Newsletter 2011/1
1
Editorial
The EUREC secretariat is
located at the German Ref-
erence Centre for Ethics in
the Life Sciences (DRZE),
which is a central institution
of the University of Bonn.
The secretariat acts as the
responsible coordinator for
the EURECNET project which
started in March 2011. It is
based on the results of a
previous project EUREC
(2006 – 2010) coordinated
by the University of Lyon
and will continue its net-
working process.
Apart from coordinating the
overall project and managing
the communication of the
project partners with the
European Commission it is
responsible for providing the
project’s interim and final
results to the public, e.g. by
circulating an Electronic
Newsletter
Content
p. 1: Article
p. 2: Imprint
p. 3: Project News
Publications by
EUREC-Members
p. 4: Upcoming Conferences
p. 5: Acquisitions
Article
EUREC
A European Representation of
National Networks of Re-
search Ethics Committees
by Elmar Doppelfeld
Just like other kinds of research,
medical research is increasingly
often carried out in transnational
settings today. As part of this pro-
cess the aims and methods of
medical research became widely
standardized, especially during the
last decade. This applies not least
to clinical trials aiming at the de-
velopment of new drugs and me-
dicinal products. Nowadays, the
various players on international
research are represented by vari-
ous interests groups which act on
the national, European and inter-
national level.
There is broad national as well as
international consent that certain
fundamental ethical principles
must be observed in the conduct
of medical research. These include
the respect for self-determination,
protection against harm as well as
of discrimination and other forms
of unfair treatment. The principles
are implemented both into na-
tional laws and into non-binding
provisions, so called ‘soft laws’.
National authorities and in par-
ticular research ethics commit-
tees (RECs) are responsible for
the adherence to these princi-
ples by a given research project.
Their ability to fulfil this task can
be challenged by difficulties
linked to different religious and
cultural traditions and the na-
tional legal system as well as
prominent moral attitudes within
the state or region where the
research shall be conducted.
In order to harmonize clinical
drug trials at least on a Euro-
pean level, the European Union
has issued the Directive
2001/20/EC binding its 27 Mem-
ber States. The Directive re-
quires the establishment of na-
tional research ethics commit-
tees. Details of their functioning,
their competences, their admin-
istrative position and regulation
are left to the Member States
and only a small number of
common principles have been
made compulsory. One such
principle is that any kind of clini-
cal drug trial needs the approval
by the responsible research eth-
ics committee. In addition the
Directive enumerates the inter-
national broadly accepted ethical
principles, such as the principles
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