An Australian Biobank Certification Scheme: A Study of Economic Costs to Participating Biobanks.

Biobanks face increasing demands for research materials of consistent quality, which can be used in collaborative studies. Several countries and some international agencies have made formal efforts to standardize biobank operations and outputs. These include the establishment of best practice guidelines for collection management, and certification programs. Such guidelines and programs increase biobanks' opportunities for participation in high impact research and funding. However, they also impose economic and time costs, which may burden biobanks. This study aimed to estimate the costs of gaining certification and maintaining certification (i.e., committing extra resources to continue standards) for three cancer biobanks participating in a biobank certification program in New South Wales, Australia. To gather cost data for a range of cancer biobanks, we recruited three with different full time equivalent (FTE) staff levels (1.0-3.0), recognizing FTE staff level as an indicator of resources and operating scale. In extended interviews with staff, we gathered biobanks' expected costs in obtaining and annually maintaining certification. The biobank with the highest staff level reported the lowest expected costs in gaining certification, due to the strong prealignment of its present operations with certification requirements. The other biobanks expected higher costs as their operations required greater adjustments. Overall, relative costs of gaining certification were between 2% and 6% of current total annual wage costs. To the authors' knowledge, this is the first such costing study of a biobank certification program. Supplementary Data include the interview schedule that other biobanks may use to estimate their own economic certification costs.