134
These issues are not unique, of course, to Lithuania and other transition
societies, however, they might have a greater impact in the countries with
more recent democratic traditions and transitional economies.
How to establish de facto independent system of ethical
review?
European RECs are very different in respect to their composition, account-
ability and representation. The international guidelines are usually setting
very broad and general guidelines of what RECs should be mainly stating
three general principles: multidisciplinarity, pluralism and independence
(4)
.
Running a certain risk of overgeneralization we could probably distinguish
between two most general models of RECs: institutional (based on a particu-
lar research institution) and regional (representing a particular administrative
region rather than a particular research institution). Institutional RECs rep-
resent the most prevalent model in both Europe and the USA where they are
called Institutional Review Boards. Regional RECs have been established in
some parts of Europe, for example, in the Nordic countries and the UK. The
diversity of RECs models and variety of ethical review systems could also be
seen in the Baltic States. Although the Baltic States are relatively small and
similar in socioeconomic characteristics, they have developed rather different
models of ethical review. Estonia has chosen the simplest system of ethical
review with two RECs established at two main medical research institutions
of the country. Lithuania has developed a two tier system of ethical review
that includes the National Bioethics Committee issuing approvals for mul-
ticenter biomedical research studies and two regional RECs. Latvia followed
the most diverse path establishing 9 different RECs that vary both in their
institutional affiliation and types of protocols reviewed. An interesting ex-
ample is Czech Republic which established 9 Regional RECs for multicenter
clinical drug trials while also having a parallel system of 100 so-called local
RECs established at particular research institution
(8)
.
The most important question which we would like to raise in the context
of our discussion deals with the independence of institutional RECs. How
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