Can You Have Consent Without Comprehension?
Here are some interesting facts and
figures about paticipant comprehension:
- 70% of participants say they do
not even know what questions to ask
- 30% claim they did not understand
that their study involvement could carry more risk and discomforts than the
standard of treatment
- One in three did not understand
that the investigational drug might be a novel approach for treating their
- One out of every five complaints
to the FDA is due to informed consent noncompliance
Source: Getz, K.A. (Nov. 2002), Informed
Consent Process, Applied Clinical Trials.