Research Ethics and Policy Series (REPS) | David A. Asch, MD, MBA
12:00pm - 1:00pm • via Zoom
2021-09-13 12:00:00 2021-09-13 13:00:00 America/New_York Research Ethics and Policy Series (REPS) | David A. Asch, MD, MBA Poking the bear vs wagging the dog: The upside-down world of low-risk research David A. Asch, MD, MBA John Morgan Professor, Medicine and Medical Ethics and Health Policy, and Executive Director, Penn Medicine, Center for Health Care Innovation, Perelman School of Medicine Professor, Health Care Management and Operations, Information and Decisions, Wharton School, University of Pennsylvania Monday, September 13, 12:00-1:00p Eastern Via Zoom. Register in advance: https://upenn.zoom.us/meeting/register/tJUqduGgqTosH9DfwQRQsK6kv56cWeSXIUTK The meeting link will be provided automatically upon registration. Abstract: The increasingly digital environment of health care facilitates pragmatic clinical research because often eligibility, interventions, and the measurement of study outcomes can occur automatically. These changes support faster and lower cost studies of unparalleled external validity. To the extent these studies are randomized trials, they also retain high internal validity. However, some investigators fear the additional patient consent burdens IRBs might impose on routine clinical care when it is paired with research. To avoid those anticipated burdens, investigators often propose weaker and less valuable investigative approaches that don’t ‘poke the bear’ of the IRB, even though patient risk is unchanged. These approaches put fears of regulatory burden ahead of considerations of study value or patient risk, and so reflect ‘the tail wagging the dog.’ These problems arise not because of regulation but because of human cognitive short cuts that misinterpret regulation—for example, the seemingly reflexive view that one must always require consent when patients are randomized. Both IRBs and clinical investigators should come to new understandings of how to take advantage of the opportunities of the learning health system while simultaneously protecting the safety and interests of participating patients. For more information, please contact Mary.Pham@pennmedicine.upenn.edu. via Zoom Penn Medical EthicsPoking the bear vs wagging the dog: The upside-down world of low-risk research
David A. Asch, MD, MBA
John Morgan Professor, Medicine and Medical Ethics and Health Policy, and Executive Director, Penn Medicine, Center for Health Care Innovation, Perelman School of Medicine
Professor, Health Care Management and Operations, Information and Decisions, Wharton School, University of Pennsylvania
Monday, September 13, 12:00-1:00p Eastern
Via Zoom. Register in advance:
https://upenn.zoom.us/meeting/register/tJUqduGgqTosH9DfwQRQsK6kv56cWeSXIUTK
The meeting link will be provided automatically upon registration.
Abstract: The increasingly digital environment of health care facilitates pragmatic clinical research because often eligibility, interventions, and the measurement of study outcomes can occur automatically. These changes support faster and lower cost studies of unparalleled external validity. To the extent these studies are randomized trials, they also retain high internal validity. However, some investigators fear the additional patient consent burdens IRBs might impose on routine clinical care when it is paired with research. To avoid those anticipated burdens, investigators often propose weaker and less valuable investigative approaches that don’t ‘poke the bear’ of the IRB, even though patient risk is unchanged. These approaches put fears of regulatory burden ahead of considerations of study value or patient risk, and so reflect ‘the tail wagging the dog.’ These problems arise not because of regulation but because of human cognitive short cuts that misinterpret regulation—for example, the seemingly reflexive view that one must always require consent when patients are randomized. Both IRBs and clinical investigators should come to new understandings of how to take advantage of the opportunities of the learning health system while simultaneously protecting the safety and interests of participating patients.
For more information, please contact Mary.Pham@pennmedicine.upenn.edu.