Ethics and Quality Improvement
Selected resources from The Hastings Center.
The American health care system has serious problems with quality and safety that can be reduced through quality improvement (QI) activities. QI uses data-based methods to bring about immediate improvements in health care delivery. There is substantial uncertainty about the relationship between QI and the federal regulations for human subjects research. Read our briefing to consider: What are the ethical requirements and regulatory processes for QI?
From Hastings Bioethics Forum:
- FDA Proposal for Regulating Laboratory Diagnostics Could Improve Patient CareWendy Chung’s commentary last month about the FDA’s proposed draft guidance for the regulation of laboratory-developed tests (LDTs) is heavily critical of the agency’s plans. Professor Chung argues that the FDA’s involvement in this space will have two primary negative consequences: it will stifle innovation and it will harm patient care. But the FDA’s proposal seems designed…
- New Bioethics Education Resources: Read about Them Here; Find Them When the Government Shutdown Is OverThe Presidential Commission for the Study of Bioethical Issues recently announced its release of new, free materials for bioethics education. The educational materials were available for download on the commission’s website, bioethics.gov, until 12:01 AM on October 1, when the government shut down and bioethics.gov went dark. But you don’t have to wait until the government…
From Hastings Center Report:
First published: 20 August 2019
In 2012, a U.S. Institute of Medicine report called for a different approach to health care: “Left unchanged, health care will continue to underperform; cause unnecessary harm; and strain national, state, and family budgets.” The answer, they suggested, would be a “continuously learning” health system. Ethicists and researchers urged the creation of “learning health organizations” that would integrate knowledge from patient-care data to continuously improve the quality of care. Our experience with an ongoing research study on atrial fibrillation—a trial known as IMPACT-AFib—gave us some insight into one of the challenges that will have to be dealt with in creating these organizations. Although the proposed educational intervention study placed no restrictions on what providers and health plans could do, the oversight team argued that the ethical principle of beneficence did not allow the researchers to be “bystanders” in relation to a control group receiving suboptimal care. In response, the researchers designed a “workaround” that allowed the project to go forward. We believe the experience suggests that what we call “bystander ethics” will create challenges for the kinds of quality improvement research that LHOs are designed to do.
First published: 19 February 2019
The view that research with competent adults requires valid consent to be ethical perhaps finds its clearest expression in the Nuremberg Code, whose famous first principle asserts that “the voluntary consent of the human subject is absolutely essential.” In a similar vein, the United Nations International Covenant on Civil and Political Rights states that “no one shall be subjected without his free consent to medical or scientific experimentation.” Yet although some formulations of the consent principle allow no exceptions, others hold that informed consent is not always strictly necessary for ethical research. The U.S. federal regulations known as the “Common Rule,” which govern research with human subjects, lists several conditions for waiving consent. However, neither guidance documents on the ethics of clinical research nor the literature in bioethics contains a general justification of research without consent. The purpose of this paper is to advance a justificatory framework that will explain why research without consent is permissible in paradigmatic cases and that can be useful in analyzing cases about which there is (or is likely to be) disagreement. We argue that research without consent can be justified on two grounds: if it stands to infringe no right of the participants and obtaining consent is impracticable, or if the gravity of the rights infringement is minor and outweighed by the expected social value of the research and obtaining consent is impracticable.
First published: 07 July 2015
Many major medical institutions have now embraced the idea that it is best to be honest with patients and families when an error causes harm that could have been avoided. This kind of disclosure improves patient safety and quality of care; enhances satisfaction for patients, families, and providers; and reduces malpractice litigation costs. The University of Michigan has perhaps the best-known program. Since 2001, that institution has seen more than a 55 percent drop in the number of new malpractice claims filed, a comparable reduction in lawsuits, and a dramatic drop in both defense costs and malpractice payouts—money then redirected toward quality improvement. A few states have also embraced this approach, sometimes known as “Candor” (for “communication and optimal resolution”). Yet all of these efforts face a major challenge. Although many physicians would like very much to achieve insight, reconciliation, and quality improvement in just this way, many fear that money paid to resolve an incident in which they were involved can result in a lifelong black mark in the National Practitioner Data Bank.
First published: 11 January 2013
The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. There has been progress in realizing the IOM’s vision, but also many challenges. One of these challenges has been lingering uncertainty about whether the data collection and monitoring central to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems. Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void.
The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight
First published: 11 January 2013
The rise of quality improvement research and comparative effectiveness research in health care settings constitutes progress toward the goal of what the Institute of Medicine has called a “learning healthcare system,” in which we are “drawing research closer to clinical practice by building knowledge development and application into each stage of the healthcare delivery process.” As clinical research and clinical practice move closer to a deliberately integrated system, the distinction between the two is increasingly blurred, although the sharp distinction in U.S. regulations and research ethics literature remains in place. In the 1970s and for two decades thereafter, this distinction was helpful: for some forms of research, it sheds light on which activities require ethical oversight. Research that is closely integrated with health care—notably, health delivery research—was then uncommon, however. That is no longer the case, and regulations and research ethics need to change to accommodate the new landscape.
In this paper, we argue that conceptual, moral, and empirical problems surround the received view that we can and should draw sharp distinctions between clinical research and clinical practice. We start with the history of the research-practice distinction in the reports of a U.S. national commission and in U.S. federal regulations, and then offer a critical assessment of five characterizations of research that have been used in policy documents and the scholarly literature to try to make a sharp distinction between research and practice. We challenge the clarity and the tenability of these characterizations as a way of distinguishing research from practice. We argue that the received view of the research-practice distinction leads to overprotection of the rights and interests of patients in some cases and to underprotection in others. We contend that a new ethical foundation needs to be developed that facilitates both care and research likely to benefit patients, and that provides oversight that, rather than being based on a distinction between research and practice, is commensurate with risk and burden in both realms.
First published: 11 January 2013
The papers by Nancy Kass, Ruth Faden, and colleagues describe an ethical imperative to study clinical care as it is being delivered. The goal of learning from each patient is attractive, but integrating research and clinical practice is not easy. The authors suggest that the bioethical framework in use for the past forty years to oversee clinical research may be as much an impediment to the development of a learning health care system as a means of protecting the interests of patients. This framework draws a bright line between clinical research and clinical care activities, subjecting clinical research to institutional review and ongoing oversight while assuming that clinical care is conducted primarily in the interests of patients and not in need of additional ethical oversight. The authors identify five characteristics that have been used to distinguish the two activities, and they conclude that none succeed. The practical implications of this conclusion are left unspecified, however. Should ethical oversight simply be eliminated for these kinds of research activities on the grounds that oversight is not mandated for clinical care and the two cannot be distinguished?
An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics
First published: 11 January 2013
Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion.
First published: 11 January 2013
Understanding the components of clinical care that work best is a cornerstone of improving health care. And yet, the more we improve the quality of quality improvement and move to continuous learning about clinical care more broadly, the more we find ourselves in a regulatory environment that makes evaluation more difficult, expensive, and, in some situations, impossible. In their paper on the ethical underpinnings of the distinction between research and treatment, Ruth Faden and colleagues raise important implications for a wide array of situations. These points give reason to rethink the definition of routine clinical operations to include evaluation of the processes and outcomes of care and dissemination of findings. We concur with the assertion by Faden and colleagues, and with previous work from The Hastings Center, that conducting continuous improvement activities such as these is an obligation of health systems and clinicians. We believe that rigorous, systematic evaluation should be considered part of normal, expected operations, rather than exceptional behavior that requires extraordinary regulatory control.
First published: March 2008
As soon as I read the headline, I thought, here we go again. As a former director of the Office for Human Research Protections at the Department of Health and Human Services, I was hardly surprised when several colleagues sent me the op-ed by Atul Gawande in the New York Times last December called “A Lifesaving Checklist.” Dr. Gawande, a surgeon at Brigham and Women’s Hospital in Boston and staff writer at the New Yorker, suggested that the federal agency responsible for protection of human subjects in research had gone too far—over the bureaucratic edge. Perhaps he was right, but his representation of the facts was not, as OHRP was quick to point out in a statement of its own. OHRP’s statement did not evoke the energetic public response that Gawande’s did, but then facts have a way of being complicated and nuanced, making drama a bit harder.
First published: March 2008
Ever greater numbers of us will be asked at some point in our lives to participate in a research study. We might be invited to participate in surveys and focus groups, asked to let researchers conduct studies with our tissue or medical information, or recruited for clinical trials that test whether drugs, medical devices, or biologics—like vaccines and genetic materials—are safe or effective. One company involved in recruiting human subjects estimated that the number of participants needed to fill industry-sponsored trials grew from 2.8 million in 1999 to 19.8 million in 2005. There is also a growing need for children, the elderly, and people with certain diseases to enroll in studies that test interventions targeted to those populations. The very fact that record numbers of people are being recruited for research makes thoughtful attention to how we safeguard human subjects of the utmost importance. On top of that, though, there are problems with the current regulatory system.
First published: January 2007
Two years ago I had a great idea. I was able to put two disparate thoughts together in the same sector of my brain. One thought was that the low-income patients of my health center needed a place to exercise at no cost. The other was that the local YWCA, where I had been exercising for twenty years, offered institutional memberships to local agencies, like day care centers, which used these memberships as a staff benefit or incentive. My idea was to purchase institutional memberships for our patients as a new intervention that we could offer in the management of chronic disease.
First published: July 2006
To speak of improving health care delivery is to call for “cultural change.” Hospitals are urged to nurture a “culture of safety” with respect to the need for error prevention and reduction, and a “blame-free culture” with respect to the just resolution of medical injuries. Institutions and professions are encouraged to build a “culture of quality improvement,” in which QI is understood as a continuous activity and obligation. These are essential goals—ones that recognize that safety and quality improvements cannot operate as discrete entities, but must be integrated into larger systems, which in turn are informed by cultural norms. Change the culture, and you change the system.
2002: Publication of: Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct
The Committee on Assessing Integrity in Research Environments, the National Research Council, and the Institute of Medicine develop a report that stresses the important role that research institutions play in providing an integrity-rich environment. Recommendations included the following:
- Funding agencies should establish research grant programs to identify, measure, and assess the factors that influence integrity in research.
- Research institution should (a) develop and implement a comprehensive program designed to promote integrity in research, (b) implement effective educational programs that enhance the responsible conduct of research, (c) evaluate and enhance the integrity of their research environments using a process of continuous quality improvement including self-assessment and external peer review, and (d) include institutional self-assessment of integrity in research as part of existing accreditation processes whenever possible.
- Office of Research Integrity (ORI) should establish and maintain a public database of institutions that are actively pursuing or employing institutional self-assessment and external peer-review of integrity in research.
The National Center for Ethics in Health Care at the Veterans Health Administration launches IntegratedEthics® Program. The program was designed to establish a national, standardized, comprehensive, systematic, integrated approach to ethics in health care. The national education and organizational change initiative is based on established criteria for performance excellence in health care organizations, methods of continuous quality improvement, and proven strategies for organizational change. The goal is to support, maintain, and improve ethics quality in health care.
E. Fox et al., “IntegratedEthics: An Innovative Program to Improve Ethics Quality in Health Care,” Innovation Journal 15, no. 2 (2010): 1-36.