Normative framework of informed consent in clinical research in Germany, Poland, and Russia.

摘要: BACKGROUND Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there the risk of compromises when involving human subjects research. Although Declaration Helsinki point reference for conduct humans, normative requirements may diverge from its provisions. The aim this examine consent biomedical Germany, Poland, Russia determine how each regulatory framework relates provisions Helsinki. METHODS For analysis, we conducted a search legal databases "Gesetze im Internet" "Internetowy System Aktow Prawnych" "ГAPAHT - Garant" Russia. was complemented by review secondary literature contained Google Scholar, PubMed, Polish National Library, eLibrary.ru. We have identified 21 containing clinical all three countries. content these documents systematically categorized analyzed. RESULTS countries shows strong commitment towards core principles envisaged Nevertheless, vary between differences range method language which information should be provided, through amount required disclosed, form documenting or withdrawal. In case vulnerable groups, are particularly visible. CONCLUSIONS can negatively impact international studies. Attention needs paid that flexibilities within not misused undermine protection subjects. Achieving global regional legislative harmonization might prove impossible. Such lack consensus reinforces significance agreements. TRIAL REGISTRATION Not applicable.