Clinical trial participation and biospecimen donation for research: Barriers, historical, and ethical issues among rural and urban residents in Maryland

Minority, urban and rural communities experience health disparities at greater rates than the general population. Yet, these communities have lower than desirable participation rates in clinical trials. They also have low rates of donating tissue (biospecimens) for storage and future research. This study examined factors and barriers to clinical trial participation and tissue donation for research in the targeted communities. Objectives for the study are as follows: examine barriers to clinical trial participation; examine factors influencing willingness to participate in clinical trials; examine awareness of the role of biospecimen donation in advancing research and factors related to willingness to donate biospecimens from diverse and underserved populations; and examine biospecimen donation consent preferences and ethical issues for the targeted populations related to future use in general and genetic research. Using qualitative and quantitative methods, focus groups and key informant interviews were the primary data collection methods. In addition, a community engaged research component (CER) was incorporated into the study. A total of six (6) focus groups were held this spring/summer with a total of 48 participants from the specified areas of Baltimore, Eastern Shore, Frederick, and Southern Maryland. Preliminary key themes which emerged are as follows: 1. Overall general knowledge of clinical trials was high, knowledge of biobanks/bio-repositories was significantly lower. 2. Trust/distrust was discussed at each of the groups as the primary influence of why people aren9t willing to participate in clinical trials. 3. Privacy was of concern to all participants and specifically Social Security number being linked to samples/research. 4. Experiments on minority/vulnerable populations – at three of the focus groups 100% of the participants had knowledge of the history of Henrietta Lacks and also the Tuskegee Syphilis Experiment. Preliminary conclusions indicate persistent lack of trust by the public in researchers. This manifests in lower recruitment of medically underserved and diverse populations in clinical studies. The public expressed ethical concerns related to donation of biospecimens for research in general and most notably for genetic research. Concerns regarding informed consent preferences, privacy, return of results and other ethical challenges were expressed. The failure of research agencies and researchers to address these concerns will only perpetuate underrepresentation of these communities in trials and in donated tissue for research. The establishment and maintenance of strong bidirectional community engaged research partnerships between community organizations/stakeholders and researchers is critical to efforts to significantly improve public trust in research and participation in both clinical trials and biospecimen donation. Each of these is essential for the advancement of medicine and public health. Note: This abstract was withdrawn after the Proceedings was printed and was not presented at the conference. Citation Format: Claudia R. Baquet, Jeanne L. Bromwell. Clinical trial participation and biospecimen donation for research: Barriers, historical, and ethical issues among rural and urban residents in Maryland. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr A03. doi:10.1158/1538-7755.DISP13-A03