1276 
THE USE OF ANIMALS IN MEDICAL RESEARCH AND EXPERIMENTATION 
ministrative policy. It is not law, but again since 
it's tied to grant and contract funds I'm sure 
that it's almost as effective as if it were a law. 
The present NIH policy we're talking about 
tonight was published round the middle of June 
of last year. I'm sure that most of you have seen 
it or at least somebody in your institution has, 
and most of them have replied to us. In essence, 
it requires your institution, if you use signifi- 
cant numbers of the six species the USDA law 
speaks of, to select one or another of two dif- 
ferent courses to assure NIH that you're pre- 
pared to use proper standards and methods in 
dealing with laboratory animals. You can either 
seek and get accreditation by a national ac- 
crediting body, of which there is only one that 
we know and that's the American Association 
for Accreditation of Laboratory Animal Care, 
or you can set up a committee in your own 
institution composed of at least three members, 
at least one of whom has a Doctor of Veteri- 
nary Medicine degree, to oversee your activities 
with these six species that are covered. This 
would really involve all aspects of what is done 
with these animals, so that it's quite possible 
that these institutional committees could get 
into the business of knowing something about 
the man's research protocol and calling it to 
question if they feel that it is out of line with 
recognized humane requirements or expecta- 
tions. 
We have had many inquiries from institu- 
tions "Where we are, w^e have to license our- 
selves with the USDA. Does this not suffice?" 
The answ^er is no, it does not suffice. This is not 
a licensing requirement. It is a requirement for 
accreditation and self-examinations by the in- 
stitution. Other institutions have asked us, 
"Well, we're in a state that has a state law that 
requires us to be inspected periodically and 
certified by, say, the Department of Health of 
the state. Does this not suffice?" Again, the 
answer is no. Our requirement is quite different 
from this. It does not pertain to inspection and 
licensing or certification. It expects either ac- 
creditation by a nationally recognized body or 
ongoing overview by a faculty or institutional 
committee, including a Doctor of Veterinary 
Medicine. Frankly, in some cases when we have 
dealt with institutions in an intellectually and 
geographically isolated area, we have had to 
think long and hard about the possibility of 
waiving the requirement for a Doctor of Veter- 
inary Medicine. Not in many, but in some cases, 
I'm sure it's been possible for them to convince 
us that a Ph.D. in physiology or something like 
that with eight years of experience in using 
animals, in that particular place, might be 
preferable to the DVM down the way who's in 
farm animal practice, whom they could get in 
if they wanted, but whom they'd have to pay 
a fee, and where does the money come. So, we 
have tried to be reasonable. This is something 
that most large institutions have been able to 
comply with without any trouble. 
To date, we have heard from 1,700 institu- 
tions. There are a few notable exceptions. We 
pointed out that it was desirable to have heard 
from you before January 1, 1972, in some fa.sh- 
ion, either "no you don't use these animals," or 
"yes" you do; you've got AAALAC accredita- 
tion or you've got a faculty committee. We are 
in the process now of preparing a list of institu- 
tions that we have had satisfactory responses 
from and this list will be distributed to all NIH 
programs, and they will be required to look at 
this list before they award a grant concerning 
the use of laboratory animals. The policy doesn't 
go beyond that. It doesn't tell them that they 
must not award that grant simply because the 
institution is not listed, but it would certainly 
have a bearing on a project on which a Study 
Section or Council raised any questions of ethics 
or any questions about how these animals are 
going to be dealt with. I think it would be to the 
benefit of all institutions if you would find out 
whether your institution has responded to this 
inquiry. We've put out at least two communica- 
tions on it, including the NIH Guide issuance. 
I think a word about the possible future is 
appropriate, too, because this will certainly 
have a bearing on your response to NIH. At 
the moment our office is busily working on a 
redraft of this policy that will expand it and 
make it applicable to all agencies in DHEW. It 
will have the chief effect of bringing in cer- 
tain other DHEW entities like the National 
Institutes of Mental Health and the Food and 
Drug Administration that are not covered now, 
where there is a significant amount of animal 
