Research Regulatory Specialist University of Texas Medical Branch Galveston, Texas, United States
Background: The inclusion of underrepresented racial and ethnic groups (URGs) in clinical research is critical for ethical and scientific reasons. This initiative aimed to assess the perspectives, barriers, needs, and recommendations encountered by research teams when enrolling and retaining URGs in clinical research.
Methods: An anonymous, web-based survey comprised of quantitative and qualitative questions was administered to individuals involved in clinical research at an academic medical center. The survey assessed three main domains: 1. Research teams' perceptions and experiences with enrolling URGs in clinical research, 2. Factors that discourage URGs from participating in clinical research, and 3. Research teams’ overall willingness to support URG enrollment. Demographics were also collected. The survey was reviewed by experts in clinical research, research ethics, and diversity, equity, inclusion, and accessibility (DEIA). The assessment was piloted among research professionals and edits were made accordingly prior to official dissemination. Data were analyzed using descriptive statistics.
Results: There was a total of 63 responses. A majority (62.1%) of respondents indicated that they have more success enrolling patients whose primary language is the same as their own and that time arranging for an interpreter has negatively impacted enrollment efforts (53.4%). Approximately half of the respondents (51.7%) believe that the race and/or ethnicity of the potential study participant influences enrollment success.
Factors discouraging URGs from participating in clinical research include unavailability for follow-up visits due to transportation issues (72.4%), distrust in doctors and/or researchers (56.9%), fear of unknown side effects (56.9%), and unavailability of medical interpreters (50%).
However, despite these potential challenges, respondents overwhelmingly report that they are not discouraged from enrolling URGs (77.6%). Overall, respondents would likely utilize various resources related to encouraging the inclusion of URGs. However, a small percentage of respondents (4.8%) expressed that DEIA and initiatives such as this assessment are racist, divisive, and/or regressive
Limitations: This assessment was carried out at a single institution with a relatively small sample size. Therefore, these results may not be generalized across other academic medical institutions and may not accurately reflect the perspectives, barriers, and needs of research teams at other institutions. Additionally, the institution surveyed includes researchers involved in NIH-funded research, which places an emphasis on, and encourages, the recruitment of women and minorities.
Discussion: Language appears to be a more influential factor than ethnicity or race when it comes to enrolling and retaining URGs. Therefore, the dedication of resources to address language barriers may increase the enrollment of URGs in clinical research. Overall, it appears that enrolling URGs is a bigger challenge than retaining URGs. Major themes that emerge with respect to retaining enrolled participants include the inability to attend follow-up visits and the lack of incentives/compensation. Therefore, streamlining processes at the institutional level, particularly related to compensation and transportation, may be an effective strategy for retaining URGs once enrolled in clinical research.
