DOD Animal Research: Improvements Needed in Quality of Biomedical
Research Database (Letter Report, 12/14/98, GAO/NSIAD/HEHS-99-24).

Members of Congress raised concerns in 1992 about the lack of disclosure
about the military's use of animals in research. In response, the
Defense Department (DOD) began submitting annual reports to Congress in
1994. The following year, DOD established the Biomedical Research
Database, which contains information on research projects and training
programs involving animals being conducted by its laboratories, military
hospitals and bases, and contractors. GAO found that the database has
improved public access to information about DOD's use of animals in its
research activities. However, GAO also found instances in which the
information in the database was inaccurate, incomplete, and
inconsistent. Although GAO did not identify the full extent of these
problems, the problems GAO identified suggest that DOD needs to improve
the accuracy and extent of the information in the database.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  NSIAD/HEHS-99-24
     TITLE:  DOD Animal Research: Improvements Needed in Quality of 
             Biomedical Research Database
      DATE:  12/14/98
   SUBJECT:  Biomedical research
             Data bases
             Data integrity
             Experimental animals
             Research programs
             Government information
             Reporting requirements
             Military research and development
IDENTIFIER:  DOD Biomedical Research Database
             
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Cover
================================================================ COVER


Report to Congressional Committees

December 1998

DOD ANIMAL RESEARCH - IMPROVEMENTS
NEEDED IN QUALITY OF BIOMEDICAL
RESEARCH DATABASE

GAO/NSIAD/HEHS-99-24

DOD Animal Research

(713013)


Abbreviations
=============================================================== ABBREV

  BRD - Biomedical Research Database
  DOD - Department of Defense
  DTIC - Defense Technology Information Center

Letter
=============================================================== LETTER


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
------------------------------------------------------------ Letter :1

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
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
------------------------------------------------------------ Letter :2

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 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. 


--------------------
\1 H.R.  Rept.  No.  102-527. 


   DOD HAS CREATED A PUBLICLY
   AVAILABLE DATABASE ON ITS
   ANIMAL RESEARCH PROGRAMS
------------------------------------------------------------ Letter :3

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
------------------------------------------------------------ Letter :4

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 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 categories\2 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 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. 


--------------------
\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. 


   RECOMMENDATIONS
------------------------------------------------------------ Letter :5

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. 


   AGENCY COMMENTS
------------------------------------------------------------ Letter :6

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
------------------------------------------------------------ Letter :7

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 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. 


---------------------------------------------------------- Letter :7.1

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 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




(See figure in printed edition.)Appendix I
COMMENTS FROM THE DEPARTMENT OF
DEFENSE
============================================================== Letter 



(See figure in printed edition.)



(See figure in printed edition.)


MAJOR CONTRIBUTORS TO THIS REPORT
========================================================== Appendix II


   NATIONAL SECURITY AND
   INTERNATIONAL AFFAIRS DIVISION,
   WASHINGTON, D.C. 
-------------------------------------------------------- Appendix II:1

John Oppenheim, Assistant Director
Dan Engelberg, Senior Evaluator
Cary Russell, Senior Evaluator


   HEALTH, EDUCATION, AND HUMAN
   SERVICES DIVISION, WASHINGTON,
   D.C. 
-------------------------------------------------------- Appendix II:2

Bruce D.  Layton, Assistant Director
Jaqueline Arroyo, Senior Evaluator
Greg Whitney, Evaluator


*** End of document. ***