Implications for Precision Accelerated Clinically Embedded Research (PACER): a novel technology-enabled approach to conducting minimal-risk research in outpatient community healthcare settings

Barriers to effective, timely, and comprehensive clinical research include the slow pace at which studies progress from design to dissemination of results, challenges enrolling research participants, and lack of participant diversity. Recent advances in technology could help address these challenges, such as the Fast Health Interoperability Resources standards and Clinical Decision Support Hooks that support data acquisition, sharing, and expansion of research across organizations and disparate electronic health records. Precision Accelerated Clinically Embedded Research (PACER) is a theoretical approach that uses these technologies to enable scalable, efficient, and cost-effective clinical research by integrating very short, minimal-risk research activities into the clinical encounter. While PACER offers enormous potential, PACER also presents ethical, sociotechnical, and implementation challenges. The purpose of the current study was to obtain insights on the potential challenges presented by PACER. We conducted 47 qualitative semi-structured interviews with patients, clinicians, research experts (individuals involved in developing and conducting research), and bioethicists. We sought participants’ perspectives on the potential ethical, sociotechnical, and implementation issues raised by PACER. We identified five key domains: impact on clinical research, consent, compensation, impacts on people and organizations, and implementation.