Last update on June 2019
The
GSEA provides support to research teams working in the in
vivo
experimentation platforms within the framework of research carried
out at IRSN on the biological effects of ionizing radiation. Its goal
is to ensure researches are performed in compliance with regulations
and ethical principles.
Background and purpose
Research
on the effects of ionizing radiation on human health still requires
in
vivo
studies. Especially for studying the response of the organism as a
whole and understanding the complex mechanisms involved in the
biological effects. To do so, there are currently no viable
alternative methods.
The
use of animals in research is strictly regulated by French and
European regulations. Other guidelines and best practices, promoting
ethical principles also apply. At IRSN, the GSEA ensures compliance
with all these obligations and provides a dedicated support for
research teams performing in
vivo
projects.
The
GSEA is responsible for:
- managing all resources related to in
vivo research:
sourcing, supplies, supervision of health and environmental
conditions, use and maintenance of equipment and facilities;
- ensuring animal welfare before, during and after all experiments;
- advising research teams on all aspects relating to animal research;
- being involved in research projects by providing expert knowledge and
advice on biological models;
- ensuring compliance with the regulations;
- maintaining a quality management system in accordance with IRSN
standards.
Supervising research
The
GSEA does not conduct its own research projects, but provides support
and expertise for projects carried out by IRSN's Human
Health and Environment
research units.
The
ethical and responsible use of animals is based on the application of
fundamental principles, called the 3Rs, which are applied worldwide.
Developed in 1959 by two British researchers, William
Moy Stratton Russell
and Rex Leonard Burch, the 3Rs are central to the ethical approach
underlying all in
vivo research
projects:
- Reduce the number of animals used in research;
- Replace in
vivo
models with alternative methods (in
vitro,
in
silico,
etc.) wherever possible;
- Refine the procedures with a view to protecting the animal’s
welfare as far as possible.
The
GSEA helps ensuring compliance with these principles, together with
the respect of the national 'charter' on the ethical use of
laboratory animals, as well as supervising research teams and
technicians in their application of the following obligations:
- to comply with the principles underlying the ethical use of animals,
since animals are sentient beings,
- to provide a suitable environment for the animals in the facilities
used to accommodate them,
- to treat the animals with all the respect and consideration they
deserve,
- to call in the so called designated veterinarian when necessary to
check, aid or treat the animals,
- to report any failure to comply with or violation of the regulations
relative to animal welfare,
- to propose, if desired, any changes that would improve animal welfare
and well-being.
To
achieve this, IRSN has set up two entities:
- The
Animal Experimentation Ethics Committee (C2EA-IRSN)
Created
in 1998, this Committee was registered and approved in 2012 by the
French Ministry for Research, and has adopted the principles set out
in France's National
charter on the ethics of animal experimentation (in French). Its members
include not only people working at IRSN, but also external members.
They provide support, advice and expertise to researchers on all
aspects of the ethical use of animals in the projects submitted for
assessment.
All
projects requiring the use of in
vivo
models are subject to prior authorization by the French Ministry for
Higher Education and Research, and the Ministry calls on the
C2EA-IRSN committee to assess the ethical aspects of each project.
For each application, the researchers submit a prospective assessment
of the suffering involved and whether that can be justified by the
expected benefits of their research. They can consult with the
designated veterinarian of the IRSN, who is also the head of the
GSEA. The C2EA-IRSN assesses whether or not IRSN projects comply with
the principles of ethical animal experimentation.
This
committee is also involved in promoting awareness of ethics in animal
research at the Institute.
- Animal-Welfare
bodies (AWB or SCBEA in French)
Two
AWB have been created, one for the Fontenay-aux-Roses site
(SCBEA-FAR) and the other for the Cadarache site (SCBEA-CAD). They
are responsible for supporting researchers using in
vivo
procedures as part of their research projects (follow-up of projects,
areas for improvement, technical support, etc.).
Equipment and methods
The
GSEA is in charge of two
in vivo
experimentation platforms at the Fontenay-aux-Roses site. The first
is used for testing external exposure to ionizing radiation, while
the second focuses on internal radionuclide contamination (PARISII).
Both these platforms conform to the new standards introduced by
Directive 2010/63/EU (standards relating to accommodation facilities,
reviews of project ethics, application of the 3Rs, SCBEA, daily
monitoring, etc.).
The
GSEA also provides its expertise to the teams based at Cadarache
regarding ecotoxicology models.
Partners and networks
IRSN
is a member of GIRCOR
(interprofessional group for discussion and communication on research
in relation to animal experimentation) and the Grice
(interprofessional group for discussion on ethics committees in
relation to animal experimentation).
The
GSEA team plays an active role in various professional associations
and networks working in the field of laboratory animal science and
ethics:
- The
ComEt IDF network,
- The
Celphedia (creation, breeding, phenotyping, distribution and
archiving of model organisms) working group on ethics,
- Afstal
(French association of laboratory animal science and techniques),
- ESLAV
(European
Society of Laboratory Animal Veterinarians).
IRSN's
designated veterinarian, who heads the GSEA team, is also a member of
the AAALAC International
Council
on Accreditation –
European section 