Non-equivalent stringency of ethical review in the Baltic States: a sign of a systematic problem in Europe?: Figure 1

Abstract

We analyse the system of ethical review of human research in the Baltic States by introducing the principle of equivalent stringency of ethical review, that is, research projects imposing equal risks and inconveniences on research participants should be subjected to equally stringent review procedures. We examine several examples of non-equivalence or asymmetry in the system of ethical review of human research: (1) the asymmetry between rather strict regulations of clinical drug trials and relatively weaker regulations of other types of clinical biomedical research and (2) gaps in ethical review in the area of non-biomedical human research where some sensitive research projects are not reviewed by research ethics committees at all. We conclude that non-equivalent stringency of ethical review is at least partly linked to the differences in scope and binding character of various international legal instruments that have been shaping the system of ethical review in the Baltic States. Therefore, the Baltic example could also serve as an object lesson to other European countries which might be experiencing similar problems.

The system of ethical review of biomedical research in Lithuania: structure, peculiarities of functioning, ways of development

“…Это так называемая неэк-вивалентная строгость этичес-кой экспертизы [11]. Так, неко-торые типы исследований не подлежат этической эксперти-зе в Литве, хотя могут причи-нять значительный ущерб уча-стникам (например, некоторые социологические или психоло-гические эксперименты/иссле-дования).…”

“…При этом классификация их как безопас-ных и безвредных для челове-ка не всегда бесспорна и оправ-дана. Литовские специалисты говорят о том, что это может быть частично связано с раз-личиями в сфере международ-но-правовой регламентации КИ ЛС и других типов биомеди-цинских исследований, а си-стемы этической экспертизы в странах Балтии в общем и в Литве в частности были сфор-мированы именно на этих до-кументах [11].…”

“…Это, по их мнению, чревато возможны-ми нарушениями в защите прав, здоровья и достоинства пациен-тов, принимающих участие в та-ких типах исследований [7,11]. ВыВОДы В настоящее время в Литве функционирует двухуровневая система этической экспертизы биомедицинских исследований.…”

Research Ethics in the Context of Transition: Gaps in Policies and Programs on the Protection of Research Participants in the Selected Countries of Central and Eastern Europe

“…Therefore, the scope of research covered by ethical review in a particular country is an important characteristic of a research ethics policy, as it reflects the extent to which participants of research are protected from possible harm. At the moment, however, official policies in CEE countries require ethical review to be conducted only for research projects that take place within a healthcare context (Gefenas et al 2010). It means that a wide range of non-biomedical human studies, including sociological, anthropological and psychological research, do not fall within the scope of REC approval, irrespective to the level of risk they might generate.…”

A European consistency for functioning of RECs? We just lost our chance

“…Certainly, there are some doubts whether already existing member states’ assessments bodies work appropriately 5. Eugenijus Gefenas et al stressed that some RECs could function only as a ‘rubber stamp’ to legitimise research 6. Richard Ashcroft warns that ethics committees in countries in transition could become only a ‘moral figleaf’ covering the structural violence 7…”