JOHNS HOPKINS BERMAN INSTITUTE OF BIOETHICS
Media Contact: Leah Ramsay
March 10, 2014
FOR IMMEDIATE RELEASE
Johns Hopkins Berman Institute of Bioethics Announces Andreas C. Dracopoulos Directorship
The Johns Hopkins Berman Institute of Bioethics has marked a major milestone in its history with the endowment of its directorship, ensuring leadership for the institute’s programs in perpetuity. Made possible by a gift from the long-time Berman Institute supporter and board member for whom it is named, the Andreas C. Dracopoulos Directorship further distinguishes the Berman Institute as the first center of bioethics scholarship known to have this type of endowed directorship.
“Mr. Dracopoulos’ extraordinary generosity further secures the Berman Institute’s future. It will enable us to multiply the impact of our work and mission, helping to shape and respond to the pressing bioethics issues of this generation, and those to come,” says Ruth R. Faden, Director of the Berman Institute and the Philip Franklin Wagley Professor of Biomedical Ethics.
“I don’t think of this donation as a gift, because the Berman Institute has earned this. Rather, I consider it a recognition of what the Institute has already achieved,” says Dracopoulos. “It’s my hope this will spur both the University and the Berman Institute to take bioethics at Johns Hopkins to the next level.”
Bioethics as a field is only a few generations old, and thus does not have the same history with philanthropists as other areas of health and academics, Faden explains. Generosity and foresight like Dracopoulos’ is helping to establish and fortify the field as a permanent feature of the academy, she says.
“We are truly grateful for Andreas’ extraordinary support of the Berman Institute. This gift embodies the depth of Andreas’ commitment to Berman’s pathbreaking work in bioethics, his vision for its continued success and, most importantly, his great humanity,” says Ronald J. Daniels, President of Johns Hopkins University.
In addition to serving on the Berman Institute’s Advisory Board, Dracopoulos is a member of the Johns Hopkins Board of Trustees. As president of the Stavros Niarchos Foundation, Dracopoulos has supported initiatives across the University, including seed money for the Berman Institute’s “rapid response” communications program, which facilitates the faculty’s timely public outreach on pressing bioethics issues as they arise. Globally, Dracopoulos and the Stavros Niarchos Foundation contribute to diverse efforts in health, education, social welfare and culture that they anticipate will have broad, lasting and positive social impact.
With more than 30 faculty members representing a range of disciplines including philosophy, medicine, public health, biomedical science, social science and law, the Berman Institute is one of the world’s largest and most distinguished centers of bioethics.
Johns Hopkins recognizes the Andreas C. Dracopoulos Directorship as a contribution to Rising to the Challenge: The Campaign for Johns Hopkins, an effort to raise $4.5 billion, primarily to support students, faculty, and clinicians and interdisciplinary solutions to some of humanity’s most important problems. The campaign, supporting both Johns Hopkins University and Johns Hopkins Medicine, was publicly launched in May 2013 and is targeted for completion in 2017. Including the Dracopoulos gift, more than $2.4 billion has been committed so far.
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February 19, 2014
Media contact: Leah Ramsay 202.642.9640, email@example.com
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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Johns Hopkins bioethicists lead a call to reform the ethical foundation of the changing American healthcare system, with new ethical obligations on providers, administrators and patients.
Experts from across disciplines at Johns Hopkins will hold a symposium on Thursday, April 11, 2013 to discuss changes to medical ethics paradigms as proposed by their own bioethics colleagues in a recent, groundbreaking publication.
“The labels ‘research’ and ‘practice’ are poor proxies for what should be our central moral concerns, and they no longer serve the purpose they did three or four decades ago,” wrote an interdisciplinary team led by Johns Hopkins bioethicists in a Hastings Center Report special report earlier this year, “Ethical Oversight of Learning Healthcare Systems.” Current guidelines and policy for oversight of research with human subjects were drafted by a national commission in the 1970s, in response to public outcry over questionable research, including the now-infamous Tuskegee Syphilis Study.
Ruth R. Faden, director of the Johns Hopkins Berman Institute of Bioethics, and Nancy E. Kass, the Berman Institute’s deputy director for public health, will present their new ethical concept to colleagues in an effort to foster internal dialogue on the ethical foundation of a ‘learning healthcare system,’ as defined by the Institute of Medicine.
“Our framework 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.
“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 Kass. Her and Faden’s presentations at the symposium will be followed by a panel discussion with Daniel Ford, Vice Dean for Clinical Investigation in the Johns Hopkins School of Medicine; Jodi Segal, co-director of the Center for Drug Safety and Effectiveness at the Johns Hopkins Bloomberg School of Public Health; Peter Terry, professor of medicine; and Elliott R. Haut, associate professor of surgery.
“We’re finding that patients are both under-protected from risks in medical treatment and over-protected from low-risk quality-improvement research, bringing progress to a dangerous stalemate that is costing lives,” Kass and Faden’s team wrote in the Hastings Center Report.
The ethics symposium is presented jointly by the Institute for Clinical and Translational Research (ICTR), the Johns Hopkins Berman Institute of Bioethics and The Center for Health Services and Outcomes Research (CHSOR). It will be held on the Johns Hopkins East Baltimore medical campus, from 8:00-10:00 AM on Thursday, April 11, 2013. To attend please contact Leah Ramsay at Lramsay@jhu.edu.
Special Report: “Ethical Oversight of Learning Health Care Systems” Hastings Center Report 43, no. 1 (2013): S1-S44.
Johns Hopkins Berman Institute of Bioethics
Media Contact: Leah Ramsay