As an ethics scholar, my work is rarely described as "radical." But this week Nancy Kass, Steve Goodman, Peter Pronovost, Sean Tunis, Tom Beauchamp, and I published what some are calling a radical proposal to transform how we think about the roles
and responsibilities of pretty much everyone involved in health care -- health professionals, managers of hospitals and clinics, insurers, payers and yes,
even patients.
As we see it, research could provide us solutions to some of these pressing problems, but unfortunately, the current ethics model makes it difficult. Any
activity designed, even in part, to generate new knowledge about which common treatments really work or how to improve patient safety has to be separated
from practice. Once the activity is identified as "research," it is subject to special oversight regulations and requirements that medical practice is not.
The segregation model thus functions as an impediment to the efficient generation and exchange of knowledge, produced at little or no risk to patients, that is critically needed to improve the quality and safety of the care patients receive, and to increase the likelihood that the ethical goal of
universal access to healthcare becomes a reality.
So my colleagues and I are calling for the end of this segregation model, and
replacing it with a new ethics framework that has been designed specifically for the
integration of research with practice. A fundamental premise of the new framework is that every medical decision we, as patients, and our clinicians make,
and each episode of care we receive, should generate data and evidence that improve the care of patients who come after us; we then, in turn, benefit from
what is systematically learned from the care received by patients who come before us. Through continuous, real-time learning, we can provide better care to
more people, save lives, become smarter, and wring every dollar of value from the system. This is what the Institute of Medicine has dubbed the "learning healthcare system."
Our framework has two distinctive feature. First, it challenges the view that our thinking about how ethically to protect patients in healthcare oversight
should turn on whether an activity is called research or medical practice. Second, the framework sets a moral presumption in favor of learning in
healthcare, where health professionals and institutions have an obligation to conduct learning activities, and patients have an obligation to contribute to
these activities.
And, yes, this involves patients too. Just as health professionals and organizations have an obligation to learn, patients have an obligation to contribute
to, participate in, and otherwise facilitate learning that will improve the quality of the healthcare system. That obligation is not absolute, however,
regardless of risk. To be clear, our patient obligation is focused on research that poses no additional risk beyond what patients face in the course of
their medical treatment. Research that poses additional risk, for example, the testing of new drugs still unapproved by the Food and Drug Administration,
are not included under the obligation and should always proceed only with the express, voluntary informed consent of the patient. Also, under our new
framework, policies would be in place to ensure that patients understood what learning activities were underway in their doctor's offices or hospital, and
what measures are being taken to protect their interests and rights.
