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Governance of Learning Activities in Learning Health Care Systems

Hastings Investigators: Sarah McGraw and Mildred Z. Solomon

Funder: Patient Centered Outcomes Research Institute (PCORI) under subcontract from University of Pennsylvania

Research activities increasingly are integrated into health care, blurring the traditional boundaries between research, quality improvement, and clinical innovation. This shift means that oversight typically focused on individual research projects is no longer tenable; instead governance and oversight of learning activities must encompass the research infrastructure more broadly. Moreover, to ensure that learning activities address questions of importance to patients and safeguard patients’ interests, governance and oversight must be transparent and accountable to the communities served by a health care system.

The best models of governance and oversight of learning activities remain undefined. For this three-year project, The Hastings Center is part of a study group that will define governance structures and processes with learning health care systems, emphasizing the roles that patients, families, and community representatives play. The study group will use qualitative methods to examine how 16 exemplary learning health care systems across the United States govern their learning activities. These research methods will include interviews with individuals who hold key governance-related positions such as directors of institutional review boards and chairs of patient/family advisory councils, as well as focus groups with the patients and family members served by the learning health care systems. A stakeholder advisory board comprised of patient and institutional leaders will be involved in all stages of the study.