Abstrakt
There are three branches of medical research: medicinal products, medical devices, and new methods (such as new surgeries or other medical interventions). The last one is the least regulated both on the national and international level, where the general rules on medical research embodied in the Convention on Human Rights and Biomedicine and its Additional Protocol concerning Biomedical Research apply to it.
While Czech law provides a formal framework for the evaluation of new methods based on the approval issued by the Ministry of Health, this system is largely ignored in practice where new methods are usually tested based only on the local ethic committee's approval. There are two areas of the Czech regulation on new methods that could potentially be problematic from the perspective of compliance with international law: first, a non-specific fault-based liability for personal injury to a research participant, and second, the lack of a robust and enforced system of research study approvals.
However, in both cases, the Czech regulation complies with the broad requirements of international law. The only real problem might be the uncertainty regarding the legality of new methods use outside of the formal evaluation framework in Czech domestic law.
While the vagueness of international law on the matter is understandable, it could arguably provide stronger support to establishing legal certainty in national regulations.