DOD plans massive database of human research
Expanded PROMIS, developed the the Office of Naval Research, would track human studies throughout the department.
A Defense Department initiative on medical research is looking to solve a problem shared by a lot of government agencies -- how to make use of the vast amounts of data generated by its programs.
In DOD’s case, it has to do with medical research. Military services conduct a lot of it, but have not always been successful at keeping track of it.
The new effort calls for expanding a successful Web application developed by the Office of Naval Research into a DOD-wide database of all human subject studies conducted by, or funded by, the department, including studies conducted by universities and contractors.
The Protections in Research, Oversight Management Information System (PROMIS) is a Microsoft SharePoint-based tool that lets researchers submit, share, track and manage details of their studies. It’s currently used by 15 Navy commands and one Army command.
“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,” Dr. Timothy Singer, director of the research protections division in ONR’s Warfighter Performance Department, said in an announcement.
Although DOD has several database systems for tracking research programs, a December 2011 report by the Presidential Commission for the Study of Bioethical Issues, intended to protect the people taking part in the studies, found that “there is no central source with information about the overall size, scope and cost of the government’s research involving human subjects.”
The commission found that the federal government supported more than 55,000 human studies in fiscal 2010 alone -- most of them health-related -- and asked the 18 agencies that conduct the most studies for information. The result was that “many federal offices could not provide basic data about the research they support.”
The Pentagon, the report said, took over seven months to produce information on studies DOD supported.
The commission recommended that each department involved in this kind of research develop a centralized database for tracking studies, and in July DOD officials issued a memorandum designating PROMIS as the template for the department’s system.
“PROMIS gives a near real-time, in-depth view of protocols,” Dr. Andy Jones, deputy director of the Research Protections division, said on 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.”
Implementing such as database across the department would not only allow researchers to track studies and enable them to reduce that seven-month lag in producing information to a matter of days, but it also could speed up the approval process for new research, an article in Forbes points out.
“After a proposal is approved by an institutional review board, it becomes subject to [service branch] headquarter review,” Jones told Forbes. “In the past, we’ve relied sometimes on e-mail, but also on snail-mail or even CDs.”
A system that could find and share existing studies in a centralized location would likely shorten that process.