Policy developments affecting NCI-supported biorepositories: Survey of current practices in quality evaluation and cost accounting.

B199

Molecular epidemiology relies heavily upon the use of biospecimens. In April 2006, the National Cancer Institute released First Generation Guidelines for NCI-Supported Biorepositories. This document provided technical, operational, ethical, legal, and policy guidance to all recipients of NCI grants and contracts. These Guidelines were created to assess and assure the quality of each NCI Supported Biorepository. As the next step in this process, the NCI has begun a comprehensive analysis of current practices in biorepository evaluation and cost accounting. We have gathered input from epidemiologists and clinicians whose studies rely on the availability of high quality biospecimens. Preliminary analysis of several biorepositories has identified approximately twenty elements by which biorepositories are commonly evaluated and costs are assigned. We find that evaluation practices appear to be rather consistent among large and actively used biorepositories. Additionally, cost models appear to track with whether the biorepository was set up to serve one study or to function as a community resource. It seems likely that future evaluation guidelines will impose little additional administrative burden to study PIs and will simultaneously ensure that the quality of the biospecimens is determined and the price is set accordingly. Most importantly, this evaluation process will increase the value and utility of NCI-Supported Biorepositories used in molecular epidemiologic and prevention research.