Healthcare systems and all who participate in them – providers, patients and administrators – have an obligation to pursue continuous quality improvement in order to quicken the pace of medical discovery, reduce harm to patients and improve the efficiency of care. To achieve these goals, traditional healthcare systems must transform into Learning Healthcare Systems that more seamlessly incorporate research into clinical care, continuously learn from daily patient-provider encounters, and use ever-expanding databases to inform patient assessment and treatment.
These activities raise thorny issues concerning the under and overprotection of human subjects, especially in healthcare settings where research has traditionally and formally been distinguished from treatment. Overprotective research ethics protocols can stall progress. Underprotection of human subjects exposes patients to significant risk without oversight.
The challenge faced by the LHS is to develop policies and procedures that maintain respect for human subjects and, at the same time, do not unnecessarily encumber the aggregation of data that allow investigations that lead to quality improvement.
The Center’s 30-year history in working with healthcare providers and consumers uniquely positions it to:
· Develop consensus and common definitions as to what constitutes “low risk, low-burden” research that may not require intense oversight;
· Raise public awareness of patient and provider responsibility to participate in research with great potential to improve quality; and
· Implement a communications strategy to engage providers and patients in a dialogue that results in their mutual understanding of roles they play in improving health outcomes and quality.
The Center has always served as an honest broker and convener in contentious cutting-edge bioethics issues and regional health care initiatives and stands poised and ready to help communities meet the obligations of Learning Healthcare Systems.
Learn more at http://www.PracticalBioethics.org