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Project authorisation and ethical review
The proposals for project authorisation and ethical review systems look good in principle, but duplication of function is likely to cause pointless administration and delays
The proposals in the revised Directive include separate systems for project authorisation and ethical review. In principle, this seems to be a good idea, but there are some potential problems.
There would be a significant increase in the administrative burden for researchers in those Member States that currently grant authorisations for broad, on-going programmes of research, since it seems highly likely that this proposal refers to such discrete, time-limited projects.
It is proposed that projects should be authorised if they meet three criteria. First, that they meet a set of fairly basic regulatory points, which should not create any real problems. Second, that there should be a deadline by which the regulatory authority must reply to an application. This would be very welcome but, as it is currently worded it could be meaningless. The reply could simply be, “We are considering your application.” This proposal will only be of any value if the deadline is for the authority to approve (or reject) the application.
The third criterion is that the project should have a positive ethical review. Ethical review would be carried out within each establishment, using a set of criteria defined by the new Directive. In principle, this would be sensible. Most countries already have local ethical review bodies. The ones that don't - typically because they have regional bodies - will face a noticeable administrative burden. However, the main problem is that there is likely to be a significant unnecessary administrative burden and delays to authorisations in many Member States caused by duplication between the authorisation and ethical review systems.
Several Member States currently have project authorisation systems which use some or all of the criteria proposed for the ethical evaluation system. It is unrealistic to expect that regulatory authorities would voluntarily remove criteria from their authorisation systems and rely on local ethical evaluation systems to make these judgements for them. Why do we know that this is unrealistic? Over the last decade, ethical review systems have evolved in most Member States. Duplication of function, with projects being assessed twice, using the same criteria, is already happening in some countries. In the worst case, essentially all the harm-benefit and justification criteria are duplicated, with the two processes operating in sequence, rather than in tandem, wasting time and effort. Unless the proposal includes some measures to prevent this duplication, a requirement to have these criteria in the ethical evaluation system will simply lead to duplication of function and unjustified additional administrative burdens and delays to project authorisations.