Beyond the Belmont Principles: A Community-Based Approach to Developing an Indigenous Ethics Model and Curriculum for Training Health Researchers Working with American Indian and Alaska Native Communities.

Individuals responsible for carrying out research within their diverse communities experience a critical need for research ethics training materials that align with community values. To improve the capacity to meet local human subject protections, we created the research Ethics Training for Health in Indigenous Communities (rETHICS), a training curriculum aligned within American Indian and Alaska Native (AI/AN) context, culture, and community-level ethical values and principles. Beginning with the Belmont Report and the Common Rule that defines research with human subjects (46 CFR 45), the authors convened three different expert panels (N = 37) to identify Indigenous research values and principles common across tribal communities. The resulting culturally grounded curriculum was then tested with 48 AI/AN individuals, 39 who also had recorded debriefing interviews. Using a thematic analysis, we coded the qualitative feedback from the expert panel discussions and the participant debriefings to assess content validity. Participants identified five foundational constructs needed to ensure cultural-grounding of the AI/AN-specific research training curriculum. These included ensuring that the module was: (a) framed within an AI/AN historical context; (b) reflected Indigenous moral values; (c) specifically linked AI/AN cultural considerations to ethical procedures; (d) contributed to a growing Indigenous ethics; and (e) provided Indigenous-based ethics tools for decision making. Using community-based consultation and feedback from participants led to a culturally grounded training curriculum that teaches research ethical principles and procedures for conducting research with AI/ANs. The curriculum is available for free and the community-based process used can be adapted for other cultural groups.