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The U.S. military is behind some of the country’s most sophisticated medical research, from brain-mediated prosthetics to laser-based wound healing. Their ability to track those myriad projects? Not so cutting edge — until now, at least.
A web-based system, developed by the Office of Naval Research, has been tapped as the first-ever platform to track and manage every single human-subject study under the Pentagon’s umbrella.
Called PROMIS (for “Protections in Research, Oversight Management System”), the innovation was initially conceived in 2006 by personnel in the Navy’s Office of Research Protections, in an effort to consolidate Navy-funded human research into a single, searchable database.
“We recognized that we needed a way, in realtime, to monitor these research activities,” Dr. Tim Singer, director of research protections division with the ONR’s Warfighter Performance Department, says. In essence, the Navy was after a system that could track a study’s every step — from initial conception by a research team, to the development of a study protocol, to the approval process, subsequent participant enrollment and (finally!) the collection of actual study data, analysis and conclusions.
Right now, PROMIS is used by fifteen Navy commands and a single Army command. But a Pentagon memorandum, finalized in July, will see PROMIS refined and built-out, in order to act as a one-stop shop for the military’s human research projects. Of course, that doesn’t merely mean studies run by military investigators — the system would also incorporate any human-subject study funded by the military, including those run out of universities or by private enterprises.
The importance of such a database — both for logistical and, most critically, ethical reasons — has already been emphasized by federal officials. A streamlined system for study proposals and approvals would no doubt hasten the research process. Among military projects, that process is particularly bogged down, largely because of a requirement for review and oversight of study proposals by both an institutional review board and military officials.
“After a proposal is approved by an institutional review board, it becomes subject to [service branch] headquarter review,” Dr. Andy Jones, deputy director of the Research Protections division, says. “In the past, we’ve relied sometimes on email, but also on snail-mail or even CDs.”
And where accountability is concerned, PROMIS could solve a critical problem: A 2011 report by the Presidential Commission for Bioethical Issues, authors noted that “many federal offices could not provide basic data about the research they support.” The Pentagon was called out specifically, with the report adding that officials there “required more than seven months to prepare information on specific studies supported by the Department of Defense.”
With the development of PROMIS, officials hope to see those seven-month time lags reduced to mere hours and a few simple keystrokes. “It would provide a look at every part of the study process, and answer questions that…used to take days and days,” Dr. Jones says. “How many studies on children? How many high-risk studies?”
Civilians looking for answers to those questions (or, for the adventurous among us, high-risk studies to enroll in ourselves) shouldn’t hold their breath. For now, PROMIS is being designed as an internal platform — though Dr. Jones and co. aren’t entirely opposed to changing that. With a few caveats, of course. “We do need to guard personal information of participants, [especially] health information,” he says. “And of course, be very careful about whatever classified information is in the system.”
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Tuesday, April 2, 2013
Military Plans Mega-Database To Track Human Studies - Forbes