Identification and Assessment of Risks in Biobanking: The Case of the Cancer Institute of Bari

SIMPLE SUMMARY: Risk assessment is one of the requirements for all activities involving the management of human biological samples within the framework of the new ISO 20387:2018. Although some theoretical approaches are available for preparing risk assessments in general, there is no evidence in the literature of examples of listed insurable risks for cancer biobanks. To fill this gap and to provide an overview of the survey performed in our cancer Biobank, we have assessed potential exposures to insurable risks. After an analysis of the Biobank structure and focusing on natural catastrophe risks, we produced a summary map of risk scenarios. In addition to implementing security awareness, this also lays the foundation for transferring the residual risk arising from Biobank activities to the insurance market. ABSTRACT: Although research biobanks are among the most promising tools to fight disease and improve public health, there are a range of risks biobanks may face that mainly need to be assessed in an attempt to be relieved. We conducted a strategic insurance review of an institutional cancer biobank with the aim of both identifying the insurable risks of our own Biobank and gathering useful evidence of primary exposure to insurable risks. In this practical scenario, risks have been outlined and categorized into inherent and residual risks, along with their possible impact on biobank maintenance. Results at the Biobank of the Cancer Institute of Bari showed evidence of potentially significant and intrinsic risk due to highly relevant threats, along with already implemented improvements that significantly reduce risks to a range of relative acceptability.