Online Program

Creating ongoing community-based governance for health research using fully identifiable medical records

Tuesday, November 5, 2013 : 1:00 p.m. - 1:15 p.m.

Barbara Koenig, PhD, Institute of Health & Aging, UCSF School of Nursing, San Francisco, CA
J. Eline Garrett, JD, Health Policy and Public Engagement Consultant, Minneapolis, MN
Lori Klein, Mayo Clinic, Rochester, MN
Walter Rocca, MD, MPH, Divisions of Epidemiology & Neurology; Co-Director, REP, Mayo Clinic, Rochester, MN
Jennifer St. Sauver, PhD, MPH, Division of Epidemiology, Mayo Clinic, Rochester, MN
Barbara Yawn, MD, MSc, Office of Research, Olmsted Medical Center, Rochester, MN
The ethical landscape for medical records research linked to population health outcomes, quality improvement, and patient safety is changing. The federal government has signaled its interest in revising the Common Rule. A special issue of the Hasting Center Report is devoted to discussing contradictions between failing to protect patients who receive unstudied therapies and stringent informed consent requirements that “over” protect research subjects participating in low risk, generalizable research using medical records. Based on the Rochester Epidemiology Project's (REP's) experience, we offer an alternative approach, one in which robust community-based governance complements an initial “opt out” research authorization process mandated by Minnesota state law. The REP links together the full medical records of Olmsted County, MN, residents for research purposes. The county is one of the few places in the US where longitudinal, population-based medical records studies can be conducted. In 2011, as the REP was expanding to additional counties, REP leadership sought to increase research practice transparency and transform its relationship with the community. We conducted a four-day deliberative democracy process to glean residents' recommendations for REP operations and expansion. Participants were recruited for diversity, so a full range of perspectives could be voiced. Participants were satisfied with REP's opt-out research authorization processes, so long as (1) REP improved its community education and, (2) REP formed a community advisory body to assure citizens' voices in governing the REP. We will report on REP's experience in forming a Community Advisory Board and launching a new model of medical records governance.

Learning Areas:

Ethics, professional and legal requirements
Public health or related research

Learning Objectives:
Discuss how a community governance model can be an ethically-robust alternative to individual patient control of access to medical records for population health research. Describe how a novel Community Advisory Board provides ongoing guidance about implementation of a state-mandated medical records research authorization process for medical-records based research. Identify the key features of a community governance model that reflects diverse perspectives and builds on voices expressed during a deliberative democracy process

Keyword(s): Research Ethics, Community Participation

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am a co-investigator of the Rochester Epidemiology Project, funded by a longstanding grant to Mayo Clinic from NIH. I was the leader of efforts to developing meaningful community engagement.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.