Sixth International Conference on Ethical Issues in Biomedical Engineering

Agenda

*Presentation times are subject to change.

Abstracts

Keynote Speakers

Ethical Stresses in Treating Kidney Failure

Eli A. Friedman, MD, SUNY, Downstate Medical Center

A recurring question raised by medical and surgical trainees participating in patient care and/or human investigation is: "Why is there a need for identifying ethics that are specific to human subjects of medical experimentation?" It is the intent of this presentation to proffer a rationale for and advantages of gaining understanding of key ethical issues arising when the subjects are human:

• Providing an analysis for decision-making in human research
• Considering benefits and risks of therapeutic options when treating kidney failure

A "benefit" is a positive effect such as life extension derived from a better therapeutic outcome—reducing the need for contemplated surgery. "Risks" of a treatment or study may range from minor, such as local pain at an injection site to major, including, as examples, convulsive seizures and even death in one in 1,000 subjects. Weighing risks relative to the probability of benefit often imposes an impossible task when a new drug or operative procedure is under initial study because neither all potential benefits nor risks can be known ahead of the study. An absolute requirement for human care or research is fully informed consent from the intended subject or legal guardian.

All Hands On Deck: Regulating the Risk of Emerging Biotechnologies

Janice Graham, PhD, Dalhousie University

The regulation of risk of emerging biotechnologies has been dominated by a technocratic approach that uses scientific evaluation to identify harms and protect citizens. Scientific uncertainty, however, has resulted in regulatory failures, where products have been licensed that result in deaths (e.g. Cox-2 inhibitors). Regulators, charged with having neglected the public, are reconsidering who should be responsible for the risk-benefit profile of products. At the same time as a series of policy initiatives encourage innovation, the regulatory approval process for new drugs and vaccines is being streamlined to ensure "faster access to the safe drugs [the public] needs." We might want to ask: Do policy initiatives to streamline and speed-up regulatory approval actually encourage innovation? Further, what are the roles of scientists and publics in regulatory decision-making? Does increasing access to the market and an emphasis on consumer choice sacrifice safety? Regulatory modernization is being carried out in several nations where strategic efforts are being advanced to open up, enable scrutiny and solicit input into decision-making from a broad range of citizens. Regulators are exploring new ways of working that include bringing in these different types of expertise to articulate real world concerns and implications of risk. Patient groups, community health workers, and members of the public are being called upon to provide evidence and assessment in the regulation of risk. This presentation draws upon a specific ethnographic case –modernization in the Canadian health products regulator – to examine the evolving role and nature of evidence. Exploring the process of modernization, it concludes with a suggestion for a symmetrical approach to evidence-based risk regulation.

Why Our Ethics Curricula Don't Work

Charles N. Bertolami, DDS, DMedSc, New York University

The impact of ethics curricula on professional school students seems marginal at best. Students take the ethics courses we offer and pass the tests we give but no one’s behavior seems to change as a result. Part of the reason may be that we teach about ethics as opposed to actually teaching ethics—and teaching it with a realistic expectation of behavioral change. Underlying this outcome might be the erroneous assumption that high intellect (a key criterion for admissions to professional or graduate school) somehow translates into ethical behavior. This presumption takes for granted buy-in by students into a shared set of ethical norms that they may not really accept. The result is that ethics instruction is initiated several steps beyond where students find themselves in terms of their own ethical formation. Much ends up being unsaid and unexplored. The premise of this presentation is that our ethics courses are inadequate in both content and form to the extent that they do not cultivate an introspective orientation to professional life. Thus, traditional approaches to other kinds of coursework may be singularly ineffective when it comes to teaching ethics. Reading assignments, lectures, group discussions, and case studies, followed by examination are not enough. Intelligent students easily pick up on what they are supposed to believe, but the approach does little to reveal what students do believe, let alone alter their belief structures in compelling ways. Fewer assumptions about a diverse student body’s antecedent ethical formation might be a good place to start, beginning with basics; inculcating a sense of ethics as a more generalized element of personal wellbeing—physical, mental, spiritual, and particularly social. Doing so requires ways of inspiring, captivating, and exciting students by formulating personal development schema. Peer evaluative approaches may be the single most robust way of doing so.

Speakers

Ethics as Meta-Engineering: A Novel Research Design for Anticipatory Governance in Tissue Biofabrication

George Khushf, PhD, University of South Carolina

A distinction can be drawn between "object level" activities of research and "subject level" activities. Object level activities are oriented toward the stated aims of the science and engineering practices; for example, understanding 3D vascular trees needed for the perfusion of organs and bioprinting such vascular trees. The language, formal tools, experimental methods, and technologies of science and engineering have been developed for efficiently and effectively advancing object level goals. In addition, researchers must engineer institutional and cultural conditions conductive to their own research. In this meta-engineering, they are engaged in an ethical practice: to foster a flourishing research community. The subject level activity is of vital importance in establishing new programs in emerging research areas, but it is rarely approached in the systematic, rigorous way that characterizes advancement of object level goals. Instead, subject level activities are promoted in an ad hoc manner, and success usually depends on the personalities of advocates and contingencies of the circumstances. This "art" is then conveyed to others in the way an older craft might be conveyed to an apprentice as part of a guild. When subject level activities have been studied, the humanities, social sciences, or business researchers conducting those studies rarely provide results that could assist those who promote that science. I report on an "upstream ethics project" that seeks to get past this "two cultures" split. By studying the subject level activities integral to a statewide, South Carolina tissue biofabrication initiative, we seek to assist scientists and engineers in developing governance strategies that both advance the object level goals and proactively address ethical and policy challenges arising from their research.

New Technologies for Homeland Security: What Are Their Ethical Implications?

Kenneth R. Foster, PhD, University of Pennsylvania

In response to homeland security concerns, new technologies are being developed for a host of security-related applications that are applications of biomedical engineering and medical imaging technologies. There is an urgent need to examine the ethical implications of these technologies, and indeed the whole process by which they are chosen and developed. In the present talk, I consider some ethical implications of X-ray backscatter machines that are now being deployed in US and other airports. Much of the public discussion surrounding the systems concerns privacy issues and, to a lesser extent, radiation exposure. But recently a more urgent issue came to public attention with both major public policy and ethical implications: the scanners can be easily fooled. This alarming conclusion was reported in a paper by Kaufman and Carlson (J. Trans. Secur. Online edition 25 November 2010). After analyzing the imaging capabilities of the systems, the authors concluded: "although images can be made at the exposure levels claimed ... detection of contraband can be foiled in these systems…a dangerous amount of plastic explosive with tapered edges [would be] difficult if not impossible to detect." The authors also report that thin metal objects such as box cutter blades or wires, if taped to the side of the body, could also escape detection. (As December 2010, the Transportation Security Administration (TSA) has not responded to that article.) One obvious issue is whether it is ethical to publish such findings, which involves finding a proper balance between the public’s right to know and maintaining security. A second, much larger, issue is what one might call the ethics of exaggerated expectation. Statements by TSA refer to the systems as "Advanced imaging technology"; demonstration of the systems employ simulated explosives in rectangular packages, and large metal objects that are quite unlike those that a terrorist cognizant of the Kaufman-Carlson work would probably employ. There is a real danger that high-technology for security applications may become what one security expert calls "security theatre", i.e. elaborate measures that give the appearance of increasing security in airports but in fact do not.

Reintegrating the Ethics of Engineering and Medicine

Daniel A. Vallero, PhD, Duke University, Pratt School of Engineering

"Bioethics" has lost some of its meaning since it was coined by Van Rensselaer Potter II (1911 - 2001) in the 1970s; now generally assumed to be a synonym for biomedical ethics. Originally, the term conveyed a sense of integration and systematic thinking in all decisions related to living things. Bioethics must be reconsidered with regard to its comprehensive roots which encompass moral decision making regarding both medicine and the environment. Human health is inextricably tied to the environment. Therefore, the ethics of the life sciences must be considered systematically in the search for proper means of intervention and prevention. Some challenges of medical practitioners and researchers are unique to their specialties. However, many ethical challenges are shared by all life scientists. Biomedicine and engineering share the objective of healthy human populations. Both apply the physical and biological sciences, albeit at different scales and complexity (e.g., physicians deal with one species and environmental scientists address many species). The discussion will explore numerous ways that the life sciences can be used within the boundaries established by the scientific method to improve the public's health and welfare and how this can be done both morally and practically.

Conference Location

Polytechnic Institute of NYU
Dibner Building
5 MetroTech Center
Brooklyn, NY, 11201

For directions, please visit the Polytechnic Institute of NYU

There will be no technical sessions  on Friday, April 1, 2011 except for a small reception & registration at the New York Marriott at the Brooklyn Bridge, 333, Adams Street, Brooklyn, NY 11201. Technical sessions will be held on April 2 and 3, 2011 at the Pfizer Auditorium, Polytechnic Institute of NYU, Universit y, 5 Metro Tech Center, Brooklyn, NY 11201. This also includes the Conference Banquet to be held on Saturday April 2, 2011 at Polytechnic Institute of NYU.

Hotel Information

New York Marriott at the Brooklyn Bridge
Website: http://brooklynmarriott.com

Phone: 718.246.7000
Fax: 718.222.6520

A block of rooms at the Marriott New York at the Brooklyn Bridge have been reserved at a special reduced rate of $189 (plus tax) per day for conference attendees during the conference

For reservations online click here
For reservations by phone Call the Toll Free number: 1-800-266-9432*

*mention the SUNY Downstate Medical Center Sixth International room block to receive the group discounted rate

Located within Renaissance Plaza, and across the street from Polytechnic Institute of NYU — located in MetroTech, the New York Marriott at the Brooklyn Bridge is 5 minutes from Manhattan and the Financial District, with 9 major subway lines all within one block. The New York Marriott at the Brooklyn Bridge is the only full service hotel in Brooklyn.