Wednesday, August 22, 2012

ONR to Enhance DOD System

A web-based application developed by the Office of Naval Research (ONR) is going to form the basis for the DOD-wide system to track and manage human subject studies funded by the Federal government. ONR provides the science and technology necessary to maintain the Navy and Marine Corps and works with states, countries, universities, and industry partners

The Navy conducts research studies with human subjects to support warfighter training and operational capability as well as naval medical department’s competency. DOD employs a number of database tools to track their research programs, such as the “electronic Institutional Review Board” (eIRB) management system, which is 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 that the government lacks a centralized database to track experiments.  In early July, the Navy Deputy Surgeon General, Rear Adm. Michael Mittelman and the Deputy Assistant Secretary for Defense Force Health Protection and Readiness, Dr. George Peach Taylor Jr. signed a Memorandum of Record.

The Memorandum designates the “Protections in Research, Oversight Management Information System” (PROMIS) as the baseline for the future DOD system.  Plans are to move selected eIRB functions into one consolidated system.

ONR is developing enhancements to PROMIS so it can function as a unified platform to serve the needs across DOD’s user community.  Users will be able to track and manage their studies using the Microsoft SharePoint-based system.

The Navy’s Research Protections Division is responsible for overseeing investigations involving human subjects conducted by Navy and Marine Corps operational forces and non-operational commands. The division also monitors Navy –sponsored experiments by non-governmental institutions, such as universities and contractors.

“PROMIS gives a near real-time in-depth view of protocols,” said Dr. Andy Jones, Deputy Director of the Research Protections Division, “As the basis of the DOD-wide system, PROMIS will enable a wide cross section of users from principle investigators to departmental leaders to monitor and manage projects to ensure that the research complies with regulations.”

According to Dr. Timothy Singer, Director of the Research Protections Division, “PROMIS offers a way for DOD to gain greater insight into protocol submissions, offer better tools to manage active projects, and report on current and historical research.”

PROMIS is currently employed by 16 DOD commands including fifteen Navy commands and one Army command to oversee or conduct research with human subjects. The Research Protections Division is training personnel in its use at additional commands.