Jennifer Erdrich
Violations in research ethics and the geo-remote location of reservations has hindered American Indian/Alaska Native patients from participating in clinical research. To address lower participation and mistrust, we designed a clinical trial delivered on the San Carlos Apache reservation grounded in the CARE Principles for Indigenous Data Governance (Collective benefit, Authority to control, Responsibility, and Ethics). These principles have bridged successful relationships between Tribes and other sectors, yet have not been implemented in clinical research. The activation of the CARE Principles in this study’s design prioritized the community, fostered transparency, showcased tribal capacity for research, and ethically facilitated regulatory exchanges. Over the course of 5 years, semi-structured interviews were conducted with Tribal members who are cancer survivors, and meetings were held with the Tribal health facility’s leadership, staff, board of directors and Tribal Council to assess needs, develop on-site infrastructure, and reiteratively refine a clinical trial responsive to feedback. This collaboration created a prehabilitation intervention designed to alter inflammatory biomarkers for American Indian patients preparing for oncologic surgery, which is now open for enrollment. A Tribal Resolution signed by the Tribal nation’s attorney general and University of Arizona officials solidified the partnership and terms of research conduct, publication, and intellectual property. Applying the CARE Principles to the protocol planning and approvals process supported Indigenous governance while meeting academic research principles. This intersection was key to developing a university sponsored clinical trial on a reservation and is a shareable example that can support other clinically focused Tribal-academic research.