Methods for Verifying Understanding

Research professionals have identified a set of challenges they have experienced when trying to illicit truly informed consent. Below are challenges, examples, and suggested solutions. If these challenges are not overcome, the ability for the participant to give informed consent may be compromised.

Challenge: Decreased Sensory Input

Example:
Poor eyesight
Poor hearing

Social isolation, increased likelihood of culture issues: specifically Americans are very independent and this works in the individual's favor in ICD. Older Americans may be depression generation therefore more accustomed to accept authority blindly.

Suggestion:
Large font (e.g. as Ophthalmology routinely does now) or video consents with individually adjustable headphone volume or visual aids. Such approaches should be considered if there is a significant likelihood that patients who would benefit from these considerations (e.g. large numbers of very old) are to be enrolled. Also consider if screening for the individual needs will be routinely done.