The Defense Health Agency Office of Research Protections protects the rights and welfare of human and animal subjects and encourages ethical research. As such, ORP plays a key role in bringing new medical treatments to the field and improving military medical readiness. The office is part of DHA’s Research and Engineering Directorate.
Research on humans is one of the last steps to gaining Food and Drug Administration approval for novel medicines and other treatments. Testing in animals precedes research in humans.
Institutional Review Boards
Institutional review boards, or IRBs, are an important component of human research protection programs—otherwise known as HRPPs. IRBs are groups formally designated to review and monitor biomedical and social and behavioral research involving human subjects. IRBs can approve, require modifications, or disapprove research projects.
In March 2020, HRPP and IRB resources for the U.S. Army, U.S. Navy, and U.S. Air Force transitioned to DHA to reduce duplicative services and improve efficiency.
Since December 2020, five remaining IRBs operate and review non-exempt human subjects research and make determinations. These IRBs operate out of:
“These five DHA IRBs alone process and approve over 9,499 life-cycle protocol actions per year for already approved protocols and continue to review and approve more than 185 new protocols a year,” said ORP Director U.S. Army Lt. Col. (Dr.) José Pizarro Matos.
“Standardizing and simplifying IRB protocol submissions, and expediting IRB reviews and approval processes are hot topics for the IRBs and ORP,” said ORP Deputy Director U.S Public Health Service Cpt. Mimi Phan.
Managing protocol life cycles “is an integral aspect of the different types of protocols processed by human research protection programs to include non-exempt, exempt, research not involving human subjects, quality improvement, and case reports,” Pizarro Matos said.
The DHA human research protection program processes and approves more than 17,563 life-cycle protocol actions (initial submissions, modifications, closures) each year within the Military Health System, according to ORP.
Streamlining the Process
ORP is streamlining oversight to standardize the human research protection program across the DHA, by using one electronic research protocol management system, the electronic IRB.
“As an enterprise, our goal should be to achieve industry standards for IRB protocol approvals, which are approximately 90 days’ turnaround for IRB approval and seven days for determination,” Phan said.
“The DHA human research protection program protocol approval process continues to be refined to the point that these processes minimize the impact on both the research project schedule and cost,” she added.
Big Caseload
The military has a robust research enterprise. Currently, there are more than 5,857 ongoing human subjects research protocols within the DHA, so ORP conducts compliance visits to ensure the safety of human subjects in approved clinical research.
ORP has five government staff members and a group of contractors who perform compliance visits. Through March 2023, ORP had audited human research protection programs at 10 military hospitals across the country.
To keep every constituent updated, ORP holds monthly meetings across the DHA research enterprise and sends newsletters to program staff members at DHA hospitals, clinics, centers, and offices. The newsletters are also posted on the ORP Milsuite website (CAC access required).
“When working with such complex teams, the key to success is transparency and continued communication,” ORP stated. “Understanding each other’s roles enhances our communication and facilitates team members’ interactions.”
“Research and development play a pivotal role in improving health and building readiness,” Pizarro Matos said. “Cutting-edge research will help to build a modernized and resilient health system.”
For questions about a protocol, investigators and others involved can contact the human research protections office at their institution. Learn more about ORP online.