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Continuous quality improvement: reducing informed consent form signing errors.

Tsui-Wen Hsu1, Chi-Hung Huang2, Li-Ju Chuang1

  • 1Institute of Medicine, Superintendent Office and CGHIRB, Cathay General Hospital, Taipei, Taiwan.

BMC Medical Ethics
|August 4, 2023
PubMed
Summary
This summary is machine-generated.

Ensuring valid informed consent forms (ICFs) is vital for ethical research. Implementing the plan-do-check-act (PDCA) cycle significantly improved ICF signature accuracy, reducing common errors.

Keywords:
Informed consent form (ICF)Institutional review board (IRB)Plan–do–check–act (PDCA)Quality improvement

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Area of Science:

  • Clinical Research Ethics
  • Data Integrity in Healthcare

Background:

  • Obtaining valid informed consent forms (ICFs) is crucial for participant autonomy and ethical research conduct.
  • Despite its importance, ICFs frequently contain signing errors, compromising data validity and regulatory compliance.
  • Common errors include missing signatures, incorrect versions, and improper corrections, necessitating systematic improvement strategies.

Purpose of the Study:

  • To analyze the types and frequency of informed consent form (ICF) signing errors.
  • To implement and evaluate the effectiveness of the plan-do-check-act (PDCA) cycle in reducing ICF signing errors.

Main Methods:

  • The study analyzed 363 ICFs from January 2016 to February 2020.
  • The plan-do-check-act (PDCA) cycle was implemented to address and prevent ICF signing errors.
  • Statistical analysis compared the proportion of correct ICF signatures before and after the intervention.

Main Results:

  • The PDCA intervention significantly increased the proportion of correctly signed ICFs from 83.3% to a higher rate (P < 0.05).
  • Specific signature errors, such as corrections without subsequent participant signatures and impersonated signatures, were significantly reduced post-intervention.
  • No significant reduction was observed in errors like multiple signatures, missing ICFs, incorrect order, or non-member signatures.

Conclusions:

  • The plan-do-check-act (PDCA) cycle is an effective strategy for improving the accuracy and validity of informed consent form (ICF) signing in research.
  • Targeted interventions can successfully reduce specific, common ICF signing errors.
  • Further strategies may be needed to address persistent error types not significantly impacted by the PDCA cycle.