App. C— Public Health Service Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions • 397 
OPRR with the Assurance. Annual reports of 
the IACUC evaluation shall be maintained by 
the institution and made available to OPRR 
upon request. The report must contain a 
description of the nature and extent of the in- 
stitution's adherence to the Guide and this pol- 
icy. 4 The report must identify specifically any 
departures from provisions of the Guide and 
this policy, and state the reasons for each 
departure. If program or facility deficiencies 
are noted, the report must contain a reason- 
able and specific plan and schedule for cor- 
recting each deficiency. The report must dis- 
tinguish significant deficiencies from minor 
deficiencies. A significant deficiency is one 
which, in the judgment of the IACUC and the 
institutional official, is or may be a threat to 
the health or safety of the animals. Failure of 
the IACUC to conduct an annual evaluation 
and submit the required report to the institu- 
tional official may result in PHS withdrawal 
of its approval of the Assurance. 
3. Institutional Animal Care and Use Committee 
(IACUC) 
a. Each institution shall appoint an Institutional 
Animal Care and Use Committee (IACUC), 
qualified through the experience and exper- 
tise of its members to oversee the institution’s 
animal program, facilities and procedures. 
b. The Assurance must include the names, posi- 
tion titles and credentials of the IACUC chair- 
person and the members. The committee shall 
consist of not less than five members, and shall 
include at least: 
(Done Doctor of Veterinary Medicine, with 
training or experience in laboratory animal 
science and medicine, who has direct or 
delegated program responsibility for activ- 
ities involving animals at the institution; 
(2) one practicing scientist experienced in re- 
search involving animals; 
(3) One member whose primary concerns are 
in a nonscientific area (for example, ethi- 
cist, lawyer, member of the clergy); and 
(4) one individual who is not affiliated with the 
institution in any way other than as a mem- 
ber of the IACUC, and is not a member of 
the immediate family of a person who is af- 
filiated with the institution. 
c. An individual who meets the requirements of 
more than one of the categories detailed in 
4 If some of the institution's facilities are accredited by AAALAC or other 
accrediting body recognized by PHS, the report should identify those facil- 
ities and need not contain any further information about evaluation of those 
facilities. 
IV.A.3.b.(l)-(4) may fulfill more than one re- 
quirement. However, no committee may con- 
sist of less than five members. 
B. Functions of the Institutional Animal Care and Use 
Committee 
As an agent of the institution the IACUC shall, 
with respect to PHS-supported activities: 
1. review at least annually the institution’s program 
for humane care and use of animals; 
2. inspect at least annually all of the institution’s 
animal facilities, including satellite facilities; 
3. review concerns involving the care and use of 
animals at the institution; 
4. make recommendations to the institutional offi- 
cial regarding any aspect of the institution’s ani- 
mal program, facilities or personnel training; 
5. review and approve, require modifications in (to 
secure approval) or withhold approval of those 
sections of PHS applications or proposals related 
to the care and use of animals as specified in 
IV.C.; 
6. review and approve, require modifications in (to 
secure approval), or withhold approval of pro- 
posed significant changes regarding the use of 
animals in ongoing activities; and 
7. be authorized to suspend an activity involving 
animals in accord with specifications set forth 
in IV.C. 5. 
C. Review of PHS Applications and Proposals 
1. In order to approve applications and proposals 
or proposed significant changes in ongoing activ- 
ities, the IACUC shall conduct a review of those 
sections related to the care and use of animals 
and determine that the proposed activities are 
in accord with this policy. In making this deter- 
mination, the IACUC shall confirm that the activ- 
ity will be conducted in accord with the Animal 
Welfare Act insofar as it applies to the activity, 
and that the activity is consistent with the Guide 
unless acceptable justification for a departure is 
presented. Further, the IACUC shall determine 
that the activity conforms with the institution’s 
Assurance and meets the following requirements: 
a. Procedures with animals will avoid or mini- 
mize discomfort, distress and pain to the ani- 
mals, consistent with sound research design. 
b. Procedures that may cause more than momen- 
tary or slight pain or distress to the animals 
will be performed with appropriate sedation, 
analgesia, or anesthesia, unless the procedure 
is justified for scientific reasons in writing bv 
the investigator. 
c. Animals that would otherwise experience se- 
vere or chronic pain or distress that cannot 
be relieved will be painlessly sacrificed at the 
