Skip to main content

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
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 ...

Article Around MHS
Mar 30, 2023

Protecting the Warfighter's Health and Readiness, Now and Into the Future

An anopheles mosquito specimen sample sits under the microscope during a demonstration of the U.S. Army’s medical technology development and modernization efforts, Fort Detrick, Maryland, on Feb. 23. (Photo by Summer Abdoh, U.S. Army)

A cure for a debilitating and sometimes deadly disease, new treatments for working military dogs, a snakebite antidote, and a treatment for respiratory disease! See how years of research collaborations are providing protections for warfighters in remote places like never before.

Article Around MHS
Mar 17, 2023

USU President Encourages Attendees to “Think Outside the Box” at Infectious Disease Symposium

Uniformed Services University President Dr. Jonathan Woodson delivered opening remarks during IDCRP's first annual Science Symposium March 6-10. The event was held in collaboration with the Defense Health Agency Infectious Disease Working Group Subcommittee. (Photo by  HJF communications)

Infectious diseases like COVID-19, HIV, and battlefield wound infections cause illness and disruptions that threaten health and military readiness around the world. To help foster collaboration in the field and share best practices, the Uniformed Services University’s Infectious Disease Clinical Research Program hosted its first Science Symposium ...

Article Around MHS
Mar 15, 2023

Walter Reed Audiology and Speech Pathology Center Focuses on Improving Quality of Life for Military Health System Beneficiaries

World Hearing Day is observed annually on March 3, and this year’s theme is “Ear and Hearing Care for All.”  (Courtesy photo)

Although World Hearing Day is observed just one day during the year, the Audiology and Speech Pathology Center at Walter Reed National Military Medical Center focuses on improving the health and quality of life for MHS beneficiaries nearly every day of the year.

Article Around MHS
Jan 25, 2023

U.S. Army Medical Laboratory Forges Relationship with Australian Defence Force Institute

Military personnel in medical laoratory

American soldiers from the 1st Area Medical Laboratory were hosted by their counterparts at the Australian Defence Force Malaria and Infectious Disease Institute in Brisbane, Australia. Find out what was discussed at this meeting to strengthen critical relationships, save lives, and enable both sides' mission readiness.

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