40 Years After Tuskegee: Reuniting Medical Research and Practice

Guidelines to protect human research subjects impede efficient generation and exchange of knowledge.

Darren Staples/Reuters

It is estimated that we lack sufficient scientific evidence about the effectiveness of over 50 percent of commonly used medical treatments, and that 100,000 patients die annually from healthcare acquired infections. The pressing need for better evidence on how to deliver medical care effectively, safely, and efficiently, however, is butting up against another moral imperative -- protecting patients from unethical research..

For almost forty years, maintaining a sharp distinction between medical research and medical practice has been the cornerstone of biomedical ethics and the federal regulations that oversee how research with human subjects is conducted. The need to build a firewall between research and practice emerged during a period of intense societal focus on egregious violations of human rights that occurred in research, including most notably the Tuskegee Syphilis Study. The dominant concern then was to protect patients and other subjects from risky and exploitative research.

Today, however, the segregation model we put in place to protect patients is actually harming them.

As an ethics scholar, my work is rarely described as "radical." But this week Nancy KassSteve GoodmanPeter PronovostSean TunisTom Beauchampand 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."

Presented by

Ruth Faden is the Wagley Professor of Biomedical Ethics and Director of the Johns Hopkins Berman Institute of Bioethics.  She is the co-author of Social Justice: The Moral Foundations of Public Health and Health Policy.

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