October 9, 2018: New Recommendations for Engaging Patients in Roles Other Than as Research Subjects

A panel funded by the Patient-Centered Outcomes Research Institute (PCORI) recently published recommendations for the oversight of patients who participate in research roles other than as “research subject.” Patients and caregivers participate in many roles, such as co-investigators, study personnel, and advisors in research studies, and this creates novel ethical and regulatory challenges. The panel provides a taxonomy for these roles and recommendations for appropriate oversight. The group also provides recommendations about identifying and engaging a diverse mix of patients and developing mechanisms to protect against possible conflicts of interest. Finally, given the ubiquity of mobile health and other emerging technologies for use by patients, the recommendations provide guidance about the inclusion of these technologies in patient-centered outcomes research, with specific attention to education, best practices, and appropriate privacy protections.

In an accompanying editorial, Dr. Robert Califf expressed his support for the panel’s efforts and their taxonomy for patients in patient-centered outcomes research:

“Given the persistent gap between the slow pace of research and the pressing need for high-quality evidence to guide practice in areas of clinical uncertainty on one hand, and the potential offered by more pragmatic, people-centered research methods on the other, we need positive approaches for making learning through research a routine part of clinical care rather than an exceptional event.”