In this study, we were able to explore factors associated with refusals to provide blood and/or mouthwash samples among genetic research study participants and its relationship to future research participation. We found that respondents who were unwilling to provide biological specimens were more likely to be African American and less trusting of medical researchers, and were also less likely to be willing to participate in future genetic research. Further, the discrepancy between African Americans and whites for blood sample donations was explained in part by less trust in medical research and researchers. Thus, despite prior participation in a genetic epidemiology study (NCCCS), factors associated with willingness to provide tissue samples reflected many demographic factors previously identified in research on public attitudes toward genetic research. This study enhances this prior work by adding trust to an examination of traditional demographic variables, and adding open-ended questions that provide more detailed explanation of participant refusals. In these open-ended queries, we found generic concerns about needle sticks and inconvenience as well as themes of discomfort and mistrust.
Prior research on public attitudes toward requests for biological specimens for research and long-term storage has examined how responses might vary based on the request and the respondent. African American race, female gender, older age, lower income, less education, higher occupation category, and worse health status have been associated with less willingness to consent to donate and store specimens.1, 16
Researchers have documented public belief in the potential of genetic research to contribute to improved health,6, 7, 10
but consistently lower acceptance among minority groups.1, 5, 6, 16, 17
One study analyzed consent forms and found that, while 87% of 1670 subjects authorized future use for any medical condition, fewer African Americans (75%) did so.18
Our study mirrors these racial differences; however, further exploration of trust appears to be important in explaining these differences. Further, our study explicitly examines the role of race and trust among a population of prior research participants, presumed to be more receptive. Despite prior participation, some participants in our study expressed distrust of medical researchers and lower willingness for future participation.
Concerns previously identified among minorities that might explain differential participation include control of DNA, potential for misuse of genetic data, racial discrimination, stigmatization, and unequal access to potential benefits.6–9, 19, 20 Such negative views among African Americans are often considered in the context of a historical legacy of discrimination often based on the assertion of genetic inferiority as well as government funded research such as Tuskegee.21
The recruitment and participation of African Americans in research has been a topic of much discussion, given the aforementioned concerns and a continued push to include diverse groups in all human research and the scientific discourse about race and genetic variation. Some have suggested that, given the complexity of the biological specimen requests for genetic studies, decisions to donate may be based less on “informed consent” – that is, participant evaluation of the purpose22
or assessment of the risks and benefits of the specific project.4
Rather, general trust that those performing the research will act responsibly may be as important as informed consent.4, 23
These findings, and the concerns described in response to open-ended interview questions, represent potential barriers to recruitment and retention of participants from diverse backgrounds for genomics studies. Interventions that help educate researchers as well as potential study participants about genetic research and efforts to improve and demonstrate the trustworthiness of the research team might help encourage future study participation. While a high proportion endorsed interest in future participation, researchers should not assume that prior experience in genetic research completely removes participants’ reservations about participation or willingness to donate biological specimens.
Our findings should be viewed in light of its limitations. First, because LeARN participants were drawn from the North Carolina Colorectal Cancer Study, the generalizability of its findings is limited to individuals who have joined similar research studies. NCCCS took many measures to demonstrate trustworthiness of the research team and build rapport with potential participants (e.g., 2 hour in home visits prior to requests for samples and a recruitment and consent process that involved multiple contacts). Individuals who have not joined such studies may have different and potentially less positive attitudes toward research participation. Additionally, while the LeARN response rate was quite good (73%), there are potential biases inherent in the sample that may further limit its generalizability. While the number of African Americans and whites who refused to participate in the LeARN study was similar, due to unusable telephone numbers the response rate differed by race.15
It is possible that differences between African Americans and whites about how positive they felt about genetic research conceivably could have been larger than we observed had we been able to recruit both races equally.
Despite these limitations, the contributions of LeARN findings are highly relevant to current goals of recruiting genetic study participants. Similar to other reports in the literature, LeARN participants demonstrate a clear willingness for biological specimen donation. This willingness appears, in part, to be driven by trust. Mistrust and concerns about genetic research studies will need to be addressed to ensure diverse future participation.