Clinical trials play a pivotal role in medical research. They are necessary to evaluate the safety and efficacy of new medical interventions, obtain regulatory approval, compare treatment options, understand disease mechanisms, and optimize treatment protocols.¹ Yet, within the framework of clinical trial participation, a variety of factors can sway the efficacy and safety outcomes depending upon the demographics of participation within the clinical trial.²

In recent decades many people have become distrustful of the health care system within America. Further research is necessary to explore the origins of this mistrust. Factors such as the high prevalence of iatrogenically induced mortality (~250,000)³ and medical waste resulting from overtreatment are likely contributing factors.⁴ A mere 23% of Americans expressed unwavering confidence in the health care system.⁴ This prevailing skepticism is especially prevalent within minority communities and likely stems from a history of medical exploitation, epitomized by infamous instances like the Tuskegee Study of Untreated Syphilis in the Negro Male and the immortalized story of Henrietta Lacks.⁵ Medical exploitation, coupled with fear, educational disparities, socioeconomic stratification, cultural nuances, and a lack of health literacy regarding clinical trials, presents multiple barriers to minority participation in clinical trials.⁶

Figure. Violin plot depicting distribution of preferred language amongst accepting and rejecting virtual reality demographic groups. Spanish-preferred language speakers were statistically more likely to decline involvement in the study than those who professed English as their preferred language.

Our study analyzed the demographics of individuals who declined participation in our vasectomy virtual reality trial. We aimed to gain a comprehensive understanding of our population’s attitudes and perceptions surrounding this innovative intervention.

By conducting a meticulous review of charts encompassing patients who underwent vasectomy under a single surgeon between October 2023 and January 2023, we evaluated the underlying motivations guiding the decision-making processes of 67 patients who declined participation as compared to the 113 individuals who consented to participate in the trial. Statistical analysis was performed via t tests upon confirming normality of sample data.

A statistically significant difference was seen in recruitment with patients who professed Spanish as their language of preference (P < .0001), with this cohort exhibiting a predilection toward declining involvement in the study (Figure). Surprisingly, variables such as age (P = .8285), race (P = .7010), ethnicity (P = .2636), or marital status (P > .9999) were similar between the men who consented as compared to those who did not. This suggests that while variables such as age, race, ethnicity, and marital status did not significantly influence participation decisions, linguistic preference did. These findings indicate the crucial role of language preference in determining participation rates and emphasize the importance of considering linguistic factors in recruitment strategies.

The recruitment of individuals with Spanish as their language preference was facilitated with the use of a translation service, which can be a barrier to recruitment. While essential, the use of a translation service lengthens patient visits and may lead to inadequately answered patient questions, thereby hindering optimal understanding of the clinical trial. Additionally, the presence of both a language barrier and concerns regarding the virtual reality headset obstructing vision, especially in the setting where trust may already be fragile, could have impeded participant recruitment. This underscores the importance of addressing language barriers in fostering inclusivity within clinical trial recruitment endeavors.

In conclusion, our study highlights the intricate interplay between societal mistrust in health care systems, historical legacies of medical exploitation, and the multifaceted barriers hindering minority participation in clinical trials. By analyzing the demographics of individuals who declined participation in our vasectomy virtual reality trial, we gleaned valuable insights into the nuanced factors influencing decision-making processes. The significant difference observed in recruitment patterns among patients who preferred Spanish as their language highlights the importance of addressing cultural and linguistic barriers in clinical trial recruitment efforts.

Despite these challenges, our study emphasizes the importance of fostering inclusivity and accessibility in clinical trial recruitment endeavors. Utilizing translation services and implementing targeted interventions can help mitigate barriers and enhance the representation of diverse populations in clinical research.

Moving forward, researchers and health care providers must collaborate in developing strategies that promote equity and diversity in clinical trial participation. By fostering trust, addressing systemic disparities, and prioritizing inclusivity, we can advance the scientific understanding of medical interventions and ensure that clinical research benefits all individuals, regardless of background.