In what is acknowledged as a seismic shift in the ethical foundation of medical research, practice and policy, a prominent group of interdisciplinary healthcare experts, led by bioethicists at Johns Hopkins University, has called for morally obligatory participation in a “learning healthcare system” more in step with the digital age.
In an article contained in the proposal for a new ethical framework, which appear in a special report from The Hastings Center Report, the experts reject the bright-line distinction between medical research and patient care.
They challenge the assumption that participation in clinical research by definition offers patients less potential benefits and puts them at greater overall risk than clinical practice, as well as the assumption that research imposes more irrelevant burdens on patients.
They say in today’s healthcare system, the labels “research” and “practice” are poor proxies for what should be central moral concerns, and no longer serve as an effective guideline for what requires ethical oversight.
Specifically, they argue that far too often, doctors do their best but simply don’t have the information to tell them which approaches or treatments work best, and patients are suffering for that lack of knowledge.
“We’re finding that patients are both underprotected from risks in medical treatment and over-protected from low-risk quality-improvement research, bringing progress to a dangerous stalemate that is costing lives.”
They say healthcare should be moving toward a system in which clinical research and clinical practice are integrated, and every clinical encounter is simultaneously an opportunity to provide needed care to patients and also to learn from that to improve the care provided to future patients.