Harmonizing individual and community ethics to protect Tribal concerns in genomics research

Background: Federally-recognized Tribal nations in the United States have the right to self-govern, which is upheld in the latest 2017 revisions to the Federal Policy for the Protection of Human Subjects (“Common Rule”). These updates are consistent with the ethos of community-engaged models in which Tribal nations can ensure that genomics research within their communities is equitable and protects Tribal concerns, including those of data privacy.   Concerns: Unfortunately, non-indigenous researchers who are unfamiliar with these models or, worse, are averse to developing community partnerships often circumvent Tribal review procedures and recruit urban Native American individuals who reside off-reservation. With the increase in large-scale, multi-ethnic population studies (i.e., All of Us, direct-to-consumer tests such as 23andMe, hospitals, and studies with individually-recruited Natives), the non-disclosure of group risk to members of small, vulnerable populations constitutes inadequate informed consent and is becoming increasingly problematic. At risk is non-Native ownership of genomic data and commercialization of technologies utilizing biomarkers collected from indigenous individuals.   Recommendations: Tribes can utilize their sovereignty to create repositories that restrict access to researchers. There must be expanded efforts to educate individuals about genomic risks. Importantly, stakeholders must know that genomic autonomy is both an individual and community concern.