A Web-based application developed by the Office of Naval Research (ONR) will form the basis of the nation's first Defense Department-wide system to track and manage human subject studies funded by the federal government, officials announced Aug. 6.
The Protections in Research, Oversight Management Information System (PROMIS) is a tool that allows command research protections staff members to submit human research protocols-plans that detail studies involving humans-as well as other documentation for review by Navy and Marine Corps research compliance specialists.
Subsequently, users can track and manage their studies using the Microsoft SharePoint-based system.
"The nation expects more accountability for research involving human subjects," said Dr. Timothy Singer, director of the research protections division in ONR's Warfighter Performance Department. "PROMIS offers a way for the entire Department of Defense [DoD] to gain greater insight into protocol submissions and offer better tools with which to manage active projects and the reporting of current and historical research."
The Department of the Navy (DoN) conducts studies with human subjects to support warfighter training and operational capability as well as the naval medical department's competency.
The Research Protections division, a component of the Navy's Office of Research Protections, is responsible for overseeing investigations involving human subjects conducted by Navy and Marine Corps operational forces and non-operational commands. It also monitors Navy-sponsored experiments by non-governmental institutions, such as universities and contractors.
DoD employs a number of database tools to track its research programs, such as the electronic Institutional Review Board (eIRB) management system, which has been a preferred application within the military health system to document protocols.
However, a December 2011 report by the Presidential Commission for the Study of Bioethical Issues found the government lacked a centralized database to track experiments.