iCONCUR: informed consent for clinical data and bio-sample use for research

Area of Science:

• Health Informatics
• Bioethics
• Clinical Research

Background:

• Patient preferences for electronic health record research data use are often limited to identifiable information.
• Tiered electronic informed consent for de-identified data has been viewed as impractical in clinical settings.

Purpose of the Study:

• To develop and pilot a web-based tiered informed consent tool (iCONCUR) that accommodates granular patient preferences for electronic health record data use in research.
• To assess the feasibility and patient acceptance of such a system in a clinical environment.

Main Methods:

• A tiered electronic informed consent tool, iCONCUR, was developed.
• The tool was piloted in four outpatient clinics at an academic medical center.
• Patient engagement with the tool and their data-sharing preferences were analyzed.

Main Results:

• 126 out of 394 participants modified their data sharing preferences via the iCONCUR website.
• Most participants consented to share data and specimens, with higher willingness observed in Human Immunodeficiency Virus (HIV) clinics.
• Participants preferred sharing demographic and body measurement data over family history and financial data, and favored granular control and transparency.

Conclusions:

• A tiered electronic informed consent system like iCONCUR is a practical solution for respecting patient preferences in research data sharing.
• This approach enhances patient satisfaction and does not significantly impede research participation.