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Published on: August 1, 2019
Streamlined versus traditional consent for low-risk comparative effectiveness trials: a randomized experimental study
Nancy E Kass1,2,3, Ruth R Faden1, Stephanie R Morain1,3
1Johns Hopkins Berman Institute of Bioethics, Baltimore, MD 21205, USA.
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.
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