338 • Alternatives to Animal Use in Research, Testing, and Education 
cations for any departures from the policy. Defi- 
ciencies in an institution’s program or facilities 
must be reported to NIH and the institution must 
adhere to an approved time frame for correction 
of the deficiencies. 
The animal care and use committee required by 
the new PHS policy is specifically structured to 
consist of at least five members including: 
. . . one Doctor of Veterinary Medicine with train- 
ing or experience in laboratory animal medicine , 
one practicing scientist experienced in research 
involving animals, one member whose primary 
concerns are in a nonscientific area, and one in- 
dividual who is not affiliated with the institution 
in any way other than as a member of the IACUC . 
New duties of this committee include reviewing 
the institution’s program for animal care and use 
and inspecting the facilities (including satellites) 
at least annually. The policy also authorizes the 
IACUC to suspend any activity involving animals 
that is found to not be in compliance with the 
policy. 
A new power of the IACUC is to “review and 
approve, require modifications in (to secure ap- 
proval), or withhold approval of those sections of 
PHS applications or proposals related to the care 
and use of animals.” The policy gives a detailed 
plan for the administrative structure to handle this 
task, along with certain specific animal care re- 
quirements that must be met by each proposal (e .g . , 
minimization of discomfort of animals). Each ap- 
plication or proposal submitted to PHS must ver- 
ify that the IACUC has approved those sections 
of the proposal related to the care and use of lab- 
oratory animals. It should be submitted along with 
the application but may be sent directly to the ex- 
ecutive secretary of the initial review group within 
60 days of the original submission. Figure 15-1 is 
the example NIH provides of an acceptable verifi- 
cation letter for a proposal. The letter must be 
signed either by the institutional official who signed 
the institution’s Animal Welfare Assurance or by 
another individual authorized by the institution 
to provide verification of IACUC approval. 
The PHS policy is implemented by the NIH's Of- 
fice for Protection from Research Risks, which is 
responsible for approving, disapproving, or with- 
drawing approval of institutional assurances. It 
also has the power to evaluate allegations of non- 
compliance with the policy and to conduct site visits 
to selected institutions to check for proper imple- 
mentation of the policy. 
The new PHS policy differs from the 1979 ver- 
sion in the following ways: 
• Institutions are required to designate clear 
lines of authority and responsibility for those 
involved in animal care and use in PHS-sup- 
ported projects, including an institutional of- 
ficer responsible for the entire program. 
• The role and responsibilities of the IACUC 
have been upgraded. The requirements of spe- 
cific types of committee members (e.g., a mem- 
ber unaffiliated with the institution or a mem- 
ber in a nonscientific area) are new, as is the 
policy that these committees review and ap- 
prove those sections of research applications 
for PHS funding that relate to the care and 
use of animals before they are actually funded. 
• If an institution is not AAALAC-accredited, 
stringent standards for self-assurances apply 
and more information about animal facilities 
must be made available to NIH. 
• Following the policy is mandatory, as opposed 
to the earlier “commitment to comply.” 
%/• Recordkeeping requirements for institutions 
are explicitly addressed. Records of IACUC 
meeting deliberations, assurance forms, ac- 
crediting body determinations, and so forth 
must be maintained for 3 years and made 
accessible for inspection to PHS officials. 
• OPRR has power to “evaluate allegations of 
noncompliance with the policy [and] . . . con- 
duct site visits to selected institutions.” 
In general, the Public Health Service now has 
a much more structured animal welfare policy that 
specifically designates what individual institutions 
must do in order to achieve satisfactory compli- 
ance. The old policy had many of the same struc- 
tures (e.g., institutional committees and assurances) 
but in a form that allowed different degrees of in- 
stitutional animal care and treatment responsibil- 
ity. The new policy defines a minimum standard 
animal care and use policy for an institution that 
wishes to obtain PHS funding. In 1979, OPRR re- 
leased a sample assurance that was two pages long 
and only required a few specifics from the insti- 
