THE FOURTHINTERNATIONAL

CONFERENCE ONETHICAL ISSUES

IN BIOMEDICALENGINEERING

THE FOURTHINTERNATIONAL

CONFERENCE ONETHICAL ISSUES

IN BIOMEDICALENGINEERING

APRIL 20-22 , 2007

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Department of Orthopaedic Surgery & Rehabilitation MedicineSUNY Downstate Medical Center450 Clarkson Avenue - Box 30Brooklyn, New York 11203

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Registration Fee $200.00

*One-day registration $150.00

*Student registration $ 90.00

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Please complete this form and mail or Fax to:Subrata Saha, Ph.D. Conference ChairDepar tment of Or thopaedic Surger y & Rehabili tat ion MedicineSUNY Downstate Medical Center450 Clarkson Avenue - Box 30Brooklyn, New York 11203 Fax - (718)-270-3983

Conference Registration FormConference Date: April 20 - 22, 2007

Conference Site: Poly technic Universi t y5 Metrotech Center, Brooklyn, NY 11201

4th INTERNATIONAL CONFERENCE ON ETHICAL ISSUES IN BIOMEDICAL ENGINEERING

or go to website:ht tp://138.5.102.101/grad/bmephd/Ethics2007.pdfht tp://www.poly.edu/graduate/bioethics2007/

Welcome from the Conference Chair

I am pleased to welcome you to the Four th Internat ionalConference on Ethical Issues in Biomedical Engineering.Our goal is to bring together biomedical engineers,philosophers, research scient ists, lawyers, students,clinicians and representat ives from the industr y and federalagencies to discuss the ethical issues that face us as wedevelop new implants, devices and treatments to improvethe quali t y of life of our pat ients. The papers to bepresented represent a broad range of topics reflect ing theexci t ing, but sometimes controversial nature of many of thenew developments in biomedical engineering.

We are for tunate that the SUNY Downstate Medical Centerand Poly technic Universi t y have sponsored this conference.We are grateful for the f inancial suppor t f rom theConversat ions in the Disciplines Program of the StateUniversi t y of New York (SUNY), Ci t y College of New Yorkand several other companies.

Many people contributed to the success of this conference.I would like to thank the Local Program Commit tee, theauthors, session moderators, panel members, and thekeynote speakers, Drs. George Bugliarello, Gregor yEastwood, and William Hendee. I am indebted to Mr.Westley Hayes and Dr. Ajay Kashi for their hard work tomake this conference a success. The abstracts f rom thisconference will be published in a special issue of theInternat ional Journal of Medical Implants and Devices thatwill be distr ibuted at the conference. I am grateful to Dr.Jafar Vossoughi, the Edi tor of this journal, for his help inpublishing this special issue.

I am convinced that you shall f ind this conferenceintellectually st imulat ing and a highly enjoyable experience.Welcome to Brooklyn, New York.

Subrata Saha

Subrata Saha, Ph.D., Conference ChairDepar tment of Or thopaedic Surger y & Rehabili tat ion MedicineSUNY Downstate Medical CenterBrooklyn, New York 11203

Accreditation Statement This act ivi t y has been planned and implemented in accordancewith the Essent ial Areas and policies of the Accredi tat ionCouncil for Cont inuing Medical Educat ion through the jointsponsorship of the State Universi t y of New York (SUNY)Downstate Medical Center and Poly technic Universi t y. SUNYDownstate Medical Center is accredi ted by the Accredi tat ionCouncil for Cont inuing Medical Educat ion (ACCME) to providecont inuing medical educat ion for physicians. SUNY DownstateMedical Center designates this cont inuing medical educat ionact ivi t y for a maximum of 17.5 AMA PRA Categor y 1CreditsTM. Physicians should only claim credi t commensuratewith the extent of their par t icipat ion in the act ivi t y.

CME Disclaimer StatementSUNY Downstate Medical Center and i ts af filiates arecommit ted to providing educational activi t ies that areobjective, balanced and as free of bias as possible. Allpar t icipating facult y are expected to disclose to theaudience, verbally or in wri t ing, any commercial relat ionshipsthat might be perceived as a real or apparent conflict ofinterest related to the content of their presentat ions, i.e. withcompanies whose products or ser vices are related to thesubject mat ter of the presentat ion; or products in theresearch and development phase.

Special NeedsIn accordance with the Americans with Disabili t ies Act(ADA), SUNY Downstate Medical Center seeks to make thisconference accessible to all. If you have a disabili t y whichmight require special accommodations, please contact Dr. Subrata Saha, Phone: (718)-613-8652,Subrata.Saha@downstate.edu.

Needs StatementThe field of biomedical research leads to new treatmentmodali t ies and the leadership at SUNY Downstate MedicalCenter and Poly technic Universi t y saw the need for aworkshop to update the medical and scient if ic communit yin Brooklyn and the tr i-state area of the ethical guidelinesthat need to be followed.

Educational ObjectivesAt the conclusion of this workshop, par t icipants will:• be aware of ethical guidelines for new potent ial treatment

modali t ies• be aware of ethical issues involved in clinical tr ials and

animal experiments• be aware of conflict of interest and regulator y issues for

new devices

Target AudienceAll pract icing physicians, research scient ists, physicaltherapists, professors, and students

Reception and Banquet will be held at:

The New York Marriot t at the Brooklyn Bridge, 333Adams Street, Brooklyn, NY 11201

Technical Programs will be held at:

Dibner Auditorium, Poly technic Universi t y, 5 MetroTechCenter, Brooklyn, NY 11201

Site Map

Hotel InformationLocated within Renaissance Pla za, and across the streetfrom Poly technic Universi t y - located in MetroTech, theNew York Marriot t at the Brooklyn Bridge is 5 minutes fromManhat tan and the Financial Distr ict, wi th 9 major subwaylines all wi thin one block. The New York Marriot t at theBrooklyn Bridge is the only full ser vice hotel in Brooklyn. A block of rooms at the Marriot t New York at the BrooklynBridge have been reser ved at a special reduced rate of$179 per day for conference at tendees during theconference. To receive this special rate, please mention“Ethics Conference” while booking the room. Please notethat this special rate is valid unt il April 6th, 2007.

Call for Reser vations: Toll Free: (888)-436-3759 Phone: (718)-246-7000 Fax: (718)-222-6520 Website - http://brooklynmarriott.com

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Friday, April 20, 2007Marriot t in Brooklyn, 333 Adams Street, Brooklyn, NY 11201

6:00–8:00pm Registration and ReceptionThe New York Marriot t at the Brooklyn Bridge

Saturday, April 21, 2007Dibner Auditorium, Poly technic Universi t y, 5 MetroTech Center,Brooklyn, NY 11201

8:00am–4:00pm Registration

9:00 – 9:15am Welcome & IntroductionsJohn R. Ryan, Vice Admiral, USN (Ret)Chancellor, State Universi t y of New York.Albany, NY 12246

John C. LaRosa, M.D.President, SUNY Downstate Medical Center, Brooklyn, NY 11203

Jerr y MacAr thur Hult inPresident, Poly technic Universi t y, Brooklyn, NY 11201

9:15 – 9:20am AnnouncementsSubrata Saha, Ph.D. Conference ChairDirector of Musculoskeletal ResearchSUNY Downstate Medical Center, Brooklyn, NY 11203

9:20 – 10:00am Keynote AddressBiomedical Engineering Ethics and Cultural SpecificityGeorge Bugliarello, Ph.D.President Emeri tus and Universi t y ProfessorPoly technic Universi t y, Brooklyn, NY 11201

10:00 – 10.30am Coffee Break

10:30am–12:30pm Ethics of Nanobiotechnology

Co-Chairs Sunil Kumar, Ph.D. Poly technic Universi t y, Brooklyn, NY 11201

Nathaniel C. Cady, Ph.D. Universi t y at Albany, Albany, NY 12203

10:30 The Next Stage in Responsible Conduct:Macroethics of Nanobiotechnology ResearchTod Laursen, Ph.D., Daniel Vallero, Ph.D., Timothy Lenoir, Ph.D., Rober t Clark Ph.D, andWilliam Reicher t, Ph.D. Duke Universi t y, Durham, NC 27708

10:45 Beyond Responsible Conduct: Macroethics ofNanobiotechnologyDaniel Vallero, Ph.D., Tod Laursen, Ph.D.,Timothy Lenoir, Ph.D., and William Reicher t, Ph.D. Duke Universi t y, Durham, NC 27708

11:00 Political Morality in Liability for MedicalNanotechnologyKuan-Ting Chi, LL.M, M.A. Universi t y of Shef f ield, Shef f ield, South Yorkshire S10 1GR, United Kingdom

11:15 Ethical Dimensions to NanotechnologyRaymond Van Dyke, Esq. M.S., J.D.Nixon Peabody LLP, Washington, D.C. 20004

11:30 Ethics of NanobiotechologyRegi Mon Cherian, M.B.A.UMC St Radboud Nijmegen Medical Centre, Nijmegen,6500HB, Netherlands

11:45 Nanobiotechnology, Ethics, and RisksWade Robinson, Ph.D.Rochester Inst i tute of Technology, Rochester, NY 14623

12:00 Ethics of Nanotechnology Across CulturesUma G. Gupta, Ph.D.SUNY Brockpor t, Brockpor t, NY 14420

12:15 A Taxonomy of the Ethical Issues Integral toNanobiotechnologyGeorge Khushf, Ph.D., Catherine Murphy Ph.D. and Qian Wang Ph.D.Universi t y of South Carolina, Columbia, SC 29208

12:30–2:00pm Panel Discussion & LunchMarketing, Payment and Regulation ofBiomedical Devices: Ethical Concern

Co-Chairs Subrata Saha, Ph.D. SUNY Downstate Medical Center, Brooklyn, NY 11203

Dane Miller, Ph.D.Biomet Inc. Warsaw, IN 46582

Panel Members James A. Albright, M.D.LSU Health Sciences Center, Shrevepor t, LA 71130

Richard Treharne, Ph.D. Act ive Implants Corporat ion, Memphis, TN 38120

Mark S. MintzerGlobal Pat ient Network, Fountain Valley, CA 92708

Timothy Kriewall, Ph.D.Wisconsin Lutheran College, Milwaukee, WI 53226

Tof y Mussivand, M.D.Universi t y of Ot tawa Hear t Inst i tute, Ot tawa, ON K1Y 4W7, Canada

2:00pm–3:30pm Advances in Biomedical Technology: EthicalConcerns

Co- Chairs Susan Schwar tz-Giblin, Ph.D., and John Chapin, Ph.D.SUNY Downstate Medical Center, Brooklyn, NY 11203

2:00 Neuroethics: Issues and Dialectic at theIntersection of Technology, Mind and SocietyJames Giordano, Ph.D., M.Phil.Georgetown Universi t y Medical Center, Washington, DC20057

2:15 Health Information Security and Sensemaking:A Case Study in Embedded EthicsTed Cooper, M.D.1, Henr y Neidermeier, Ph.D.2, andJef f Collmann, Ph.D.3

1 Stanford Universi t y, Stanford, CA 94305 2 Kaiser Permanente, Lafayet te CA 945493 Georgetown Universi t y Medical Center,

Washington, DC 20057

2:30 Reducing the Cost of Delivering HealthGlobally–An Intellectual Property PerspectiveDjims MiliusUniversi t y of Shef f ield, Shef f ield, South Yorkshire S10 1FL, Uni ted Kingdom

2:45 Ethical Implications of Neural Repairs UsingMEMS TechnologiesWarren Grundfest1 M.D., FACS, and Andrea Scot t2 Esq., J.D.1 UCLA, Los Angeles, CA 900242 Bioethics USA Inc., Los Angeles, CA 90077

3:00 Whose Ethical Standard is it Anyway?Shun-liang (Steven) Hsu, Ph.D. Nat ional Chung-Hsing Universi t y, Taichung, 402, Taiwan

3:15 “Converging NBIC Technologies for ImprovingHuman Performance” A Critical Assessmentof the Novelty and the Prospects of the ProjectBer t Gordijn, Ph.D.Radboud Universi t y Nijmegen Medical Centre, Nijmegen,6500 HK, Netherlands

3:30 – 4:00pm Coffee Break

4:00 – 5:00pm Keynote Address:Biomedical Engineering in a Complex EthicalEnvironment: Are You Prepared to Lead?Gregor y L. Eastwood, M.D.Interim PresidentCase Western Reser ve Universi t yCleveland, OH 44106

5:00 – 6:30pm Clinical Trials & Animal Experimentation:Ethical Issues

Co-Chairs Kathleen Powderly, CNM, Ph.D. and Susan Pugliese, R.N., D.D.S.SUNY Downstate Medical Center, Brooklyn, NY 11203

5:00 Regulations Encourage the Ethical use ofAnimals in Biomedical Engineering ResearchJafar Vossoughi, Ph.D.1 and John W. Karanian, Ph.D.2

1 Biomed Research Foundat ion, Olney, MD 208322 CDRH, USFDA, Laurel, MD 20708

5:15 The Need for Animal Models in BiomedicalResearchAjay Kashi, B.D.S., M.S., and Subrata Saha, Ph.D. SUNY Downstate Medical Center, Brooklyn, NY 11203

5:30 Ethical Issues in Clinical Trials with HumanTissue Engineered ProductsHelena Trommelmans, M.A., M.Sc., Joseph Selling, Ph.D.,and Kris Dierickx, Ph.D.Katholieke Universi tei t Leuven, Leuven, B-3000, Belgium

5:45 The Need for Regulator y Reform in Protectingthe Viablity and Entrepreneurship of SmallBusinesses in America R.W. Christensen, DDS, FAIMBE TMJ Implants Incorporated, Golden, CO 80401

6:00 Ethical Problems of Clinical Trials of theSocially Important Drugs in the Republic ofKazakhstanK.B. Murzagulova and M.E. Kim"Romat" Pharmaceut ical Limited Company, Pavlodar Ci t y,140011, Ka zakhstan

6:15 Animal Experimentation and Clinical Trial ofGuided Tissue Regeneration MembraneS. Pal1, Ph.D., Sheba Rani1, M.E., S. K. Bhandari2,T.K.Pal3, Ph.D., and S. N. Chakrabor thy4, Ph.D.1 Jadavpur Universi t y, India2 Dental Surger y Depar tment, INMAS, Delhi, India3 Guru Nanak Inst i tute of Dental Sciences & Research,

Kolkata, India4 Indian Inst i tute of Chemical Biology, India

7:00pm BanquetThe New York Marriot t at the Brooklyn Bridge

Sunday, April 22, 2007Dibner Auditorium, Poly technic Universi t y, 5 MetroTech Center, Brooklyn, NY 11201

8:00 – 9:00am Keynote Address:Research Ethics in Biomedical EngineeringWilliam Hendee, Ph.D. Dist inguished Professor of Radiology, Radiat ionOncology, Biophysics and Communit y and Public HealthMedical College of Wisconsin, Milwaukee, WI 53226

9:00 - 10:00am Panel DiscussionUniversity Industr y Relationships: Ethical Challenges

Co-Chairs M. Guven Yalcintas, Ph.D.SUNY Research Foundat ion, Albany, NY 12201

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Panel Members Randall L. Barbour, Ph.D.SUNY Downstate Medical Center, Brooklyn, NY 11203

William Mihalko, M.D., Ph.D.Universi t y of Virginia, Charlot tesville, VA 22901

Subrata Saha, Ph.D.SUNY Downstate Medical Center, Brooklyn, NY 11203

10:00–10:30am Coffee Break

10:30–12:15pm Ethical Issues in Stem Cells andGenetics Research

Co- Chairs Uma G. Gupta, Ph.D.SUNY Brockpor t, Brockpor t, NY 14420

John Allen SUNY Downstate Medical Center, Brooklyn, NY 11203

10:30 Ethics of Alternatives to the Use of SpareEmbr yos for Developing Embr yonic Stem Cell Lines Thomas F. Budinger, M.D., Ph.D., and Miriam D.Budinger, M.D. Universi t y of California, Berkeley, Berkeley, CA 94720

10:45 Proceedings of Embr yonic Stem CellsRegulations in TaiwanShun-liang (Steven) Hsu, Ph.D. and Chao-Han Huang, M.A.Nat ional Chung-Hsing Universi t y, Taichung, 402, Taiwan

11:00 Human reproductive cloning: Should we if wecould?Udo Schuklenk, Ph.D.Glasgow Caledonian Universi t y, Glasgow G4 0BA, United Kingdom

11:15 Stem Cells in Medicine: Applications and ConcernsMar t in Bluth, M.D., Ph.D.SUNY Downstate Medical Center, Brooklyn, NY 11203

11:30 Genetic Exceptionalism and the Metaphor of the PlanMark Greene, B.V.Sc, Ph.D.Universi t y of Delaware, Newark , DE 19716

11:45 Preimplantation Genetic Diagnosis and theCourse of Social JusticeTim Krahn, Ph.D.Dalhousie Universi t y Halifax, Nova Scot ia B3H 3P7,Canada

12:00 The Restoration of Brain Function Using StemCells: Issues to ConsiderAndrea Scot t1 Esq., J.D., and Warren Grundfest2 M.D., FACS1 Bioethics USA Inc., Los Angeles, CA 900772 UCLA, Los Angeles, CA 90024

12:15–1:30pm Panel Discussion & LunchNeed for Tor t Reform: An Ethical Imperative

Co-Chairs: Rober t W. Christensen, D.D.S, FAIMBETMJ Implants Incorporated, Golden, CO 80401

Subrata Saha, Ph.D. SUNY Downstate Medical Center, Brooklyn, NY 11203

Panel Members Dane Miller, Ph.D.,Biomet Inc. Warsaw, IN 46582

Kuan-Ting Chi, LL.M, M.A.Universi t y of Shef f ield, Shef f ield, South Yorkshire S10 1GR, United Kingdom

Stanley Gordon, M.D. SUNY Downstate Medical Center, Brooklyn, NY 11203

Alice Herb J.D., LLM, SUNY Downstate Medical Center, Brooklyn, NY 11203

1:30–2:45pm Biomedical Ethics Education

Co-Chairs Dawn Mor ton Rias, Ed.D, PA-CSUNY Downstate Medical Center, Brooklyn, NY 11203

Harold P. Sjursen, Ph.D. Poly technic Universi t y, Brooklyn, N.Y. 11201

1:30 In Defence of Professional Ethics for theBiomedical SciencesNiall W.R. Scot t, Ph.D. Universi t y of Central Lancashire, Preston, LancashirePR1 2HE, Uni ted Kingdom

1:45 Methods for Teaching Ethics and Tools forResolving DilemmasThomas F. Budinger, M.D., Ph.D. and Miriam D. Budinger, M.D. Universi t y of California, Berkeley, Berkeley, CA 94720

2:00 Ethical Challenges Arising from Dealing withCreationist Students in BiomedicalEngineeringHoward Winet, Ph.D.UCLA, Los Angeles, CA 90007

2:15 A Brief Histor y of Bioengineering Ethics Jerr y C. Collins, Ph.D.Vanderbilt Universi t y, Nashville, TN 37235

2:30 Teaching Ethics Across the CurriculumJoanne S. Katz, P.T., D.P.T., Ph.D. and Mark L’Eplat tenier, M.P.A.S., R.P.A-CSUNY Downstate Medical Center, Brooklyn, NY 11203

2:45 – 3:15pm Coffee Break

3:15 – 5:30pm Ethical Issues in Biomedical Engineering

Co- Chairs Wade Robinson, Ph.D.Rochester Inst i tute of Technology, Rochester, NY 14623

Warren Grundfest M.D., FACSUCLA, Los Angeles, CA 90024

3:15 Use of Implantable RadiofrequencyIdentification Tags in HumansKenneth R. Foster, Ph.D. and Jan Jaeger, Ph.D. Universi t y of Pennsylvania, Philadelphia, PA 19104

3:30 Ethical Considerations in the BiomedicalPatent GrantAnthony F. LoCicero, Esq. J.D., and Michael P. Kenney, Esq. M.S., J.D.Amster Rothstein & Ebenstein, LLP, New York, NY 10016

3:45 Is Tor t Reform a Placebo?W. Ross Scot t, Esq. J.D.W. Ross Scot t Law Firm, Andover, NY 14806

4:00 Is Apollo Fading? Industr y, Government andthe Hippocratic Oath: An OrthopaedicSurgeon’s Viewpoint Larr y Bowman, M.D.Blue Ridge Or thopaedics, Clemson, SC 29678

4:15 Challenges Including Ethics in EvaluatingHuman Impact Injur y ToleranceA. Deb, Ph.D.1, and C.C. Chou2

1Indian Inst i tute of Science, Bangalore 560012, India2Wayne State Universi t y, Detroi t, MI 48201

4:30 A Call to Systematically Evaluate MedicalDevicesAbraham P. Schwab, Ph.D.Brooklyn College – CUNY, Brooklyn, NY 11210

4:45 Free Inquir y, Democracy, and BioscienceAust in Dacey, Ph.D.Center For Inquir y, New York, NY 10020

5:00 Ethical Issues in Pharmacogenomic ResearchM. Joshi1, A. Deb2, and S.R. Shankapal31 M.S. Ramaiah Medical College, Bangalore

560054,India2 Indian Inst i tute of Science, Bangalore 560012, India3 M.S. Ramaiah School of Advanced Studies, Bangalore

560054, India

5:15 Guidelines for AuthorshipPamela Saha, M.D., Subrata Saha, Ph.D., and SusanSchwar tz-Giblin, Ph.D. SUNY Downstate Medical Center, Brooklyn, NY 11203

5:30 Development and Marketing of Similar MedicalDevices and ImplantsWestley Hayes, M.S., and Subrata Saha, Ph.D. SUNY Downstate Medical Center, Brooklyn, NY 11203

Local Program Committee

1. Subrata Saha, Ph.D., Program Chairman, Research Professor and Director of Musculoskeletal ResearchSUNY Downstate Medical CenterBrooklyn, New York 11203.

2. Kathleen Powderly, R.N., M.S., Ph.D.Acting Director, Humanit ies in MedicineSUNY Downstate Medical CenterBrooklyn, New York 11203.

3. Alice Herb, J.D., LLM,Clinical Assistant Professor, Humanit ies in MedicineSUNY Downstate Medical CenterBrooklyn, New York 11203

4. Susan Schwartz-Giblin, Ph.D.Dean, School of Graduate StudiesSUNY Downstate Medical CenterBrooklyn, New York 11203

5. William Urban, M.D.Chairman, Depar tment of Or thopaedic Surger y and Rehabili tat ion MedicineSUNY Downstate Medical CenterBrooklyn, New York 11203

6. John AllenAssistant Vice President of Scient if ic Af fairs SUNY Downstate Medical CenterBrooklyn, New York 11203

7. Judith A. RuddockDirector of ConferencesSUNY Downstate Medical CenterBrooklyn, New York 11203

8. Jim Darrow, M.A., M.S.Director of Educat ion, Depar tment of Or thopaedic Surger y andRehabili tat ion MedicineSUNY Downstate Medical CenterBrooklyn, New York 11203

9. Ellen B. Telesca, M.B.A.Director of Recrui tment and Liaison for the Biomedical EngineeringProgramSchool of Graduate StudiesSUNY Downstate Medical CenterBrooklyn, New York 11203

10. Sunil Kumar, Ph.D.Professor of Mechanical Engineering & Associate Provost, Graduate Educat ionPoly technic Universi t yBrooklyn, New York 11201

This conference is jointly sponsored by SUNY Downstate Medical Centerand Poly technic Universi t y

We wish to thank the following for their support:

SUNY Downstate Medical Center

Of f ice of the President

College of Medicine

College of Health Related Professions

School of Graduate Studies

Depar tment of Or thopaedic Surger y and Rehabili tat ion Medicine

American Inst i tute for Medical and Biological Engineering (AIMBE)

Engineering in Medicine & Biology Societ y (IEEE/EMBS)

Cit y College of New York

New York Academy of Sciences

Financial support has been received from:

SUNY Conversat ions in the Disciplines Program

United Universi t y Professions (UUP)

Begell House, Inc. Publishers

Amster Rothstein & Ebenstein, LLP

John Wiley & Sons Inc.

Design: Depar tment of Biomedical Communicat ions

Notes