LENGTH AND FORMAT OF INFORMED CONSENT FORMS IN CLINICAL TRIALS IN DIFFERENT PATIENT POPULATIONS (PEDIATRIC, ADULT, ELDERLY) BASED ON SAMPLES FROM POLAND.

The length of informed consent documents is not regulated by clinical trial guidelines except for some internal Ethical Review Board decisions. This study involved a review of 140 informed consent forms approved for use in clinical trials in Poland in differing trial population age groups: adult, elderly, and pediatric. The study analyzed the growing length of the forms over time, the use of visual aids in the informed consent forms, and how these factors were dependent on the intended reader of the document. The study also reviewed the availability and format of any age-specific, abbreviated informed consent and assent forms. The results showed a significant increase in the length of the informed consent forms during the years 2011-2014 in comparison with 2001-2010. The examination also showed that the use of visual aids is over 5 times less frequent in the adult and elderly populations than in the guardian consent forms for pediatric trials, despite the fact that the forms for each group are aimed at adult readers. Additionally, the developers of the informed consent forms did not take into consideration the decreasing reading skills of the elderly population. [ABSTRACT FROM AUTHOR]