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Related Experiment Videos

A Randomized Controlled Study Comparing the National Cancer Institute's Original and Revised Consent Form Templates.

Holly A Masset1, Michelle Hiser2, Nancy L Atkinson

  • 1National Cancer Institute.

IRB
|February 1, 2019
PubMed
Summary

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This summary is machine-generated.

The revised National Cancer Institute (NCI) consent form template maintained participant knowledge and satisfaction while reducing length. Pre-trial education increased satisfaction, though form review decreased trial participation likelihood.

Area of Science:

  • Clinical Trials
  • Informed Consent
  • Health Literacy

Background:

  • The National Cancer Institute (NCI) has required a specific consent form template for NCI-funded clinical trials since 1998.
  • A revised, more concise template was introduced in 2013 to improve clarity and participant understanding.

Purpose of the Study:

  • To evaluate the impact of the revised NCI consent form template on cancer survivors' knowledge, satisfaction, and clarity.
  • To assess the effect of the revised template on participants' likelihood of future trial engagement.

Main Methods:

  • A randomized controlled trial was conducted with 153 cancer survivors.
  • Participants reviewed either the original or revised NCI consent form template.

Main Results:

Keywords:
NCI consent templatecancer patientsclinical trialsconsent forminformed consentinformed decision-makingpatient education

Related Experiment Videos

  • The revised template yielded comparable knowledge and satisfaction scores to the original template.
  • The revised form was significantly shorter, with fewer words and pages.
  • Reviewing either consent form decreased the likelihood of future trial participation.
  • Prior knowledge about clinical trials positively correlated with increased satisfaction after reviewing the consent form.

Conclusions:

  • The revised NCI consent form template is effective in maintaining participant comprehension and satisfaction while being more concise.
  • Educational interventions to enhance pre-consent trial understanding are recommended to improve the informed decision-making process.
  • Combining the revised consent form with educational strategies can optimize participant engagement and satisfaction in clinical trials.