Objective To obtain information about the similarities and differences in regulating different types of medical research in the European Union .Methods Web searches were performed from September 2009 to January 2011. Notes on pre-determined topics were systematically taken down from the web pages. The analysis relied only on documents and reports available on the web, reflecting the situation at the end of 2010.Results In several countries, regulatory legislation applied only to clinical trials on drugs and medical devices, in other states (...) various types of research were also regulated but by laws different from those concerning trials, and in many countries, some research areas were not controlled by legislation at all. In very few countries was all medical research handled similarly from a legal point of view. The number of research ethics committees in a single country varied from one to 264. Their areas of responsibility, working principles and length of time to grant research permission varied as well as the rules for obtaining informed consent from vulnerable groups. In 10 EU countries, there was no appeal mechanism after a negative decision by an REC. The RECs were not accountable to any organisation in five EU countries.Conclusions There is a need for a fundamental debate regarding whether and which kinds of changes are needed for the further harmonisation of medical research governance in the EU and how cross-country medical research could be facilitated in the future. (shrink)

The purpose of the research was to study Finnish people's attitudes towards biomedical research and whether the research sponsor makes a difference to those attitudes. A survey questionnaire was sent to a random sample of 25-64 years old. Respondents had a positive attitude towards biomedical research and there were only small variations by population group. When asked whether one's own clinical blood samples could be used in scientific biomedical research, 84 per cent of the respondents would allow it. The most (...) important reasons for giving routinely collected samples to a biobank were altruistic. Attitudes were strongly dependent on the sponsor of the research. Domestic research was looked at more positively than international research. Whether research was made by a public or private actor had less impact. The results suggest that people want to be research participants to help such research of their own free will, and to choose whom they help. This has an impact on the way participants are informed, on the criteria used by ethics committees and other research regulators, and also on transparency and access to research results. (shrink)

The purpose of the research was to study Finnish people's attitudes towards biomedical research and whether the research sponsor makes a difference to those attitudes. A survey questionnaire was sent to a random sample of 25-64 years old. Respondents had a positive attitude towards biomedical research and there were only small variations by population group. When asked whether one's own clinical blood samples could be used in scientific biomedical research, 84 per cent of the respondents would allow it. The most (...) important reasons for giving routinely collected samples to a biobank were altruistic. Attitudes were strongly dependent on the sponsor of the research. Domestic research was looked at more positively than international research. Whether research was made by a public or private actor had less impact. The results suggest that people want to be research participants to help such research of their own free will, and to choose whom they help. This has an impact on the way participants are informed, on the criteria used by ethics committees and other research regulators, and also on transparency and access to research results. (shrink)