‘Best bewezen zorg’ niet altijd beste controle

Willems et al. have recently argued in the Dutch Journal of Medicine that Research Ethics Committees should follow the Declaration of Helsinki in its 2000 version since they believe that this version guarantees better protection for control groups in clinical trials than the 2008 version (and currently its 2013 version). They fear that the sections on placebo-controlled trials in the recent versions allow non-innovative research. We show that the Declaration of Helsinki does not allow research that has no social value. Moreover, we show that the 2000 version is internationally contested. We agree with the authors that the Declaration of Helsinki inadequately protects control groups, but for other reasons. We think that the Council for International Organizations of Medical Sciences (CIOMS) guidelines offer better protection since they require that control groups cannot be withheld an established effective intervention for the condition under study. Unlike the Declaration of Helsinki, the CIOMS guidelines claim that control groups have a right to more than the best proven intervention.

Conflict of interest and financial support: disclosure forms provided by the authors are available along with the full text of this article at www.ntvg.nl, search for A7227; click on ‘Belangenverstrengeling’ (‘Conflict of interest’).