Evaluation of length and complexity of written consent forms in English and Hebrew for participation in clinical trials authorized in one medical institution in Israel: A descriptive study.

Informed consent forms (ICFs) in clinical trials are the only objective testimony whether the information provided to participants is comprehensive and presented in an accessible language. We evaluated the length of Hebrew ICFs and their English translations and evaluated the readability of the latter. In fifteen clinical trials (5 with pharmacogentic sub-study), the median number (IQR) of pages and words were: English clinical ICFs - 16 pages (13,18) and 7360 words (6959,8289); Hebrew clinical ICFs - 12 pages (10,14), 5807 words (5258,6403); English pharmacogenetics ICFs - 7 pages (4,11), 2930 words (2234,5100); Hebrew pharmacogenetics ICFs - 5 pages (4,8.