Rethinking ethical oversight in the era of the learning health system
David A. Asch, Steven Joffe, Barbara E. Bierer, Sarah M. Greene, Tracy A. Lieu, Jodyn Platt, Danielle Whicher, Mahnoor Ahmed, Richard Platt
Abstract
Opportunities to advance science increasingly arise through investigations embedded within routine clinical practice in the form of learning health systems. Such activities challenge conventional approaches to research regulation that have not caught up with those opportunities, often imposing burdens generalized from riskier research. We analyze the rules and conventions in the US, demonstrating how even those rules are compatible with a much more flexible approach to participant risk, institutional oversight, participant consent, and disclosure for low-risk learning activities in all jurisdictions.
Topics & Concepts
Informed consentEngineering ethicsPsychologyBusinessPublic relationsKnowledge managementPolitical scienceMedicineComputer scienceAlternative medicineEngineeringPathologyEthics in Clinical ResearchEthics in medical practiceMedical Malpractice and Liability Issues