This paper advances the discussion of how to handle IFs and IRRs in genetic and genomic research by providing a systematic analysis of how IFs and IRRs should be handled in a biobank research system and clarifying how the CARR issues should be addressed at each stage of the process. We challenge the conventional view that would generally locate nearly all responsibilities with the primary researchers who collected the data and samples and place few, if any, responsibilities on the biobank itself. We suggest instead that biobanks should accept significant responsibilities for the management of IFs and IRRs. This paper focuses on return of IFs and IRRs in the context of research governed by U.S. policies, regulations, and laws. We address these issues within the framework of current policy, regulation, and law, while acknowledging that the Department of Health and Human Services (DHHS) has invited comment on proposed changes to the Common Rule.2 While we focus on the U.S. context and rules, the debate over return of IFs and IRRs is international. We refer to international sources where they illuminate key questions.
