United States General Accounting Office

GAO Report to Congressional Committees

December 1998 DOD ANIMAL

RESEARCH

Improvements Needed

in Quality of

Biomedical Research

Database

GAO/NSIAD/HEHS-99-24

GAO United States

General Accounting Office

Washington, D.C. 20548

National Security and

International Affairs Division

B-278778 

December 14, 1998

The Honorable Floyd Spence

Chairman

The Honorable Ike Skelton

Ranking Minority Member

Committee on National Security

House of Representatives

In 1992, congressional concerns were expressed about the lack of

disclosure of the Department of Defense’s (DOD) animal use programs and

activities. In response, DOD began submitting annual reports to the

Congress in 1994. In 1995, to respond to continued congressional concerns

and direction, DOD established the Biomedical Research Database (BRD)

containing information on individual research projects and training

programs involving animals being conducted by its laboratories, military

hospitals and bases, and contractors.

House Report 103-499, issued by the House Armed Services Committee in

its consideration of the National Defense Authorization Act for Fiscal Year

1995, directed us to examine several issues related to DOD’s administration

of its animal research programs. We are examining the extent to which

DOD’s research using animals addresses validated military objectives, does

not unnecessarily duplicate work done elsewhere, and incorporates

methods to reduce, replace, and refine the use of animals. In the course of

doing this work, we identified problems with the quality of information in

the BRD. The purpose of this report is to bring these problems to your

attention. We are continuing our work on the broader issues and will

report the results of our review of DOD’s use of animals in research at a

later date.

Results in Brief The BRD provides improved public access to information about DOD’s use

of animals in its research activities. However, we found instances in which

the information in the BRD was inaccurate, incomplete, and inconsistent,

resulting in inadequate public disclosure. Specifically, the fiscal year 1996

BRD (1) misstated the number of animal use projects because it omitted

some projects that used animals and included others that did not involve

animals; (2) did not include information, such as the numbers and types of

animals used, that was identified in House Report 103-499; and

(3) contained significant differences in the specificity reported for the

research projects. Although we did not quantify the full extent of these

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B-278778 

problems, the problems we have identified suggest a need for DOD action

to improve the accuracy and extent of the information in the database.

Background DOD provides information to the public about its animal use projects

through two main sources—an annual report to the Congress and the BRD.

The annual report to the Congress provides information in a summary

form on animal use activities, including numbers and types of animals

used, general purposes for which animals were used, and DOD’s animal

care and use oversight procedures. DOD provided its first annual report in

1994 in response to the direction of the House Armed Services Committee,

as contained in its Committee Report on the National Defense

Authorization Act for the Fiscal Year 1993.1

In House Report 103-499, however, the House Armed Services Committee

noted that DOD’s annual report had not provided sufficient detail about its

animal research programs and activities. The House Report directed DOD

to “develop a mechanism for providing the Congress and interested

constituents with timely information . . . about its animal use programs,

projects, and activities, both intramural and extramural.” One mechanism,

according to the House Report, would be a database with information

about the research goal and justification, cost, procedures, kinds and

numbers of animals used, and information about the pain to which these

animals are subjected.

In response to that report, in October 1995 DOD established the BRD, a

database about individual projects using animals that is accessible by the

public through the Internet. For each ongoing DOD animal use project, it

provides a project summary that includes the funding amount, the location

of the research, and a brief statement of the project’s research objectives

and methods. Research projects cover a broad range of topics such as

using animals in the development of vaccines to protect against biological

warfare agents and technologies to improve treatment methods for

combat casualty care.

Information for the BRD is collected from DOD agencies and military

commands, organizations, and activities involved in the performance and

funding of animal care and use programs. Typically the researcher or the

veterinary services department at each facility provides the information

about each research project for the BRD and the annual report. This is

information that facilities routinely maintain as part of the process of

1

H.R. Rept. No. 102-527.

Page 2 GAO/NSIAD/HEHS-99-24 DOD Animal Research
B-278778 

granting researchers the approval to conduct research and then

subsequently ordering animals for the research project. The BRD includes

research funded by DOD as well as research performed by DOD that is

funded by external sources such as the National Institutes of Health and

the Alzheimer Association. The BRD, which is updated annually, contained

805 project summaries for fiscal year 1996. It was updated to reflect fiscal

year 1997 projects on October 1, 1998, one year after the fiscal year ended;

project summaries for fiscal year 1996 were replaced by those for fiscal

year 1997.

DOD Has Created a

Publicly Available

Database on Its

Animal Research

Programs

DOD has made progress in making information available to the public on its

animal research programs and activities. Prior to the creation of the BRD,

information on animal research was contained as part of a larger Defense

Technology Information Center (DTIC) database, which includes the broad

range of DOD research and development projects. However, DOD did not

require all of its animal research activities, such as those involving clinical

training or investigations, to be reported to the DTIC database. DOD now

requires all animal research projects to be reported separately in the BRD.

In addition, the BRD is publicly available on the Internet, while the DTIC

database has restricted public access.

Problems With DOD’s

Animal Use

Information

The fiscal year 1996 BRD had a number of problems, including inaccurate

and incomplete disclosure of information about DOD’s animal use projects.

These problems stem from DOD not collecting certain valuable information

from animal use facilities and not reporting certain other information that

it did collect. Other problems of inaccuracy or inconsistency in the

database were due to flawed data reported to DOD by facilities.

The BRD is inaccurate with respect to the number of animal use projects.

For example, in the course of performing our work, we found seven

projects or research protocols that were not included in the database.

These projects were performed at three different DOD organizations: the

Armed Forces Radiobiology Research Institute, the Army’s Landstuhl

Regional Medical Center, and the Marine Corp’s Camp Lejeune Field

Medical Service School. The animals used included goats, sheep, rodents,

and nonhuman primates. Alternatively, we identified 19 projects in the

fiscal year 1996 BRD related to medical research for biological defense that

did not involve the use of animals that year (although they did involve

animals in other years). In addition, we identified one project that was

Page 3 GAO/NSIAD/HEHS-99-24 DOD Animal Research
B-278778 

reported twice in the database—two different DOD organizations reported

the same project.

Cost information provided in the BRD is not always accurate and

consistent. For example, the fiscal year 1996 funding amount provided in

the BRD for some projects covered a longer period than just fiscal 

year 1996. In other cases, the amounts of funding shown was inconsistent

because the funding for some projects was listed as an abbreviated

notation of a larger amount without providing adequate explanation. For

example, in the case of the project erroneously reported twice, one project

summary showed funding as “28,” while the other showed the amount as

“28000.” These discrepancies make it difficult, if not impossible, to

accurately determine from the BRD the cost of these animal research

projects for the fiscal year. Additionally, the BRD does not disclose the

funding source for the projects, making it impossible to determine which

projects were funded by DOD and which by external sources.

Furthermore, the BRD does not contain certain information identified in

House Report 103-499. For instance, it does not provide the numbers and

species of animals used for DOD projects nor does it include information

about the pain to which animals were subjected. Summary information is

provided for numbers and types of animals used and pain categories2

 in

DOD’s annual reports to the Congress, but these reports lack information

on individual programs and activities.

Another type of information that was mentioned in the House report is

generally absent in BRD project summaries. Few project summaries

identify the military or nonmilitary justification of the project. Although

some of the projects are directly tied to a military goal, such as developing

more effective transfusion fluids for combat casualties, others are not tied

to a military goal but are still being done under a specific congressional

directive, such as DOD’s extensive breast cancer research program. Without

this information the Congress and the public cannot identify projects by

the type of requirement they support. DOD does not collect information on

the justification of each project as part of its data collection for the BRD.

The version of the BRD available to the public also does not contain a data

field that describes the broader animal use categories listed in DOD’s

annual report to the Congress on animal care and use. Examples of these

categories are research on infectious diseases, research relating to combat

2

DOD uses a system developed by the U.S. Department of Agriculture to categorize the level of pain or

distress to which animals are exposed and whether their pain or distress is alleviated during the

research project, for example, through the use of anesthesia.

Page 4 GAO/NSIAD/HEHS-99-24 DOD Animal Research
B-278778 

casualty care, and training for medical personnel. The absence of this

information prevents the public from identifying how individual research

projects link together into these broader research areas.

We also found variations in the levels of specificity reported on the

projects in the BRD. Whereas most of the 805 project summaries represent

an individual line of research, several summaries report broad groups of

research projects. For example, the Uniformed Services University of

Health Sciences placed 64 separate project summaries in the BRD reflecting

detailed distinctions among its various clinical research activities, such as

“Virulence Mechanisms of Salmonella Typhi.” In contrast, Fitzsimons

Army Medical Center reports only two clinical research project summaries

that are described broadly as “Animal-Facilitated Clinical Medicine Studies

in Support of Graduate Medical Education” and “Animal-Facilitated

Clinical Surgical Studies in Support of Graduate Medical Education.”

These two summaries merged as many as 29 separate projects. DOD

guidance to the animal use facilities on preparing project summaries

allows facilities broad discretion in determining what constitutes a

project.

We identified one classified project in the BRD that involved research on

animals for the development of a weapon system. While we found no

problem with the information reported in the BRD for this project, it

appears inconsistent with DOD’s fiscal year 1996 annual animal care and

use report to the Congress, which stated that no animals had been used for

offensive weapons testing during fiscal year 1996.

Recommendations We recommend that the Secretary of Defense continue to take steps to

improve the BRD. Specifically, the Secretary should improve the data

collection and reporting procedures to ensure that the BRD contains

accurate, detailed information about individual animal research projects,

including information on the number and species of animals used in each

project, the research goal and justification, and the pain categories for

each project as identified in House Report 103-499. In addition, to improve

public accountability, we recommend that the Secretary provide other

information in the BRD, such as the appropriate animal use categories for

each project, consistent with information reported in the DOD’s annual

reports to the Congress, and ensure that the information contained in the

BRD be presented in a uniform manner for all projects.

Page 5 GAO/NSIAD/HEHS-99-24 DOD Animal Research
B-278778 

Agency Comments In written comments on a draft of this report (see app. I), DOD partially

concurred with our first recommendation and concurred with our second

recommendation. Specifically, DOD said it will provide additional training

to on-site veterinarians who are responsible for submitting data, take steps

to clarify funding information for individual project summaries, include

animal use categories for each project summary, and require reporting of

all projects that have any animal use. They stated that they will institute

these changes prior to the fiscal year 1999 annual report. DOD, however,

expressed a concern that our recommendation to provide further detail on

the number and species of animals, the research goals and justifications,

and pain categories for each project summary would require an extensive

upgrade of the existing BRD software and hardware capacity, duplicate

information that is already available in the DOD annual report on animal

use activities, and would not improve animal welfare. DOD also contended

that information in the BRD is uniformly presented. DOD also provided

technical comments, which we incorporated where appropriate.

The changes that DOD proposes adopting will improve the quality of the

BRD. But we believe that additional detail on each project summary is

necessary to respond to the original direction of the House Armed

Services Committee as well as to improve public accountability. Moreover,

we feel that this detail can be provided in the BRD without a significant

increase in resource expenditures. As pointed out in this report, the

number and species of animals used and the pain category of the research

are collected on a routine basis by DOD research and training facilities as a

means of monitoring and tracking animal use activities. Furthermore,

much of this information is already gathered for the DOD annual report

although it is only reported in terms of aggregate animal use and not by

individual projects. DOD also needs to ensure a more consistent level of

reporting of animal use activities. Facilities conducting clinical research,

for example, should submit summaries for the BRD at a project rather than

program level. Incorporating these additional changes would further

improve what is an important source of information on animal welfare to

the public.

Scope and

Methodology

In the course of our work examining issues related to DOD’s oversight of its

animal research programs, we are reviewing the BRD because it contains

information on individual animal use projects. As we reviewed information

contained in the BRD, conducted interviews with DOD officials, reviewed

relevant congressional reports, and performed data analyses to address

Page 6 GAO/NSIAD/HEHS-99-24 DOD Animal Research
B-278778 

the objectives for our study, we identified problems with information in

the BRD.

The BRD is prepared annually by DOD based on a questionnaire that it sends

to those of its laboratories and contractors who use animals for research

or training purposes. We reviewed the BRD in two forms. First, we

selectively reviewed a version that is publicly available on the Internet (at

http://ocean.dtic.mil/basis/matris/www/biowww/sf). Second, DOD supplied

us with an electronic file that also identified the animal use category (for

example, research on infectious diseases) on the 805 projects in the 1996

database. We reviewed all the projects in three animal use categories

involving medical research—biological defense, combat casualty care, and

ionizing radiation. These categories comprise approximately 22 percent of

the 805 projects. We reviewed the summaries in these categories and

compared the information contained in them with other sources, including

DOD’s annual report to the Congress on its animal care and use programs

for 1996.

We interviewed officials from DOD’s Office of the Director of Defense for

Research and Engineering; the Armed Forces Radiobiology Research

Institute; the Uniformed Services University of the Health Sciences; the

Office for Naval Research; the Naval Medical Research Institute; and

Walter Reed Army Institute of Research in the Washington, D.C., area. We

also interviewed officials from the U.S. Army Medical Research and

Materiel Command in Frederick, Maryland; the Air Force Research

Laboratory and the U.S. Army Clinical Investigations Regulatory Office in

San Antonio, Texas; and the Army’s Landstuhl Regional Medical Center in

Landstuhl, Germany. We reviewed DOD documents and reports relevant to

animal care and use as well as related congressional reports.

Our review was not based on a random sample of records from the BRD

and, as a result, we have not drawn conclusions about the extent to which

certain of our observations are present in the database as a whole.

We conducted our review from October 1997 to October 1998 in

accordance with generally accepted government auditing standards.

As agreed with your office, unless you publicly announce its contents

earlier, we plan no further distribution of this report until 30 days from its

issue date. At that time, we will send copies of this report to other

interested congressional committees, the Secretary of Defense, and other

Page 7 GAO/NSIAD/HEHS-99-24 DOD Animal Research
B-278778 

interested parties. We will also make copies available to others upon

request.

Please contact us if you or your staff have questions concerning this

report. Kwai-Cheung Chan can be reached at (202) 512-3652. Stephen

Backhus can be reached at (202) 512-7101. Other major contributors are

listed in appendix II.

Kwai-Cheung Chan, Director

Special Studies and Evaluations

National Security and International Affairs Division

Stephen P. Backhus, Director

Veterans’ Affairs and Military Health Care Issues

Health, Education, and Human Systems Division

Page 8 GAO/NSIAD/HEHS-99-24 DOD Animal Research
Page 9 GAO/NSIAD/HEHS-99-24 DOD Animal Research
Appendix I 

Comments From the Department of Defense

Page 10 GAO/NSIAD/HEHS-99-24 DOD Animal Research
Appendix I 

Comments From the Department of Defense

Now on p. 5.

Page 11 GAO/NSIAD/HEHS-99-24 DOD Animal Research
Appendix I 

Comments From the Department of Defense

Now on p. 5.

Page 12 GAO/NSIAD/HEHS-99-24 DOD Animal Research
Appendix II 

Major Contributors to This Report

National Security and

International Affairs

Division, Washington,

D.C.

John Oppenheim, Assistant Director

Dan Engelberg, Senior Evaluator

Cary Russell, Senior Evaluator

Health, Education,

and Human Services

Division, Washington,

D.C.

Bruce D. Layton, Assistant Director

Jaqueline Arroyo, Senior Evaluator

Greg Whitney, Evaluator

(713013) Page 13 GAO/NSIAD/HEHS-99-24 DOD Animal Research
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