Background and Objective: The use of randomized consent designs has been subject of methodologic and ethical controversy. In most Western countries, research ethics committees make the decision as to whether a randomized consent design can be applied. The purpose of the study is to assess to what extent a randomized consent design and a modification of this design is accepted by research ethics committees, in terms of ethics, health law, and methodology. Methods: A postal survey was conducted among members of research ethics committees in the United Kingdom, and in The Netherlands, with professional competence in ethics, (health) law, methodology, or clinical practice. Results: In both the UK and in The Netherlands, the modified randomized consent design appears to be statistically significantly more acceptable than the randomized consent design, with respect to ethical and judicial aspects. The overall rejection rate of the randomized consent design was 66% in the UK and 59% in The Netherlands. However, the modified randomized consent design was rejected by 47 and 41% in the two countries, respectively. Conclusion: The modified randomized consent design appears to be more acceptable than the randomized consent design. To increase consistency in the way research ethics committees handle study protocols, a discussion about the use of randomized consent designs appears necessary.

Informed consent, prerandomization, Randomized consent design, Research ethics committees, Research protocols, Zelen design
dx.doi.org/10.1016/j.jclinepi.2004.11.021, hdl.handle.net/1765/62151
Journal of Clinical Epidemiology
Erasmus MC: University Medical Center Rotterdam

Schellings, R, Kessels, A.G, ter Riet, G, Kleijnen, J.M.P, Leffers, P, Knottnerus, J.A, & Sturmans, F. (2005). Members of research ethics committees accepted a modification of the randomized consent design. Journal of Clinical Epidemiology, 58(6), 589–594. doi:10.1016/j.jclinepi.2004.11.021