November 4, 2013
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Johns Hopkins bioethicist Nancy Kass is a guest editor of the AJPH special issue taking a comprehensive look at the current ethical landscape of human subjects research with minority populations
Remarkable improvements in the quality of life, prevention and treatment of disease have been made possible through advancements in biomedical research, including clinical trials involving human subjects. Future progress will depend in large measure on the inclusion of women and racial and ethnic minority populations into the research enterprise. Unfortunately, research abuses in the past have contributed to fear and mistrust among these populations resulting in regulatory measures designed to protect them due to their real or perceived “vulnerability.”
Increasingly groups seen as vulnerable are demanding access to the benefits of research and investigators are making progress in successful inclusion of women and minorities. This question of vulnerability is just one of many ethically relevant concepts raised in the current theme issue of the American Journal of Public Health, titled “The Ethics of Human Subjects Research on Minorities”.
“While there is growing attention to the participation of minority populations in research, there has been far less attention on the ethical issues raised through research recruitment, enrollment and engagement; our goal was to shine a spotlight on those issues in particular,” says Nancy E. Kass, ScD, one of three guest editors of the issue and the Deputy Director for Public Health at the Johns Hopkins Berman Institute of Bioethics.
The theme issue opens with an editorial by Kass and her co-guest editors Sandra C. Quinn, PhD, and Stephen B. Thomas, PhD, of the Maryland Center for Health Equity (M-CHE) at the University of Maryland School of Public Health. In their editorial, “Building Trust for Engagement of Minorities in Human Subjects Research: Is the Glass Half Full, Half Empty or the Wrong Size?” The editors contextualize the history of human subjects protections for “vulnerable persons,” recognizing that the protections themselves, while critically important and very successful, may also have limited the benefits of research among the populations that were “protected”. They discuss the progress we’ve made, the challenges still to be tackled, and propose a shift in the way researchers approach minority communities.
Other topics explored in the issue include recruitment of minority populations, community engagement, and training of researchers and health professionals in ethics and working with minority populations. Articles in the volume focus on specific populations including Native American and Alaskan Native populations, persons with disabilities, populations at risk of contracting HIV, and racial and ethnic minority populations.
The theme issue is one of the scholarly products made possible by the National Bioethics Research Infrastructure Initiative grant from the NIH-NIMHD, “Building Trust Between Minorities and Researchers ” awarded to the University of Maryland Center for Health Equity. The issue assembles a collection of peer-reviewed papers that explore the complexities involved in the ethical inclusion of minority populations in research and the challenges facing the nation in having a research enterprise that is both protective and inclusive of vulnerable groups. Additionally, contemporary research operates in the long shadow cast by the abuse of human subjects in research, Kass says.
Drs. Quinn, Kass, and Thomas are uniquely suited to guest editing this theme issue. Kass holds a joint appointment in Johns Hopkins’ Berman Institute of Bioethics and Bloomberg School of Public Health as the Phoebe R. Berman Professor of Bioethics and Public Health; she is a globally recognized public health expert and has served on international and national ethics committees, in addition to leading the Johns Hopkins-Fogarty African Bioethics Training Program for the last 13 years.
Quinn has extensive experience investigating the impact of disasters on preparedness of minority communities and the willingness of these groups to accept seasonal flu and other vaccines. Thomas is Professor and Founding Director of the Maryland Center for Health Equity at the University of Maryland School of Public Health and a recognized national expert on community engaged research. His work with Quinn on the legacy of the US Public Health Service Syphilis Study done at Tuskegee contributed to the 1997 Presidential Apology to survivors. Together Thomas and Quinn are principal investigators of the Building Trust project at M-CHE.
According to Dr. Thomas, “It is impressive how several of the articles call for the re-imagination of human subjects protections for vulnerable populations and a reengineering of the research enterprise to elevate the ‘community’ to be as important as the ‘individual’ when it comes to improving the informed consent process” he said.
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The full theme issue is available online now at http://ajph.aphapublications.org/
The print version will be available December 2013.
Funding for the theme issue was provided the by Award Number 7RC2MD004766 (Quinn & Thomas, Principal Investigators) from the National Institute on Minority Health and Health Disparities (NIMHD) and the Office of the Director, National Institutes of Health (NIH).
Matthew DeCamp, MD, PhD, a post-doctoral fellow at the Johns Hopkins Berman Institute of Bioethics, received an Excellence in Global Health Advising Award from the John Hopkins Center for Global Health. Dr. DeCamp advised and mentored Sam Enumah, a medical student, throughout the design and conduct of a project interviewing recipients of short-term medical aid in the Dominican Republic. Mr. Enumah nominated Dr. DeCamp, who was one of five honorees recognized by the Center and Johns Hopkins University President Ronald Daniels.
Mr. Enumah’s project was developed as part of the Scholarly Concentrations course required for all first year medical students; his particular concentration was co-directed by Berman Institute faculty members Joe Carrese and Gail Geller, titled “Medical Humanities, Bioethics and the Healing Arts.”
Bioethicists Call for Collaborative Consent To Ensure Ethical Practices While Leveraging The Web’s Research Potential
Status updates, patient forums, blog comments – among the incredible amount of personal information on the Web is a potential trove of health data. Bioethicists writing in Science Translational Medicine acknowledge the value of this resource but argue that to be ethically acceptable for use in research, traditional models of informed consent must be adapted to suit the dynamic online environment.
“Context is crucial to what people reveal about themselves on the Web, and it should be central to how informed consent is obtained,” says co-author Jeffrey Kahn, PhD, MPH, the Levi Professor of Bioethics and Public Policy at the Johns Hopkins Berman Institute of Bioethics. “The Web is inherently interactive, and that can be used in innovative ways to create a collaborative consent process that will build trust, a key element in making Web-based research more useful, more user-friendly and ultimately more respectful of the rights and interests of individuals whose information is collected,” Kahn says.
In the essay, titled Caught in the Web: Informed Consent for Online Health Research, Kahn and his co-authors argue that traditional approaches to informed consent for research do not translate effectively to research taking place in the online environment. Likewise, they say typical consent agreements found on the Web are opt-in or opt-out models used in consumer contexts, which do not meet the ethical standards for informed consent in research.
Kahn offers the scenario of a researcher collecting information openly shared on Facebook or a patient community forum, removing individuals’ names, and using that data in a study; did users who posted online give consent for such research use of their information? “The central ethical question is whether a person sharing information online in a non-research context has consented to research use of that information, and the answer is ‘no’,” Kahn says. “The Web should not be turned into the Wild West of health research; rather, its unique features must be used to effectively and creatively satisfy the ethical requirements of the research consent process,” he adds.
“At a minimum, transparent disclosure of the research uses of online personal data is required,” write Kahn and his co-authors, Effy Vayena, PhD, senior fellow at the Institute of Biomedical Ethics, University of Zurich, and Anna Mastroianni, JD, MPH, professor in the School of Law and Institute for Public Health Genetics, University of Washington.
The authors note a recent controversial proposal in the European Union on the processing and ‘free movement’ of data beyond the original context and intention of the Web user. The proposal includes a digital “right to be forgotten,” requiring that users have the option to permanently delete personal data from the Web.
“We want Web-based research to move forward, because it offers unprecedented depth and breadth of information, with potential applications to health research that will improve our understanding across a wide range of areas as we enter the age of Big Data,” Kahn says. “Giving users more control in a more robust and transparent consent process will build trust, which is crucial to all research, whether online or not.”
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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.