Chapter 15 
Institutional and Self- Regulation 
of Animal Use 
The most important check on the proper treat- 
ment of animals is the conscience of the individ- 
ual investigator (23). A person's view about ani- 
mal welfare is influenced by many forces; some 
of the most formidable include exposure to pro- 
fessional peers, mentors, and formal course work 
on animal care or the ethics of animal experimen- 
tation. 
Beyond individual conscience, the most visible 
means of self -regulation is institutional commit- 
tee review of animal care and use. The use of ani- 
mals is also overseen by the peer review of scien- 
tific colleagues and others outside of the research 
facility— an important part of the grants adminis- 
tration process. 
In addition, most scientists are members of one 
or more professional associations, some of which 
have codes of ethics for research with animal sub- 
jects. These statements of principles can serve to 
inspire ethical behavior and alert researchers to 
etnical issues raised by their work. Codes can some- 
times provide advice on specific cases and sanc- 
tions for violations (reviewed in ref. 21). 
REVIEW OF ANIMAL CARE AND USE 
All research supported by the Public Health Serv- 
ice (PHS), including that of the National Institutes 
of Health (NIH), is subject to the provisions of the 
PHS Policy on Humane Care and Use of Labora- 
tory Animals by Awardee Institutions (revision ef- 
fective Dec. 31, 1985) (44). Each institution so 
funded must submit an acceptable assurance to 
NIH’s Office for Protection from Research Risks 
(OPRR) that commits the facility to active promo- 
tion of compliance with the policy and the NIH 
Guide for the Care and Use of Laboratory Animals 
(42). 
The NIH peer-review system can be construed 
as external rather than self -regulation (46). Site 
visits to determine compliance can occur, and fund- 
ing can be terminated for lack of compliance with 
contractual assurances, as happened in the Taub 
case (see ch. 14). In the broadest sense, however, 
NIH is fully dependent on grant recipients for ef- 
fective policing of its provisions. 
The enactment in 1985 of Public Law 99-158 (see 
ch. 13) provided statutory authority and recogni- 
tion for some provisions of the PHS policy , requir- 
ing, for example, all entities conducting research 
with PHS funds to organize and operate institu- 
tional animal care and use committees. Also in 
1985, amendments to the Animal Welfare Act (see 
ch. 13) extended the mandate for institutional com- 
mittee oversight to research facilities covered by 
the Animal Welfare Act and to Federal research 
facilities. 
NIH Assurance Review 
To test the operation of written assurances of 
compliance with the PHS policy regarding humane 
care and treatment of experimental animals by in- 
vestigators in the field, and perhaps in response 
to congressional and public pressure, the NIH Of- 
fice of Extramural Research and Training in 1983 
conducted site visits to 10 grantee facilities (43). 
These institutions were chosen from a stratified 
sample of the more than 800 awardees with gen- 
eral assurances on file at the NIH Office for Pro- 
tection from Research Risks. 
The 10 institutions were distributed among those 
receiving more than $10 million in annual support 
from NIH (3 institutions), between $5 million and 
$10 million (3 institutions), and less than $5 mil- 
lion (4 institutions). The sample was further de- 
fined by selecting institutions from each of those 
categories with valid written assurances on file 
335 
