By Kate Blenner, Program Analyst, FasterCures
At FasterCures, we believe biobanks are critical resources for biomedical research and personalized medicine, which is why we were so pleased to see significant advances in the field at the end of 2008. In December, two major regional biobanks were launched with significant investment of resources and big goals for donor recruitment, and a national biobank has been mentioned in legislation and is being explored by the NIH. But even as biobanking is embraced by health systems, researchers, legislators, and funders, will the field be ready to meet the expectations of patients and donors?
The two new banks announced in December will be housed at Mayo Clinic and at Kaiser Permanente (Kaiser’s bank is funded by the Robert Wood Johnson Foundation.) Both banks will attempt to link samples to information stored in the donors’ medical records, and both aim to use the DNA samples to study how genetics, environment, and lifestyle contribute to the development of disease and the effectiveness of treatment and preventive measures. They will also both rely on the voluntary participation of tens of thousands of donors—Mayo plans on building a bank of 20,000 or more donor samples, and Kaiser Permanente hopes to collect as many as half a million.
A recent study conducted by the Johns Hopkins University Genetics and Public Policy Center (GPPC) suggests recruiting these numbers of participants may not be as daunting as it sounds. GPPC conducted a public engagement study on behalf of the National Institutes of Health to assess attitudes and concerns about a proposed national biobank. Researchers found that most (84%) of survey respondents reacted favorably to the proposed bank, and 60% said they would be willing to donate. Interestingly, when participants were offered different incentives to participate, it was the feedback of research results to the donor that motivated participants most—even more so than monetary compensation. What’s more, 75% of survey respondents said they would be less likely to participate if they were unable to receive research results generated from their samples. (The findings of this study are summarized in the November issues of The American Journal of Bioethics and Genetics in Medicine. )
Returning research results to genetic study participants is a topic of significant debate; while there is much literature regarding the return of medically relevant results from clinical trials to participants, research data from genetics studies is difficult to assess for clinical relevance because of the often tenuous connection between genotype and clinical outcomes. The pioneering studies providing feedback to participants often do so on a case-by-case basis, with laborious review and deliberation by the researchers and IRB (the Genetics and Pharmacogenetics of Airways Diseases project at Partners Healthcare is one example of a study providing limited, case-by-case feedback to participants.) Clarity and guidelines on this issue are sorely needed.
But the good news is, where there is consumer demand, there is a vacuum waiting to be filled—if participation in studies is contingent on information feedback, researchers and study sponsors of large and ambitious banks will have to find a way to provide it. As consumer awareness and engagement grow, we could see not only increased participation and funding to large-scale genetic studies, but new channels of feedback, more sophisticated models of consent, and appropriate integration into care processes to meet the demands of a more informed patient population—if we do it right. The GPPC study and the initiation of two ambitious new banks show that funders are willing to invest resources and patients are willing to ‘invest’ samples, but of course a return is expected on any investment for support to be long-lived. The will is there—it is up to the biobanking community to find a way.