Timely and accurate dissemination of outcomes is essential to accomplish main benefits of scientific research including clinical trials. Clinical trial results can be disseminated in two main ways: by publication in a peer‐reviewed journal and by posting on a publicly available clinical trial register. The credibility of the literature on clinical trials is significantly diminished because a high percentage of trials is not published. While current legal regulations both in the European Union (EU) and the USA impose a duty to submit summary results of clinical trials to a respective register (EU Clinical Trial Register and http://ClinicalTrials.gov, respectively), the compliance with this requirement has been generally inadequate. Trial outcomes can be also made accessible by data sharing. However, in spite of the wide promotion of this idea, the access of investigators to participant‐level datasets remains limited. The main objective of this review is to discuss current legal regulations, international standards, ethical guidelines and recent policies pertaining to dissemination of clinical trial results.
Th is article is devoted to a selection of ECHR judgements concerning the right of a patient to have his or her privacy respected, and the corresponding duty of doctors to keep medical confi dentiality. Th e case law of this court confi rms the fundamental importance of trust between the patient and the therapist. It also underlines that one important scope of the right to privacy is the patient's medical data, which is subject to legal protection. Th e law allows for a limitation of the obligation to maintain medical confi dentiality, but only on the basis and within the limits of the law.
W wielu państwach funkcjonują narodowe/centralne komitety bioetyki, których rolą jest monitorowanie i opiniowanie aktualnych problemów bioetycznych pojawiających się ze względu na postęp wiedzy medycznej oraz nauk biologicznych. Procedura ich powoływania oraz sposoby działania, a także wpływ na praktykę różnią się w poszczególnych krajach. UNESCO opracowała szereg wskazówek dotyczących organizacji i funkcjonowania tego typu ciał. W Polsce istnieje potrzeba sprecyzowania zasad działania narodowego/centralnego komitetu bioetyki. Celem tekstu jest przegląd prawnych możliwości powoływania i funkcjonowania komitetów bioetycznych o charakterze narodowym/centralnym wraz z przedstawieniem ich roli oraz refleksją nad kształtem, miejscem, znaczeniem i funkcją tego typu ciała w warunkach polskich.
The main goal in this paper is to present the legal rules connected with medical experiment on human beings in emergency medicine and to explain the scope, significance, and meaning of these rules, especially with regard to their interpretation. As the provisions about medical experiments truly make sense only if they can be observed by the whole "civilised" international community, they are presented in the context of international law with reference to Polish law. By considering the appropriate regulations of research contained in legal documents, it is possible to formulate a catalogue of doctors' duties and patients' rights. This general catalogue refers to all kinds of medical research involving human beings. In the field of emergency medicine, general provisions are sometimes involved, and they are sometimes limited. The main and most important conclusion is that a medical experiment in emergency medicine is admissible only if previously indicated conditions based on general rules of conducting research are fulfilled.
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