Research Use of Electronic Health Records: Patients’ Views on Alternative Approaches to Permission

Abstract

Background: The increased use of electronic health records (EHRs) has resulted in new opportunities for research, but also raises concerns regarding privacy, confidentiality, and patient awareness. Because public trust is essential to the success of the research enterprise, patient perspectives are essential to the development and implementation of ethical approaches to the research use of EHRs. Yet, little is known about patients’ views and expectations regarding various approaches to seeking permission for research use of their EHR data. Methods: We conducted semi-structured interviews with 120 patients in four counties in diverse regions of the southeastern United States: Appalachia, the Mississippi Delta, and the Piedmont area of North Carolina. We asked participants to consider, from multiple stakeholder perspectives, the advantages and disadvantages of three approaches to notifying patients of, or obtaining permission for, research use of their EHR data; whether they believed it would be acceptable if their healthcare organization used each approach; and which approach would be most appropriate. Results: Nearly all participants said General Notification, Broad Permission, and Categorical Permission would each be acceptable approaches to notification of, or permission for, EHR research. Over half identified Broad Permission as the most appropriate approach. Across all of these discussions, major themes included the importance of clarity, simplicity, and usability of patient-facing materials, as well as the level of transparency, trustworthiness, and respect for patients the approach conveys. Conclusions: Our findings help to inform the development and implementation of ethical approaches to the research use of EHRs by identifying key patient considerations regarding various approaches to permission and suggesting potential actions for healthcare organizations and researchers.