Inactive

The Department of the Navy, Office of Naval Research (ONR), Human Research Protection Program (DON HRPP) is a headquarters element comprised of military, government civilian, and contractor staff that... The Department of the Navy, Office of Naval Research (ONR), Human Research Protection Program (DON HRPP) is a headquarters element comprised of military, government civilian, and contractor staff that provides oversight and monitoring of human research protection activities across the Navy and Marine Corps. The DON HRPP consists of the Bureau of Medicine and Surgery (BUMED) and the Research Protections Division of ONR’s Warfighter Performance Department. The Research Protections Division (ONR Code 343) is responsible for implementation of the DON HRPP in the Navy’s systems commands, operational forces, training commands, and at Navy-sponsored extramural institutions. The Division reconciles the competing priorities of conducting potentially risky work involving human subjects and compliance with Federal, DoD, and DON policies intended to protect the safety and welfare of human subjects. For more information visit: http://www.med.navy.mil/bumed/humanresearch /Pages/default.aspx and http://www.onr.navy.mil/About-ONR/compliance-protections/Research- Protections.aspx. DoD Instruction 3216.02 establishes policy and assigns responsibilities for the protection of human subjects in DoD-supported programs to implement Part 219 of Title 32, Code of Federal Regulations (CFR) and requires Heads of DoD Components to establish and oversee DoD Component policies and procedures that ensure compliance with Federal and DoD requirements. SECNAVINST 3900.39 establishes policy and assigns responsibility for the protection of human subjects in research conducted by, within, or for DON. The Secretary of the Navy delegated the sole authority and responsibility for execution and oversight of the DON HRPP to the Surgeon General (SG) of the Navy. The SG is the single authority for policy development, oversight, compliance, and ongoing monitoring concerning human research protections in the DON. DON HRPP has implemented the Department of the Navy’s Human Research Protections Information Technology Management System (DON RPITMS) for management and compliance oversight of ongoing human research protections activities —hereafter referred to as the “System.” The System is a web-based application, which runs on Microsoft servers using Internet Information Services and Microsoft’s structured query language server on the back-end. The document store is based on SharePoint sites; this allows the Office of Naval Research’s IT Division (Code 06) to manage permissions and related infrastructure in a standardized fashion. Many of the user interactions are executed through custom developed interfaces, which rely on Simple Object Access Protocol (SOAP), Representational State Transfer (REST), and other application programming interfaces (APIs) for state and storage of information. Each command module within the System contains a set of libraries and functions to store and process the data collected. Many state changes require artifacts to be provided or created. These changes trigger workflows in the System, which then create, request, or begin tracking artifacts. The relationships between events and artifacts create the value for the System as a compliance tool by providing the underpinnings for reporting. DON HRPP is interested in maintaining situational awareness of ongoing human research protection activities. To monitor compliance, program staff must be able to quickly locate information about research protocols, including status, data on subjects, funding, Institutional Review Boards (IRBs), performing institutions, agreements in place, and other related information. Managing the scope and complexity of data for human subject research protections oversight requires a comprehensive, automated information tracking system. See attached RFI.