February 19, 2014
Media contact: Leah Ramsay 202.642.9640, firstname.lastname@example.org
Patient Consent to Research Not Always Necessary, Bioethicists Say
Under the right conditions, full informed consent is not ethically required for some types of health research, according to leading bioethics experts. The experts focus in particular on the comparison of common treatments in the February 20 issue of the New England Journal of Medicine (NEJM), arguing that in some cases a time-consuming consent process is not only unnecessary from the standpoint of protecting patients, but also potentially harmful to patients when it functions as an obstacle to gaining new knowledge that can improve the quality of the care patients receive.
The position is a considerable break from ethics principles that have guided research ethics and regulation for decades. The commentary addresses two concepts generating debate in the healthcare and bioethics fields: the idea of learning healthcare systems, as articulated by the Institute of Medicine (IOM), in which “continuous learning” from clinical practice feeds directly into improving future patient care; and randomized comparative effectiveness research (CER), in which patients are randomly assigned to different, widely used treatments for their condition – all of which are thought to be effective and safe – to determine which treatments work best for which patients.
“In a mature learning healthcare system with ethically robust oversight policies and practices, some randomized CER studies may justifiably proceed with a streamlined consent process and others may not require patient consent at all,” the commentary states.
However, the authors note that no such system exists today with fully developed ethical safeguards, including patient engagement, to allow a study impacting patient care to be ethically acceptable.
The commentary’s authors are thought leaders in the field of bioethics: Ruth R. Faden and Tom L. Beauchamp, co-authors of the book A History and Theory of Informed Consent, and Nancy E. Kass, an innovator in public health ethics and author of the widely referenced “Kass framework” for ethics analysis of public health programs. Beauchamp was also the principal author of The Belmont Report in 1978, which established the ethical principles that have formed the foundation of national and professional policy regarding research with human subjects in the decades since.
“Current consent and oversight practices too often overprotect patients from research that has little impact on what matters to patients, while in other cases oversight practices underprotect patients from medical errors and inappropriate medical management,” the commentary states, echoing concepts put forth in the authors’ previous publication on the topic, a two-article justification and ethical framework for a learning healthcare system, published in the Hastings Center Report in January 2013.
According to the commentary in NEJM, the necessary ethics oversight in the proposed learning healthcare system would require “significant patient engagement,” incorporating patients in significant numbers on ethics committees that approve research for one of three tiers of consent: 1) research that is determined to have no negative effects on clinical or other outcomes or values that matter to patients will proceed without consent but with “public notification” to the patient community in the healthcare system; 2) research determined to have minor but still meaningful effects on patients’ interests, will proceed with specific notification to affected patients, who will have an option to decline participation; and 3) research with potential negative impact will require written, informed consent from individual patients before proceeding.
The authors provide examples of research involving randomization they believe could qualify for the first two categories if a fully “ethically mature” learning healthcare system were in place, including studies comparing the effectiveness of using email or text messages as medication reminders to patients, or comparing two commonly used medications for hypertension, with physicians able to make alterations at any time.
Of the context for the creation of The Belmont Report and the policy it has influenced, Beauchamp, Faden and Kass write: “The current oversight system, requiring informed consent for most clinical research, grew out of a scandal-ridden period in which people were used in research and exposed to significant risk without their knowledge or consent,” referring to the oft-cited Tuskegee Syphilis Study and other lesser-known, unethical research that came to light in the 1960’s and ‘70s. “Our Common Purpose Framework builds on traditional principles of clinical and research ethics, including The Belmont Report, but is designed to provide guidance for activities where research and practice are integrated to enable rapid, systematic learning,” a concept more in step with today’s moral priorities of health care access and quality, and with the digital age’s ever-increasing data crunching and rapid sharing capacity.
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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:
- Respect the rights and dignity of patients
- Respect the clinical judgment of clinicians
- Provide optimal care to each patient
- Avoid imposing nonclinical risks and burdens on patients
- Address health inequalities among populations
- Conduct continuous learning activities that improve the quality of clinical care and health care systems
- 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.
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.