background: clinical trial is the standard method to assess efficacy of a medical intervention. because of its experimental nature, meaning that subjects are exposed to an intervention with uncertain outcome and according to historical evidences of criminal researches, clinical trial is of something of a lightning rod for ethical concerns. ethical issues surrounding clinical trials are very per...

This article focuses on whether a certain form of consent used by biobanks--open consent--is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection...

Background Informed consent forms must be clear and include all the necessary information of the possible risks, benefits and complications of the procedure needing consent to. Thus, the form should not include illegible handwriting, medical jargons and abbreviations. Ethically, it should be obtained by a higher ranked physician [1]. In a thirteenweek audit conducted in a Dublin hospital, we ob...

BACKGROUND Informed consent of trial participants is both an ethical and a legal requirement. When facing a decision about trial participation, potential participants are provided with information about the trial and have the opportunity to have any questions answered before their degree of 'informed-ness' is assessed, usually subjectively, and before they are asked to sign a consent form. Curr...

BACKGROUND The issue of what type of compensation a research participant would be entitled to in a clinical trial when they have signed an informed consent document excluding certain forms of compensation recently came before our courts in the matter of Venter v Roche Products (Pty) Limited and Others (Case No. 12285/08). In this case, the court had to consider whether the plaintiff, Mr Venter,...

BACKGROUND Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. PURPOSE To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest w...

BACKGROUND High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and ther...