Experts Aim to Redefine Healthcare and Research Ethics

January 11, 2013

Johns Hopkins bioethicists lead a call to reform the ethical foundation of the changing American healthcare system

In what they acknowledge as a seismic shift in the ethical foundation of medical research, practice and policy, a prominent group of interdisciplinary healthcare experts has rejected an ethical paradigm that has guided the American system since the 1970s.  A pair of articles in a special report from The Hastings Center Report calls for morally obligatory participation in a “learning healthcare system” more in step with the digital age, along with seven commentaries from other experts responding to their ideas.

In one article, the authors reject the bright-line distinction between medical research and patient care that has been central to the ethical underpinnings of federal human subject research regulations for decades. They argue that it is increasingly difficult to distinguish clinical research from practice and the daily operations of healthcare organizations, and that widely held assumptions about how research differs ethically from practice may be incorrect.  Specifically, the authors 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.

In today’s healthcare system, the labels “research” and “practice” are poor proxies for what should be our central moral concerns, the authors argue, and no longer serve as an effective guideline for what requires ethical oversight.  They point out, for example, that over 50 percent of medical treatments are used without sufficient proof of their effectiveness, and approximately 100,000 die annually from healthcare acquired infections.

“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,” says Nancy E. Kass, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics, and lead author of the article. “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,” the authors write.

Instead, the authors say that 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.

In their second article, the authors put forward a new ethical framework for the integration of research with practice in what the Institute of Medicine calls a learning healthcare system. The framework includes seven obligations, six of which fall on health professionals and institutions, and the 7th on patients:

  1. Respect the rights and dignity of patients
  2. Re­spect the clinical judgment of clinicians
  3. Provide opti­mal care to each patient
  4. Avoid imposing nonclinical risks and burdens on patients
  5. Address health inequalities among populations
  6. Conduct continuous learning activities that improve the quality of clinical care and health care systems
  7. Contribute to the common purpose of improving the quality and value of clinical care and health care systems

The framework includes familiar tenets of both medical and research ethics, but also new obligations that the authors acknowledge “substantially revise traditional conceptions” of the roles played by health systems, providers and patients. “In addition to long-standing ethical obligations to ensure that burdens and benefits of research are fairly distributed and that patients are appropriately respected, our ethical framework directs research towards aggressive efforts to reduce or eliminate unfair inequalities in health outcomes and in the evidence base for clinical decision-making,” notes Ruth R. Faden, director of the Johns Hopkins Berman Institute of Bioethics and lead author of the article outlining the framework.  Among the examples of unfair inequalities the authors say should be addressed by obligation five is the scarcity of evidence for managing chronic illness in pregnant women, as compared to other adults with the same conditions.  Women, and their children, would be well-served by a healthcare system that continually learns from patient care.

“The framework also challenges previous thinking in research and clinical ethics by calling for an ethical obligation on the part of clinicians, administrators, payors and purchasers to conduct research to improve health care quality and value, and on patients to contribute to such research,” says Faden. The authors write, “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.

The authors emphasize, however, that this is not a blanket obligation, regardless of risk.  Some kinds of medical research, such as early testing of drugs still unapproved by the Food and Drug Administration, are not included and should always proceed only with the express, voluntary informed consent of the patient, they say.  The patient obligation is focused on research that poses no additional risk beyond what patients face in clinical care, and would also exclude research that compares different types of treatments, for example, surgery to medical management.  The authors add that the framework also includes obligations to avoid imposing nonclinical risks and burdens on patients (4), and to protect their rights and interests (1).

“There is nearly universal agreement that we need to be able to efficiently learn about the effectiveness and safety of health care as an integral aspect of providing clinical care to patients,” said Sean Tunis, President and CEO of the Center for Medical Technology Policy. “We are hopeful that these papers and commentaries will help to focus and catalyze further debate, leading to changes in policy that accelerate learning while protecting patients.”

Extraordinary opportunities for learning are lost in our current system, the authors say, because physicians and researchers face significant hurdles in capturing the rich information generated from thousands of daily medical encounters with patients due to overly burdensome oversight and consent rules.  The new framework is intended to help reduce these hurdles.

The authors write that they expect their articles will spark debate, and hope they will move the transformation to a learning healthcare system forward, both in its ethical underpinnings and in practice.  They write, “We claim no more than a start on a subject that mer­its extensive investigation, and we welcome suggestions and commentary moving forward…We are in the early days of a progressive realization of a lofty aspirational goal, but given the preventable harm, waste, and uncertainty about clinical effectiveness in health care, efforts to accelerate learn­ing should be given high priority.”

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The authors’ work was supported by grant RC1RR028876 from the National Institutes of Health—National Center for Research Resources.

Media Contact:
Leah Ramsay

Ethical Oversight of Learning Health Care Systems, Hastings Center Report Special Report 43 (s1); January-February 2013.

The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight,Hastings Center Report Special Report 43(s1); s4-s15. January-February 2013

An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics, Hastings Center Report Special Report 43 (s1); s16-s27. January-February 2013.

Profile: Berman Institute Director Ruth Faden

Featured in the December 2012 Hadassah Magazine

By Barbara Pash

When Ruth Faden looks back on her long career, she can pinpoint the moment she decided to go into public health.

She was doing her master’s degree in American studies at the University of Chicago, working for a professor doing research on female contraception. Her job was to recruit young women to test a new intrauterine device. She considered volunteering to use the IUD herself. But when Faden told the professor—whom she remembers as a kind and caring person—his response shocked her: “Oh no, my dear,” he replied, “why don’t you wait until we know more.”

“It turned my world upside down,” says Faden, who was horrified that she had been recruiting women for such a risky project. She changed her course of study, and got a master’s and a doctoral degree in public health, both from the University of California Berkeley, and embarked on a new career.

Faden is the founder of Johns Hopkins Berman Institute of Bioethics, and has been the director since it opened in 1995. The institute focuses on the ethics of clinical practice, biomedical science and public health locally and globally, and engages students and policymakers in discussions of those issues. Located on the Johns Hopkins East Baltimore Medical Campus, site of Hopkins Hospital and Kennedy Krieger Institute, the institute, with a staff of over 30 core and affiliated faculty, is one of the largest such facilities in the world. Since inception, the institute has received more than $30 million in federal research funds and $49 million in philanthropic support.

Not only did she help found the premier institute on bioethics, Faden has also written seminal books in the field and won numerous awards, most recently the 2011 Lifetime Achievement Award granted to Faden and her husband, bioethicist Tom Beauchamp, by Public Responsibility in Medicine and Research, a nonprofit dedicated to advancing the highest ethical standards in the conduct of research. …

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