Rights, interests and expectations: Indigenous perspectives on unrestricted access to genomic data.

Addressing Indigenous rights and interests in genetic resources has become increasingly challenging in an open science environment that promotes unrestricted access to genomic data. Although Indigenous experiences with genetic research have been shaped by a series of negative interactions, there is increasing recognition that equitable benefits can only be realized through greater participation of Indigenous communities. Issues of trust, accountability and equity underpin Indigenous critiques of genetic research and the sharing of genomic data. This Perspectives article highlights identified issues for Indigenous communities around the sharing of genomic data and suggests principles and actions that genomic researchers can adopt to recognize community rights and interests in data.

Two-eyed seeing: Embracing the power of Indigenous knowledge for a healthy and sustainable Ocean.

Indigenous knowledge is often disregarded and opportunities for positive change are lost. To protect the Ocean, a "two-eyed seeing" approach combining Indigenous and western knowledge systems can create advancements while empowering coastal Indigenous Peoples.

Balancing openness with Indigenous data sovereignty: An opportunity to leave no one behind in the journey to sequence all of life.

The field of genomics has benefited greatly from its "openness" approach to data sharing. However, with the increasing volume of sequence information being created and stored and the growing number of international genomics efforts, the equity of openness is under question. The United Nations Convention of Biodiversity aims to develop and adopt a standard policy on access and benefit-sharing for sequence information across signatory parties. This standardization will have profound implications on genomics research, requiring a new definition of open data sharing. The redefinition of openness is not unwarranted, as its limitations have unintentionally introduced barriers of engagement to some, including Indigenous Peoples. This commentary provides an insight into the key challenges of openness faced by the researchers who aspire to protect and conserve global biodiversity, including Indigenous flora and fauna, and presents immediate, practical solutions that, if implemented, will equip the genomics community with both the diversity and inclusivity required to respectfully protect global biodiversity.

Ethical, legal, and social issues in the Earth BioGenome Project.

The Earth BioGenome Project (EBP) is an audacious endeavor to obtain whole-genome sequences of representatives from all eukaryotic species on Earth. In addition to the project's technical and organizational challenges, it also faces complicated ethical, legal, and social issues. This paper, from members of the EBP's Ethical, Legal, and Social Issues (ELSI) Committee, catalogs these ELSI concerns arising from EBP. These include legal issues, such as sample collection and permitting; the applicability of international treaties, such as the Convention on Biological Diversity and the Nagoya Protocol; intellectual property; sample accessioning; and biosecurity and ethical issues, such as sampling from the territories of Indigenous peoples and local communities, the protection of endangered species, and cross-border collections, among several others. We also comment on the intersection of digital sequence information and data rights. More broadly, this list of ethical, legal, and social issues for large-scale genomic sequencing projects may be useful in the consideration of ethical frameworks for future projects. While we do not-and cannot-provide simple, overarching solutions for all the issues raised here, we conclude our perspective by beginning to chart a path forward for EBP's work.

Genomic Research Through an Indigenous Lens: Understanding the Expectations.

Indigenous scholars are leading initiatives to improve access to genetic and genomic research and health care based on their unique cultural contexts and within sovereign-based governance models created and accepted by their peoples. In the past, Indigenous peoples' engagement with genomicresearch was hampered by a lack of standardized guidelines and institutional partnerships, resulting in group harms. This article provides a comparative analysis of research guidelines from Canada, New Zealand, Australia, and the United States that pertain to Indigenous peoples. The goals of the analysis are to identify areas that need attention, support Indigenous-led governance, and promote the development of a model research policy framework for genomic research and health care that has international relevance for Indigenous peoples.

Creating space for Indigenous perspectives on access and benefit-sharing: Encouraging researcher use of the Local Contexts Notices.

A recent Molecular Ecology editorial made a proactive statement of support for the "Nagoya Protocol" and the principle of benefit-sharing by requiring authors to provide a "Data Accessibility and Benefit-Sharing Statement" in their articles. Here, we encourage another step that enables Indigenous communities to provide their own definitions and aspirations for access and benefit-sharing alongside the author's "Statement". We invite the Molecular Ecology research community to use Biocultural-, Traditional Knowledge-, and Cultural Institution Notices to help Indigenous communities gain visibility within our research structures. Notices are one of the tools offered by the Biocultural Labels Initiative (part of the Local Contexts system) designed specifically for researchers and institutions. The Notices are highly visible, machine-readable icons that signal the Indigenous provenance of genetic resources, and rights of Indigenous communities to define the future use of genetic resources and derived benefits. The Notices invite collaboration with Indigenous communities and create spaces within our research systems for them to define the provenance, protocols, and permissions associated with genetic resources using Labels. Authors contributing to Molecular Ecology can apply Notices to their articles by providing the persistent unique identifier and an optional use-statement associated with the Notice in their "Data Accessibility and Benefit-Sharing Statement". In this way, our research community has an opportunity to accelerate support for the principles of the Nagoya Protocol, to alleviate concerns regarding Indigenous Data Sovereignty and equitable outcomes, and to build better relationships with Indigenous collaborators to enhance research, biodiversity, and conservation outcomes.

Correction to: Native Hawaiian Views on Biobanking.

The original version of this article unfortunately contained a mistake. The name of "Maile Taualii" is now corrected in the author group of this article.

Mapping a route to Indigenous engagement in cancer genomic research.

Precision oncology guided by genomic research has an increasingly important role in the care of people with cancer. However, substantial inequities remain in cancer outcomes of Indigenous peoples, including Indigenous Maori in Aotearoa New Zealand (New Zealand). These inequities will be perpetuated unless deliberate steps are taken to include Indigenous peoples in all parts of cancer research-as research participants, in research leadership, and in research governance. This approach is especially important when there have been historical breaches of trust that have discouraged their participation in health research. This Personal View describes a precision oncology research roadmap for neuroendocrine tumour research, which seeks to reflect the values of New Zealand's Indigenous Maori people. This roadmap includes facilitating ongoing dialogue, Maori leadership, reciprocity, agreed kawa (guiding principles), tikanga (cultural protocols), and honest monitoring of what is and what is not being achieved. We challenge cancer researchers worldwide to generate locally appropriate roadmaps that honestly assess their practices to benefit Indigenous people internationally.

He Pikinga Waiora: supporting Maori health organisations to respond to pre-diabetes.

BACKGROUND: Type 2 Diabetes (T2D) is a common long-term condition affecting the health and wellbeing of New Zealanders; one in every four New Zealanders is pre-diabetic. Maori, the Indigenous people of New Zealand, are at an increased risk of developing pre-diabetes and T2D and there are significant inequities between Maori and non-Maori for T2D complications. The purpose of this study was to explore the questions of how the strengths of Maori heath organisations may be leveraged, and how the barriers and constraints experienced by Maori health organisations may be negotiated, for the benefit of Maori; and from a systems perspective, to identify strategic opportunities that may be considered and applied by Maori health organisations, funders and policy makers to respond more effectively to pre-diabetes and reduce health inequities between Maori and non-Maori. METHODS: Utilising case study methodology, a range of data sources were triangulated including nine semi-structured interviews, documents, and a diabetes system map to identify possible strategic opportunities for key stakeholders to respond more effectively to pre-diabetes. RESULTS: Key themes and possible actions to improve health outcomes for Maori with pre-diabetes include: (1) Recognising Maori health organisations as conduits for the community voice and influential partners in the community to effect change; (2) Strengthened partnerships with Maori health organisations for community benefit and to support measurable, evidence-based change and service delivery, particularly when Maori knowledge systems are viewed alongside a Western scientific approach; and (3) Intersectoral integration of health and social services to support provision of whanau-centred care and influence the social determinants of health and local environment. CONCLUSIONS: Maori health organisations are important actors in systems seeking to improve outcomes and eliminate health inequities. Support from funders and policy makers will be required to build on the strengths of these organisations and to overcome system challenges. To realise improved health outcomes for Maori, the value placed on whanau and community perspectives not only needs to be acknowledged in the implementation of health interventions, health and social policies and funding arrangements, but performance measures, service design and delivery must evolve to accommodate these perspectives in practice.

Views on clinical trial recruitment, biospecimen collection, and cancer research: population science from landscapes of the Haudenosaunee (People of the Longhouse).

Biomedical research in culturally distinct communities is often a challenge. Potential barriers to participation occur because science is presented in a format that lacks cultural acknowledgement. Investigations may also fail to showcase beneficial relevance to the communities or include them in true partnership. The history of biomedical research within Native American societies has been complicated by these issues. Historical trauma among many Native groups sometimes transcends into contemporary challenges in both recruitment to and participation particularly in biobanking research. The participants for this study included members of the Haudenosaunee, the People of the Longhouse. Native Americans, including the Haudenosaunee, endure some of the worst health disparities in the country. These include high rates of cancer, obesity, and diabetes which may be linked at least partially to genetic predisposition. Results from a Haudenosaunee urban population shared response on ways to improve recruitment strategies for biospecimen, cancer, and other health-related clinical trials. Mixed methods approaches were used, and community responses indicated the importance of creating trust through respectful partnership; promoting culturally appropriate recruitment materials; the need for a greater understanding of consenting and signature processes; the necessity for concise summary sheets; and a desire to have information that community member understand. Discussion items also include international Indigenous perspectives to biobanking and genetic-related health disparity research.

Engaging Maori in biobanking and genomic research: a model for biobanks to guide culturally informed governance, operational, and community engagement activities.

PURPOSE: He Tangata Kei Tua, a relationship model for biobanks, was developed to facilitate best practice in addressing Maori ethical concerns by guiding culturally informed policy and practice for biobanks in relation to governance, operational, and community engagement activities. METHODS: The model is based on key issues of relevance to Maori that were identified as part of the Health Research Council of New Zealand-funded research project, Te Mata Ira (2012-2015). RESULTS: This project identified Maori perspectives on biobanking and genetic research, and along with tikanga Maori it developed cultural guidelines for ethical biobanking and genetic research involving biospecimens. The model draws on a foundation of matauranga (Indigenous knowledge) and tikanga Maori (Maori protocols and practices) and will be useful for biobanks, researchers, ethics committee members, and those who engage in consultation or advice about biobanking in local, regional, national, or international settings. CONCLUSION: This article describes the model and considers the policy and practice implications for biobanks seeking to address Maori ethical concerns. Although the model has focused on Maori aspirations in the New Zealand context, it provides a framework for considering cultural values in relation to other community or indigenous contexts.Genet Med 19 3, 345-351.

Implementation framework for chronic disease intervention effectiveness in Maori and other indigenous communities.

BACKGROUND: About 40% of all health burden in New Zealand is due to cancer, cardiovascular disease, and type 2 diabetes/obesity. Outcomes for Maori (indigenous people) are significantly worse than non-Maori; these inequities mirror those found in indigenous communities elsewhere. Evidence-based interventions with established efficacy may not be effective in indigenous communities without addressing specific implementation challenges. We present an implementation framework for interventions to prevent and treat chronic conditions for Maori and other indigenous communities. THEORETICAL FRAMEWORK: The He Pikinga Waiora Implementation Framework has indigenous self-determination at its core and consists of four elements: cultural-centeredness, community engagement, systems thinking, and integrated knowledge translation. All elements have conceptual fit with Kaupapa Maori aspirations (i.e., indigenous knowledge creation, theorizing, and methodology) and all have demonstrated evidence of positive implementation outcomes. APPLYING THE FRAMEWORK: A coding scheme derived from the Framework was applied to 13 studies of diabetes prevention in indigenous communities in Australia, Canada, New Zealand, and the United States from a systematic review. Cross-tabulations demonstrated that culture-centeredness (p = .008) and community engagement (p = .009) explained differences in diabetes outcomes and community engagement (p = .098) explained difference in blood pressure outcomes. IMPLICATIONS AND CONCLUSIONS: The He Pikinga Waiora Implementation Framework appears to be well suited to advance implementation science for indigenous communities in general and Maori in particular. The framework has promise as a policy and planning tool to evaluate and design effective interventions for chronic disease prevention in indigenous communities.

Native Hawaiian views on biobanking.

Genomic science represents a new frontier for health research and will provide important tools for personalizing health care. Biospecimen-based research is an important mechanism for expanding the genomic research capacity, and indigenous peoples are a target of biospecimen-based research due to their relative isolation and the potential to discover rare or unique genotypes. This study explored Native Hawaiian perceptions of and expectations for biobanking. Ten discussion groups were conducted with Native Hawaiians (N = 92), who first heard a presentation on biobanking. Six themes emerged: (1) biobank governance by the Native Hawaiian community, (2) research transparency, (3) priority of Native Hawaiian health concerns, (4) leadership by Native Hawaiian scientists accountable to community, (5) re-consenting each time specimen is used, and (6) education of Native Hawaiian communities. Considered together, these findings suggest that biobanking should be guided by six principles that comprise "G.R.E.A.T. Research" (Governance, Re-consent, Education, Accountability, Transparency, Research priorities). These recommendations are being shared with biobanking facilities in Hawai'i as they develop protocols for biobanking participation, governance, and education. These findings also inform researchers and indigenous peoples throughout the world who are working on biobanking and genomic research initiatives in their nations.

Competing interests: digital health and indigenous data sovereignty.

Digital health is increasingly promoting open health data. Although this open approach promises a number of benefits, it also leads to tensions with Indigenous data sovereignty movements led by Indigenous peoples around the world who are asserting control over the use of health data as a part of self-determination. Digital health has a role in improving access to services and delivering improved health outcomes for Indigenous communities. However, we argue that in order to be effective and ethical, it is essential that the field engages more with Indigenous peoples´ rights and interests. We discuss challenges and possible improvements for data acquisition, management, analysis, and integration as they pertain to the health of Indigenous communities around the world.

Indigenous Peoples and research: self-determination in research governance.

Indigenous Peoples are reimagining their relationship with research and researchers through greater self-determination and involvement in research governance. The emerging discourse around Indigenous Data Sovereignty has provoked discussions about decolonizing data practices and highlighted the importance of Indigenous Data Governance to support Indigenous decision-making and control of data. Given that much data are generated from research, Indigenous research governance and Indigenous Data Governance overlap. In this paper, we broaden the concept of Indigenous Data Sovereignty by using the CARE Principles for Indigenous Data Governance to discuss how research legislation and policy adopted by Indigenous Peoples in the US set expectations around recognizing sovereign relationships, acknowledging rights and interests in data, and enabling Indigenous Peoples' participation in research governance.

Indigenous Peoples' Rights in Data: a contribution toward Indigenous Research Sovereignty.

Indigenous Peoples' right to sovereignty forms the foundation for advocacy and actions toward greater Indigenous self-determination and control across a range of domains that impact Indigenous Peoples' communities and cultures. Declarations for sovereignty are rising throughout Indigenous communities and across diverse fields, including Network Sovereignty, Food Sovereignty, Energy Sovereignty, and Data Sovereignty. Indigenous Research Sovereignty draws in the sovereignty discourse of these initiatives to consider their applications to the broader research ecosystem. Our exploration of Indigenous Research Sovereignty, or Indigenous self-determination in the context of research activities, has been focused on the relationship between Indigenous Data Sovereignty and efforts to describe Indigenous Peoples' Rights in data.

Benefit sharing: Why inclusive provenance metadata matter.

Fair and equitable benefit sharing of genetic resources is an expectation of the Nagoya Protocol. Although the Nagoya Protocol does not yet formally apply to Digital Sequence Information ("DSI"), discussions are currently underway regarding to include such data through ongoing Convention on Biological Diversity ("CBD") negotiations. While Indigenous Peoples and Local Communities ("IPLC") expect the value generated from genomic data to be subject to benefit sharing arrangements, a range of views are currently being expressed by Nation States, IPLC and other stakeholders. The use of DSI gives rise to unique considerations, creating a gray area as to how it should be considered under the Nagoya Protocol's Access and Benefit Sharing ("ABS") principles. One way for benefit sharing to be enhanced is through the connection of data to proper provenance information. A significant development is the use of digital labeling systems to ensure that the origin of samples is appropriately disclosed. The Traditional Knowledge and Biocultural Labels initiative offers a practical option for data provided to genomic databases. In particular, the BioCultural Labels ("BC Labels") are a mechanism for Indigenous communities to identify and maintain provenance, origin and authority over biocultural material and data generated from Indigenous land and waters held in research, cultural institutions and data repositories. This form of cultural metadata adds value to the research endeavor and the creation of Indigenous fields within databases adds transparency and accountability to the research environment.

Extending the CARE Principles from tribal research policies to benefit sharing in genomic research.

Indigenous Peoples have historically been targets of extractive research that has led to little to no benefit. In genomics, such research not only exposes communities to harms and risks of misuse, but also deprives such communities of potential benefits. Tribes in the US have been exercising their sovereignty to limit this extractive practice by adopting laws and policies to govern research on their territories and with their citizens. Federally and state recognized tribes are in the strongest position to assert research oversight. Other tribes lack the same authority, given that federal and state governments do not recognize their rights to regulate research, resulting in varying levels of oversight by tribes. These governance measures establish collective protections absent from the US federal government's research oversight infrastructure, while setting expectations regarding benefits to tribes as political collectives. Using a legal epidemiology approach, the paper discusses findings from a review of Tribal research legislation, policy, and administrative materials from 26 tribes in the US. The discussion specifies issues viewed by tribes as facilitators and barriers to securing benefits from research for their nations and members/citizens, and describes preemptive and mitigating strategies pursued by tribes in response. These strategies are set within the framing of the CARE Principles for Indigenous Data Governance (Collective Benefit, Authority to Control, Responsibility, Ethics), a set of standards developed to ensure that decisions made about data pertaining to Indigenous communities at the individual and tribal levels are responsive to their values and collective interests. Our findings illustrate gaps to address for benefit sharing and a need to strengthen Responsibility and Ethics in tribal research governance.

Using Indigenous Standards to Implement the CARE Principles: Setting Expectations through Tribal Research Codes.

Biomedical data are now organized in large-scale databases allowing researchers worldwide to access and utilize the data for new projects. As new technologies generate even larger amounts of data, data governance and data management are becoming pressing challenges. The FAIR principles (Findable, Accessible, Interoperable, and Reusable) were developed to facilitate data sharing. However, the Indigenous Data Sovereignty movement advocates for greater Indigenous control and oversight in order to share data on Indigenous Peoples' terms. This is especially true in the context of genetic research where Indigenous Peoples historically have been unethically exploited in the name of science. This article outlines the relationship between sovereignty and ethics in the context of data to describe the collective rights that Indigenous Peoples assert to increase control over their biomedical data. Then drawing on the CARE Principles for Indigenous Data Governance (Collective benefit, Authority to control, Responsibility, and Ethics), we explore how standards already set by Native nations in the United States, such as tribal research codes, provide direction for implementation of the CARE Principles to complement FAIR. A broader approach to policy and procedure regarding tribal participation in biomedical research is required and we make recommendations for tribes, institutions, and ethical practice.