One of the Clinical Effectiveness Research Innovation Collaborative (CERIC) group’s priority actions is to create a supportive regulatory environment for learning activities that aim to provide evidence for healthcare improvement. In support of this goal, the National Academy of Medicine hosted a day-long meeting on January 25, 2018, to propose and communicate streamlined approaches for oversight of learning activities, informed consent, and privacy protection. The meeting attendees included key representatives from health systems, institutional review boards, patient groups, the Office for Human Research Protections (OHRP), and privacy experts. Dr. Richard Platt is a co-chair of the collaborative, and Dr. Jeremy Sugarman was part of a panel on the revisions to the Common Rule. Background materials for the meeting included articles from the Collaboratory Regulatory/Ethics Core’s special series in Clinical Trials. Meeting attendees sought to clarify regulatory barriers to embedding continuous learning activities in health systems, practices, and health plans and also to suggest possible solutions that would help streamline approaches in support of an enduring learning health system.
Participants discussed the grey area between quality improvement and research, and the differences in regulations for each. One critical issue that was identified is that the foundations of the current regulatory environment are built on the Belmont Report, a forty-year old document originally intended to prevent incidents like the Tuskegee Syphilis Study from ever happening again. While the ethical principles in the Belmont Report—respect for persons, beneficence, and justice—are still relevant today, much has changed since the original writing of the document. Healthcare is increasingly complex and conducted in a digital world, and bold ideas may be needed to create an alternate system for the betterment of all. Next steps for the group include the creation of a document that describes a framework for learning activities and includes a series of case examples for OHRP to review in order to provide clarification and answers to frequently asked questions (FAQs).