ABSTRACT
The research review covers the evaluation of the legal, ethical and methodological aspects of clinical trials, evaluation of the changes in authorized clinical trials and the control of the trial from the beginning until the final report. To begin a clinical trial, the previous favourable decision of the Clinical Research Ethics Committee is required, as well as other authorizations. The Royal Decree is complemented with good clinical practice rules and the instructions on how to run clinical trials in Spain, and the guidelines of the European Commission that will be published by the Ministry of Sanitary Health and Consumption. Research ethics committees (RECs) consider that at least when identification of the human source is directly or indirectly possible, processing human biological material for genetic research falls within the scope of data protection law. In Spain, RECs are aware of the obligation to review each trial in relation to data protection rules.
