Using Community-Based Participatory Research Principles to Develop More Understandable Recruitment and Informed Consent Documents in Genomic Research

Abstract

BackgroundHeart Healthy Lenoir is a transdisciplinary project aimed at creating long-term, sustainable approaches to reduce cardiovascular disease risk disparities in Lenoir County, North Carolina using a design spanning genomic analysis and clinical intervention. We hypothesized that residents of Lenoir County would be unfamiliar and mistrustful of genomic research, and therefore reluctant to participate; additionally, these feelings would be higher in African-Americans.MethodologyTo test our hypothesis, we conducted qualitative research using community-based participatory research principles to ensure our genomic research strategies addressed the needs, priorities, and concerns of the community. African-American (n = 19) and White (n = 16) adults in Lenoir County participated in four focus groups exploring perceptions about genomics and cardiovascular disease. Demographic surveys were administered and a semi-structured interview guide was used to facilitate discussions. The discussions were digitally recorded, transcribed verbatim, and analyzed in ATLAS.ti.Results and SignificanceFrom our analysis, key themes emerged: transparent communication, privacy, participation incentives and barriers, knowledge, and the impact of knowing. African-Americans were more concerned about privacy and community impact compared to Whites, however, African-Americans were still eager to participate in our genomic research project. The results from our formative study were used to improve the informed consent and recruitment processes by: 1) reducing misconceptions of genomic studies; and 2) helping to foster participant understanding and trust with the researchers. Our study demonstrates how community-based participatory research principles can be used to gain deeper insight into the community and increase participation in genomic research studies. Due in part to these efforts 80.3% of eligible African-American participants and 86.9% of eligible White participants enrolled in the Heart Healthy Lenoir Genomics study making our overall enrollment 57.8% African-American. Future research will investigate return of genomic results in the Lenoir community.

Engaging rural communities in genetic research: challenges and opportunities

“…Previous community-based genetic studies in the USA have been broadly population-based or primarily focused on racial and ethnic minorities, including African-American communities and Native American tribes, but there is little research that has been done looking at isolated rural populations of European descent (Foster et al 1999;Terry et al 2012;Rotimi et al 2007;Skinner et al 2015). Our group has hypothesized that the nature of the founding of many rural communities in the USA may have facilitated the development of genetic founder effects which may contribute to underlying disease risk variability (Jenkins et al 2016).…”

“…Focus groups allow for participants to provide open-ended feedback and an additional avenue for community engagement and establishing a foundation of trust that can facilitate genetic research, as the community is often engaged in this qualitative research not only as participants but as Brecruiters^of participants. Including the community in the recruitment process has been effective for both community-based focus groups and genetic research (Cristancho et al 2008;Skinner et al 2015). Focus group findings have provided researchers with better information how to better consider community concerns, recruit research participants, and disseminate research findings in genetic research (Rotimi et al 2007;Terry et al 2012).…”

Engaging Hmong adults in genomic and pharmacogenomic research: Toward reducing health disparities in genomic knowledge using a community-based participatory research approach

“…Similarly, these ethical concerns have led researchers to consider a variety of processes to obtain community input into genomic research and increase community interest in potential results (George et al 2014;Green et al 2011;Millon Underwood et al 2013;Skinner et al 2015;Yu J-H and Burke W 2012). These processes have included conducting community interviews, focus groups, and rapid ethnographic assessments (Skinner et al 2015;Tindana et al 2012) to identify perceptions and barriers to participate in community-based genetic studies; and working with communities through community advisory boards (Quinn 2004), community fora (Mascalzoni et al 2008) and community consultations (Dickert and Sugarman 2005) to increase engagement of community members in conducting genomic studies.…”

“…These processes have included conducting community interviews, focus groups, and rapid ethnographic assessments (Skinner et al 2015;Tindana et al 2012) to identify perceptions and barriers to participate in community-based genetic studies; and working with communities through community advisory boards (Quinn 2004), community fora (Mascalzoni et al 2008) and community consultations (Dickert and Sugarman 2005) to increase engagement of community members in conducting genomic studies. Several genomic studies have reported successful outcomes using various community engagement processes Marsh et al 2013;Marsh et al 2010;Skinner et al 2015;Tindana et al 2012;Vreeman et al 2012), and particularly in designing an informed consent process with appropriate vocabularies that address more complex ethical issues, such as whether or not genetic data should be given to participants (Lemke et al 2012;Skinner et al 2015).…”

“…Partnering with community members to conduct research via community-based participatory research (CBPR) could move the ethical processes one stage further to allow equal power sharing between researchers and community members throughout the research steps, from conceptualizing the study, to collecting and analyzing the data, and finally to communicating the results back to the community (Israel 2005;Israel et al 1998). An interwoven CBPR partnership has the potential to identify and then address the social, cultural, logistical, and ethical issues that arise in conducting research focused on actionable outcomes (Chen et al 2006;De las Nueces et al 2012;George et al 2014;Skinner et al 2015).…”