JMIR Publications

ABSTRACT

Background:

There is a paucity of controlled clinical trial data based on research with Indigenous peoples. A lack of data specific to Indigenous peoples, will mean that new therapeutic methods such as those involving eHealth will be extrapolated to these groups based on research with other populations. Rigorous, ethical research can be undertaken in collaboration with Indigenous communities but requires careful attention to culturally safe research practices. Literature on how to involve Indigenous peoples in the development and evaluation of eHealth /mHealth applications that responds to the needs of Indigenous patients, providers and communities is still scarce, although the need for community-based participatory research (CBPR) to develop culturally safe technologies is emerging as an essential focus in Indigenous eHealth research. To be effective, researchers must first gain an in-depth understanding of Indigenous determinants of health including the harmful consequences of colonialism. Second, researchers need to learn how colonialism affects the research process. The challenge then for eHealth researchers is to braid Indigenous ethical values with the requirements of good research methodologies into a culturally safe research protocol.

Objective:

A recent systematic review showed that Indigenous peoples are underrepresented in randomized controlled trials (RCTs), primarily due to a lack of attention to provide space for Indigenous perspectives within the study frameworks of RCTs. Given the lack of guidelines for conducting RCTs with Indigenous communities, we conducted an analysis of our large evaluation data set collected in the DREAM-GLOBAL trial over the period of five years. Our goal is to identify wise practices for culturally safe, collaborative eHealth and RCT research with Indigenous communities based on our analysis.

Methods:

We thematically analyzed survey responses and qualitative interview/focus group data that we collected over five years in six culturally diverse Indigenous communities in Canada during the evaluation of the clinical trial DREAM-GLOBAL. We established themes that reflect culturally safe approaches to research and then developed wise practices for culturally safe research in pragmatic eHealth research.

Results:

Based on our analysis, successful eHealth research in collaboration with Indigenous communities requires a focus on cultural safety that includes: (1) building a respectful relationship, (2) maintaining a respectful relationship, (3) good communication and support for the local team during the RCT, (4) commitment to co-designing the innovation, (5) supporting task shifting with the local team, and (6) reflecting on our mistakes and lessons learned or areas for improvement that supports learning and cultural safety.

Conclusions:

Based on evaluation data collected in the DREAM-GLOBAL RCT, we found that there are important cultural safety considerations in Indigenous eHealth research. Building on the perspectives of Indigenous staff and patients, we gleaned wise practices for RCTs in Indigenous communities. Clinical Trial: ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6oxfHXege)