the pace of development in this field of work/research as having resulted in researchers being expected to involve consumers/communities without the environment that supports it. The role of research institutions is one of the areas that needs to be included, but that cannot be performed without significant ongoing funding. In addition to the roles/responsibilities already described, we feel this section of the Statement should articulate that institutions – with support - should:
- create infrastructure and systems to support CCI, including recruitment processes, onboarding, payment, grievance and feedback processes.
- build and maintain capability across (staff and student) workforces. This should include integrating CCI into existing undergraduate and post-graduate programs (e.g. similar to cultural sensitivity training), as well as offering post-qualification professional development (e.g. short courses, micro-credentialled units).
- invest funds in the preservation of CCI platforms such as Committees, Coordination roles, Consumer representatives, etc., so that the work can continue outside of grant funding schemes (i.e. when the cost of engaging consumers cannot be easily covered).

The Statement should outline funders’ responsibilities to:
- fund the true cost of research. To move away from tokenistic engagement, we need to embed - with funding - skilled CCI coordinators in projects to engage meaningfully with community members. Funding bodies should also fund researchers to cover the cost of consumer expenses (e.g. travel, child care, translation/interpretation) as a minimum; and ideally also fund the compensation of expertise on top. It is considered best practice for researchers to provide this compensation where the consumers/community members would like it. We note that some NHMRC funding schemes do not allow Chief Investigators to be paid from grant funds, yet also encourage consumers to be included as Chief Investigators.
- ensure the approaches and platforms used to engage consumers, particularly as Investigators (e.g. SAPPHIRE, grant platforms) are accessible, user-friendly and easy for members of the general public to navigate. CI one and two-page summaries need to have an adapted template for consumer investigators.

It depends on the research. As explained above, we recognise that it would not be appropriate to mandate CCI for all research schemes, all the time. For some schemes, it won’t be appropriate and/or add the same value as it does to others. However, we feel there are some schemes/sub-schemes where it should be mandatory for all.

We suggest exploring integrating a self-assessment and screening process to grant submission portals, etc., similar to what is used in some cases regarding ethics, budgets or risk assessments. Such a process could prompt researchers to identify how and to what extent consumers/community members have been involved in the development of the submission and/or how they will be involved in the proposed research. And in cases where CCI is not relevant, researchers could be asked to provide a paragraph explaining why.

We agree this depends significantly on the research, along with many other factors and therefore prescribing specific steps or rules is not only impossible, but would also attract criticisms of a ‘one-size-fits-all’ approach. However, the Statement’s current broad principles and statements risk leaving researchers wondering how to adopt them. To articulate researchers’ roles and responsibilities into a more operational and actionable form, we suggest developing and providing resources such as implementation models, roadmaps and decision trees, or linking to existing ones. These would help researchers across a diverse research landscape think about and apply the Statement as appropriate to them, rather than disregard it because it either prescribes something that is not right for them/their work, or offers only broad statements with little grounding.

We encourage consideration of accessibility when it comes to publishing and disseminating the revised Statement. The Statement’s many and varied audiences (e.g. researchers, consumers, community members/the public, research administrators, research funding bodies, etc) will have different characteristics, needs and preferences - all of which will influence whether it is received, understood and used. Therefore, we suggest multiple forms of dissemination, for example, versions of differing lengths (e.g. 1 page: 3 pages: 25 pages) and forms (e.g. webpage/digital hard copy, audio-visual). We also suggest separating the sections for different audiences (e.g. consumers, institutions) and producing condensed summaries with relevant calls-to-action.