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

Abstract

Background: Implementation of patient preferences for use of electronic health records for research has been traditionally limited to identifiable data. Tiered e-consent for use of de-identified data has traditionally been deemed unnecessary or impractical for implementation in clinical settings.Methods: We developed a web-based tiered informed consent tool called informed consent for clinical data and bio-sample use for research (iCONCUR) that honors granular patient preferences for use of electronic health record data in research. We piloted this tool in 4 outpatient clinics of an academic medical center.Results: Of patients offered access to iCONCUR, 394 agreed to participate in this study, among whom 126 patients accessed the website to modify their records according to data category and data recipient. The majority consented to share most of their data and specimens with researchers. Willingness to share was greater among participants from an Human Immunodeficiency Virus (HIV) clinic than those from internal medicine clinics. The number of items declined was higher for for-profit institution recipients. Overall, participants were most willing to share demographics and body measurements and least willing to share family history and financial data. Participants indicated that having granular choices for data sharing was appropriate, and that they liked being informed about who was using their data for what purposes, as well as about outcomes of the research.Conclusion: This study suggests that a tiered electronic informed consent system is a workable solution that respects patient preferences, increases satisfaction, and does not significantly affect participation in research.

Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

“…According to research participants, access to their own health information is a key benefit of participation [ 46 ]. Research participants requested more transparency regarding the use of their data [ 38 , 58 ]. They expressed the right to control the sharing and use of their private health information [ 37 , 42 ].…”

“…Research participants exposed to positive valence annotations indicated feeling less informed than participants receiving a combination of positive and negative valence annotations [ 30 ]. Various studies [ 15 , 37 , 58 , 62 ] provided insights into a personalized approach of an electronic informed consent platform. Research participants stated that they would like to receive personalized elements and tailored information such as the display of their name in the electronic informed consent form or the impact of their contribution on a specific research question [ 15 , 37 ].…”

Population Health Management for Inflammatory Bowel Disease

“…Furthermore, there are still concerns and barriers related to the tradeoffs between individual and institutional privacy and the societal benefits of sharing clinical data and to the practical challenges of harmonizing data across several institutions to build predictive models and decision support systems. [65][66][67][68][69][70]…”

Leveraging electronic health records for clinical research

“…Examples of EHR-integrated patient consent dashboards are demonstrating how patients can be active stewards of their own data, as well as controlling and managing consent and permissions. 60 Lastly, sharing with patients the clinical research results stemming from their involvement in EHR, face-to-face clinic visits that focus on engaging the patient in their care, and in-person contact with an individual who represents the research institution may all be ways of facilitating a culture of trust between patients and researchers.…”