336 • Alternatives to Animal Use in Research, Testing, and Education 
but lacking accreditation by the American Asso- 
ciation for Accreditation of Laboratory Animal 
Care (AAALAC). Awardee institutions were noti- 
fied of the prospective visits by publication of the 
selection criteria and the site names (43), and the 
NIH chairperson notified the appropriate institu- 
tional representative(s) at least 1 month prior to 
the scheduled visit. 
Site-visit team size depended on the size of the 
institution and the complexity of its physical facil- 
ities. At a minimum, teams consisted of a veterinar- 
ian, a biological scientist engaged in research using 
animals, and an NIH scientist/administrator. In 
addition, non-Federal consultants were included 
“with a view towards ensuring impartiality and 
enhancing expertise” (43). Between June and Sep- 
tember 1983, the 10 site visits were conducted to 
receive information and impressions in order to 
answer the following questions: 
• Is NIH’s current assurance system adequate 
for promoting the proper care and use of ani- 
mals involved in federally funded biomedical 
research? 
• If it is adequate, how can it be further im- 
proved? 
• If it is not adequate, what alternatives should 
be considered? 
The NIH site visits were generally criticized 
within the animal welfare community on three 
grounds: 
• 10 institutions may not represent a sizable 
enough sample to generate sufficiently repre- 
sentative data on which to base policy; 
• the 1 -month advance notification to the in- 
stitutions to be visited may have skewed the 
findings; and 
• too few smaller institutions were visited, since 
the majority of NIH -funded recipients fall into 
the unaccredited, less-than-$5-million category. 
Despite these potential shortcomings, information 
generated by the 10 site visits led NIH to draw con- 
clusions and make recommendations about the 
PHS policy regarding laboratory -animal welfare. 
In early 1984, NIH reported on the site visits (43). 
Based on the finding of these visits, two general 
conclusions were reached: 
• Reliance upon voluntary compliance with PHS 
policy and recommendations in the NIH Guide 
is a realistic approach to fostering proper care 
and use of laboratory animals in biomedical 
research. There is no reason to believe that 
regular NIH inspections are needed or would 
be more effective than the traditional assur- 
ance process. 
• The present assurance system should be 
strengthened by modifying the 1979 PHS pol- 
icy on animal welfare to promote more con- 
scientious involvement by both NIH and its 
awardee institutions. 
In addition, the report stated that “no incidents 
of animal abuse were observed” (43). 
From the findings of the site -visit teams , a series 
of recommendations concerning the adequacy of 
the current policy and its enforcement were made. 
The site-visit report recommended that NIH: 
• undertake a program for helping institutional 
officials, scientists, and responsible veterinar- 
ians “understand fully their responsibilities” 
for policy implementation; 
• expand the policy to include "more specific 
information regarding responsibilities of the 
institution that receives funds for research 
involving the use of animals," including new 
and more specific assurances to be negotiated 
with institutions receiving funds “carefully 
and promptly”; 
• modify the policy to define more precisely in- 
stitutional responsibilities, “particularly the 
role of the animal welfare committee,” to which 
the appointment of a nonscientist and a per- 
son unaffiliated with the institution should be 
given serious consideration; 
• conduct or sponsor a survey to assess whether 
the number of veterinarians trained in labora- 
tory-animal science is sufficient to meet the 
needs of institutions conducting biomedical 
research involving animals; and 
• conduct further assessments of the assurance 
process, including visiting more awardee in- 
stitutions receiving total annual support of less 
than $5 million, since that category of institu- 
tions is the largest with assurance statements 
on file (43). 
In response to the above recommendations and 
criticisms, five additional institutions receiving less 
than $5 million were visited in 1984. Using the same 
