Formal clinical ethics review first developed in the USA and most hospitals there have structures in place. This is often a clinical ethics committee. Developments have been slower in the UK, where there has been uncertainty and variability about the role of clinical ethics committees. Even in the USA, their exact role is uncertain. Although we now have a good idea of the mechanisms for ethical...

Research ethics review is an important process, designed to protect participants in medical research. However, it is increasingly criticised for failing to meet its aims. Here, two researchers reflect on their experiences of applying for ethical approval of observational research in clinical settings. They highlight some problems faced by reviewers and researchers and propose a two-stage ethica...

When several decades ago the IRB system was established trying to balance major moral consideration in research with human subjects, the main impetus were severe cases of unethical behaviour and experiences, often protected by state and institutional administration. The first phase of the IRB aimed at protecting subjects from serious hazards, while in later stages the IRB turned to „lesser risk...

Local review of research by ethics committees in the UK has long been held to be an important right of the local research ethics committee and, even with the introduction of the European Clinical Trials Directive, the governance arrangements for research ethics committees continue to allow for local review of multicentre studies. There is no requirement for local review in either the European U...

Article history: Received: 18-06-2015 Revised: 24-09-2015 Accepted: 11-11-2015

The paper provides description of the system of ethical review for biomedical research in Belarus, with special emphasis on its historical background, legal and regulatory framework, structure and functioning. It concludes that the situation with research ethics in Belarus corresponds to the tendency of bureaucratic approach to establishment of systems of ethical review for biomedical research,...

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The future health of infants and children is dependent on the performance of clinical research in which infants participate. Achieving a proper balance between this social good and the obligation to protect infants who participate in research is a significant challenge. As investigators design and implement research protocols, they should be aware of the ethical and legal requirements that gove...