Barriers to Participation
Lack of Trust. A growing number of published articles address reasons why minority groups and historically disenfranchised groups are underrepresented in clinical research. African Americans, in particular, have historically harbored suspicions about participating in clinical research studies, regardless of age. Lack of time, poor health status, low accessibility, and distrust are just a few barriers to participation in research that have been well documented. Trust issues surrounding science and medicine and their perceived conflicts with religion have etiology in years of victimization and exploitation, misrepresentation, and serving as a disposable commodity to be traded and shared among those seeking scientific, academic, and financial advancement with little direct or lasting benefit to the participant, dating back to slavery.
Many posit adaptive and historical distrust of medical and scientific systems ripe with overt and covert forms of racial discrimination and exploitation in the United States, as an obstacle to effective ascertainment [1]. Others note that historical and even recent national and personal atrocities committed against African Americans such as the Public Health Study at Tuskegee [2, 3] or personally recollected events with families and communities as causes for distrust and poor subject ascertainment. The Jim Crow era includes the years from 1877 to 1954 in the United States when laws were established to enforce racial segregation in the South. Older African Americans who lived through the Jim Crow era, and the systematic diminution of their value solely as a function of their race, represent a cohort that has intimate knowledge of atrocities. They often serve as the source of distrust for future generations via cultural transmissions of information [4-6]. Mistrust has been reported as a major barrier across several racial and ethnic minority groups, including African American, Asian American, Latino, and Pacific Islander [7]. Consequently, mistrust can manifest in several different ways and with several different themes, such as research benefiting only or mostly Whites (“I refuse to be your guinea pig or lab rat”), or fear of mistreatment or losing rights by signing a research consent document during the research process [1,3,8-13].
Retention in Research. Retaining underrepresented groups in studies is just as significant as, if not more than, recruiting them. This is especially true for longitudinal studies and studies that require multiple contact points. Without retention, statistical power for studies and generalization of study results are compromised. Numerous studies have reported (1) that women are more likely to engage in follow-up studies than men [14, 15]; (2) that older adults are more likely to follow up (barring illness or access) than younger adults [16, 17]; (3) that persons of higher education and socioeconomic status are more likely to follow up than persons of lower education and socioeconomic status [18]; (4) that Whites and Asian Americans are more likely than African Americans and American Indians to remain in studies [19-21]; and (5) that being single with multiple children is a barrier to following up and retention in longitudinal studies [22] . Understanding of the likelihood that potential participants will remain (or not remain) in a study should be an important factor in study design and planning for enrollment targets.
Minority Physician Participation. According to Powell et al. [23] and Christian and Trimble [24], an important barrier to recruiting minorities and women in research studies and clinical trials is the lack of minority physicians who are interested in participating in clinical research trials. While many physicians would appreciate the opportunity, there are significant barriers that might preclude their participation. These include lack of awareness of clinical trial opportunities, lack of appropriate clinical staff, lack of robust patient information data systems, as well as lack of time. Such studies suggest that more broadly including clinical trial training in physicians’ formal education will become increasingly important. They also suggest that a paradigm shift is needed to more intentionally make physicians aware of clinical trial opportunities, particularly when they practice in rural areas and areas where there are high numbers of underrepresented groups [25].
Gender Participation among Minorities. According to the Department of Health and Human Services, not only is there a need to address disparities in participation among races/ethnicities, but there is also an important need to assure that gender lines, within these groups are considered. In fact, the need to include minorities and diverse ethnic groups in research funded by the NIH was initiated at the National Institutes of Health (NIH) and precipitated by the urgency in 1986 to include women in clinical research trials funded by the NIH. From 2003 to 2012 the percentage of females that enrolled in all NIH clinical research ranged from 56.1 to 63.9 %. Since 2003 this trend for female enrollment has remained relatively stable and has surpassed male enrollment in minority enrollment and overall. These data support the idea that implementation of policies that foster engagement of marginalized and minority populations has made a substantial impact on domestic clinical research enrollment.
Minority males in the United States have the worst age-adjusted all-cause mortality rates as compared to their gender or racial counterparts [26]. Recent results, however, suggest that minority males are no less willing to participate in research studies than non-Hispanic Whites [27-31]. Understanding the intrinsic and cultural motivations to engage minorities in investigations will contribute significantly to reducing health disparities and improving overall health.
Perceptions, Assumptions, and Goal Setting of Principal Investigators. A major barrier to minority inclusion in clinical studies has been the perception that many underrepresented groups refuse to participate in studies. Because of this perception, investigators have often failed to set recruitment goals for racial and ethnic minority groups. In a national survey of 440 NIH-funded investigator respondents, conducted by Ard et al. [32] only 2.7 % of investigator respondents set goals for all of the racial/ethnic minorities defined by the NIH. Results from the study showed that these investigators, through open enrollment processes, most often failed to reach their enrollment targets for African Americans, Asian Americans, and Hispanics, when compared to Whites. Smaller minority groups (American Indians/Native Alaskans and Native Hawaiians/Pacific Islanders) were not included in the analysis because so few investigators did not input recruitment goals for these underrepresented populations. This study reveals just one ongoing challenge with inclusion, despite the mandate of the NIH Revitalization Act, which requires trials to be designed for inclusion of underrepresented groups and valid analyses of differences in race and ethnicity.
Many minority research participants are inappropriately labeled “non-participants.” These individuals are highly likely to reject participation in studies that (1) have no perceived benefit to them or their communities; (2) do not match their time demands, ethical considerations, or interests; or (3) are run by researchers that they do not know, respect, or trust. Study nonparticipants. are not a homogeneous group. With increasing frequency toward the goal of refining their interests, study methods, and recruitment strategies, researchers must distinguish “research participant,” or lack thereof, from circumstantial issues associated with subject ascertainment.
In the past, researchers have often incorrectly assumed that because a potential research subject did not participate in study X, he or she was not a participant in any study. The incorrect assumption, which placed the blame for underrepresentation on the diverse subjects, has been challenged by the recognition that potential subjects make smart and informed decisions about where, how, and with whom they will invest their limited time and energies. A broad labeling and conceptualization of a potential research subject as a “nonparticipant” may more accurately be viewed as incompatibility between the researchers, their study, and the subject’s interests and or resources. What were once perceived as universal barriers to subject participation (subject-based) may, in fact, be better accounted for in many circumstances by the failure to ascertain (researcher-based).
Unintentional Barriers. Researchers today are paying more attention to unintended barriers to participation. These might include convenience or location of the research site, participant knowledge or familiarity with the researcher or research institution, level of comfort with research recruiters, and perhaps adequacy of compensation for the time and commitment involved for participation. In some ways, these additional barriers may be overcome by culturally competent research design and training of research staff on how to access or reach a particular population. African American research participants have also emphasized the importance of having African American investigators as collaborators, and suggest a role for historically black colleges and universities to help improve African American participation and address health disparities research [33]. Collaborations that bridge basic science research and educational outreach, with a culturally relevant staff, can serve as good models for improving not only research participation, but also health care knowledge, care management, and trust, all of which may help lower barriers for participation in clinical research trials.
Socioeconomics may impact access to participation in clinical trials and access to adequate health care. Patients’ earned income may serve as a predictor of clinical trial participation, independent of whether or not they have insurance. Research studies should consider a patient’s socioeconomic status when thinking of how participants may access the study. Time away from the workplace, or travel to the research site, might be a barrier for participants from low socioeconomic groups. However, a survey of more than 500 African Americans found that approximately 60 % of the participants stated that they were willing to participate in future studies without receiving compensation or the promise of future compensation [28, 34]. In the 40-59 age group for this study, monetary compensation was the least motivator for individuals to participate in research studies. They also expressed a willingness to participate, in a diverse array of research types. However, the idea of having time to participate and the relevance of the research topic to their family or loved ones were high motivators for participation. To improve participation of underrepresented groups in clinical research trials, it is important to highlight the relevance of the research to particular groups, to meet people where they are, and to assure that potential participants understand the importance of their participation.
By the year 2043, the United States will become a mostly minority nation. According to the United States Census Bureau, the Hispanic American population will increase from 53.3 million to 128.8 million by 2060. The African American population is expected to increase by 50 % by the year 2060, and the Asian population is expected to double by 2060 to 34.4 million and will then become 8.2 % of the population. Native Americans and Alaska Natives will reach 1.5 % of the US population while Pacific Islanders will increase from 706,000 to 1.4 million within the same time period. Individuals that self-identify as more than one race will reach
26.7 million by 2060. By 2030, ethnic minority elders are expected to increase by 12 %. The older population will present to healthcare providers with multiple chronic illnesses. These illnesses are influenced by race, gender, and socioeconomic status. With issues of cultural competency at the heart of medically and socially appropriate services, stakeholders will be forced to engage minority populations in much more intentional ways. This ethnogeriatric imperative facing providers will dictate an evaluation of recruitment, retention, assessment, medical adherence, and care. A major risk for minority groups is the heterogeneity of culture, language, health beliefs, risk for disease, and other factors. Models of successful ethnogeriat- ric care will need to include and respond to differences in levels of acculturation, health literacy, stigma, and preferences related to end-of-life care.
