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Patient-Centered Outcomes Research: Stakeholder Perspectives and Ethical and Regulatory Oversight Issues

Abstract: The Patient-Centered Outcomes Research Institute (PCORI), the leading research institute in the United States for patient-centered outcomes research (PCOR), funded our multiyear mixed-methods project, the Patient Centered Outcomes Research Oversight Study, to begin systematically answering two crucial questions: What are the main ethical and regulatory oversight challenges for PCOR? And are those oversight challenges substantively new or different as compared with those arising in other types of research (therefore demanding new approaches), or are they simply familiar issues playing out in a new context (and therefore satisfactorily addressed within existing ethical and regulatory frameworks)? The qualitative data-gathering effort described here was primarily intended to inform a national survey of institutional review board chairpersons. These qualitative and quantitative efforts, in combination with a literature review, will ultimately form the basis for recommendations to facilitate appropriate ethical and regulatory oversight of PCOR, as well as inform a policy conference. Our preliminary data suggest that familiarity with PCOR is incomplete and that, while oversight challenges do arise, existing frameworks are likely adequate to address them. Additionally, our data raise a critical issue: for all the emphasis placed on patient engagement and for all the resources PCORI devotes to it, very few investigators reported that patient-centeredness was having any substantive impact on their studies.

Key words: patient-centered outcomes research (PCOR), Patient-Centered Outcomes Research Institute (PCORI), regulatory oversight of clinical research, patient perspectives, patient engagement