“Forward-Thinking” in U.S. Biobanking

Abstract

Aims: Do biobanks enact policies and plans that allow them to anticipate and respond to potential challenges? If a biobank has one such policy or plan, is it likely to have more? Using survey data from 456 U.S. biobanks, we assess four possible indicators of such ''forward-thinking.'' Methods: We present response frequencies and cross-tabulations regarding policies for return of results and ownership of specimens, and for having a formal business plan and a plan for what happens to specimens if the biobank closes. We analyze the relationships among these indicators, using chi-square for tests of statistical significance.Results: Policies-Sixty-two percent of biobanks have a policy about returning individual research results; 70% have a policy designating ownership of specimens and/or technology. Having these two policies is significantly related ( p < 0.001). Plans-34% of biobanks have a formal business plan; 26% have a written plan for what will happen to the specimens if the biobank closes. Having these two plans is significantly related (p < 0.001). Relationships among indicators-only 7% of biobanks are forward-thinking across all four indicators; 12% are forward-thinking across none. Discussion: The two policies we examined tend to occur together, as do the two plans. These policies and plans seem to tap different aspects of accountability and responsiveness. Specifically, the policies reflect issues most commonly raised in the ethical and legal literature on biobanking, while the plans are indicators of sustainability, a separate area of concern in biobanking.

Returning actionable genomic results in a research biobank: Analytic validity, clinical implementation, and resource utilization

“…A majority of research participants 1 , 2 , 3 and researchers 4 , 5 favor returning such results to participants, and many research studies that collect genomic data have written policies encouraging the return of actionable genomic results to participants (gRoR). 6 , 7 , 8 , 9 Yet the vast majority of such studies in the US and around the world have not implemented gRoR because of uncertainties around how to consent participants; which genes to select for return; how to analyze, classify, and report research variants; the logistics of recontacting participants; regulatory requirements necessitating the confirmation of research results; the transition of research participants into an appropriate clinical workstream; and the effort and cost associated with each of these steps. 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 Despite these challenges, it is likely that research participants will increasingly expect gRoR in genomic research.…”

The Availability of Human Biospecimens to Support Biomarker Research

“…It can also become necessary because of major legacy events, such as reduced funding or limits to storage resources or biobank closure. 67 , 68 Nevertheless it is challenging to determine the best approach to rationalizing and culling biobank inventories. 69 Figure 2 summarizes the 4 main aspects to the decision process to keep or discard collections of biospecimens, and for many collections all aspects will be important to consider.…”