Considerations for bio-specimen collection among black women residing in the rural Deep South participating in a cancer prevention study

Abstract

Cancer is a leading cause of mortality and morbidity in the USA (Hoyert et al. 2012). Additionally, cancer health disparities (incidence, morbidity, mortality) exist in the USA despite notable progress in diagnosis and treatment (Ward et al. 2004). Racial/ethnic minorities, low socioeconomically disadvantaged populations, and persons living in rural areas experience the greatest cancer burden (Jemal et al. 2008). Bio-specimen collection is vital for the advancement of enhanced diagnostic, prevention, and treatment tools for cancer and other diseases. Bio-specimens, materials taken from the human body, provide valuable information about how to (1) identify and validate ways to deliver drugs or agents to specific cells, (2) identify how diseases progress and vary, (3) group patients, based on their genetic characteristics or biomarkers of their disease, to determine which treatment is most appropriate, and (4) develop screening tests to detect biomarkers that are associated with certain stages or subtypes of a disease (National Cancer Institute 2013b). Given the potential impact of personalized medicine to improve disease outcomes and eliminate health disparities, research on bio-specimens from samples of diverse populations of patients and healthy controls are critical. However, historically, racial/ethnic minorities are poorly represented in bio-specimen, bio-banking, and cancer research (Scott et al. 2010; Murthy et al. 2004; Rodriguez et al. 2013). The 2010 American Society of Clinical Oncology (ASCO) Statement on Attributes of Exemplary Research Sites, a series designed to help clinical research sites exceed Good Clinical Practice guidelines, highlights the following as important considerations for engaging individuals in bio-specimen research: talking with patients, informed consent, and disclosing of research results (Baer et al. 2010). Though grounded in clinical practice and aimed at helping oncologists make clinical trials a key part of their practices, similar considerations are also relevant for community-based bio-specimen research. ASCO recommends that “communication about bio-specimen collection be thorough, open, and honest” and should include information about the rationale for collecting bio-specimens along with risks and benefits (Baer et al. 2010). ASCO also endorses an informed consent process that includes specific information that is in regulatory compliance for bio-specimen research and also highlights that there may be a need for additional focus on the issue of custodianship (i.e., how specimens and privacy will be maintained) (Baer et al. 2010). Finally, ASCO highlights the patient's desire for wanting to receive results of tests performed on their sample and suggests that the ability to honor this request is dependent upon the nature of the trial (Baer et al. 2010). Challenges for recruitment of racial/ethnic minorities and rural populations into bio-specimen research are similar to ongoing challenges of recruiting this population into clinical trials despite a greater burden of cancer-related morbidity and mortality among these groups relative to their white and urban counterparts. In an attempt to address the need for diversity in bio-specimen research, the National Cancer Institute (NCI) recently launched The National Bio-specimen Awareness and Collection Campaign (National Cancer Institute 2013a). The goal of this campaign is to advance the ability “to diagnose, treat, and prevent cancer among all people as well as reduce cancer disparities among high-risk population groups” (National Cancer Institute 2013a).