Military building out database on human research projects

Despite cutting-edge research, the military's methods for tracking that research have been decidedly old school. Now the Office of Naval Research (ONR) has created a web-based application to track and manage all the government-funded studies involving humans, and provide results in close to real time.

The Protections in Research, Oversight Management Information System (PROMIS) builds off of Microsoft's SharePoint system, according to a recent ONR announcement. 

 "PROMIS offers a way for the entire Department of Defense 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," Timothy Singer, director of the research protections division in ONR's Warfighter Performance Department, said in a statement.

Though it uses a number of database tools to track research, the military was seeking a tool that could track a project's every step, from conception to conclusion. It needed a streamlined system to send research through its significant review processes.

So far, PROMIS is used by 15 Navy commands and a single Army command, but a Pentagon memorandum in July authorized PROMIS to be refined and built out as a central repository of data about all the military's human research projects.

A December 2011 report by the Presidential Commission for the Study of Bioethical Issues specifically dinged the Pentagon, finding that there was no central source for information about the size, scope and cost of government research involving human subjects, according to Government Computer News.

The commission found the government funded 55,000 human studies in fiscal 2010 alone, most of them health-related, but many federal agencies could not provide even basic information about the studies they funded. For the DoD, it could take seven month to produce that information.

Beyond tracking, PROMIS also holds the potential to shorten the approval process by a an institutional review board.

"PROMIS gives a near real-time, in-depth view of protocols," Andy Jones, deputy director of the Research Protections division, said in ONR's announcement. "As the basis of the DoD-wide system, PROMIS will enable a wide cross-section of users, from principal investigators to departmental leaders, to monitor and manage projects and ensure that research is in compliance with regulations."

Tracking research--and applications of such research--tends to particularly vex federal agencies. An Institute of Medicine report in July took the Defense and Veterans Affairs departments to task for failing to track the cost and effectiveness of their treatment of post-traumatic stress disorder. Two members of Congress also have called for the U.S. Food and Drug Administration to overhaulits databases on medical devices.

The FDA also has been called out for failing to capture adequate information on medical devices' privacy and security.

To learn more:
- read the announcement
- here's the Government Computer News article

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