Capacity building from the inside out: Adapting the citi ethics certification training course for American Indian HIV and substance misuse community researchers

Informed engagement of American Indian (AI) community partners in the review of research protocols helps ensure community-based research avoids cultural misunderstandings, stigmatization, or culturally inappropriate, irrelevant, and disrespectful science. However, available certified human subjects trainings fail to resonate with AI community members.

Using participatory research processes, we adapted the Collaborative IRB Training Initiative (CITI) certified human subjects training module “Assessing risk and benefits”. Investigators prepared materials for panel review including mapping the modules' core components to the code of federal regulations. Three expert panels (AI community members, scientific and ethicist; n = 11,) adapted the module to meet AI cultural perspectives and concerns. In a two-arm randomized controlled trial, followed by debriefing interviews, we evaluated module acceptability and feasibility (i.e. relevance of materials, self-efficacy/confidence in applying concepts and satisfaction), and understandability of module (test scores)among 40 AI reservation-based community members.

Participates who took the adapted module, as compared to those who took the standard module reported higher scores on relevance of the material (82.7 versus 65.8, t= 3.06, p<0.01), overall satisfaction (81.4 versus 69.4, t= 2.10, p<0.05), module quiz scores (75.7 versus 62.9, t= 2.15, p<0.05) and a trend toward higher self-efficacy (76.3 vs. 68.1, t= 1.71 p<0.10).

Culturally-relevant ethical training materials were preferred by AI community members and imperative to address AI health and wellness. Developing human subject research training materials and programs that are collaborative, community driven, and nationally supported offer the most promising potential for community acceptability, long-term success, and sustainability.