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E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
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A randomized controlled trial of an electronic informed consent process.

Erin Rothwell1, Bob Wong2, Nancy C Rose3

  • 1University of Utah, Salt Lake City, USA erin.rothwell@nurs.utah.edu.

Journal of Empirical Research on Human Research Ethics : JERHRE
|March 10, 2015
PubMed
Summary

Electronic informed consent improved understanding of study details in a pilot randomized controlled trial (RCT). While some aspects were better understood electronically, paper consent also showed strengths, suggesting a hybrid approach may be beneficial.

Keywords:
electronicinformed consentrandomized controlled trials

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Area of Science:

  • Clinical Trials
  • Informed Consent Process
  • Health Informatics

Background:

  • Informed consent is crucial for ethical research participation.
  • Traditional paper-based consent forms can be complex and may hinder participant comprehension.
  • Exploring digital alternatives for informed consent is an active area of research.

Purpose of the Study:

  • To evaluate an electronic informed consent model compared to a traditional paper-based model.
  • To assess the impact of electronic informed consent on participant understanding of research study components.

Main Methods:

  • A pilot study was conducted within a randomized controlled trial (RCT).
  • Participants were randomized into two groups: electronic consent (n=32) and simplified paper-based consent (n=30).
  • Participant understanding was assessed via surveys.

Main Results:

  • The electronic consent group demonstrated significantly higher understanding of the study's purpose, alternatives, and contact information.
  • Participants in the paper-based consent group reported higher satisfaction with certain survey items.
  • Overall comprehension varied across different aspects of the informed consent process.

Conclusions:

  • Electronic informed consent models show promise for enhancing participant understanding of key research elements.
  • A simplified paper-based approach also retains certain advantages in participant perception.
  • Further research is warranted to optimize electronic informed consent for diverse populations and study types.