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REPRESENT: REPresentativeness of RESearch data obtained through the 'General Informed ConsENT'.

Cristina Bosmani1, Sonia Carboni2, Caroline Samer3

  • 1Faculty of Medicine, Clinical Research Center, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 4, 1205, Geneva, Switzerland. cristina.boehm-bosmani@hcuge.ch.

BMC Medical Ethics
|February 14, 2023
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Actively seeking patient consent for data use introduces bias, compromising the validity of general consent programs. Alternative opt-out consent methods warrant further investigation for better representation.

Keywords:
Consent biasExternal validityInformed consentRepresentativenessVolunteer bias

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Area of Science:

  • Medical Informatics
  • Public Health
  • Clinical Research

Background:

  • Assessed consent bias in a large tertiary hospital's general consent program.
  • Investigated the use of past, present, and future clinical and biological data.

Purpose of the Study:

  • To evaluate potential consent bias in a large patient cohort.
  • To determine the representativeness of patients consenting to data use.

Main Methods:

  • Retrospective cohort study of adult patients hospitalized between April 2019 and March 2020.
  • Compared demographic and clinical characteristics of consent signatories versus non-responders using electronic health records (EHR).
  • Analyzed data using R studio.

Main Results:

  • 10,299 out of 44,819 (23%) patients consented.
  • Signatories were older, more comorbid, and more likely to be of Swiss nationality compared to non-responders.
  • Significant differences observed in age (p < .0001), comorbidity (p < .0001), and nationality (p < .0001).

Conclusions:

  • Actively seeking consent introduces bias, potentially compromising external validity.
  • General consent programs may not represent the broader patient population.
  • Opt-out consent procedures should be explored as an alternative.