Ch. 15— Institutional and Self-Regulation of Animal Use • 341 
e According to NIH, approximately 26 percent of 
e j existing animal care and use committees review 
t- research protocols (25). Under the new PHS pol- 
d icy, all IACUCs will be required to approve all sec- 
il tions of each research protocol that involves ani- 
0 mals . Some committees have established a system 
> of expedited review where only protocols that raise 
- questions regarding pain and suffering are con- 
1 sidered by the full committee. More innocuous 
projects are reviewed perfunctorily by smaller sub - 
i, j committees . Rating scales have been established 
s |! for expedited reviews . One suggestion of such a 
scale has five categories, detailing a range of de- 
s gree of harm inflicted on animals. This proposal, 
f already in place in some form in a number of insti- 
tutions, is designed to provide a calculus so that 
"ethical risks” can be weighed against "the benefit 
, in terms of improvement of animal or human 
i health or other societal good” (27). Other commit- 
tees have a bifurcated review, with parallel proc- 
] esses for considering animal care and ethical is- 
sues (32). 
In a broad sense, animal welfare concerns are 
by definition inextricably intertwined with scien- 
tific issues. The threshold question of the validity 
of an animal model approach and the possible avail- 
ability of alternatives is followed closely by ques- 
tions of the efficiency of animal use . Is the smallest 
number of animals of an appropriate species be- 
ing used? Would a more sophisticated statistical 
methodology assure this is the case? Are genetic 
variables manipulated to the extent necessary? Will 
the data generated by the experiment be under- 
1 stood and of use to other scientists? Does the re- 
search answer an important question and has the 
researcher made sure it does not unintentionally 
duplicate already published work? Is the research- 
er qualified to undertake the project? These are 
among the questions that raise twin concerns of 
scientific and ethical appropriateness. 
The dual nature of the scientific and care review 
issues were the focus of remarks by one commit- 
tee proponent (20): 
Concern for the reduction or elimination of pain 
is inseparable from consideration of the poten- 
tial scientific value or the benefits to humankind 
to be derived from the work . . . Decisions about, 
for example, the species and number of animals 
to be used, or the necessity for particular inva- 
sive procedures, simply cannot be made intelli- 
gently without reference to the scientific value 
of the work; or without an understanding of the 
scientific discipline represented in the proposal. 
Research of inferior quality should not be done 
on any species, regardless of how humanely it 
is done. Concern for humane treatment of ani- 
mals is not only consistent with good science, but 
augments its quality by assuring us of well-main- 
tained and nourished animals that are behavior- 
ally comfortable. 
Many people feel that the IACUC is not qualified 
to judge the science or "scientific merit” of an ex- 
periment. Yet, it may be impossible to discuss ani- 
mal care and use issues without some discussion 
of the science involved. How does an IACUC draw 
the line between discussing and approving the ani- 
mal care and use issues and the scientific merit, 
feasibility, and potential scientific gain of a par- 
ticular experiment? Depending on the member- 
ship of a particular committee or the institution 
itself, science issues may or may not be addressed 
in the approval process. This may lead to an in- 
consistent system : A proposal that might be modi- 
fied in one IACUC could be approved in a differ- 
ent committee depending on whether only animal 
care and use issues were addressed. 
In addition to the above functions, animal care 
and use committees can also play an educational 
role. The process by which investigators justify 
their research can be an educational one and the 
committee can also be used to teach the research 
community as a whole. The availability of alterna- 
tives, ways to avoid unintentional duplication, and 
amelioration of pain are all subjects the commit- 
tee can discuss. Some committees also monitor ani- 
mal welfare legislation and advise institutional offi- 
cials about pending State and Federal initiatives. 
Financial and Procedural Issues 
A number of questions about how committees 
operate involve "housekeeping” details that, as a 
practical matter, may be as important as substan- 
tive concerns. The operation of the committee in 
terms of recordkeeping and voting has important 
implications. Whether it operates on a consensus 
or majority vote may determine how much influ- 
ence unaffiliated members have. In addition, some 
committees have provisions for investigators to 
