The Common Rule from an Indigenous Perspective: Setting New Standards in the Conduct of Ethical Research with American Indian and Alaska Native Communities

• Background: American Indian and Alaska Native (AIAN) community partner informed engagement in the review of research protocols helps ensure community-based research (CBPR) serves community interest, enhances recruitment and study retention and avoids cultural misunderstandings, stigmatization, or culturally inappropriate, irrelevant, and disrespectful science. Although review boards and researchers are trained to minimize risks to participants, all parties must also know how to apply research ethics principle that are culturally responsive, at a community level, and weigh studies’ potential pathologizing effects for entire social groups. Traditional ethics training curricula have yet to keep pace with the rapid expansion of CBPR and have failed to address the unique situations across AIAN communities. We brought together national panels of AIAN community members, AIAN academic scholars and allies, and policy leaders to co-design and evaluate a culturally tailored online human subjects training curriculum.
• Methods: In a national randomized sample of 490 AIAN community members, we compared our AIAN ethics training curriculum (n= 244) with a standard nationally used online curriculum (n= 246). We evaluated pre-and post-test measures to assess group differences in ethics knowledge, perceived self-efficacy to apply such knowledge to protocol review, and trust in research. Analysis of regional tribal differences assessed curriculum generalizability.
• Results: The AIAN curriculum, as compared to the standard curriculum, achieved significantly higher levels of participants’ research ethics knowledge at first attempt (9% quiz items correct versus 65.3%, t= 8.09, p <.001), acceptability (4.2 versus 3.8, t= 6.21, p <.001), satisfaction (4.1 versus 3.7, t= 5.26, p <.001), ease of responding to curriculum and completion of the training requirements. There were no regional, urban, or rural differences. For both arms, participants reported a significant increase in trust in research and in research review efficacy.
• Conclusion: We produced a validated research with human subject training curriculum, a trainer’s toolkit with case studies, and quiz items that is ready for immediate use. The curriculum is available for free download at Culturally-grounded training curricula may help remedy the impact of historical research ethics abuses involving minority communities that have contributed to mistrust of research and lack of community engagement in research.