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Sixth International Conference on Ethical Issues in Biomedical Engineering

Sixth International Conference on Ethical Issues in Biomedical Engineering

Friday, April 1, 2011 - Sunday, April 3, 2011

Polytechnic Institute of NYU, 5 Metrotech Center, Brooklyn, NY, 11201

Presented By

Presented by SUNY Downstate Medical Center, Polytechnic Institute of New York University, and The New York Academy of Sciences


The field of biomedical research leads to new treatment modalities, many of which raise new ethical issues and demand the design and improved knowledge of ethical guidelines to be implemented.

Following five successful international conferences, The SUNY Downstate Medical Center, the Polytechnic Institute of New York University, and The New York Academy of Sciences are co-hosting a 3-day conference that aims to examine the ethical issues associated with the development of new implants, devices, and treatments to improve the quality of life of patients with devastating diseases. Biomedical engineers, philosophers, research scientists, lawyers, students, clinicians and representatives from industry and federal agencies will convene to explore ethical guidelines to address the controversial nature of many of these new exciting developments in biomedical engineering.

The conference will include keynote lectures, panel discussions, and presentations by invited speakers and individuals selected from submitted abstracts. In addition, the program will feature special sessions devoted to address: (i) ethical issues in Dentistry; (ii) the ethical challenges associated with Rehabilitation Engineering & Medicine; and (iii) Regulation and Reimbursement for Medical Devices.

Please note that 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, University, 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.

Read SUNY's Chancellor Nancy L. Zimpher's, Congressmember Yvette D. Clarke's and Senators Kirsten Gillibrand's and Charles E. Schumer's welcome letters to the attendees of the Sixth International Conference on Ethical Issues in Biomedical Engineering by clicking on the corresponding hyperlinks.

*Titles of the talks and names of additional invited speakers will be announced shortly.

The abstracts for this conference will be published as a special issue of the International Journal of Medical Implants and Devices that will be distributed at the conference. The authors are also encouraged to submit their papers for publication in Ethics in Biology, Engineering & Medicine, An International Journal. Click here for more information about submitting a manuscript to Ethics in Biology, Engineering & Medicine, An International Journal. 

Topical Areas of Interest:

•  Animal testing for medical devices
•  Clinical trials of biomedical devices and implants
•  Code of ethics for bioengineers
•  Ethical issues in biomedical research
•  Ethical issues in clinical engineering
•  Ethics issues in dentistry
•  Ethical issues in tissue engineering
•  Ethics of genetic engineering and cloning
•  Ethics of nanobiotechnology
•  Ethics of stem cell use and research
•  Marketing and regulation of impacts and devices
•  Medical liability reform
•  Privacy and Bioinformatics

Presented by


*Presentation times are subject to change.

Day 1: Friday, April 1, 2011

Location: The New York Marriott at the Brooklyn Bridge,
333 Adams Street, Brooklyn, NY 11201

5:00 PM - 8:00 PM

The New York Marriott at the Brooklyn Bridge

6:00 PM - 8:00 PM

The New York Marriott at the Brooklyn Bridge

Day 2: Saturday, April 2, 2011

Location: Pfizer Auditorium, Polytechnic Institute of New York University,
5 MetroTech Center, Brooklyn, NY 11201

7:30 AM - 4:00 PM


8:30 AM

Welcome and Introductions

8:45 AM

Keynote Address I
Management of Progressive Kidney Failure: Ethical Challenges
Eli A. Friedman, MD, MACP, FACP, SUNY Downstate Medical Center

9:30 AM

Subrata Saha, PhD, SUNY Downstate Medical Center

9:35 AM

Coffee Break

SESSION I: Advances in Biomedical Technology: Ethical Concerns I

Co-Chairs: Herbert Voigt, PhD, Boston University and Daniel Vallero, PhD, Duke University

10:00 AM

The Ethics of Synthetic Cells
Alan Warner, BA, University of Toronto, Toronto, Ontario, Canada

10:15 AM

The Presidential Commission for the Study of Bioethical Issues- the benefits, risks and Ethics of Synthetic Biology
Toni Van Pelt, Institute for Science and Human Values, Tampa

10:30 AM

An Integrated Approach to Combatting PTSD: The Need for Enhanced Education & Awareness Programs for the Military and First Responders on National, Community & Familial Levels
Warren S. Grundfest, MD, FACS, University of California, Los Angeles

10:45 AM

On the Environmental Impact of Ethics
Giles R. Scofield, JD, MA, University of Toronto; McMaster University, Toronto, Ontario, Canada

11:00 AM

Keynote Address II
All Hands on Deck: Regulating the Risk of Emerging Biotechnologies
Janice E. Graham, PhD, Dalhousie University, Halifax, Canada

12:00 PM

Lunch and Announcements

SESSION II: Medical Practice and Ethics

Co-Chairs: William Urban, MD, SUNY Downstate Medical Center and Charles Rosen, MD, University of California, Irvine

1:00 PM

The Association for Medical Ethics and the Physician Payment Sunshine Act
Charles Rosen, MD, University of California, Irvine

1:15 PM

Error-Provocative Designs in Medical Practice
Wade L. Robison, PhD, Rochester Institute of Technology

1:30 PM

Surgical Placebos in Clinical Research: Ethical Consideration
Vahid Entezari, MD, Beth Israel Deaconess Medical Center

1:45 PM

Ethics of End-of-Life Care: Reducing Communication Gaps Between Physicians, Patients and Families
Dustin Passigli, MA, SUNY Downstate Medical Center
Rishi Sarkar, MD, SUNY Downstate Medical Center

2:00 PM

Is There Truly Informed Consent in the Clinical uses of Ionizing Radiation?
Joseph A. Spadaro, PhD, SUNY Upstate Medical University

2:15 PM

Complex Tissue Transplantation: An Urgent Need for National Guidelines
Warren S. Grundfest, MD, FACS, University of California, Los Angeles

2:30 PM

Ethical Issues in Healthcare Delivery to Indigenous Population in Canada
Preeti Nayak, McMaster University, Hamilton, Ontario, Canada

2:45 PM

Trigeminal Neural Gia: An Elusive Diagnosis
Daniel Soeffing, JD, MBE, University of Pennsylvania Center for Bioethics

3:00 PM

Coffee Break

SESSION III: Regenerative Medicine, Nanotechnology and Ethics

Co-Chairs: Victor Goldburg, MD, Case Western Reserve University and Shankar. M. Krishnam, PhD, Wentworth Institute of Technology 

3:30 PM

INVITED TALK: Ethics as Meta-Engineering: A Novel Research Design for Anticipatory Governance in Tissue Biofabrication
Geroge Khushf, PhD, University of South Carolina

3:50 PM

Legal and Ethical Issues in Regenerative Nanomedicine
Linda MacDonald Glenn, JD, LLM, Albany Medical Center

4:05 PM

Understanding Ethics and Technical Knowledge in Regenerative Medicine: A Case Based Approach
Rosa L. Pinkus, PhD, University of Pittsburgh

4:30 PM

Ethical Challenges in Global Organ Trade
Sharmila Chatterjee, MBBS, George Washington University

4:45 PM

Neuroscience as Advanced Sciences’ Convergence: The Need For Pragmatism and Preparedness in Addressing Neuroethical Issues and Problems
James Giordano, PhD, Potomac Institute for Policy Studies and University of Oxford, Oxford, UK
Ashok Vaseashta, PhD, Institute for Advanced Sciences Convergence and International Clean Water Institute, NUARI

6:30 PM

Polytechnic Institute of New York University, Brooklyn, NY 11201

Day 3: Sunday, April 3, 2011

Location: Pfizer Auditorium, Polytechnic Institute of New York University,
5 MetroTech Center, Brooklyn, NY 11201

8:00 AM - 4:00 PM


8:00 AM

Keynote Address III
Why Our Ethics Curricula Don't Work
Charles N. Bertolami, DDS, DMedSc, College of Dentistry at New York University

SESSION IV: Symposium: Ethical Issues in Dentistry

Co-Chairs: Amit Chattopadhyay, PhD, National Institute of Dental and Crainiofacial Research, NIH and TBA

8:45 AM

Ethics of the "Lack of Evidence" in an Evidence Based Practice Era - The Case of Oral Cancer Screening
Amit Chattopadhyay, PhD, National Institute of Dental and Craniofacial Research, NIH

9:00 AM

Dental Registry and DNA Repository: Ethical Concepts Imposed on Reasons for Nonparticipation
David A. Anderson, DDS, MDS, University of Pittsburgh School of Dental Medicine

9:15 AM

Ethical Guidelines for the Quality Assessment of Oral Healthcare
Khushdeep Malhotra, BDS, MPH, National Institute of Dental and Craniofacial Research, NIH

9:30 AM

Radiation Exposure in Dentistry: Is There a Need for Concern?
Ajay Kashi, DDS, MS, PhD, University of Rochester Eastman Institute for Oral Health

9:45 AM

Need for Ethical Framework for Testing for Systemic Diseases in Dental Offices
Marushka Silveria, BDS, MPH, University of Massachusetts, Amherst

10:00 AM

Issues that Affect Recruitment of African American Applications to Dental School: A Qualitative Evaluation
Christine Wankiiri-Hale, DMD, University of Pittsburgh School of Dental Medicine

10:15 AM

Property and Privacy Paradigms of "Marketable Spit": An Ethical and Legal Counterpart to Blood?
Anthony Vernillo, DDS, PhD, MBE, New York University College of Dentistry

10:30 AM

Coffee Break

SESSION V: Advances in Biomedical Technology and Ethical Concerns

Co-Chairs: Mark Stewart, MD, PhD, SUNY Downstate Medical Center and Adrian R. Upton, MD, McMaster University, Hamilton, Ontario, Canada

11:00 AM

Brain Imaging in the "Real World" - What Limits Should be Placed on it?
Daniel D. Langleben, MD, University of Pennsylvania

11:20 AM

An Ancient Hindu Perspective on Suicide and Its Relevance for  Euthanasia and Physician Assisted Suicide
Kisor Kumar Chakrabarti, PhD, Davis and Elkins College

11:35 AM

Ethical Issues in Bioinformatics: Privacy and More
Bonnie Kaplan, PhD, FACMI, Yale University

11:50 AM

Organ Transplantation: Ethical Issues
Ana Lita, PhD, Appignani Bioethics Center

12:05 PM

INVITED TALK: New Technologies for Homeland Security: What are Their Ethical Implications?
Kenneth R. Foster, PhD, PE, University of Pennsylvania

12:20 PM

Attitudes Towards Ethical Issues in Biomedical Researches in Iran as a Developing Country
Hossein Dabiri, PhD, School of Medicine, Shaheed Beheshti University, MC, Tehran, Iran

12:35 PM

Lunch and Announcements

SESSION VI: Ethical Issues in Biomedical Research

Co-Chairs: Rena Bizios, PhD, University Texas at San Antonio and TBA

1:30 PM

The NIH Human Embryonic Stem Cell Eligibility Working Group: The First Year
Dena S. Davis, JD, PhD, Cleveland State University

1:45 PM

Presumed Consent in Research on Biological Material from Deceased Persons
Goran Mijaljica, MD, University of Split School of Medicine, Split, Croatia; Union Graduate College, Advanced Certificate Program in Research Ethics in Central and Eastern Europe

2:00 PM

Confronting Ethical Issues in Biomedical Research: A Problem-Based Learning Approach and Consulting Model
Roberta M. Berry, JD, PhD, Georgia Institute of Technology

2:15 PM

Regulatory Approval of New Vaccinomics Tests: Anticipating The Valley of Death
Yann Joly, PhD, McGill University, Montreal, Quebec, Canada

2:30 PM

Does Financial Conflicts of Interest Bias Research?: An Inquiry into the "Funding Effect" Hypothesis
Sheldon Krimsky, PhD, Tufts University

2:45 PM

Can Patents Shape The 'WHO', 'HOW', and 'WHAT' of Academic Science? Evidence from Cancer Epigenetics
Matthew Herder, JSM, Dalhousie University, Halifax, Nova Scotia, Canada

3:00 PM

"Genethics" and Commercial Society
Regi M. Cherian, Eberhard Karls University, Tuebingen, Germany

3:15 PM

The Ethics of Executive Compensation of Companies Marketing Medical Devices
Richard W. Treharne, PhD, University of Memphis

3:30 PM

Coffee Break

SESSION VII: Ethical Issues in Biomedical Engineering

Co-Chairs: Simon Ben Avi, PhD, Cooper Union and Subrata Saha, PhD, SUNY Downstate Medical Center

4:00 PM

INVITED TALK: Reintegrating the Ethics of Engineering and Medicine
Daniel A. Vallero, PhD, Duke University

4:20 PM

The Ethical Code for Medical and Biological Engineers Should Preclude Their Role in Juditial Execution
Herbert F. Voigt, PhD, Boston University

4:35 PM

Interrelation of Biomedical Engineering, Surgery and Ethics in Ancient India
Anindya Deb, PhD, Indian Institute of Science, Bangalore, India

4:50 PM

Innovation in Audiology; Ethical Considerations
Kerry Bowman, PhD, Mount Sinai Hospital, University of Toronto, Toronto, Ontario

5:05 PM

Beyond the Metaphor of Gift: Genetic Enhancement and its Impact on Human Autonomy
Michael Steinmann, PhD, Stevens Institute of Technology

5:20 PM

A Standard of Competency for Evaluating the Engineering Efficacy of Medical Devices
Anton E. Bowden, PhD, PE, Brigham Young University

5:35 PM

Is Human Enhancement also a Personal Matter?
Vincent Menuz, PhD, University of Montreal, Montréal, Quebec, Canada

5:45 PM

End of Conference


All posters should be set-up from 7:30 to 8:30 AM on Saturday, April 2nd, 2011 and removed at 4:00 PM on Sunday, April 3rd, 2011.


Conference Chair

Subrata Saha, PhD

SUNY Downstate Medical Center

Dr. Saha is presently the Director of Musculoskeletal Research and Research Professor in the Department of Orthopaedic Surgery & Rehabilitation Medicine at SUNY Downstate Medical Center in Brooklyn, New York. Dr. Saha received a BS in Civil Engineering from Calcutta University in 1963, an MS in Engineering Mechanics in 1969 from Tennessee Technological University, and Engineering and PhD degrees in Applied Mechanics from Stanford University in 1972 and 1974, respectively. He has been a faculty member at Yale University, Louisiana State University Medical Center, Loma Linda University, Clemson University, and Alfred University.

He has received numerous research grants from federal agencies (NIH and NSF), foundations, and industry. Dr. Saha is the founder of the Southern Biomedical Engineering Conference Series. He also started the International Conference on Ethical Issues in Biomedical Engineering. Dr. Saha has published over 90 papers in journals, 35 book chapters and edited volumes, 347 papers in conference proceedings, and 84 abstracts. His research interests are bone mechanics, biomaterials, orthopedic and dental implants, drug delivery systems, rehabilitation engineering, and bioethics.

Dr. Saha has received many awards from professional societies, including Orthopedic Implant Award, Dr. C. P. Sharma Award, Researcher of the Year Award, C. William Hall Research Award in Biomedical Engineering, Award for Faculty Excellence, Research Career Development Award from NIH, and Engineering Achievement Award. He is a Fellow of The Biomedical Engineering Society (BMES), The American Society of Mechanical Engineers (ASME), and the American Institute for Medical and Biological Engineering (AIMBE).

Dr. Saha is presently the Editor-in-Chief of the Journal of Long-Term Effects of Medical Implants and Associate Editor of the International Journal of Medical Implants & Devices and was an Associate Editor of the Annals of Biomedical Engineering and Trends in Biomaterials and Artificial Organs. He has been a Member of the Editorial Boards of many journals, including Journal of Biomedical Materials Research; Medical Engineering and Physics; Journal of Applied Biomaterials; Medical Design and Material; Biomaterials, Artificial Cells, and Immobilization Biotechnology; Biomaterials, Medical Device and Artificial Organs; Journal of Bioengineering, Biotelemetry and Patient Monitoring; Journal of Basic & Applied Biomedicine and TM Journal.

Keynote Speakers

Charles N. Bertolami, DDS, DMedSc

New York University

Dr. Bertolami, a leader in the dental research, education, and clinical communities, is Herman Robert Fox Dean of the New York University (NYU) College of Dentistry, the Nation's Largest Dental School. His research and scholarly interest has focused on orofacial tissue repair, the biochemistry of hyaluronic acid, the use of sodium hyaluronate in treatment of temporomandibular disorders, and professional ethics. He has been the recipient of and principal investigator on many research grants, and the author of numerous articles in scholarly and research publications.

Dr. Bertolami is also the recipient of many awards and honors. He is the President-elect of the American Dental Education Association and is the former President of the American Association for Dental Research. He has served as a two-term member of the Overseers' Visiting Committee for the Faculty of Medicine and Dental Medicine at Harvard; was named as Distinguished Alumnus of the Ohio State University College of Dentistry (1996); Distinguished Alumnus, Harvard School of Dental Medicine (2000); served as the Percy T. Phillips Visiting Professor at Columbia University (2002); named the Vincent A. Barr Visiting Professor at the University of Kentucky; and received the Paul Goldhaber Award of the Harvard School of Dental Medicine (2003). He co-chaired (with Harvard Medical School Dean, Joseph Martin) the NIDCR Blue Ribbon Panel on Research Training and Career Development (2000); co-chaired (with Peter Johnson) the NIH Workshop on Biomimetics, Tissue Engineering, and Biomaterials (1998); and chaired the American Association of Dental Schools (AADS) Committee on Future Faculty, 1998-99. He is currently co-chairing (with Wendy Mouradian) a joint ADEA-AAMC panel on joint curricular issues for dental and medical students. He is a diplomate of the American Board of Oral and Maxillofacial Surgeons, a Fellow of the American College of Dentists (FACD), and a Fellow of the International College of Dentists (FACD). He has been a frequently invited speaker for the Council for the Advancement and Support of Education (CASE), addressing deans and development officers on fundraising in higher education.

Prior to joining NYU in September 2001, Dr. Bertolami was Dean and Professor of Oral and Maxillofacial Surgery at the University of California-San Francisco School of Dentistry, posts he has held since 1995. A native Ohioan, Dr. Bertolami received his doctoral degree from Harvard in 1979, and received specialty training in the field of oral and maxillofacial surgery at the Massachusetts General Hospital.

Eli A. Friedman, MD, MACP, FACP

SUNY Downstate Medical Center

Eli A. Friedman is Distinguished Teaching Professor of Medicine, Chief, Division of Nephrology at SUNY Downstate. Dr. Friedman was Chief of the Division of Nephrology in SUNY Downstate's Department of Medicine until 2009.

In 1976, Dr. Friedman invented the "Suitcase Kidney," a portable dialysis machine scaled to fit a metal attache case that permits dialysis patients to be mobile performing their hemodialyses off site in hotel rooms or on ships. By being able to dialyze themselves, patients gained a large degree of freedom from large, centralized treatment centers enhancing their life quality.

Friedman's research focuses on kidney failure; he has performed clinical studies in the course of diabetes and high blood pressure. His work has been recognized by the American College of Physicians which conferred the distinction of terming him a "Master." He received two honorary degrees (Madras, India and Long Island University, New York) and has been made a Fellow of the Royal College of Physicians in the United Kingdom. Having edited nine books and published over 500 peer reviewed papers, Dr. Friedman is a recognized authority in Nephrology serving as President of several scientific societies including the American and International Societies for Artificial Organs and The International Society for Geriatric Nephrology and Urology. Dr. Friedman has been consistently listed as a "Best Doctor" in New York and the National and International Who's Who. Both the International Society for Hemodialysis and the Alumni Association of Downstate Medical Center awarded Lifetime Achievement Awards to Dr. Friedman who celebrated his 75th Birthday in 2008.

Janice Graham, PhD

Dalhousie University

Dr. Graham is Canada Research Chair in Bioethics and Scientific Director of the Technoscience and Regulation Research Unit (TRRU) and the Qualitative Research Commons & Studio (QuRCs) in the Faculty of Medicine at Dalhousie University, Halifax, Canada. As a medical anthropologist, Dr. Graham draws upon anthropology, science studies, technology assessment and bioethics to approach cultural, technical and moral issues in health. Challenges of safety, effectiveness, standardization, risk, and trust figure prominently into Dr. Graham's mapping of biotechnological innovation to health inequalities. Dr. Graham's work on Alzheimer's disease and other dementia diagnostics during the 90's led to an interest in the moral basis of profit when disease is seen as a market opportunity. She studies regulatory practices, diagnostic imaginaries, and databases as cultural texts. Her more recent ethnographic research examines safety and efficacy in the regulation of emerging biotherapeutics and vaccines at Health Canada and internationally.

Dr. Graham held a postdoctoral fellowship in geriatric medicine and neuroepidemiology (1996-8) at Dalhousie University, an endowed Research Chair in Medical Anthropology at the University of British Columbia (1998-2002), and a Canadian Institutes of Health Research New Investigator award (1999-2002). She has been a visiting senior fellow, BIOS Centre for the Study of Bioscience, Biomedicine, Biotechnology and Society, London School of Economics and Political Science, observer to Scientific and Technical meetings of the World Health Organization, and chaired the Health Canada Expert Advisory Panel on the Special Access Program.

Along with several book chapters, and a forthcoming edited book, Aging and Loss: Contesting the Dominant Paradigm, University of Toronto Press, her numerous articles have appeared in hight-impact scientific journals. Forthcoming research explores the development and introduction of a new conjugate vaccine in sub-Saharan Africa. She is the in-coming President of the Canadian Anthropology Society (2009-2010).

Invited Speakers

Kenneth R. Foster, PhD

University of Pennsylvania

Dr. Foster is Professor of Bioengineering, and Electrical and Systems Engineering at Penn Engineering, University Pennsylvania. Dr. Foster's research interests relate to biomedical applications of non-ionizing radiation from audio through microwave frequency ranges, and health and safety aspects of electromagnetic fields as they interact with the body. For example, he examines the prospects of workers in electrical occupations and the possibility (or lack of) cancer risk. Another and somewhat broader topic of interest is technological risk, and impact of technology (principally, electrotechnologies) on humans.  Dr. Foster's goal in this area is to examine technology, putting into perspective its relative risks and benefits to society.

George Khushf, PhD

University of South Carolina

Dr. Khushf is an Assistant Professor in the Department of Philosophy at the University of South Carolina. He has written extensively on medical ethics and served as the managing editor of the Journal of Medicine and Philosophy. Dr. Khushf is also the Humanities Director at the Center for Bioethics at USC. After receiving a B.S. (1983) in civil engineering at Texas A&M University, Dr. Khushf studied in religion and philosophy at Rice University, receiving an M.A. in 1990, and a PhD in 1993 and was a Fulbright Graduate Fellow in Philosophy at the University of Tübingen.. From 1993-95 he was the managing editor of The Journal of Medicine and Philosophy and a Research Associate at Baylor of Medicine. In Spring 1995 he was the Rockwell Visiting Scholar at the University of Houston. Since July 1995 he has served as Humanities Director of the Center for Bioethics, and as a faculty member of the Department of Philosophy, University of South Carolina. Recent activities have included service as co-chair of the Program Committee of the American Society for Bioethics and the Humanities, and as a consultant for the state of South Carolina strategic planning initiative in public health, developing a schema for integrating diverse health concepts that are implicit in various health agencies. Dr. Khushf serves on the editorial boards of five journals, and has published extensively in bioethics and the philosophy of medicine. Current research focuses on administrative and organizational ethics, concepts of health and disease, and medical epistemology.

Daniel Vallero, PhD

Duke University

Dr. Vallero is Adjunct Associate Professor at the Pratt School of Engineering, Duke University, where he conducts research focused on transport and transformation of organic compounds in environmental media, especially soil and the troposphere. He also leads the Pratt School's "Ethics across the Curriculum," which addresses ethics from introduction of academic integrity to first-year undergraduate students and throughout the students' academic and research experiences at Duke. He co-facilitates the Responsible Conduct of Research (RCR) training for all Duke PhD students actually or potentially engaged in research, and conducts research and develops teaching approaches related to macroethics of emerging technologies.


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.


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

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.