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

The 2016 Statement on Consumer and Community Participation in Health and Medical Research (hereafter ‘the Statement’) provides a helpful starting point to consider the micro and meso dimensions of consumer and community involvement (CCI). However, there is little guidance on how to unpack the macro issues and challenges. The Statement merely stipulated that “health and medical research should develop processes and systems to incorporate and support sustainable consumer and community involvement.” [FN 1] For a comparative perspective, we quote from the Department of Health and Aged Care Principles for Consumer Involvement in Research Funded by the Medical Research Future Fund (‘MRFF CI Principles’):

"The Consumer Reference Panel acknowledges that the full and consistent implementation of these [CI] principles will require both structural and cultural change, time and resources to build the capacity and capability of researchers and consumers, and additional time and funding for researchers to deliver their projects within this new framework." [FN 2]

The above extract adopts a realistic perspective of CI research by acknowledging the structural, cultural, temporal and economic issues at play. The MRFF principles also set out guidance on implementation and the Consumer Reference Panel’s future work plans to strengthen “consumer engagement throughout the grant life cycle.” [FN 3]

A common shortcoming of the 2016 Statement and the MRFF CI Principles is the need for clarification on its scope of application. From the titles of these documents, it appears that the CCI/CI principles only apply to research. However, the NHMRC and MRFF funds not only research projects but also initiatives to build infrastructure including national critical research infrastructure. Are CCI/CI Principles applicable in the context of designing research infrastructure? If so, what implementation guidance is required for such projects? From our work, CCI/CI Principles should be applicable where the research infrastructure is designed to facilitate access to, and use of, data. Empirical research commissioned by the ARDC for the HeSANDA (the Health Studies Australia National Data Asset) Program [FN 4], advised that consumers should be fully engaged in the design and development process [FN 5]. The participants in this study consisted of consumers and researchers. Therefore, we propose that the revised Consumer Statement should (i) delineate the scope of the application of CCI/CI principles, and (ii) offer a clear explanation of macro considerations for the reasons outlined above.

1. NHMRC, Consumer Health Forum, Statement on Consumer and Community Participation in Health and Medical Research (2016) available at <https://www.nhmrc.gov.au/about-us/publications/statement-consumer-and-community-involvement-health-and-medical-research> 2.
2. Australian Government, Medical Research Future Fund, Principles for Consumer Involvement in Research Funded by the Medical Research Future Fund, Advice from the Medical Research Future Fund Consumer Reference Panel - March 2023, available at <https://www.health.gov.au/resources/publications/principles-for-consumer-involvement-in-research-funded-by-the-medical-research-future-fund?language=en> 5.
3. As above, 5.
4. HeSANDA is a collaboration involving 72 health research organisations across Australia. For more information, see <https://ardc.edu.au/program/health-studies-australian-national-data-asset/>.
5. Alison Evans, Jen Henwood and Fiona Nemah, HeSANDA Stakeholder Consultation Report: Summary of Consultation Feedback (2021) <https://zenodo.org/records/5275823#.YXDTaxpBxim>.

There are numerous benefits of CCI research for consumers, researchers and the wider community. As discussed in the 2016 Statement, the benefits include research quality, relevance, impact and “public confidence in research through improved openness and transparency in the conduct of research.” [FN 6]

6. As above n 1, 4.

As discussed in our response to the initial question, the CCI/CI principles are critical in the context of research infrastructure supporting the secondary use of data. We would be happy to work with stakeholders to build infrastructure to support CCI research. The ARDC is Australia's peak body for research data. We aim to accelerate research and innovation by driving excellence in the creation, analysis and retention of high-quality data assets. Many of these datasets are relevant for health and medical research. Informed consent and the social licence for the use of these datasets in research are critical. We facilitate access to national digital research infrastructure structure, platforms, skills, data sets and tools from academia, industry and government for all Australian researchers. The ARDC is funded through the Australian Government's National Collaborative Research Infrastructure Strategy (NCRIS) to support national digital research infrastructure for Australian researchers.

We propose the value of mutually respectful relationships from the UK Standards for Public Involvement: Better public involvement for better health and social care research (2019). In the same way that researchers contribute to the public good through their writing and research activities, consumer and community representatives can offer valuable complementary insights and knowledge through their lived experience as patients, carers, families or other users of health services.

As the quote in the question indicates, the 2016 Statement listed three values. This list presupposes that the meaning of the selected values are self-evident. Yet if we read the 2016 Statement with the MRFF CI Principles, we can see that there are divergent and contrasting perspectives on CCI/CI research. Instead of a ‘shared understanding’, there could appear to be a lack of consensus. For example, there are differences of opinion on a key term - CCI or CI? Thus, we suggest an explanation of the agreed values to provide clarity and guidance for readers. A discussion on values can be found in the National Statement on Ethical Conduct in Human Research (2023). We propose that a similar approach be adopted in the revised Consumer Statement.

Yes. We note that some of these values have been incorporated into the MRFF CI Principles either implicitly or explicitly.

In our opinion, the Principles for Consumer Involvement in Research Funded by the Medical Research Future Fund offer a helpful starting point to respond to this question. Below we extracted the text which we believe set out the most important principles that should be included in the revised Consumer Statement.

"It is the view of the Consumer Reference Panel that to achieve the best quality, outcomes and value for money in MRFF funded research, consumers should be involved:

- At all stages of research, from defining the need/priority of a research question, refining the research question and research design through to conduct of the research and sharing and sharing and translation of results.

- In partnership with researchers, with consumers respected and recognised for the valuable and complementary knowledge, expertise and perspectives they bring to the research.

- Effectively, with sufficient time, resources and depth of relationships to enable consumers to understand and actively engage with and contribute to the research.

- Sensitively and safely, through research teams with strong and broad capacity and capabilities in consumer involvement, appropriate training and a supportive environment for consumers, and clearly defined and agreed roles.

- With broad diversity and equity, with the goal of increasing involvement of priority populations through culturally safe and appropriate engagement.

The form and level of consumer involvement should be appropriate to the specific project and to that cohort of consumers." [FN 7]

7. Above n 1, 6.

No comment.

No comment.

We note that the MRFF CI Principles adopted the position that consumer and community involvement should be an expectation of research. (‘While consumer involvement is not a requirement of MRFF funding at this time, it is nonetheless expected and viewed favourably in the assessment of MRFF grant applications [FN 8].”) However, in a 2023 paper, Dr Sandra Reeder and colleagues from Monash University reported that “CCI has not traditionally been a core component of research or health training” in Australia [FN 9]. Clearly, a researcher would struggle to meet expectations proposed in the above question if s/he does not have the relevant training and institutional support to carry out such research.

8. Above n 2, 5.
9. Reeder, Sandra, Darshini Ayton, Helena J. Teede, Helen Skouteris, Melissa Simmons, and Angela Jones. "Opportunities to enhance consumer and community engagement training for researchers and healthcare providers: a qualitative study." BMJ open 13, no. 9 (2023): e073114.

We speculate that some researchers may argue that this question could best be addressed on a case-by-case basis rather than generalising across all types of health and medical research.

No comment.

No comment.

Without substantive evidence supporting a mandate, it would not be not advisable to compel researchers to involve consumer and community representatives in public funded research. Such a mandate could have adverse unintended consequences for all stakeholders involved. Funders could consider designing grant programs to specifically support “consumer-led research.” The learnings and insights gained from an evaluation of these programs can inform the design of future grant programs and research training programs.

Implementation guidelines should offer guidance to all parties on their shared roles and responsibilities. To illustrate, we will quote from the MRFF CI Principles.

"To achieve best practice consumer involvement, MRFF-funded project/grantees and their supporting research organisations would:

- Maximise return on investment by ensuring outcomes of research are shared (including through publication, but also through feedback to the community, health services and policy makers), and (where appropriate) translated into practice." [FN 10]

The above guidance recognises that grantees do not only have a responsibility to deliver on the research. S/he also has an obligation to ensure that the return on public investment is maximised through the dissemination and sharing of research outputs and, where appropriate, through the translation of research findings into practice.

The above extract from the MRFF CI Principles could be further developed by offering guidance on all types of research outputs including research data and software. The sharing of datasets and analytical codes is critical to facilitating open, reproducible and transparent research practices. Access to code ensures that readers can reproduce the research methodology described in a journal article with precision. The secondary use of quality data has also become important with the emergence of generative AI. Empirical research conducted by the Australian Clinical Trials Alliance (ACTA) on behalf of the ARDC found “support from participating consumers and trialists for the goal of facilitating secondary use of data from clinical trials for research purposes, with a strong emphasis placed on the need for secondary sharing and use of data to be facilitated in an appropriate, effective and efficient way [FN 11].” Consumers in the study also emphasised “the importance of informed consent for sharing data from clinical trials and the need to protect individual identification through shared data to protect against misuse or misrepresentation [FN 12].” Therefore, given the rationale for reproducible science and support amongst stakeholders for the secondary use of data, we propose that implementation guidance for the revised Statement address the shared role of researchers and consumers in maximising the return on public investment including the potential impact of the data for patients and the wider community.

10. Above n 2, 8.
11. Alison Evans, Jen Henwood and Fiona Nemah, HeSANDA Stakeholder Consultation Report: Summary of Consultation Feedback (2021) <https://zenodo.org/records/5275823#.YXDTaxpBxim> 3.
12. As above.

We suggest that the revised Consumer Statement could be launched and socialised through an online webinar or conference.