Legal regulations, ethical guidelines and recent policies to increase transparency of clinical trials.

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 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.

Legal and ethical aspects of ghostwriting in medicine.

Ghostwriting in medicine represents a highly significant problem in both legal and ethical terms, and particularly in recent years owing to a sudden increase in the practice. The main goal in this paper is to present the legal and ethical rules connected with the ghostwriting phenomenon. The problem is presented in the context of international, European and Polish law. From a legal perspective the issues bound up with ghostwriting are those of the notion and authorship of a work, authors' rights (both moral rights and copyright), the content of these rights and their nature, as well as the question of the transfer of such rights. From the point of view of ethics there arises a need for reflection on honesty, accuracy and credibility as defined both generally and scientifically.

The admissibility of research in emergency medicine.

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.