The purpose of this FOA is to seek revision applications to cooperative agreements that are supporting networks or consortia of researchers who conduct or will be interested in conducting research in the following areas: The effectiveness of current human subjects protections and the development of tools and methods to examine evolving, evidence-based approaches to improve human subjects protections. The feasibility, costs, benefits, and impacts of requiring consent for research on deidentified human specimens and data using novel models of consent, e.g., notification, opt-out, opt-in, broad consent.