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

Cristina Bosmani; Sonia Carboni; Caroline Samer; Christian Lovis; Thomas Perneger; Angela Huttner; Bernard Hirschel

doi:10.1186/s12910-022-00877-7

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

BMC Med Ethics. 2023 Feb 13;24(1):10. doi: 10.1186/s12910-022-00877-7.

Authors

Cristina Bosmani¹, Sonia Carboni², Caroline Samer³, Christian Lovis⁴, Thomas Perneger⁵, Angela Huttner^{2

6}, Bernard Hirschel⁷

Affiliations

¹ Faculty of Medicine, Clinical Research Center, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 4, 1205, Geneva, Switzerland. cristina.boehm-bosmani@hcuge.ch.
² Faculty of Medicine, Clinical Research Center, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 4, 1205, Geneva, Switzerland.
³ Clinical Pharmacology and Toxicology Department, Geneva University Hospitals, Geneva, Switzerland.
⁴ Division of Medical Information Sciences, Geneva University Hospitals, Geneva, Switzerland.
⁵ Division of Clinical Epidemiology, Geneva University Hospitals, Geneva, Switzerland.
⁶ Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.
⁷ Health Department of the Canton of Geneva, Geneva Cantonal Ethics Commission, Geneva, Switzerland.

Abstract

Background: We assessed potential consent bias in a cohort of > 40,000 adult patients asked by mail after hospitalization to consent to the use of past, present and future clinical and biological data in an ongoing 'general consent' program at a large tertiary hospital in Switzerland.

Methods: In this retrospective cohort study, all adult patients hospitalized between April 2019 and March 2020 were invited to participate to the general consent program. Demographic and clinical characteristics were extracted from patients' electronic health records (EHR). Data of those who provided written consent (signatories) and non-responders were compared and analyzed with R studio.

Results: Of 44,819 patients approached, 10,299 (23%) signed the form. Signatories were older (median age 54 [IQR 38-72] vs. 44 years [IQR 32-60], p < .0001), more comorbid (2614/10,299 [25.4%] vs. 4912/28,676 [17.1%] with Charlson comorbidity index ≤ 4, p < .0001), and more often of Swiss nationality (6592/10,299 [64%] vs. 13,813/28,676 [48.2%], p < .0001).

Conclusions: Our results suggest that actively seeking consent creates a bias and compromises the external validity of data obtained via 'general consent' programs. Other options, such as opt-out consent procedures, should be further assessed.

Keywords: Consent bias; External validity; Informed consent; Representativeness; Volunteer bias.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adult
Bias
Electronic Health Records*
Humans
Informed Consent*
Middle Aged
Retrospective Studies
Switzerland