In clinical research scientific, legal as well as ethical aspects are important. It is well known that clinical investigators at university hospitals have to undertake their PhD-studies alongside their daily work and reconciling work and study can be challenging. The aim of this project was to create a web based course in clinical research bioethics (5 credits) and to examine whether the method is suitable for teaching bioethics. The course comprised of six modules: an initial examination (to assess knowledge in (...) bioethics), information on research legislation, obtaining permissions from authorities, writing an essay on research ethics, preparing one’s own study protocol, and a final exam. All assignments were designed with an idea of supporting students to reflect on their learning with their own research. (shrink)

Background:Medical research involving human subjects must be evaluated by a research ethics committee before a study is initiated. However, knowledge of REC decision processes, particularly in relation to evaluating the risk–benefit balance in various study types, appears scant.Methods:The study protocols and records of a Finnish university hospital REC were surveyed for a time span of 5 years. All study procedures in each study plan were examined, and the studies were divided into clinical drug trials, clinical trials with medical devices, studies (...) with other invasive interventions, studies with non-invasive physical procedures, and non-physical procedures only.Results:In clinical drug trials, the REC posed queries more frequently about the risk–benefit ratio and less frequently about study methods and participant-related issues in comparison with other study types. Relative to other studies, those with non-physical procedures were subject to more frequent queries related to reliability of the study... (shrink)

Randomised clinical trials involve procedures such as randomisation, blinding, and placebo use, which are not part of standard medical care. Patients asked to participate in RCTs often experience difficulties in understanding the meaning of these and their justification.