Comparing Paper-based and Tablet-delivered Informed Consent for Older Adults

Clinical research is crucial for advancing healthcare, but patients must be able to make informed and voluntary choices about whether or not to participate in a research study. The informed consent process aspires to convey the purpose of research, the procedures involved, and the potential harms and benefits of taking part. Yet, the challenge of making informed consent easy to follow and understand is great: there are specific challenges for older research populations.

This study will develop and test a tablet-delivered informed consent process. The study will have two phases.

In the first phase, focus groups comprised of older adults will give their impressions of both a prototype tablet-delivered and paper consent, and the prototype will be refined according to feedback.

The second phase will evaluate whether older subjects judge a tablet-delivered consent to be more user-friendly than a paper-based version. It will also evaluate whether older subjects who participate in a tablet-delivered consent process have a better understanding of the research than those who participate in the paper-based version, and whether they remember the research details more fully after a one-week delay.

Inclusion criteria

• Age 65 years and older
• Cognitively intact
• Ability to speak and read English

Exclusion criteria

• Legal blindness
• Severe hearing loss not corrected by assistive device
• Inability to use hands to swipe a tablet's touch screen
• No working telephone in the home