Maximizing Medical Research Through a Single MHS Enterprise
From Combat & Casualty Care, Fall 2018 Issue
Dr. Joseph Caravalho Jr.
President and Chief Executive Officer
Henry M. Jackson Foundation
Joseph Caravalho Jr., MD, is the president and chief executive officer of the Henry M. Jackson Foundation for the Advancement of Military Medicine, a Congressionally authorized, not-for-profit organization of 2,800 employees who advance military medicine at locations throughout the U.S. and around the world.
Before joining HJF, then MG (Dr.) Caravalho culminated his 38-year military career as the Joint Staff Surgeon, where he was the senior medical adviser to the Chairman of the Joint Chiefs of Staff. Immediately prior, he was the Army Deputy Surgeon General.
He is a graduate of Gonzaga University and the Uniformed Services University of the Health Sciences. Clinically, he served as a staff internist, nuclear medicine physician and cardiologist. Operationally, he served as the senior medical officer for a number of Army and Joint special operations units, including the 75th Ranger Regiment and 1st Special Forces Group. He also served in two combat deployments in support of Operation Iraqi Freedom.
C&CC: What role does the Henry M. Jackson Foundation (HJF) play in medical research?
Dr. Caravalho: HJF is a global organization dedicated to advancing military medicine for our nation’s Warfighters. We partner with military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. The not-for-profit foundation is authorized by Congress to support research and education projects at the Uniformed Services University of the Health Sciences and throughout military medicine. Since its founding in 1983, HJF has served as the connective tissue between the military medical community and its federal and private partners. HJF’s support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and to accomplish their research goals effectively and efficiently.
C&CC: As the Military Health System (MHS) transforms under the Defense Health Agency, how do you see the changes affecting military medicine?
Dr. Caravalho: The last three National Defense Authorization Acts (for fiscal years 2017 through 2019) place much of the DoD medical mission under the Defense Health Agency’s (DHA) direct control. With this centralized authority, DHA has primary responsibility for the health benefit, overseeing the direct and purchased health care for all military health beneficiaries. It also remains answerable to the combatant commands in doing their part to ensure the deployed joint force is medically ready and responsive to the readiness training requirements mandated by the Services through their respective Surgeons General. Finally, DHA bears ultimate responsibility for Defense Health Program-funded clinical research and requirements-driven research and development.
C&CC: Since the DHA has been granted centralized authority for military medical research, what steps can be taken to fulfill this mandate?
Dr. Caravalho: From my vantage point, I envision a relatively straightforward way for military medicine to consolidate forces, exercise unity of effort and gain immediate relevance of its medical research programs with the DoD senior leadership, senior uniformed Warfighters and Congress. The “secret sauce” is in creating a single MHS research enterprise.
I believe an effective system requires these three elements:
- A single Institutional Review Board (IRB) system that allows each of the IRBs to have enterprise-wide approval authority.
- This specific process is addressed under recent revisions to the Department of Health and Human Services’ Common Rule governing human subjects research.
- DHA-approved duty time for medical staff to conduct clinical research. Heretofore, clinicians were generally only allowed to conduct research on non-duty time or if other patient throughput productivity measures were met.
- Centrally funded research support teams at each military treatment facility (MTF), scaled to meet the research capacity of each site. This removes the onus from the local clinicians and administrative staff to identify, recruit, train and sustain research assistants, research nurses and clinical research coordinators. These teams would be able to support any of the on-site researchers, regardless of specialty or clinical practice.
C&CC: How would these three elements establish the conditions for success?
Dr. Caravalho: Functioning as a single enterprise, every IRB-approved study could be potentially executed as a multi-site study. Clinician researchers at each MTF would be free to conduct meaningful military medical research with minimal time away from patient care. Multi-site research support teams would implement work across the enterprise without unnecessary variance.
In his role as the DoD’s senior medical adviser, the Assistant Secretary of Defense for Health Affairs would be able to direct high-priority, requirements-driven clinical research that would best address pressing DoD readiness issues each year. Well-powered multi-site studies would be completed in a timely fashion, which would then lead to relevant knowledge products, clinical practice guidelines or DoD policies. Additionally, results of these well-designed and well-executed studies would potentially drive generalizable civilian health practices and policies.
The MHS comprises approximately 9.4 million military beneficiaries, whose demographics reflect America. In addition to the readiness questions that can be answered only by military medical research, I believe both academia and industry will avail themselves of the MHS to partner on other clinical research protocols. These private-military partnerships will not only help offset the burdensome costs of research but also have the advantage of demonstrating to the civilian community that military medicine is world-class.
C&CC: What would a single research enterprise mean for research personnel?
Dr. Caravalho: There are very smart physicians, dentists, nurses and other clinicians assigned at MTFs throughout the DoD. Lack of research support personnel—not the lack of readiness issues to address or the lack of eligible human subjects—currently hinders research initiatives at the smaller, more remote camps, posts and stations. Making use of a single MHS research enterprise, with appropriately assigned research support teams at each MTF, would allow these clinician researchers to study pressing DoD-wide readiness issues.
C&CC: How would military personnel benefit from this single research enterprise approach?
Dr. Caravalho: The Services’ respective basic training sites are located at Fort Benning, Georgia; Fort Jackson, South Carolina; Fort Leonard Wood, Missouri; Marine Corps Recruit Depot Parris Island, South Carolina; Marine Corps Recruit Depot San Diego, California; Naval Station Great Lakes, Illinois; and Lackland Air Force Base, Texas. Collectively, these locations do not generate much by way of medical research, let alone coordinated medical research.
As an example of how Servicemembers could benefit from this model, multi-site research could assess the impact of various basic training interventions on pass rate among the services. Whether it involves measuring feet for appropriate running shoes and boots or assessing the use of athletic trainers during physical training, rigorously designed studies are needed for senior leaders to make informed decisions.
C&CC: What is HJF’s role in advancing military and civilian medicine in the United States and around the world?
Dr. Caravalho: HJF’s original mission was to support military medical research and education projects because that was what the Uniformed Services University of the Health Sciences (USU) needed to remain competitive as a top-notch medical school. We partnered with military medical researchers across the DoD by managing and staffing research programs around the world, enabling true breakthroughs in myriad research areas to improve not just the Warfighters’ health and well-being but also the health and well-being of civilians.
As the needs of military medicine have grown, we have widened our aperture to expand through partnerships with new DoD organizations, such as the Defense POW/MIA Accounting Agency, along with more U.S. government agencies, academic centers and private industry. Internationally, we have also expanded our portfolio with the U.S. government, foreign governments and nongovernmental agencies. All told, we currently have 2,800 employees located across the globe to achieve our mission of advancing military medicine.We have built our expertise over the past 35 years, since Congress first authorized us to partner specifically with USU in this role. Our experience, connections and knowledge of the research process make us a high-value partner for any organization—public or private—wishing to work with DoD and civilian medicine. n