Improved informed consent documents for biomedical research do not increase patients' understanding but reduce enrolment: a study in real settings.

ABSTRACT:

Aims

The aim was to evaluate the comprehension of participants of an improved informed consent document (ICD).

Method

This was a randomized controlled French multicentre study performed in real conditions. Participants were adult patients undergoing screening for enrolment in biomedical research studies, who agreed to answer a validated questionnaire evaluating objective and subjective comprehension scored from 0 (no comprehension) to 100 (excellent comprehension). Patients were provided either the original ICD or an ICD modified in terms of structure and readability. The primary end point was the score of objective comprehension. The secondary end-points were the enrolment rate in the clinical study and patient characteristics associated with the score of objective comprehe

SUBMITTER: Paris A 

PROVIDER: S-EPMC4631174 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature