Home » Bulletin 2006
Openness and transparency - proposals not well designed
The new Directive wants a high level of transparency and public information, but the proposal for achieving this looks very complex and is unlikely to achieve the objectives
The proposals for the revised Directive aim to promote openness and transparency. It is proposed that all non-confidential information from project authorisations and ethical review to be made public, with exceptions for information that would risk intellectual property rights or personal safety.
The legal definition of confidential varies from Member State to Member State and there is no European case law on the subject. However, in many Member States the definition is quite broad and would result in the majority of the content of project authorisations and ethical review material being non-disclosable. Experience with such disclosures suggests that each document has to be reviewed on a line-by-line basis by an expert to identify the material that cannot be disclosed. This creates a substantial administrative burden, significant delays in releasing documents and limited additional transparency as so much of the resulting documentation is deleted that it becomes almost meaningless.
The United Kingdom routinely publishes anonymous, non-technical summaries of all project authorisations, written by the applicants and agreed by the national authority, as part of the authorisation process. This provides significantly greater transparency and public information, whilst safeguarding the identity of the applicant, with minimum additional administrative burden. We consider that a similar system should be incorporated in the revised Directive instead of the present poorly-designed proposal.