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United States Government Accountability Office: 
GAO: 

Report to Congressional Committees: 

February 2013: 

Defense Health: 

Actions Needed to Help Ensure Combat Casualty Care Research Achieves 
Goals: 

GAO-13-209: 

GAO Highlights: 

Highlights of GAO-13-209, a report to congressional committees. 

Why GAO Did This Study: 

DOD estimates that about 24 percent of servicemembers who die in 
combat could have survived if improved and more timely medical care 
could be made available. Because multiple DOD organizations conduct 
research to develop medical products and processes to improve combat 
casualty care, it is critical that these organizations coordinate 
their work. It is also important that agencies monitor and assess 
their performance to help achieve organizational goals, which for DOD 
include addressing gaps in its capability to provide combat casualty 
care. The National Defense Authorization Act for Fiscal Year 2012 
directed GAO to review DOD’s combat casualty care research and 
development programs. This report assesses whether DOD (1) uses a 
coordinated approach to plan this research; and (2) monitors and 
assesses this research to determine the extent to which it fills 
capability gaps and achieves other goals. GAO reviewed DOD’s policies 
and documentation; interviewed officials from DOD and other federal 
agencies; and analyzed metrics DOD used to gauge the progress of its 
research. 

What GAO Found: 

The biomedical research organizations of the Department of Defense 
(DOD) use a coordinated approach to plan combat casualty care research 
and development, but not all of DOD’s nonmedical research 
organizations share information early in the research process. GAO has 
previously reported that federal agencies can enhance and sustain 
collaboration of efforts by using key practices, such as agreeing on 
roles and responsibilities and establishing the means to operate 
across organizational boundaries. In 2010, DOD established a planning 
committee to coordinate the efforts of organizations conducting combat 
casualty care research. The committee developed a draft charter in 
2010 identifying members respective roles and responsibilities. DOD 
issued the final charter in early January 2013, while GAO was 
conducting its review. DOD also facilitated operation across 
organizational boundaries by colocating most of the organizations 
conducting combat casualty care research. However, DOD organizations 
that typically do not conduct biomedical research, such as the Army 
Research Laboratory, are not involved in DOD’s efforts to coordinate 
this research. When these organizations conduct research relevant to 
combat casualty care they do not always share information with 
appropriate officials early in the research process, as they are not 
aware of the need to coordinate early and may not fully understand 
medical research requirements. As a result, some researchers have had 
to repeat some work to adhere to these requirements. DOD has also 
taken steps to coordinate with other federal agencies that are 
involved in this research. 

The Office of the Assistant Secretary of Defense for Health Affairs 
(Health Affairs) and the Army Medical Research and Materiel Command 
(MRMC) assess the progress of combat casualty care research and 
development projects, but they have not assessed the extent to which 
this research fills gaps in DOD’s capability to provide this care or 
achieves other DOD goals. Federal internal control standards state 
that agencies should assess their performance to ensure they meet the 
agency’s objectives. Health Affairs and Army MRMC—the two 
organizations that fund most combat casualty care research and 
development—monitor research projects to determine whether to continue 
funding, make necessary corrections, or terminate these projects. 
However, in 2008 DOD identified gaps in its capability to provide 
combat casualty care, and although Health Affairs and Army MRMC have 
completed 44 research projects since then designed to address these 
gaps, they have not assessed whether the results of this research fill 
the gaps identified in 2008. In addition, Health Affairs and Army MRMC 
established other goals for this research portfolio to improve combat 
casualty care. For example, in 2010, Health Affairs set goals to improve 
DOD’s ability to control bleeding. However, neither organization has 
developed an assessment that comprehensively identifies each of the 
goals for the portfolio and includes information about the extent to 
which each goal has been met. Health Affairs and Army MRMC officials 
stated that they intend to complete a strategic roadmap for the 
portfolio, but GAO was unable to determine if the roadmap will include 
a plan for a comprehensive assessment of this research portfolio. 
Without such a plan for a comprehensive assessment, these organizations 
cannot be sure the research they are conducting is producing results 
that most effectively improve combat casualty care to save lives on 
the battlefield. 

What GAO Recommends: 

GAO recommends that DOD (1) communicate the importance of early 
coordination among DOD’s nonmedical organizations and (2) develop and 
implement a plan to determine the extent to which research fills gaps 
and achieves other goals. DOD concurred with these recommendations. 

View [hyperlink, http://www.gao.gov/products/GAO-13-209]. For more 
information, contact Linda T. Kohn (202) 512-7114 or kohnl@gao.gov, or 
Brenda S. Farrell, (202) 512-3604 or farrellb@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

DOD Uses a Coordinated Approach to Plan Its Combat Casualty Care 
Research and Development, but Not All of Its Organizations Share 
Information Early: 

DOD Monitors the Progress of Combat Casualty Care Research Projects, 
but Not Whether the Research Fills Gaps or Achieves Other Goals: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Comments from the Department of Defense: 

Appendix II: Comments from the Department of Health & Human Services: 

Appendix III: GAO Contacts and Staff Acknowledgments: 

Figures: 

Figure 1: DOD Combat Casualty Care Research and Development Funding 
from Fiscal Year 2005 through Fiscal Year 2012: 

Figure 2: Percent of Fiscal Year 2012 Combat Casualty Care Research 
and Development Funding by Organization: 

Figure 3: Organizations That Oversee Combat Casualty Care Research and 
Development: 

Abbreviations: 

DARPA: Defense Advanced Research Projects Agency: 

DOD: Department of Defense: 

FDA: Food and Drug Administration: 

Health Affairs: Office of the Assistant Secretary of Defense for 
Health Affairs: 

HHS: Department of Health and Human Services: 

JPC-6: Joint Program Committee for Combat Casualty Care: 

MRMC: Army Medical Research and Materiel Command: 

NIH: National Institutes of Health: 

VA: Department of Veterans Affairs: 

[End of section] 

United States Government Accountability Office: 
Washington, DC 20548: 

February 13, 2013: 

Congressional Committees: 

The Department of Defense (DOD) estimates that approximately 24 
percent of all servicemembers who die in combat could have survived if 
improved and more timely medical care could be made available in the 
combat setting. To reduce the combat mortality rate as well as the 
impact of the disabling medical conditions that servicemembers suffer 
as a result of combat wounds, multiple DOD organizations conduct 
medical research to develop medical devices, pharmaceuticals, and new 
methods or processes that are designed to improve combat casualty 
care.[Footnote 1] Using the results of this research, DOD intends to 
fill gaps that it identified in its capability to provide combat 
casualty care, such as its ability to control bleeding.[Footnote 2] 
The Office of the Assistant Secretary of Defense for Health Affairs 
(Health Affairs), the military departments, and the Defense Advanced 
Research Projects Agency (DARPA) are responsible for this research, 
with funding of over $537 million in fiscal year 2010, $272 million in 
2011, and $321 million in 2012. Because multiple organizations plan 
this research and development, it is important that they coordinate 
their actions to maximize their effectiveness in conducting the 
research, applying its findings, and producing results that ultimately 
save lives on the battlefield. It is also important that agencies 
monitor and assess their performance to help address organizational 
goals. For DOD, organizational goals include filling gaps in its 
capability to provide combat casualty care, such as improving DOD's 
ability to control bleeding, which is the primary cause of potentially 
survivable deaths on the battlefield. Such monitoring and assessment, 
as part of a system of effectively designed and implemented internal 
controls, provide reasonable assurance that an agency's operations are 
effective and efficient.[Footnote 3] 

The National Defense Authorization Act for Fiscal Year 2012[Footnote 
4] directed GAO to review DOD's medical research and development 
programs designed to improve combat casualty care. The act requires 
GAO to evaluate aspects of DOD's combat casualty care research 
programs, including the extent to which DOD organizations coordinate 
their efforts to plan this research. In response to the act, this 
report addresses the extent to which DOD (1) uses a coordinated 
approach to plan for combat casualty care research and development and 
(2) monitors and assesses whether combat casualty care research and 
development fill capability gaps or achieve other goals. 

To determine the extent to which DOD uses a coordinated approach to 
plan for combat casualty care research and development, we reviewed 
DOD's policies and documentation on coordinating research, and we 
analyzed various pertinent documents, including DOD summaries of the 
portfolio of ongoing research designed to improve combat casualty 
care. We also interviewed knowledgeable officials from various DOD 
organizations involved in planning this research and from other 
relevant federal agencies, including the Food and Drug Administration 
(FDA), the National Institutes of Health (NIH), and the Department of 
Veterans Affairs (VA). The DOD officials we interviewed include those 
from Health Affairs, which is organizationally aligned under the Under 
Secretary of Defense for Personnel and Readiness; the Assistant 
Secretary of Defense for Research and Engineering, which is 
organizationally aligned under the Under Secretary of Defense for 
Acquisition, Technology and Logistics; the Army Medical Research and 
Materiel Command (MRMC); the Office of Naval Research; the Naval 
Medical Research Center; the Air Force Medical Support Agency; and 
DARPA. Furthermore, we analyzed DOD's efforts to coordinate combat 
casualty care research and development by comparing those efforts to 
key collaboration practices that we previously reported, such as 
agreeing on roles and responsibilities and establishing a means to 
operate across organizational boundaries. We define both 
"collaboration" and "coordination" as any joint activity by two or 
more organizations intended to produce more public value than could be 
produced when the organizations act alone.[Footnote 5] To determine 
the extent to which DOD monitors and assesses whether combat casualty 
care research and development fill capability gaps or achieve other 
goals, we obtained and analyzed data from Health Affairs, the military 
departments, and DARPA regarding metrics the department uses that 
gauge the progress and performance of its research projects. We also 
interviewed knowledgeable officials from a variety of DOD 
organizations, including the Army Institute for Surgical Research and 
the Naval Medical Research Center, about their monitoring efforts to 
apply findings from research. In addition, we reviewed the relevant 
internal control standards for the federal government, which address 
monitoring and assessing performance, and compared DOD's efforts to 
these standards.[Footnote 6] We focused this portion of our analysis 
on Health Affairs and the Army because they are responsible for the 
majority of combat casualty care research in DOD, with over 82 percent 
of DOD's combat casualty care funding in 2012. 

We conducted this performance audit from May 2012 to February 2013 in 
accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe 
that the evidence obtained provides a reasonable basis for our 
findings and conclusions based on our audit objectives. 

Background: 

Application of Combat Casualty Care Research Findings: 

DOD's combat casualty care researchers focus their efforts on the 
major causes of injury and death on the battlefield, and on improving 
medical care in specific battlefield conditions. For example, DOD 
estimates that approximately 84 percent of potentially survivable 
battlefield deaths are caused by bleeding. Therefore, DOD focuses a 
significant amount of its research on ways to control bleeding on the 
battlefield. Other areas on which DOD researchers focus include 
extremity trauma, diagnosis and treatment of traumatic brain injury, 
and ways to improve the care provided to casualties prior to and 
during evacuation to a hospital. 

In order to improve medical care in these areas, DOD researchers use 
various means to apply findings from combat casualty care research to 
develop drugs or medical devices. For example, DOD researchers convene 
multidisciplinary teams to decide whether a research project is ready 
and feasible to support development of a drug or medical device, 
according to DOD officials. These teams consist of researchers and 
other DOD personnel who are involved in acquiring and maintaining 
drugs and medical devices. At multiple meetings, the teams make 
decisions on whether to allow the project to proceed. In addition, DOD 
researchers work with the FDA to understand and share general 
information about regulatory requirements for drugs and medical 
devices that DOD develops. DOD officials also told us that in some 
cases DOD researchers also share the results of DOD research with 
medical corporations, which develop these products. 

In addition to developing drugs or medical devices, DOD researchers 
apply findings from combat casualty care research by disseminating 
information on medical practices. For example, the Army Institute for 
Surgical Research publishes clinical-practice guidelines that clinical 
subject-matter experts develop in response to needs identified while 
providing care to combat casualties. These guidelines are based on the 
best existing clinical evidence and experience, approved by senior DOD 
medical officials, and are available to all military medical 
practitioners. In addition, DOD researchers share new medical 
knowledge and best-practice information by publishing research results 
in medical journals and making presentations at conferences. 

Combat Casualty Care Research Capability Gaps and Funding: 

In May 2008, then-Secretary of Defense Robert Gates publicly expressed 
his commitment to improving medical care and support for wounded 
servicemembers. In that same month, DOD completed a program assessment 
of its medical research and development investments, which became the 
basis for DOD's June 2008 Guidance for the Development of the Force 
report.[Footnote 7] Among other matters, this assessment identified 
gaps in DOD's capabilities to protect the health of servicemembers, 
including health care provided to servicemembers who are wounded on 
the battlefield. For example, the 2008 report identified a gap in 
DOD's capability to diagnose, resuscitate, and stabilize casualties 
with survivable wounds. DOD used the capability gaps identified in the 
2008 report as the justification for funding requests that DOD 
subsequently made for medical research and development, including for 
research to address gaps in DOD's capability to provide combat 
casualty care. This assessment also concluded that a consolidated 
medical research and development budget structure with a centralized 
planning, programming, and budget authority and with centralized 
management would provide the most efficient and effective process and 
governance for DOD's medical research and development investment. 
[Footnote 8] 

To address the gaps in its capability to provide combat casualty care, 
DOD has increased this research funding overall, as shown in figure 1. 

Figure 1: DOD Combat Casualty Care Research and Development Funding 
from Fiscal Year 2005 through Fiscal Year 2012: 

[Refer to PDF for image: line graph] 

Fiscal year 2005: $96.9 million; 
Fiscal year 2006: $81.8 million; 
Fiscal year 2007: $307.1 million; 
Fiscal year 2008: $277.6 million; 
Fiscal year 2009: $422.6 million; 
Fiscal year 2010: $537.1 million; 
Fiscal year 2011: $272.3 million; 
Fiscal year 2012: $320.8 million. 

Source: GAO analysis of DOD information. 

[End of figure] 

In fiscal year 2010, DOD's funding for combat casualty care research 
increased to $537 million, and 2 years later it fell to $321 million. 
Health Affairs and the Army, with 82 percent of the funding in fiscal 
year 2012, were responsible for the majority of this research (see 
figure 2). The Navy, the Air Force, and DARPA were responsible for the 
remainder. 

Figure 2: Percent of Fiscal Year 2012 Combat Casualty Care Research 
and Development Funding by Organization: 

[Refer to PDF for image: pie-chart] 

Office of the Assistant Secretary of Defense for Health Affairs: 59%; 
Army: 23%; 
Air Force: 8%; 
Navy: 5%; 
Defense Advanced Research Projects Agency (DARPA): 5%. 

Source: GAO analysis of DOD information. 

Note: Funding for combat casualty care research and development 
totaled $321 million in fiscal year 2012. This amount does not include 
funding for other DOD organizations that do not typically conduct 
combat casualty care research but sometimes conduct research that is 
related to combat casualty care. 

[End of figure] 

Multiple DOD Organizations Oversee and Plan Research and Development: 

Multiple officials and organizations oversee DOD's combat casualty 
care research and development. The Assistant Secretary of Defense for 
Research and Engineering--who reports to the Under Secretary of 
Defense for Acquisition, Technology and Logistics--is responsible for 
promoting coordination of all research and engineering within DOD, 
including health-related research such as combat casualty care 
research. In addition, the Assistant Secretary of Defense for Health 
Affairs serves as the principal advisor to the Under Secretary of 
Defense for Personnel and Readiness on a variety of health issues, 
including medical research, which includes research to improve combat 
casualty care. The Assistant Secretary of Defense for Research and 
Engineering and the Assistant Secretary of Defense for Health Affairs 
cochair the Armed Services Biomedical Research and Evaluation 
Management committee. This committee's charter states that it was 
established to facilitate coordination and prevent unnecessary 
duplication of effort within DOD's biomedical research and development 
program. Joint Technology Coordinating Groups[Footnote 9] support the 
committee in specific research areas, including combat casualty care. 
Joint Technology Coordinating Groups are responsible for coordinating 
plans for research in their areas and for submitting recommendations 
on the distribution of responsibility for program execution and 
resources. (See figure 3 for organizations that oversee combat 
casualty care research and development.) 

Figure 3: Organizations That Oversee Combat Casualty Care Research and 
Development: 

[Refer to PDF for image: organizational chart] 

Top level: 
Secretary of Defense: 

Second level, reporting to Secretary of Defense: 
* Under Secretary of Defense for Acquisition, Technology and Logistics: 
- Assistant Secretary of Defense for Research and Engineering; 
* Under Secretary of Defense for Personnel and Readiness; 
- Assistant Secretary of Defense for Health Affairs; 
* Navy; 
* Army: 
- Army Medical Research and Materiel Command (MRMC); 
* Air Force. 

Third level, reporting to both Assistant Secretary of Defense for 
Research and Engineering and Assistant Secretary of Defense for Health 
Affairs: 
* Armed Services Biomedical Research Evaluation and Management 
Committee. 

Third level, reporting to both Assistant Secretary of Defense for 
Health Affairs and Army Medical Research and Materiel Command (MRMC): 
* Joint Program Committee for Combat-Casualty-Care (JPC-6). 

Source: GAO analysis of DOD information. 

Note: The JPC-6 includes representatives from each military service 
(Army, Navy, Air Force, and Marine Corps) and is chartered by Army 
Medical Research and Materiel Command (MRMC). 

[End of figure] 

With regard to planning, there are multiple DOD organizations 
specifically devoted to biomedical research, and these organizations 
plan research and development designed to improve the medical care 
provided to injured servicemembers. They include the Army MRMC, the 
Office of Naval Research, the Naval Medical Research Center, the Air 
Force Office of Scientific Research, the Air Force Medical Support 
Agency, and DARPA. In March 2011, Health Affairs signed an interagency 
support agreement with the Army MRMC to take advantage of existing 
Army MRMC staff and infrastructure. Under the agreement, the Army MRMC 
manages certain Health Affairs funds for medical research and 
development. To help manage these funds, the Army MRMC established 
Joint Program Committees (JPC) for the major areas of medical research 
that DOD conducts, including combat casualty care, which is managed by 
the Joint Program Committee for Combat Casualty Care (JPC-6). The JPC-6 
includes representatives from the DOD biomedical research organizations 
within each military department, including the Marine Corps, as well 
as from DARPA, NIH, VA, and other DOD organizations that use the results 
of combat casualty care research--such as DOD's Special Operations Command. 
These organizations coordinate to prioritize how to spend the Health 
Affairs funding for combat casualty care research. 

Other DOD research organizations also conduct research that is at 
times related to combat casualty care. Typically these research 
organizations do not plan or conduct biomedical research, but 
sometimes they identify ways that applications of their research could 
improve combat casualty care. These organizations include the Army 
Research Laboratory and the Naval Postgraduate School. 

DOD Uses a Coordinated Approach to Plan Its Combat Casualty Care 
Research and Development, but Not All of Its Organizations Share 
Information Early: 

DOD's biomedical research organizations use a coordinated approach to 
plan for combat casualty care research and development in a manner 
that is consistent with key collaboration practices. Further, DOD 
research organizations do not always share information early in the 
research process. DOD has also taken steps to coordinate with other 
federal agencies that are involved in combat casualty care research. 

DOD's Combat Casualty Care Research Planning Is Consistent with Key 
Collaboration Practices: 

DOD's biomedical research organizations coordinate combat casualty 
care research and development planning in a manner that is consistent 
with key collaboration practices identified in prior GAO work to 
enhance and sustain coordination.[Footnote 10] These key practices 
include agreeing on roles and responsibilities and establishing a 
means to operate across organizational boundaries. 

Agreement on Roles and Responsibilities: 

DOD's biomedical research organizations responsible for combat 
casualty care research and development have agreed on their roles and 
responsibilities, including establishing a key leadership position 
responsible for combat casualty care research. As we have previously 
reported, agreement on roles and responsibilities among coordinating 
organizations is important because it enables each organization to 
stay informed about the others' individual and joint efforts, and it 
facilitates decision making. 

DOD's biomedical research organizations have agreed on the roles and 
responsibilities for the organizations involved in planning, 
overseeing, and executing this type of research. First, Health Affairs 
and the Army MRMC--the two organizations that fund most combat 
casualty care research and development--have outlined their roles in 
an Interagency Support Agreement, which designates the Army MRMC as 
the organization responsible for managing the day-to-day use of Health 
Affairs funding for medical research, including research to improve 
combat casualty care. Second, the JPC-6 developed a draft charter in 
2010 that explains the roles and responsibilities for all of the JPC-6 
member organizations, including the non-DOD organizations, such as VA 
and NIH. The draft charter was finalized in early January 2013, while 
we were conducting our review.[Footnote 11] Health Affairs and Army MRMC 
officials told us that the JPC-6 began using the charter in 2010, but 
that they delayed finalizing it in part because they wanted to have 
the opportunity to incorporate lessons learned during the operation of 
the committee during its first 2 years. The charter states that JPC-6 
members represent the interests of their member organizations as well 
as provide subject-matter expertise and advice to the JPC-6 chair on 
requirements, program management, transition planning, and planning 
and programming for future investments. 

In addition to establishing a JPC-6 charter, Health Affairs and Army 
MRMC have established a key leadership position responsible for combat 
casualty care research by having one official serve simultaneously in 
three complementary roles: JPC-6 chair, Director of the Army Combat 
Casualty Care Research Program, and chair of the Joint Technology 
Coordinating Group for Combat Casualty Care. As noted in the JPC-6 
charter, the group's chair is responsible for making recommendations 
to Health Affairs for planning, programming, budgeting, and executing 
research and development to improve medical care provided to combat 
casualties, and the chair is to make these recommendations with the 
advice and support of the JPC-6 members. Because the DOD official 
serving as JPC-6 chair also serves as Director of the Army Combat 
Casualty Care Research Program and chair of the Joint Technology 
Coordinating Group for Combat Casualty Care, this official oversees 
the majority of this research in DOD. From fiscal years 2008 through 
2011, this official oversaw approximately 600 research projects, 
constituting over 80 percent of DOD's funding for combat casualty care 
research. Health Affairs and Army MRMC officials told us they expect 
that one official will lead all three organizations in the future. 

Means to Operate across Organizational Boundaries: 

DOD's biomedical research organizations responsible for combat 
casualty care research and development have established mechanisms to 
facilitate working across organizational boundaries--a step that, as 
we have previously reported, helps to enhance and sustain 
coordination.[Footnote 12] For example, DOD located nearly all of the 
DOD biomedical research organizations that conduct combat casualty 
care research at the Joint Center of Excellence for Battlefield Health 
and Trauma Research at Fort Sam Houston, Texas.[Footnote 13] The 
center includes the U.S. Army Institute for Surgical Research and 
other principal DOD biomedical research organizations that conduct 
combat casualty care research, such as the combat casualty care 
research functions from the Naval Medical Research Center and from 
Walter Reed Army Institute of Research. DOD officials told us that 
being located in the same place is useful in enabling them to know 
what other DOD organizations are doing with their related research and 
development. Another example of a mechanism to facilitate working 
across organizational boundaries is the Military Health System 
Research Symposium, an annual conference that provides DOD researchers 
the opportunity to discuss and address multiple medical research 
topics, including combat casualty care, with researchers from other 
federal agencies, academia, and private industry. DOD officials told 
us that these annual conferences have led to interagency collaboration 
on research and development for combat casualty care. 

Other DOD Research Organizations Do Not Always Coordinate Early in the 
Research Process, Which Can Result in Inefficiencies: 

DOD organizations that typically do not conduct biomedical research 
are generally not involved in DOD's efforts to coordinate combat 
casualty care research. When these nonmedical research organizations 
conduct research relevant to combat casualty care, they do not always 
share relevant information with appropriate officials early in the 
research process. We have previously reported that organizations 
involved in similar missions should coordinate and share relevant 
information early to avoid unnecessary duplication of work.[Footnote 
14] 

The JPC-6 chair, who is the lead official responsible for coordinating 
combat casualty care research, told us that he periodically has 
identified cases in which researchers began conducting research 
relevant to combat casualty care, but did not coordinate with him 
early in the process. He stated that in these cases, the research 
typically had been underway for a period of 1 to 5 years before he 
learned about it. He stated that he coordinates with nonmedical 
research organizations when he becomes aware of research relevant to 
combat casualty care. However, he stated that he has not always been 
aware of relevant research, and that there may be similar ongoing 
research projects about which he is currently unaware. For example, 
the Army Research Laboratory, which typically conducts research in the 
physical, engineering, and environmental sciences, started developing 
a product in 2006 that had the potential to control the bleeding of 
wounded soldiers--the leading cause of preventable deaths on the 
battlefield--but did not inform the JPC-6 chair of this research until 
2 years later. In addition, multiple DOD officials--including the JPC-
6 chair and other officials responsible for health research--stated 
that other DOD research organizations, such as the Naval Postgraduate 
School, the Defense Threat Reduction Agency, and the Joint Improvised 
Explosive Device Defeat Organization, have conducted research related 
to combat casualty care in the past and have not always coordinated or 
shared information early in the research process. 

The JPC-6 chair also stated that some DOD researchers do not share 
information with him early in the research process because they are 
not aware of the need to coordinate early and may not fully understand 
medical research requirements, such as those that are necessary to 
support FDA processes for approval of new drugs and medical devices. 
He also stated that a lack of awareness and understanding can result 
in researchers duplicating each other's work. As discussed above, Army 
Research Laboratory researchers did not inform the JPC-6 chair of 
their work for 2 years, and as a result they learned that some of 
their initial testing did not fully adhere to medical testing 
protocols associated with wounds and wound severity. Subsequently, the 
researchers had to redo some steps in their research. An Army Research 
Laboratory official responsible for the project told us that they 
could have avoided the inefficiency of duplicating these steps if they 
had shared information with the JPC-6 chair at an earlier point. The 
JPC-6 chair stated that, since this occurrence, the Army Research 
Laboratory and Army MRMC now coordinate with one another regularly to 
identify Army Research Laboratory projects with potential implications 
for combat casualty care. 

DOD Takes Steps to Coordinate with the FDA and Federal Agencies That 
Conduct Research Related to Combat Casualty Care: 

DOD coordinates medical research information with other federal 
agencies, including FDA, NIH, and VA. DOD coordinates with FDA with 
regard to drugs and medical devices it develops because FDA is 
responsible for overseeing the safety and effectiveness of these 
products--including those that are developed through DOD's combat 
casualty care research--and DOD must obtain FDA's regulatory review 
and approval or clearance to field medical products. FDA officials 
stated that they regularly meet with the commanding general of the 
Army MRMC to review DOD's medical research priorities and to share 
general information about regulatory requirements. FDA officials also 
provide product-specific advice to DOD regarding regulatory 
requirements by meeting with DOD researchers throughout the 
development process. This coordination is consistent with FDA's 
efforts, noted in previous GAO reports, to address concerns from 
industry and advocacy groups, including those related to the 
timeliness of the review process and the need to improve communication 
between FDA and stakeholders throughout the development process. 
[Footnote 15] DOD officials told us that FDA regulators were very 
responsive to their regulatory questions and concerns, and they 
reported that sometimes this communication helped to expedite the 
development process. 

Likewise, it is important for DOD, NIH, and VA to coordinate with each 
other because all of these agencies conduct research that is directly 
related to combat casualty care research. DOD, NIH, and VA conduct 
joint program reviews, prepare joint strategic documents, complete 
joint research projects, and attend joint symposiums and conferences 
to share their research. Our prior work identified some issues 
concerning the ability of DOD, NIH, and VA to readily access 
comprehensive medical research information funded by the other 
agencies.[Footnote 16] We found that the three agencies could improve 
their ability to efficiently identify potential duplication if they 
improved access to each others' comprehensive electronic information 
on funded health research. DOD officials recently stated that DOD and 
the other two agencies are working together to address these concerns. 
Specifically, NIH has provided a DOD official with access to an NIH 
database that contains information about funded health research 
projects, and it has also provided training and support so that the 
DOD official can search the database for potential duplicated 
research. If this effort is successful, DOD plans to identify 
additional medical research officials who will be granted access to 
NIH's health research database. Because VA's medical research 
information resides in this database, DOD will also be able to 
identify VA research that is directly related to DOD's combat casualty 
care research.[Footnote 17] 

DOD Monitors the Progress of Combat Casualty Care Research Projects, 
but Not Whether the Research Fills Gaps or Achieves Other Goals: 

Health Affairs and Army MRMC monitor and assess the progress of combat 
casualty care research and development projects, but they have not 
assessed the extent to which this research fills gaps in DOD's 
capability to provide combat casualty care or achieves other goals for 
this research, including those related to improving DOD's ability to 
control bleeding, which is the primary cause of death on the 
battlefield. Internal control standards for the federal government 
state that agencies should monitor and assess their performance over 
time to help ensure that they meet the agency's missions, goals, and 
objectives.[Footnote 18] Using performance information such as 
performance metrics can aid agencies with monitoring results, 
developing approaches to improve results, and helping determine 
progress in meeting the goals of programs or operations. 

Health Affairs and Army MRMC monitor and assess the progress of combat 
casualty care research and development projects. For example, Health 
Affairs and Army MRMC monitor and assess cost, schedule, and 
performance metrics for individual research projects to determine 
whether to continue funding, make necessary corrections to, or 
terminate these projects. Senior leadership in these organizations 
reviews projects annually to determine whether they are meeting 
established cost, schedule, and performance baselines. In addition, 
these leaders assess technology readiness levels--which are 
measurements of maturity level--to determine whether findings from a 
research project are sufficiently mature to move to the next phase of 
development. Health Affairs and Army MRMC also monitor and assess some 
aspects of the progress of the overall combat casualty care research 
portfolio, such as the number of projects completed, ongoing, or 
canceled, as well as the number of products available to users in the 
field. These organizations have applied findings from combat casualty 
care research to field five such products between fiscal years 2008 
and 2011. For example, Health Affairs and Army MRMC officials told us 
that DOD fielded a combat gauze product that was the result of combat 
casualty care research. This gauze includes a mineral to help form 
blood clots and is designed to stop severe bleeding in less than 4 
minutes. Following the annual combat casualty care research portfolio 
review in September 2012, Health Affairs and Army MRMC reported that 
they plan to identify new performance metrics, such as data related to 
peer-reviewed publications and FDA approved drugs and medical devices 
that will provide additional information on the overall portfolio's 
progress. 

However, Health Affairs and Army MRMC have not assessed the extent to 
which the results of combat casualty care research fill gaps in DOD's 
capability to provide care to combat casualties. As we discussed 
earlier, DOD identified a number of gaps in its capability to provide 
combat casualty care in the 2008 Guidance for the Development of the 
Force analysis and report.[Footnote 19] Since 2008, Health Affairs and 
Army MRMC told us that they have completed about 44 combat casualty 
care research projects that are each designed to address one or more 
of these capability gaps. Health Affairs and Army MRMC officials told 
us that in 2010 they attempted to measure the extent to which the 2008 
capability gaps had been filled on the basis of the research results. 
However, they abandoned that effort because, according to officials, 
in 2010 researchers had not completed a sufficient amount of research 
designed to fill the 2008 capability gaps. In addition, these 
officials indicated that the capability gaps were not specific, were 
not organized to correspond with DOD's research areas, and did not 
reflect the state of medical knowledge at the time. Health Affairs 
officials told us that they are currently revising these capability 
gaps and they expect to complete the revision in 2013. Following the 
Health Affairs revision, the Joint Staff--a group of senior military 
leaders in DOD--will then validate the capability gaps. Health Affairs 
and Army MRMC officials told us that they plan to assess whether the 
results of future research fill the revised capability gaps once the 
Joint Staff validates them. 

In addition, Health Affairs and Army MRMC have not developed an 
assessment of the extent to which the results of combat casualty care 
research have achieved other goals for this research. Both Health 
Affairs and Army MRMC have established goals for the combat casualty 
care research portfolio including several related to improving DOD's 
ability to control bleeding, which is the primary cause of death on 
the battlefield. For example, Health Affairs set a goal for DOD to 
improve its ability to control bleeding in areas of the human body 
where it is not feasible to apply a tourniquet, such as on internal 
organs or the groin. Health Affairs and Army MRMC officials told us 
that they periodically review and discuss progress toward these 
research goals for certain research topics. However, these officials 
have not developed an assessment that comprehensively identifies each 
of the goals for the portfolio and includes information about the 
extent to which each goal has been met. They acknowledged that more 
work is needed to do this. Following a review and analysis of the 
combat casualty care research portfolio in September 2012, Health 
Affairs and Army MRMC officials reported to us that they intended to 
complete an overarching strategic roadmap for the portfolio by March 
2013. They told us that they expect the roadmap could include specific 
project timelines and goals, among other things. However, on the basis 
of the information provided by DOD officials, we were unable to 
determine if the plan will clearly delineate how Health Affairs and 
Army MRMC will assess the extent to which results from combat casualty 
care projects fill capability gaps and achieve other goals. Until 
Health Affairs and Army MRMC assess the results of DOD's research 
against revised capability gaps and other goals, DOD will not have 
reasonable assurance that the research it is conducting meets its 
needs. 

Conclusions: 

Coordination among the various organizations that plan and conduct 
combat casualty care research and development is important to 
effectively produce medical solutions to save or improve the lives of 
injured servicemembers. DOD has taken important steps to agree on 
roles and responsibilities and to establish the means for coordination 
and collaboration across organizational boundaries. However, DOD's 
research organizations can only coordinate with each other when they 
become aware of relevant research. Without communicating to nonmedical 
research organizations about the importance of coordinating with the 
JPC-6 chair early in the research process, DOD research organizations 
may have to redo some steps of their research to address medical 
research requirements that they may not fully understand. Moreover, 
while DOD assesses the progress of combat casualty care research 
projects, it is also important that DOD monitor and assess the extent 
to which the results of its combat casualty care research fill the 
gaps in DOD's capability to provide combat casualty care and achieve 
other goals that it established for the research. However, without a 
plan for monitoring and assessment, DOD runs the risk that it may not 
be producing results that most effectively improve combat casualty 
care to save lives on the battlefield. 

Recommendations for Executive Action: 

1. To ensure that nonmedical DOD research organizations coordinate 
with the Assistant Secretary of Defense for Health Affairs early in 
the research process to understand medical research requirements and 
avoid inefficiencies that may lead to duplicative work, we recommend 
that the Secretary of Defense direct the Under Secretary of Defense 
for Acquisition, Technology and Logistics to: 

* communicate to DOD's nonmedical research organizations the 
importance of coordination with the JPC-6 chair on combat casualty 
care issues, and require this coordination early in the research 
process when these organizations conduct research with implications 
for combat casualty care. 

2. To improve DOD's ability to assess the overall performance of its 
combat casualty care research portfolio, we recommend that the 
Secretary of Defense direct the Under Secretary of Defense for 
Personnel and Readiness to direct the Assistant Secretary of Defense 
for Health Affairs to: 

* develop and implement a plan to assess the extent to which combat 
casualty care research and development fills gaps in DOD's capability 
to provide combat casualty care and achieves DOD's other goals for 
this portfolio of research. 

Agency Comments and Our Evaluation: 

We provided a draft of this report to DOD, VA, and the Department of 
Health and Human Services (HHS), which includes FDA and NIH. In 
response, we received written comments from DOD and HHS, which are 
reprinted in appendixes I and II, respectively. VA did not comment on 
this report. DOD and HHS also provided technical comments that we have 
incorporated as appropriate. 

Department of Defense: 

In its written comments, DOD concurred with the recommendations we 
made to the department and also described steps it had taken or 
planned to take in response to our recommendations. Specifically, DOD 
concurred with our first recommendation to communicate to nonmedical 
research organizations the importance of coordination with the JPC-6 
chair and require this coordination early in the research process. DOD 
also concurred with our second recommendation to develop and implement 
a plan to assess the extent to which combat casualty care research 
addresses DOD's capability gaps and achieves its other goals. In its 
comments on our second recommendation, DOD stated that it planned to 
revise its process to better assess the extent to which each combat 
casualty care research project closes capability gaps. Moreover, when 
we sent our draft report to DOD for comment in December 2012, Health 
Affairs and Army MRMC had not yet finalized the JPC-6 charter. 
Therefore, we included a recommendation in our draft report that DOD 
issue the final charter. In early January 2013, after we sent the 
draft report to DOD, the commanding general of Army MRMC signed and 
issued the final JPC-6 charter. As a result, we did not include the 
recommendation to finalize the charter in our final report. 

Department of Health and Human Services: 

In its written comments, HHS responded to a statement in the draft 
report that DOD, NIH, and VA could improve their ability to 
efficiently identify potentially duplicative research with improved 
access to each agency's electronic health research information, as 
noted in a 2012 GAO report.[Footnote 20] HHS stated that DOD has 
access, to varying degrees, to NIH and VA medical research 
information. Consistent with our 2012 report, HHS stated that NIH and 
VA need access to DOD medical research information to reduce the risk 
of potentially duplicative research. HHS also stated that the agencies 
continue to evaluate the best approach to providing NIH and VA with 
access to DOD's medical research information. 

We are sending copies of this report to the appropriate congressional 
committees; the Secretary of Defense, the Deputy Under Secretary of 
Defense for Personnel and Readiness; the Deputy Under Secretary of 
Defense for Acquisitions, Technology and Logistics; the Assistant 
Secretary of Defense for Health Affairs; the Secretaries of the Army, 
Navy, and Air Force and the Commandant of the Marine Corps; the 
Secretary of Health and Human Services; the Secretary of Veterans 
Affairs; and other interested parties. In addition, the report is 
available at no charge on the GAO website at [hyperlink, 
http://www.gao.gov]. 

If you or your staff have any questions about this report, please 
contact Linda Kohn at (202) 512-7114 or kohnl@gao.gov or Brenda 
Farrell at (202) 512-3604 or farrellb@gao.gov. Contact Points for our 
Offices of Congressional Relations and Public Affairs may be found on 
the last page of this report. GAO staff who made key contributions to 
this report are listed in appendix III. 

Signed by: 

Linda T. Kohn: 
Director, Health Care: 

Signed by: 

Brenda S. Farrell: 
Director, Defense Capabilities and Management: 

List of Committees: 

The Honorable Carl Levin: 
Chairman: 
The Honorable James Inhofe: 
Ranking Member: 
Committee on Armed Services: 
United States Senate: 

The Honorable Chairman: 
The Honorable Ranking Member: 
Subcommittee on Defense: 
Committee on Appropriations: 
United States Senate: 

The Honorable Howard P. "Buck" McKeon: 
Chairman: 
The Honorable Adam Smith: 
Ranking Member: 
Committee on Armed Services: 
House of Representatives: 

The Honorable C.W. "Bill" Young: 
Chairman: 
The Honorable Pete Visclosky: 
Ranking Member: 
Subcommittee on Defense: 
Committee on Appropriations: 
House of Representatives: 

[End of section] 

Appendix I: Comments from the Department of Defense: 

The Assistant Secretary of Defense: 
Health Affairs: 
1200 Defense Pentagon: 
Washington, DC 20301-1200: 

January 16, 2013: 

Ms. Linda T. Kohn: 
Director, Health Care: 
U.S. Government Accountability Office: 
441 G Street, N.W. 
Washington, DC 20548: 

Dear Ms. Kohn: 

This is the Department of Defense response to the Government 
Accountability Office (GAO) Draft Report, GA0-13-209, "Defense Health: 
Actions Needed to Help Ensure Combat Casualty Care Research Achieves 
Goals," dated December 19, 2012 (GAO Code 291032). 

Thank you for the opportunity to review and comment on the draft 
report. After careful review, we concur with the report 
recommendations, but would like to offer technical comments. My 
response to the recommendations contained in the draft report is 
enclosed. 

My points of contact for this action are Dr. Terry Rauch (Functional) 
and Mr. Gunther Zimmerman (Audit Liaison). Dr. Rauch may be reached at 
(703) 681-8390, or Terry.Rauch@ha.osd.mil. Mr. Zimmerman may be 
reached at (703) 681-4360, or Gunther.Zimmerman@tma.osd.mit. 

Sincerely, 

Signed by: 

Jonathan Woodson, M.D. 

Enclosures: As stated. 

GAO Draft Report Dated December 19, 2012: 
GAO-I3-209 (GAO Code 291032): 

"Defense Health: Actions Needed To Help Ensure Combat Casualty
Care Research Achieves Goals" 

Department Of Defense Comments To The GAO Recommendation: 

Recommendation 1: The GAO recommends that the Secretary of Defense 
direct the Under Secretary of Defense for Personnel and Readiness to 
direct the Assistant Secretary of Defense for Health Affairs to issue 
the final Joint Program Committee 6 Charter to formally establish 
clear agreement on roles and responsibilities in the area of Combat 
Casualty Care research and development. 

DoD Response: On January 2, 2013 the Joint Program Committee 6 Charter 
was signed and issued by the Commanding General, U.S. Army Medical 
Research and Materiel Command. consistent with the provisions of the 
Interagency Support Agreement between the Office of the Assistant 
Secretary of Defense for Health Affairs and the U.S. Army Medical 
Research and Materiel Command. Therefore. this recommendation has been 
completed. 

Recommendation 2: The GAO recommends that the Secretary of Defense 
direct the Under Secretary of Defense for Acquisition, Technology, and 
Logistics to communicate to DOD's non-medical research organizations 
the importance of coordination with the Joint Program Committee 6 
Chair for combat casualty care issues. and require this coordination 
early in the research process when these organizations conduct 
research with implications for combat casualty care. 

DoD Response: Concur. 

Recommendation 3: The GAO recommends that the Secretary of Defense 
direct the Under Secretary of Defense for Personnel and Readiness to 
direct the Assistant Secretary of Defense for Health Affairs to 
develop and implement a plan to assess the extent to which combat 
casualty care research and development addresses gaps in DoD's 
capability to provide combat casualty care and achieves DoD's other 
goals for this portfolio of research. 

DoD Response; The OASD(HA) Combat Casualty Care research portfolio 
review and analysis process evaluates the alignment of research 
efforts to the identified capability gaps as well as other DoD 
research goals on a regular basis. We will revise the current process 
to better assess the extent to which each Combat Casualty Care 
research project closes the identified capability gaps. The revised 
plan will be used in subsequent Combat Casualty Care research program 
reviews to assure that research efforts align to capability gaps, to 
analyze the extent of gap closure, to assess the current state of 
research and science, and to identify other gaps that provide 
additional research opportunities. 

[End of section] 

Appendix II: Comments from the Department of Health & Human Services: 

Department Of Health & Human Services: 
Office Of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

January 15, 2013: 

Linda T. Kohn: 
Director, Health Care: 
U.S. Government Accountability Office: 
441 G Street NW: 
Washington, DC 20548: 

Dear Ms. Kohn: 

Attached are comments on the U.S. Government Accountability Office's 
(GAO) report entitled, "Defense Health: Action Needed to Help Ensure 
Combat Casualty Care Research Achieves Goals" (GA0-13-209). 

The Department appreciates the opportunity to review this report prior 
to publication. 

Sincerely, 

Signed by: 

Jim R. Esquea: 
Assistant Secretary for Legislation: 

Attachment: 

General Comments Of The Department Of Health And Human Services (HHS) 
On The Government Accountability Office's (GAO) Draft Report Entitled. 
" Defense Health: Actions Needed To Help Ensure Combat Casualty Care 
Research Achieves Goals" (GAO-13209): 

The Department appreciates the opportunity to review and comment on 
this draft report. 

In this report, GAO references previously identified issues concerning 
the ability of the Department of Defense (DoD), the National 
Institutes of Health (NIH), and the Department of Veterans Affairs 
(VA) to readily access comprehensive medical research information 
funded by the other agencies. GAO stated, "the three agencies could 
improve their ability to efficiently identify potential duplication if 
they improved access to each others' comprehensive electronic 
information on funded health research." 

All DoD and VA research scientists and program administrators have had 
access to award data on NIH-funded health research via the public 
database [hyperlink, http://report.nih.gov] to determine potential 
duplication of NIH's and VA's funded research. Further, all NIH and VA 
staff and one DoD official have access to an NIH internal database 
that contains comparable data on NIH and VA grants and unfunded 
applications. NIH only makes the internal database available to other 
federal agency officials contingent upon acceptance of a formal data 
access agreement. 

Those data access efforts are only one part of the equation. NIH 
continues to evaluate with its DoD colleagues the best approach to 
achieving NM and VA access to DoD medical research grants and 
applications. NIH and VA access to a DoD database of medical research 
grants and applications is necessary to identify research directly 
related to NIH and VA programs and to reduce the risk of potential 
duplication. 

[End of section] 

Appendix III: GAO Contacts and Staff Acknowledgments: 

GAO Contacts: 

Linda T. Kohn, (202) 512-7114 or kohnl@gao.gov: 

Brenda S. Farrell, (202) 512-3604 or farrellb@gao.gov: 

Staff Acknowledgments: 

In addition to the contacts named above, Will Simerl, Assistant 
Director; Steve Boyles; La Sherri Bush; James P. Klein; Monica Perez-
Nelson; Michael Pose; Mike Silver; Sarah Veale; and Cheryl Weissman 
made key contributions to this report. 

[End of section] 

Footnotes: 

[1] DOD officials define combat casualty care as the medical care 
provided to servicemembers from the time when they are wounded in 
combat through their hospitalization at a facility out of the combat 
theater, including evacuation and surgery. 

[2] DOD, Guidance for the Development of the Force FY2010-2015, 
Program and Budget Assessment A4.16, Medical Research and Development 
Investments (June 2008). 

[3] GAO, Standards for Internal Control in the Federal Government, 
[hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1] 
(Washington, D.C.: November 1999). 

[4] Pub. L. No. 112-81, § 1076, 125 Stat. 1298, 1595-1596 (2011). 

[5] GAO, Results-Oriented Government: Practices That Can Help Enhance 
and Sustain Collaboration among Federal Agencies, [hyperlink, 
http://www.gao.gov/products/GAO-06-15] (Washington, D.C.: Oct. 21, 
2005). 

[6] [hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1]. 

[7] DOD, Guidance for the Development of the Force FY2010-2015. 

[8] GAO, Defense Health Care: Applying Key Management Practices Should 
Help Achieve Efficiencies within the Military Heath System, 
[hyperlink, http://www.gao.gov/products/GAO-12-224] (Washington, D.C.: 
Apr. 12, 2012). 

[9] Joint Technology Coordinating Groups are composed of a single 
member from each of the Army, Navy, and Air Force. 

[10] [hyperlink, http://www.gao.gov/products/GAO-06-15]. 

[11] DOD, US Army Medical Research and Materiel Command Joint Program 
Committee-6 Charter for the Combat Casualty Care JPC, (Jan. 2, 2013). 

[12] [hyperlink, http://www.gao.gov/products/GAO-06-15]. 

[13] DOD established this center in response to a recommendation in 
the 2005 Base Realignment and Closure Report. DOD, 2005 Base Closure 
and Realignment Report, vol. X (Washington, D.C.: May 9, 2005). 

[14] GAO, Interagency Collaboration: Key Issues for Congressional 
Oversight of National Security Strategies, Organizations, Workforce, 
and Information Sharing, [hyperlink, 
http://www.gao.gov/products/GAO-09-904SP] (Washington, D.C.: Sept. 25, 
2009) and Managing for Results: Using the Results Act to Address 
Mission Fragmentation and Program Overlap, [hyperlink, 
http://www.gao.gov/products/GAO/AIMD-97-146] (Washington, D.C.: Aug. 
29, 1997). For more information on fragmentation, overlap, and 
duplication in federal programs see GAO, 2012 Annual Report: 
Opportunities to Reduce Potential Duplication in Government Programs, 
Save Tax Dollars, and Enhance Revenue, [hyperlink, 
http://www.gao.gov/products/GAO-11-318SP] (Washington, D.C.: Mar. 1, 
2011) and Opportunities to Reduce Duplication, Overlap and 
Fragmentation, Achieve Savings, and Enhance Revenue, [hyperlink, 
http://www.gao.gov/products/GAO-12-342SP] (Washington, D.C.: Feb. 28, 
2012). 

[15] GAO, Prescription Drugs: FDA Has Met Most Performance Goals for 
Reviewing Applications, [hyperlink, 
http://www.gao.gov/products/GAO-12-500] (Washington, D.C.: Mar. 30, 
2012) and Medical Devices: FDA Has Met Most Performance Goals but 
Device Reviews Are Taking Longer, [hyperlink, 
http://www.gao.gov/products/GAO-12-418] (Washington, D.C.: Feb. 29, 
2012). 

[16] [hyperlink, http://www.gao.gov/products/GAO-12-342SP]. 

[17] As noted in [hyperlink, 
http://www.gao.gov/products/GAO-12-342SP], NIH also maintains a public 
database containing award data on NIH-funded health research, which 
DOD officials could search for potential duplicative research. 

[18] [hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1]. 

[19] DOD, Guidance for the Development of the Force FY2010-2015. 

[20] [hyperlink, http://www.gao.gov/products/GAO-12-342SP]. 

[End of section] 

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