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Patient Consent to Publication and Data Sharing in Industry and NIH-Funded Clinical Trials
UMB Dataset

UID: 16

Author(s): O'Mareen Spence, Richie Onwuchekwa Uba, Seongbin Shin, Peter Doshi* * Corresponding Author
Description
Clinical trial participants are often motivated by the altruistic assumption that study results will contribute to medical knowledge. Additionally, the sharing of research data is rapidly developing into an ethical standard. An evaluation of 144 blank (sample) informed consent forms (ICF) was undertaken to determine the extent to which clinical trial participants were apprised of researchers’ intent to publish results, share de-identified data, and the overall benefit to medical knowledge. This dataset consists of 98 ICFs from industry-funded trials from the European Medicines Agency (EMA) and 46 ICFs from publicly-funded trials listed in the National Heart, Lung and Blood Institute (NHLBI) Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). The documents were reviewed for identification and extraction of stated or implied language for the following 5 aspects of each study: publication of results, sharing de-identified data, data ownership, confidentiality of identifiable data and, whether the trial will produce knowledge that offers public benefit. Results indicate that investigators rarely disclose intent to share de-identifiable data or commitment to publish. All ICFs are available via 2 zip files, one for the industry-funded trials and the other for the trials in BioLINCC. Also included is the study extraction sheet.
Timeframe
1983 - 2013
Subject Domain
Keywords
Access via Zenodo

144 sample ICFs in 2 zip files and 1 extraction datasheet

Access Restrictions
Free to All
Access Instructions
Available to download from the Zenodo site
Associated Publications
Data Type
Study Type
Observational
Dataset Format(s)
Microsoft Excel, PDF
Dataset Size
99.0 MB (Industry Funded ICFs); 24.9 MB (Publicly Funded ICFs); 98.0 kB (Study Extraction Sheet)