Genomic Research and American Indian Tribal Communities in Oklahoma: Learning From Past Research Misconduct and Building Future Trusting Partnerships

Abstract

Research misconduct and consequential harms have been inflicted upon American Indian/Alaska Native communities for decades. To protect their people and culture and to retain oversight over research, many Native communities have established tribal health research and institutional review boards. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study showcases a successful, trusting research collaboration with tribal nations and academic investigators in Oklahoma. In 2006, the TODAY Study investigators proposed a modification of the study protocol to collect biological specimens from participants for genomic analyses and indefinite storage. Partnering American Indian tribal nations elected not to participate in the genomics collection and repository proposal. Reasons included 1) protection of cultural values, 2) concerns regarding community anonymity, 3) a potential threat to tribal services eligibility, 4) broad informed consent language, and 5) vague definitions of data access and usage. The nations believed the proposed genomics analyses presented a risk of harm to their people and nations without clear benefit. Since the 2006 proposal and the advancement of genomics research, many tribal communities in Oklahoma, appreciating the potential benefits of genomic research, are developing policies regarding oversight of/access to data and biological specimens to mitigate risks and provide members and communities with opportunities to participate in safe and meaningful genomic research.

Access and Management: Indigenous Perspectives on Genomic Data Sharing

“…1,2 In particular, Indigenous peoples have been reluctant to allow sharing and secondary data uses because of past research misconduct, including inadequate informed consent procedures, uses unauthorized by tribal organizations, and stigmatizing interpretations of data. [3][4][5][6][7] Indigenous communities and scholars have articulated that Indigenous data comprise knowledge, information, and data (including biospecimen samples) about peoples, lands, resources, and cultures at both the individual and collective levels. 8,9 These issues pose conflict with federal policies for sharing genomic data.…”

“…[13][14][15][16] To ensure culturally appropriate oversight, many tribal organizations have developed research oversight committees and Institutional Review Boards (IRBs) or have partnered with Indian Health Service IRBs. 7 They have also developed regulations to govern research, research agreements that limit or prevent data sharing, and researcher-signed contracts detailing terms like prereview of presentations and publications and returning data to the tribe at the end of a research study. [17][18][19] But with advances in genetic and genomic research and the move toward broad data sharing and open data, new mechanisms are needed to protect the rights and interests of Indigenous peoples.…”

Inclusion of American Indians and Alaskan Natives in Large National Studies: Ethical Considerations and Implications for Biospecimen Collection in the HEALthy Brain and Child Development Study

“…In 2006, institutional review board (IRB) of the Cherokee Nation, the Chickasaw Nation, and the Choctaw Nation of Oklahoma, the Oklahoma City Area Indian Health Service IRB, and the Absentee Shawnee Tribal Research Board did not approve collection of biological specimens for genomic analyses from their tribal members for the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study due to concerns about unfavorable risk-benefit ratio. They were particularly concerned about entering of the specimens into a repository (Chadwick et al, 2019). However, more recently tribal communities in Oklahoma, appreciating the potential benefits of genomic research, started developing policies for safe and meaningful participation in genomic research (Chadwick et al, 2019).…”

“…They were particularly concerned about entering of the specimens into a repository (Chadwick et al, 2019). However, more recently tribal communities in Oklahoma, appreciating the potential benefits of genomic research, started developing policies for safe and meaningful participation in genomic research (Chadwick et al, 2019).…”

“…The laws of AIAN communities are recognized in the Common Rule because federally recognized tribes have a form of sovereignty (right of self-governance), and have government-to-government relations with the USA (Executive Order 13175: Consultation and Coordination with Indian Tribal Governments, 2000). Understanding both tribal sovereignty and research regulation is an ethical requirement for conducting research in AIAN communities (Claw et al, 2018).…”