Biomedical Engineering Reference
In-Depth Information
document must include organizational structure and lines
of authority; qualifications of the veterinarian; composition
of the IACUC; employee occupational health and training
programs; an animal facility description; and animal census
information.
Each research facility must establish at least one
IACUC appointed by the chief executive officer. The PHS
Policy requires that the committee must be composed of at
least five members (a veterinarian, a scientist experienced
with animal research, a nonscientist, a member unaffiliated
with the facility, and at least one other member). IACUC
responsibilities include reviewing all proposed and ongoing
activities involving animals, approving all experimental
animal studies, advising senior institutional officials about
research animal issues, conducting semiannual evaluations
of all animal facilities and programs, and providing detailed
record keeping and reporting documents.
Institutions receiving PHS funding that are also
accredited by AAALAC International are released from the
obligation to submit a copy of the most recent semiannual
report of the IACUC evaluations to OLAW with the Insti-
tution's Assurance, thereby removing this document from
any potential public information request received by
OLAW. A failure of the institution to comply with the terms
and policy conditions of their assurance may result in
sanctions including the termination of PHS fiscal support
for all projects involving animals.
Under the PHS Policy, training of scientists, animal
technicians, and other personnel involved with animal care
must be provided by the institution. The training program
should include: (1) humane techniques of animal care and
use; and (2) techniques that minimize “the number of
animals required to obtain valid results and minimize
animal distress.”
OLAW has developed and continues to add to a very
informative list of OLAW Frequently Asked Questions
(
http://grants.nih.gov/grants/olaw/faqs.htm
) that assist
Assured institutions in understanding OLAW expectations
in fully implementing the PHS Policy.
indispensability of a specific chimpanzee and the critical
nature of the research is accepted); provisions regarding the
housing of the chimpanzees; provisions regarding the
behavioral well-being of the chimpanzees; the requirement
that the chimpanzees be cared for in accordance with the
AWA; the chimpanzees be prevented from breeding;
the requirement that complete histories be maintained on
the health and use in research of the chimpanzees; the
chimpanzees must be monitored for the purpose of
promptly detecting any condition that may be a threat to the
public health or the health of other chimpanzees; steps to
contain such a disease threat; none of the chimpanzees may
be subjected to euthanasia, except in the best interests of the
chimpanzee involved, as determined by the system and an
attending veterinarian; and the chimpanzees may not be
discharged from the system.
Europe
The use of animals in scientific procedures in Europe is
covered by two overlapping legal instruments that for
around 25 years have been very similar. The first is the
European Convention for the Protection of Vertebrate
Animals used for Experimental and other Scientific
Purposes (also known as ETS 123), (
http://conventions.
coe.int/Treaty/en/Treaties/html/123.htm
), and the second
is the European Union's Council Directive on the
Approximation of Laws, Regulations and Administrative
Provisions of the Member States Regarding the Protection
of Animals Used for Experimental and Other Scientific
Purposes
EU 2010/63 (Directive) (
http://eur-lex.europa.
eu/LexUriServ/LexUriServ.do?uri
e
¼
OJ:L:2010:276:0033:
0079:EN:PDF
).
The standards in animal care and husbandry listed in
Appendix A of the Convention have been reviewed over
recent years as part of the Multilateral Consultation of
Parties to the Convention and the Parties to the Convention
ratified an updated Appendix A in June 2006 (
http://
conventions.coe.int/Treaty/EN/Treaties/PDF/123-Arev.pdf
).
The changes from the previous versions were considerable,
with much greater emphasis on the quality of the envi-
ronment and accommodation because of its potential to
affect animal well-being. For some species, particularly
nonhuman primates, enclosure sizes were increased
considerably (
Federation of European Laboratory Animal
Science Associations, 2007
). In June 2007 European
Commission Recommendation (2007 526 EC)
Specific Controls on the Use of Chimpanzees
The Chimpanzee Health Improvement, Maintenance, and
Protection Act (
http://history.nih.gov/research/downloads/
PL106-551.pdf
), passed in 2000, established a national
sanctuary system for federally owned or supported chim-
panzees no longer needed for research. The sanctuary
system is operated by a nonprofit private entity with
appropriate expertise under contract with the NIH, under
standards established by the Secretary of the Department of
Health and Human Services and meeting the criteria
established in the Act. Key stipulations of the Act include:
the chimpanzees may not be used for research (unless
extremely stringent criteria are met concerning the
(
http://
eur-lex.europa.eu/JOHtml.do?uri
OJ:L:2007:197:SOM:EN:
HTML
) replaced the existing Annex II guidance in the
Directive, with new guidelines aligned to the revised
Appendix A of the Convention on accommodation and care
of laboratory animals.
Appendix A of ETS 123 contains species-specific
provisions
¼
for nonhuman primates based on their
