Skip main navigation

Military Health System

Clear Your Browser Cache

This website has recently undergone changes. Users finding unexpected concerns may care to clear their browser's cache to ensure a seamless experience.

DHA Office of Research Protections Streamlines IRB Process

Image of DHA Office of Research Protections Streamlines IRB Process. Dr. Hua Wei Chen, a research scientist with Naval Medical Research Command’s infectious diseases diagnostic laboratory, prepares a sample to test for the presence of the Zika virus on May 24, 2023. (U.S. Navy photo by Michael Wilson)

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.

You also may be interested in...

Article Around MHS
Aug 24, 2023

Walter Reed National Military Medical Center Performs First Robotic Bronchoscopy Within the Defense Health Agency

Walter Reed’s Interventional Pulmonology team gears up for first Robotic Bronchoscopy within the Defense Health Agency. Retired U.S. Navy Capt. Robert F. Browning (1st row 4th from left) and U.S. Navy Capt. Sean McKay (1st row 5th from left). (Photo: James Black)

Walter Reed performed the first robotic bronchoscopy procedure in the Defense Health Agency. Using the robotic bronchoscope to augment our current cutting edge cone beam CT Bronchoscopy program, Walter Reed now offers state of the art services in precision lung biopsy and early lung cancer diagnosis previously unavailable within the DHA.

Article Around MHS
Aug 23, 2023

Researchers Say 'Warfighters Must Train like They Fight,' Emphasizing Mental Resilience During MHSRS

Susannah Knust, a research psychologist at the Walter Reed Army Institute of Research, speaks during a 2023 Military Health System Research Symposium session on Warfighter Operational Resilience on August 17, 2023. (Photo credit: Danae Johnson, USAMRDC Public Affairs)

Nearly all military physical and field training exercises can enhance mental toughness and physical endurance, which researchers at the U.S. Army Medical Research and Development Command believe can prepare Warfighters for the future, they explained during a session on the final day of the 2023 Military Health System Research Symposium on August 17, ...

Article Around MHS
Aug 23, 2023

Forward Care for the Warfighter: U.S. Army Medical Research and Development Command Talks Battlefield Countermeasures at MHSRS

Soldiers with the U.S. Army Medical Research and Development Command perform a battlefield care scenario during the MRDC 2023 Best Squad Competition at Fort A.P. Hill, Virginia, on April 11, 2023.  (Photo: Danae Johnson)

With time spent on the battlefield being an increasing reality, products to help deliver immediate prolonged care to the Warfighter are now more important than ever. A concept known well by Maj. Zachary Booms, an emergency medicine physician at the Combat Casualty Care Research Team at the U.S. Army Medical Research and Development Command's Institute ...

Article Around MHS
Aug 23, 2023

MHSRS 2023 Kicks Off with Powerful Message: Medical Readiness for the Future Fight

Team members from the U.S. Army Medical Research and Development Command's Medical Material Development Activity - Broad Spectrum Snakebite Antidote (BSSA) program, receive the Military Health System Research Symposium 2023 Outstanding Research Accomplishment award in team/program management in Kissimmee, Florida on August 14, 2023.  (Photo: Danae Johnson)

Assistant Secretary of Defense for Health Affairs Dr. Lester Martinez-López kicked off the 2023 Military Health System Research Symposium with a keynote speech on the morning of August 14, delivering powerful words to the more than 4,000 people attending the event. Weaving his heartfelt sentiments into an overall call for action, Martinez put the ...

Article Around MHS
Jul 13, 2023

Entomologist Augments Warfighter Research Across Indo Pacific Region

U.S. Navy Lt. Thomas McGlynn, a medical entomologist at the Navy Entomology Center of Excellence, poses for a photo with Malaysian commissioned and noncommissioned officers, Malaysian public health officials, and researchers from the University of Malaysia Sabah during their training in Johor Bahru, Malaysia on Feb. 9. (Photo: U.S. Navy Lt. Nicholas Johnston)

Naval Medical Research Unit 2 was established during World War II in Guam to conduct applied research in support of force health protection and has operated intermittently since 1955. Currently, NAMRU-2 is located in Singapore and acts as the center of a hub-and-spoke research model in multiple southeastern Asian countries such as Vietnam, Thailand, ...

Article Around MHS
Jul 7, 2023

Fate Brings Accident Victim to Brooke Amy Medical Center for Groundbreaking Procedure

Madisyn Cardenas, center, is pictured with her family after a graduation ceremony for her sister Larissa Sanchez at Texas A&M University in Kingsville, Texas, on May 12. From left, dad Stephen Cardenas, brother Stevie Cardenas, sister Larissa Sanchez, Madisyn Cardenas, mother Jennifer Cardenas, sister Natalie Villarreal. Cardenas was severely injured in a roadside accident on Oct. 5, 2022 and brought to Brooke Army Medical Center for a groundbreaking procedure. (Photo Courtesy Department of Defense)

After being struck by a car, Madisyn Cardenas had a torn aorta, broken hip, pinky finger, pelvis, and clavicle; lacerated tongue; separated abdomen; kidney lacerations; colon tear; brain hematoma; and multiple cuts, bruises, and puncture wounds. “The scariest of all was a tear in my aorta that went undetected until my arrival at Brooke Army Medical ...

Article Around MHS
Jun 9, 2023

TriService Nursing Research Program Cultivates Medical Innovative Solution Through Evidence-Based Practice and Research

The TriService Nursing Research Program held its annual Research and Evidence-Based Dissemination Course from April 4-6, 2023 in San Antonio, Texas. (Photo by U.S. Air Force Sgt. Kelsey Martinez)

The TriService Nursing Research Program held its annual Research and Evidence-Based Dissemination Course from April 4-6, 2023 in San Antonio, Texas. This course included keynote lectures by military leaders and nationally known clinical experts, along with plenary sessions featuring research and presentations from tri-service active, National Guard ...

Skip subpage navigation
Refine your search
Last Updated: June 26, 2023
Follow us on Instagram Follow us on LinkedIn Follow us on Facebook Follow us on X Follow us on YouTube Sign up on GovDelivery