Consent forms for clinical trials are too aggressiveBMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f4879 (Published 13 August 2013) Cite this as: BMJ 2013;347:f4879
- Richard J Wassersug, adjunct professor, psycho-oncology, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada
I have the privilege of being a cancer patient as well as a cancer researcher. So I have looked at informed consent forms for clinical trials from both sides of the fence. But it wasn’t until I had to produce one for my own research that I began to understand why every consent form that I had read as a patient had made me uncomfortable. It wasn’t anything about the study itself that bothered me—it was the language used in the forms.
I had assumed that the researchers simply didn’t know how to write a document that was reader friendly, but then I found out that my own university’s institutional review board actually required me to write in that same unfriendly manner.
What I have learnt from having to design consent forms for my own clinical trials is that two contradictory principles drive their language. One says …