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Assessment of a shortened informed consent form for pediatric research: a pilot study

Peter D Murray1,2, Barbara E Bierer3,4, Steven Hirschfeld5

  • 1The Department of Pediatrics, Floating Hospital for Children at Tufts Medical Center, Boston, MA, USA. PM7DN@hscmail.mcc.virginia.edu.

Pediatric Research
|July 4, 2018
PubMed

Insights

A simplified informed consent form (ICF) did not improve participant understanding of clinical trial components. Further comparison of shortened and conventional ICFs in actual trials is needed.

Area of Science:

  • Clinical Research
  • Human Participant Protection

Background:

  • The informed consent process is crucial in clinical research.
  • The informed consent form (ICF) is central to protecting human participants.

Purpose of the Study:

  • To evaluate if a shortened, simplified ICF with an appendix enhances participant understanding compared to a conventional ICF.
  • Assessing the impact of ICF simplification on comprehension of study details.

Main Methods:

  • Developed a shortened ICF from a conventional version for a neonatal study.
  • Randomly assigned either the shortened or conventional ICF to parental advocacy group members.
  • Collected participant feedback via surveys on their understanding and perception of the distributed ICF.

Main Results:

  • Higher participant satisfaction with the shortened ICF, with 76% finding it "short and to the point" versus 68% for the conventional ICF.
  • Despite perceived brevity, participants in the shortened ICF group indicated it lacked sufficient information.
  • No statistically significant differences were observed in the understanding of key study components between the two groups.

Conclusions:

  • A shortened informed consent form did not significantly alter participant comprehension of clinical trial information.
  • Future research should directly compare shortened and conventional ICFs within active clinical trials to validate these findings.
Abstract

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