Biorepository Regulatory Considerations: A Detailed Topic Follow-Up to the Blueprint for the Development of a Community-Based Hospital Biorepository

Abstract

Human specimen and associated clinical data are crucial resources for uncovering new biomarkers as well as identifying factors in the pathogenesis of disease. As tissue banking becomes more widespread in response to increased researcher demand, the need for specific guidance documents and standards to be developed and/or updated becomes more urgent. This article discusses 4 aspects of current regulation and guidance considerations. First is the application of the Common Rule and the Privacy Rule to the Institutional Review Board review process. Second is the honest broker concept, which supports the further protection of donor confidentiality and allows for future updates to data. The third consideration discusses the regulatory approval process. Finally, inconsistencies between regulatory bodies are identified and possible ways to reconcile those inconsistencies are suggested.