Streamlined versus traditional consent for low-risk comparative effectiveness trials: a randomized experimental study to measure patients’ and public attitudes

Streamlined versus traditional consent for low-risk comparative effectiveness trials: a randomized experimental study to measure patients’ and public attitudes
Research Article
Nancy E Kass, Ruth R Faden, Stephanie R Morain, Kristina Hallez, Rebecca A Stametz, Amanda R Milo, Deserae Clarke
Journal of Comparative Effectiveness Research, 3 March 2022
Abstract
Aim
Streamlining consent for low-risk comparative effectiveness research (CER) could facilitate research, while safeguarding patients’ rights.
Materials & methods
2618 adults were randomized to one of seven consent approaches (six streamlined and one traditional) for a hypothetical, low-risk CER study. A survey measured understanding, voluntariness, and feelings of respect.
Results
Participants in all arms had a high understanding of the trial and positive attitudes toward the consent interaction. Highest satisfaction was with a streamlined approach showing a video before the medical appointment. Participants in streamlined were more likely to mistakenly think a signature was required.
Conclusion
Streamlined consent was no less acceptable than traditional, signed consent. Streamlined and traditional approaches achieved similar levels of understanding, voluntariness and a feeling that the doctor–patient interaction was respectful.