Rights for participants in medical research must be improved, finds FP5 project
In some cases not enough is being done in Member States to protect the rights and freedoms of people involved in medical research programmes, says a team of European researchers. Presenting their findings in Brussels recently, the researchers insisted that more efforts are needed to communicate this to national ethics committees responsible for reviewing research proposals. The PRIVIREAL project, funded under the Fifth Framework Programme (FP5), set out to discover how effective the EU's Data Protection Directive is at safeguarding the fundamental rights and freedom of medical research subjects. The Data Protection Directive was passed in 1995 in order to remove obstacles to the flow of personal data by securing EU citizens' fundamental rights (in particular, privacy). Member States have tended to implement the Directive differently, and it is, therefore, unclear how medical research in particular has been affected by legislation impacting upon the review of project proposals by ethics committees. PRIVIREAL was created to fill this knowledge gap. 'Medical research is vital for the continued health of the population and arguably could be afforded exemptions to some regulations to facilitate this improvement in health,' said David Townend from the Sheffield Institute of Biotechnological Law and Ethics at the University of Sheffield in the UK. 'It is an important part of any business economy, but this means that it is tempting to relax provisions relating to the fundamental rights and freedoms - especially privacy - of individuals too much,' he added. Since understanding the balance between the advancement of science and personal privacy was critical to the PRIVIREAL study, the researchers approached this question in three stages. First they studied how effectively the Data Protection Directive (95/46/EC) was being implemented in relation to medical research in European countries; then they examined how the legislation influences ethics committees when they are reviewing research applications. The PRIVIREAL research team then combined these results to evaluate the Directive's implementation in each country and to determine what remit should be given to ethics committees in protecting a research participant's rights under the EU regulation. 'For each country, we provide on our website the pertinent data protection laws and regulations, as well as commentaries and other background information,' explains the team. The project's recommendations, unveiled at the Brussels meeting, revolve around seven major themes: the definition of personal data, the 'anonymisation' of data, what information is provided to the data subject, what kind of prior checking should take place, the consent process, how to handle exemptions, and generally the role of research ethics committees.