Table 2.

Thematic analysis of review findings.

BEST PRACTICES	CHALLENGES AND LESSONS LEARNEDS
Community-driven and Nation-based
Theme 1: Native American Led/Tribe Specific
• Engage Native American researchers, especially in leadership roles  • Ensure tribal oversight, engage a cultural broker or advisor  • Value and leverage Indigenous knowledge – elders’, traditional, or spiritual/religious knowledge – more than scientific knowledge from Western paradigms  • Include Native American language and community driven standards in projects	• Time is necessary for engagement and development of trust
Theme 2: Tribal History
• Understand unique tribal histories and political standings  • Establish programmes grounded in an understanding of power and history and that build upon community strengths and cultural restoration	• Lack of knowledge or appreciation for tribal histories, cultures, and diversity • Failure to understand local contextual issues
Theme 3: Community-based Participatory Research
• Prioritise issues of concern to the community  • Use community–academic partnerships with efforts informed by local community perspectives  • Hire a local team to build community research capacity  • Establish a tribal/community advisory board comprised of community members with appropriate experience and knowledge to guide research  • Incorporate culturally appropriate methods, such as smudge, offering tobacco	• Varying definitions of what constitutes community-based participatory research (CBPR) and varied methodological fidelity • CBPR gone wrong is rarely published nor the evolutionary steps of building relationships with communities • Continuing CBPR outside of funding windows is difficult
Ownership, Control, Access, and Possession (OCAP)
Theme 1: Tribal Governance
• Establish tribal resolutions for authorising research conducted within tribal jurisdictions and memoranda of agreement to address issues related to community collaboration  • Engage tribal IRB* and ethical review processes  • Establish institutional infrastructure, such as NIH’s Tribal Advisory Committee (TAC), to provide a venue for exchange of information between tribes and non-tribal institutions engaged in research with Native American communities	• Researchers try to avoid tribal government review processes by conducting research with urban Native American communities • Limited or absent sharing of research updates and/or reporting of findings to community
Theme 2: Data Sovereignty
• Establish data control and ownership agreements directed by tribal and community leaders  • Understand that sovereign, federally recognised tribes have the right to decide when, if, and how to share data  • Develop and implement plans for adherence to ethical guidelines between project partners in data ownership, management, and protection  • Disseminate findings to community in accessible formats (e.g. newsletters with updates, publications using appropriate language)	• The ethical principle of respect must recognise tribal sovereignty and tribes’ inherent right to govern research that takes place on their lands, including decision-making related to data ownership and use, as well as dissemination (e.g. review of publications) • The ethical principle of justice requires that sample selection must consider distributive justice and ensure that Native American communities are neither excluded from nor exploited in research
Theme 3: Secondary Data
• Acknowledge that human subjects review may be necessary for secondary data analysis  • Include a statement in consent forms about future and/or additional use of data, if that is part of the plan	• Any re-analysis of data may compromise trust, standards of confidentiality, and data quality established in initial data collection efforts
Relationships
Theme 1: Trust vs. Mistrust
• Prioritise building and maintaining trust  • Build trusting relationships that rely on frameworks of resilience and positive change rather than deficits  • Use a CBPR approach to aid in developing trust through equitable distribution of all aspects of research and shared decision-making	• Distrust of researchers and western medical model • Helicopter research (i.e. researchers collect data, then have limited to no involvement with the community as data are analysed and disseminated) creates distrust • History of tribes being misrepresented by researchers and grant writers • Tendency to pathologise Native American individuals and communities
Theme 2: Authentic Partnerships
• Prioritise and foster collaboration, establish shared goals, respect cultural and local knowledge, and privilege community needs through genuine partnerships  • Create opportunities for partners to learn from each other; well-crafted collaborative practice results in positive outcomes for both parties  • Decolonise research to instil a balance between Indigenous and Western frameworks and methods	• Previous negative experiences, in which results were used to support legal claims that did not benefit tribes, undermine partnership • Potential stigmatisation through the discovery of “negative” findings
Transparency and Accountability
Theme 1: Confidentiality
• Establish confidentiality agreements with tribes, at their request and guidance, if needed  • Communicate research engagement practices  • Engage community members or leaders to inform decisions about using self-identified tribal affiliation or tribal enrolment as an inclusion criterion for research participants	• Ensuring confidentiality in small communities when community members are employed in research can be challenging, and considering a risk assessment matrix may be useful • Traditional methods of reporting qualitative research, such as combining data into themes and removing a participant’s name, may be perceived as disrespectful to the knowledge and experiences contributed to the research by elder study participants
Theme 2: Consent
• Establish community consent in the form of memorandum of understanding/agreement (MOU/MOA)  • Have a tribal advisory board review research material, and engage a tribal IRB to conduct human subjects review	• Difficult to ascertain appropriate mechanisms for establishing community approval outside of tribal jurisdictions • Complexity and unique nature of consent regarding the jurisdiction of Native American communities when members/citizens live outside of tribal lands (e.g. in a proximal urban setting) • History of ethical violations undermines the principle of informed consent
Theme 3: Ethical Review and Monitoring Processes
• Engage in ethical reflective practice as researchers  • Respect tribal leaders’ dual roles of protecting people from research harms and advancing health research  • Develop plans for adherence to ethical guidelines between project partners in data ownership, management, and protection  • Uphold bioethics principles important to Native American research, including respect tribal sovereignty, promote transparency, hear community priorities, learn from each other, and take collective action	• Many communities do not have the resources to create and sustain an ethical review process • History of ethical violations including forced sterilisation and misuse of tissue samples for research that goes against the wishes and belief systems of tribes
Quality Community-driven Standards and Indicators
Theme 1: Indigenous vs. Western Methodologies
• Promote understanding of Indigenous methodologies and primacy of Indigenous knowledge and worldviews  • Use Indigenous methods alone or in conjunction with appropriate Western methods  • Address health from a positive ecological perspective  • Incorporate traditional cultural practices into prevention and health promotion strategies  • Engage community members in data analysis and interpretation  • Promote an asset-based framework	• Prioritising Western models over Indigenous models • Culturally adapted interventions are generally described and understood through Western theoretical systems potentiating colonial ideals • Promotion of evidence-based interventions might be perceived as a colonising behaviour in instances where the interventions were developed for and tested with majority populations • Publication outlets and available measures tend toward pathology, reductionism, and deficit models rather than the resiliency-framed, holistic, and spirituality models favoured by communities
Theme 2: Planning
• Plan with the community and include plans for an extended timeline and for potential leadership changes in the community  • Proactively budget time and resources for measurement development when planning research  • Recognise that many communities have limited resources and competing priorities; as a result, researchers may encounter delays in implementation of projects  • Prepare for data sharing/use discussions at the outset of the project in collaboration with community partners	• The length of time to complete research, particularly randomised controlled trials, can be disheartening to communities, especially considering urgent needs • Time demands on community members must be considered • Some common validated measures fail to capture important constructs in ways that are reliable and valid in Native American cultural contexts; however, highly tailored novel measures may introduce unknown errors of reliability, dimensionality, and other psychometric indices • Measures validated in Native American communities, as well as community-level measures that consider the unique cultural and socioecological contexts of tribal settings and use appropriate Native American theories to guide their development, are lacking
Nation (Re)Building
Theme 1: Tribal Sovereignty
• Recognise tribal sovereignty and adhere to tribal research oversight processes, including tribal resolutions, tribal research oversight committees, and the development of tribal research codes  • Appreciate the role of tribal IRBs, as research oversight is a right of tribes as sovereign nations, and they are necessary due to federal and tribal differences in how human subjects research is defined  • Protect community knowledge, culture, and self-governance	• High-quality Native American data are limited, in part because Native populations are small and rarely represented in national epidemiological surveys, which limits tribal leaders’ ability to make informed decisions on behalf of their communities • Gaps in understanding of tribal policies and the policy-making processes necessary for research partnerships and the development of multilevel policy interventions to facilitate them • The federal definition of research in the US fails to protect tribal sovereignty when informed consents are not obtained in ethnographic research involving interviews with tribal members
Theme 2: Tribal Research Infrastructure
• Build tribal research infrastructure by hiring and training a local team  • Consider that research led by Native American researchers may be a more culturally appropriate approach to the design and execution of research involving Native Americans  • Repair research relationships that have been upset or damaged  • Prioritise dissemination of progress reports and findings to research participants and community	• Absence of processes that enable tribal governments to express concerns about research related harms • Funding models often do not consider the additional time required to build relationships and respectfully start a project • Infrastructure and capacity are not universally distributed across communities
Equity and Capacity
Theme 1: Capacity
• Increase the number of Native American researchers with adequate funding and infrastructure  • Support capacity building within communities  • Prioritise increasing research capacity as an outcome of the research process  • Value the expertise of community members in the cultural and political context relevant to data collected in their communities	• Long-term sustainability and maintaining community buy-in can be challenging due to lack of resources • Tribal employee retention can be an issue • Competing demands on time and resources can result in research not being a priority
Theme 2: Academic Institutions and Funding Agencies
• Offer training to academic researchers on how to work with Native American communities  • Provide access to funding and sustainable methods of engagement  • Reconceptualise intervention research time frames beyond the typical three-to-five-year grant funding cycle to an enhanced understanding of how change in complex systems occurs over a time span of decades, not years  • Account for how people locally define and understand their own context and the nature of outside researchers before intervention  • Create a project registration database for research that involves collaboration with Native American communities to support the use of CBPR  • Revise tenure processes in universities to recognise CBPR	• Federal regulations require review by an accredited IRB; however, when a Native American community does not have its own accredited IRB, the default IRB of record (often from the researcher’s institution) may not have the cultural or contextual knowledge to ensure that the community’s needs are sufficiently prioritised • Grant administration processes that require academic institutions to sponsor or partner undermine the ability of tribal nations and organisations to carry out research programmes • Research with tribal communities takes a long time and can slow career progress for academics due to the structure of tenure evaluations • Grant requirements are not aligned with the context and needs of Native American communities (e.g. strengths-based, timelines)
Effective Technology and Policy
Theme 1: Data Management
• Train community members to manage data  • Develop an agreement, directed by the tribe(s) or Native American community(is), for data use and/or sharing, even when the data are managed by another entity, to afford legal protections against the potential risk of a data breach or misuse of data	• Native Americans are often not represented or misrepresented in national epidemiological surveys
Theme 2: Institutional Review and Belmont Principles *
• Implement plans for adherence to ethical guidelines between project partners in data ownership, management, and protection  • Include modules on group harms to tribes and on conflict of interest when training researchers  • Understand that tribal sovereignty means tribes can establish additional research protections, and this is acknowledged in the Common Rule*	• Federal regulations that govern human subjects research protect individuals from research harm but do not adequately specify protections for community level harms • Available human subjects training modules fail to resonate with community members due to use of jargon, lack of cultural and contextual relevance, and absence of discussion about community risks and benefits • Absence of research ethics trainings tailored to needs of Native Americans can be a barrier to research participation • The principle of beneficence necessitates consideration of benefits and harms to Native American communities participating in research

^*Key terms and acronyms: Belmont Principles = foundational ethical principles for research in the US, IRB = Institutional Review Board, Common Rule = common federal research regulations in the US.