Patients, privacy and trust: Patients' willingness to allow researchers to access their medical records

The federal Privacy Rule, implemented in the United States in 2003, as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), created new restrictions on the release of medical information for research. Many believe that its restrictions have fallen disproportionately on researchers prompting some to call for changes to the Rule. Here we ask what patients think about researchers' access to medical records, and what influences these opinions. A sample of 217 patients from 4 Veteran Affairs (VA) facilities deliberated in small groups at each location with the opportunity to question experts and inform themselves about privacy issues related to medical records research. After extensive deliberation, these patients were united in their inclination to share their medical records for research. Yet they were also united in their recommendations to institute procedures that would give them more control over whether and how their medical records are used for research. We integrated qualitative and quantitative results to derive a better understanding of this apparent paradox. Our findings can best be presented as answers to questions related to five dimensions of trust: (1)Are medical records kept confidential?(2)Does the research being conducted demonstrate high priority on patient welfare?(3)Are researchers held accountable and responsible for protecting privacy?(4)Are systems to protect medical records sufficiently secure?(5)Do researchers fully disclose the research being conducted and how medical records are used to conduct that research? Patients' trust in VA researchers was the most powerful determinant of the kind of control they want over their medical records. More specifically, those who had lower trust in VA researchers were more likely to recommend a more stringent process for obtaining individual consent. Insights on the critical role of trust suggest actions that researchers and others can take to more fully engage patients in research.