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

BMC Medical Ethics

Research

Caroline Samer¹  Thomas Perneger²  Christian Lovis³  Cristina Bosmani⁴  Sonia Carboni⁴  Angela Huttner⁵  Bernard Hirschel⁶ 

[1] Clinical Pharmacology and Toxicology Department, Geneva University Hospitals, Geneva, Switzerland;Division of Clinical Epidemiology, Geneva University Hospitals, Geneva, Switzerland;Division of Medical Information Sciences, Geneva University Hospitals, Geneva, Switzerland;Faculty of Medicine, Clinical Research Center, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 4, 1205, Geneva, Switzerland;Faculty of Medicine, Clinical Research Center, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 4, 1205, Geneva, Switzerland;Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland;Health Department of the Canton of Geneva, Geneva Cantonal Ethics Commission, Geneva, Switzerland;

关键词: Informed consent;    Consent bias;    Volunteer bias;    External validity;    Representativeness;   

DOI  :  10.1186/s12910-022-00877-7

 received in 2022-08-26, accepted in 2022-12-15,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundWe 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.MethodsIn 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.ResultsOf 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).ConclusionsOur 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.

【 授权许可】

CC BY   
© The Author(s) 2023

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