DOD To Track Human Subjects Studies

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.

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.

In early July, Navy Deputy Surgeon General Rear Adm. Michael Mittelman and Deputy Assistant Secretary of Defense Force Health Protection and Readiness Dr. George Peach Taylor Jr. signed a Memorandum of Record designating PROMIS as the baseline for the future DoD system.

As plans are laid out to migrate selected eIRB functions into one consolidated system, ONR is developing enhancements to PROMIS so it can function as a unified platform to serve needs across the DoD’s user community.

“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 principal investigators to departmental leaders, to monitor and manage projects and ensure that research is in compliance with regulations.”

The system is currently employed by 16 DoD commands—15 Navy and 1 Army—that oversee or conduct research with human subjects. The Research Protections division is training personnel in its use at additional commands.

From the Office of Naval Research