Long-Term Recall of Elements of Informed Consent: A Pilot Study Comparing Traditional and Computer-Based Consenting

IRB. Jan-Feb 2015;37(1):1-5.

Abstract

Background:: The purpose of this study was to evaluate long-term recall of elements of informed consent.

Methods:: Men enrolling in a biobank for a study of prostate cancer were randomized to traditional or computer-based consenting. Two-page questionnaires were mailed to participants six months after the consent process.

Results:: Thirty-five men were randomized to the computer-based arm and 36 to the traditional consenting arm. Follow-up questionnaires were returned by 25 in the computer-based and 31 in the traditional group. The men ranged in age from 55 to 86 years (mean 73.2). Participants in the computer-based group were more likely to answer some of the knowledge questions correctly. The computer-based respondents were more likely to report higher levels of understanding for 13 of 14 statements.

Discussion:: The computer-based consenting process decreased staff time required and lead to improved retention of the elements of informed consent. It has been adopted prospectively.

Publication types

  • Comparative Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Comprehension
  • Consent Forms
  • Humans
  • Informed Consent*
  • Male
  • Mental Recall*
  • Pilot Projects
  • Precision Medicine*
  • Research Subjects*
  • Surveys and Questionnaires
  • User-Computer Interface*