Facilitators, barriers, and recommendations related to the informed consent of Marshallese in a randomized control trial

Abstract

Background The Pacific Islander population is the second fasting growing population in the United States and Arkansas is home to the largest Marshallese population in the continental US. The Marshallese community have significant health disparities with high prevalence of diabetes, heart disease, and obesity compared to the general US population. Using a community-based participatory research approach, researchers and Marshallese community stakeholders identified diabetes as the top health issue for research. Methods From 2014 to 2018, a randomized control trial was conducted comparing standard diabetes management education with a culturally adapted family model of standard diabetes management education delivered in participants’ homes by Marshallese community health workers and certified diabetes educators. Interviews were held with Marshallese participants to document their experiences with and perceptions of the informed consent process for this randomized control trial. Results Participants provided feedback on the process of enrolling in the study, describing barriers and facilitators to giving informed consent from their perspective, and offering recommendations for improving the informed consent process. Conclusion Findings suggest that informed consent with underserved communities, including immigrant and migrant populations who do not speak English or have limited English proficiency, is possible, and that using a community-based participatory research approach can help facilitate the informed consent process.

Faith-based health screenings for Marshallese adults living in the Republic of the Marshall Islands: Study design and results

“…Previous research with the Marshallese community has highlighted Marshallese participants' desire for a simplified consent process and the preference for verbal discussion of study requirements ( 21 ). Therefore, as the health screenings were considered a minimal risk study, a waiver of consent documentation was requested and granted by the University of Arkansas for Medical Sciences Institutional Review Board (IRB #262557).…”

Multicomponent Informed Consent with Marshallese Participants

“…Participants were asked to agree to allow UAMS researchers to “use my information for future research related to this study that is approved by the UAMS IRB” and to opt in or out of allowing “UAMS to link information from this study to other UAMS studies I have participated in.” In addition to consenting to participate in a GWG study, the participants were asked the questions in Figure 1. Study results will be disseminated to participants, Marshallese research stakeholders such as federally qualified health centers, community clinics, faith-based organizations and community-based organizations, the broader Marshallese community, and fellow researchers (Purvis et al, 2020, 2021).…”

“…The CHWs ensured that participants had time for discussion about the study requirements, risks, and benefits in their preferred language. Prior research has shown that time for discussion in a participant's native language is effective in improving participant understanding of the informed consent process (Al Tajir, 2018;Nishimura et al, 2013;Purvis et al, 2020Purvis et al, , 2021. The limitations of the study include a nonrandom, small sample size from one racial group in a single geographic area.…”

“…In addition to consenting to participate in a GWG study, the participants were asked the questions in Figure 1. Study results will be disseminated to participants, Marshallese research stakeholders such as federally qualified health centers, community clinics, faith-based organizations and community-based organizations, the broader Marshallese community, and fellow researchers (Purvis et al, 2020(Purvis et al, , 2021.…”