Table 1.

Consolidated Criteria for Strengthening Reporting of Health Research involving Indigenous Peoples (CONSIDER) checklist

Domain	Criteria	Indigenous Oral HPV-Oropharyngeal Cancer study
Governance	a. Describe partnership agreements between the research institution and Indigenous-governing organization for the research.	● Formal letters of support from participating Aboriginal Community Controlled Health Organisations (ACCHOs)
	b. Describe accountability and review mechanisms within the partnership agreement that addresses harm minimization	● Harm minimisation included as part of informed consent processes and the human research ethics requirements
	c. Specify how the research partnership agreement includes protection of Indigenous intellectual property and knowledge arising from the research, including financial and intellectual benefits generated	● Protection of Indigenous intellectual property and knowledge emphasized in each of the community consultation and engagement sessions, and also individually with participants through the informed consent process
Prioritisation	a. Explain how the research aims emerged from priorities identified by either Indigenous stakeholders, governing bodies, funders, non-government organization(s), stakeholders, consumers, and empirical evidence	● Idea for the study first portrayed by Indigenous community members following feedback session for another health research project by the study investigators ● Extensive community engagement and consultation to refine the study aims
Relationships (Indigenous stakeholders/participants/research team)	a. Specify measures that adhere and honour Indigenous ethical guidelines, processes, and approvals for all relevant Indigenous stakeholders, recognizing that multiple Indigenous partners may be involved	● Ethics approval sought and obtained from two separate human research ethics committees; University of Adelaide and Aboriginal Health Council of South Australia
	b. Report how Indigenous stakeholders were involved in the research processes (i.e., research design, funding, implementation, analysis, dissemination/ recruitment).	● Initial consultations with all interested ACCHOs. ● Funding application submitted that reflected Indigenous community views and inputs in study design and methodology ● Nine Indigenous investigators included. ● Community consultation repeated once funding was received, with ACCHOs providing structures, strategies and recommendations for recruitment and data collection. ● Staff hired (3 Indigenous, 3 non-Indigenous), with non-Indigenous staff undertaking cultural competency training. ● An Indigenous Reference Group established to provide oversight and cultural guidance.
	c. Describe the expertise of the research team in Indigenous health and research	● Nine Indigenous investigators all recognised leaders in their respective Indigenous health research fields ● Three of the nine non-Indigenous research team extensive experience working with Indigenous communities
Methodology	a. Describe the methodological approach of the research including a rationale of methods used and implication for Indigenous stakeholders e.g., privacy and confidentiality (individual and collective)	● Large scale observational study with follow-up after 12 and 24 months ● All data de-identified, with field staff not analysing data once entered in database
	b. Describe how the research methodology incorporated consideration of the physical, social, economic and cultural environment of the participants and prospective participants. (e.g., impacts of colonization, racism, and social justice). As well as Indigenous worldviews	● Baseline questionnaire (as consequence of community consultation) included items pertaining to experiences of racism, major life events (incarceration, death, child removal), social disadvantage and access to health services
Participation	a. Specify how individual and collective consent was sought to conduct future analysis on collected samples and data (e.g., additional secondary analyses; third-parties accessing samples (genetic, tissue, blood) for further analyses).	● Consent forms explicitly stating that no third parties will have access to samples or data ● Any secondary analyses/long-term follow-up of study participants will only be conducted by research team
	b. Described how the resource demands (current and future) placed on Indigenous participants and communities involved in the research were identified and agreed upon including any resourcing for participation, knowledge, and expertise	● Participating ACCHOs provided support only when their resources allowed ● Participants were made aware, during the informed consent process, of the time commitments to being involved in the study
	c. Specify how biological tissue and other samples including data were stored, explaining the processes of removal from traditional lands, if done, and of disposal.	● Saliva samples genotyped for HPV once and then destroyed ● Data stored on password-protected computer software at the University of Adelaide for 15 years
Capacity	a. Explain how the research supported the development and maintenance of Indigenous research capacity	● Study employed three Indigenous staff (one the project manager) ● Indigenous research assistants, including those volunteered by ACCHOs, trained in research skills, ethics principles, data collection, data checking, data filing and disseminating research findings back to community. ● ACCHO staff given opportunity to represent the study at national and international meetings.
	b. Discuss how the research team undertook professional development opportunities to develop the capacity to partner with Indigenous stakeholders	● ACCHOs and study participants were able to bolster their knowledge of HPV infection and OPSCC, and the links between the two, through free and frank conversations with the research team. ● Knowledge-sharing was two-way, with substantial benefits for the non-Indigenous research staff in being included in Indigenous consultative processes and learning from ACCHOs and study participants.
Analysis and interpretation	a. Specify how the research analysis and reporting supported critical inquiry and a strength-based approach that was inclusive of Indigenous values.	● Research analysis still in its infancy, but thus far has included all key Indigenous stakeholders and Indigenous researchers as co-authors in publications. This has enabled Indigenous values and perspectives to contribute to interpretation of the study findings
Dissemination	a. Describe the dissemination of the research findings to relevant Indigenous governing bodies and peoples.	● Still in its infancy, but thus far has included presentations to key Indigenous stakeholder and other Indigenous community groups, presentations at international conferences (Indigenous project manager and two ACCHO staff)
	b. Discuss the process for knowledge translation and implementation to support Indigenous advancement (e.g., research capacity, policy, investment).	● The findings will hopefully support increased resourcing for Aboriginal Health Workers to be specifically employed to facilitate increased understanding of the links between HPV and OPSCC ● This will, in turn, facilitate increased capacity for other areas of research involving HPV, including translation to policy for screening for HPV-related oral cancers