Capacity Building from the inside Out: Development and Evaluation of a CITI Ethics Certification Training Module for American Indian and Alaska Native Community Researchers

Abstract

Current Human Subject Research training modules fail to capture ethically relevant cultural aspects of research involving American Indian and Alaska Native (AI/AN) community members. Applying a Community Engaged Research (CEnR) approach, we adapted the Collaborative IRB Training Initiative training module “assessing risk and benefits.” In a two-arm randomized controlled trial, followed by debriefing interviews, we evaluated module acceptability and understandability (test scores) among 40 reservation-based community members. Participants who took the adapted module, compared to those who took the standard module, reported higher scores on relevance of the material overall satisfaction, module quiz scores, and a trend toward higher self-efficacy. Implications of the efficacy of this approach for enhancing ethics training and community participation in research within AI/AN and other cultural populations within and outside the United States are discussed.

A Web-Based Platform for Educating Researchers About Bioethics and Biobanking

“…Previous research has shown that the use of CEnR with the intended population improves the quality of researcher training materials, resulting in higher scores on relevance of the material, overall satisfaction, module quiz scores, and a trend toward higher self-efficacy [11]. By conducting focus groups with IFRs and other vulnerable populations, the final curriculum included material directly contributed by the population under study.…”

“…Therefore, Community Engaged Research (CEnR) plays a significant role for outreaching to IFR and racial/ethnic minority populations [10] by providing the researcher with an understanding of what a new innovation means to a specific community. The insights and perspectives gained from outreach to IFR and racial/ethnic minority populations can inform the development and evaluation of human subjects’ protections training materials [11]. …”

Culturally Relevant Human Subjects Protection Training: A Case Study in Community-Engaged Research in the United States

“…These standard research ethics training modules have been translated into other languages (i.e., Spanish, Japanese, and Korean). However, in community-engaged research, research ethics training issues remain related to cultural and contextual relevance, risks and benefits of research to communities, and areas of confusion to community members engaged in research (4,5). Pearson and colleagues’ (5) work with American Indians and Alaska Natives demonstrated that adaptations to human subjects protection training should include issues that are pertinent to ethnic minority communities, references to specific cultures, use of simplified terminology and clarification of concepts, examples relevant to communities (e.g., misuse of data), and topics related to community-level risk and benefits (e.g., discomfort or distress from discussing traumatic events).…”

“…As the role of community members in research grows, so does concern over the ethical research training they receive (5,15,16). Research in communities may lead to different research ethical challenges than those in traditional academic and clinical settings.…”

“…For example, underserved populations, with whom much of community-engaged research is conducted, may also experience lower socioeconomic status, education, and literacy, adding to difficulties in trying to understand terminology in ethics training, discomfort completing online training or difficulty accessing the Internet. To ensure understanding of and compliance with research ethics, it is essential to eliminate such barriers and engage underserved populations by using materials appropriately targeted to their needs (4,5). Because community members engaged in research are likely to know research participants as neighbors, friends, business associates, or relatives, maintaining confidentiality and anonymity presents different challenges.…”