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.
Original language | English (US) |
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Pages (from-to) | 329-346 |
Number of pages | 18 |
Journal | Journal of Comparative Effectiveness Research |
Volume | 11 |
Issue number | 5 |
DOIs | |
State | Published - Apr 2022 |
Keywords
- comparative effectiveness research
- ethics
- informed consent
- learning health system
- streamlined consent
ASJC Scopus subject areas
- Health Policy