Biomedical Engineering Seminar Series: Topics in Medical Ethics and Responsible Conduct in Research

Calendar

SES #	Topics	Overviews
Fall 2005
1	Authorship Speaker Dr. Julie Ingelfinger, Professor of Pediatrics, Harvard Medical School and Deputy Editor, New England Journal of Medicine	Dr. Ingelfinger discussed the policies, procedures, and politics of authorship from the perspective of the editorial office of the New England Journal of Medicine - Who’s an author, who’s a contributor, who’s a guarantor, and who gets mentioned in the footnotes?
2	Ethical and Professional Conduct Issues in Engineering Breakthrough Medical Technologies Speaker John Abele, Founder and Chairman of Boston Scientific Corporation	John Abele explored the ethical and professional conduct issues related to engineering breakthrough medical technologies, based in large part on his experience in the early days of developing products at BSC. How safe is ‘safe enough’ for a new medical product? What is the role of training in the adoption of medical technologies? How important is post-market surveillance and who should pay? Mr. Abele encouraged students to think about these issues as they move into corporate biomedical engineering design positions, and to participate in evaluating the risk-benefit ratio throughout the design process.
3	HST Graduate Program Design and Administration Speaker Dr. Sangeeta Bhatia, an HST Graduate and Recent Addition to the Faculty at HST	Dr. Bhatia used the seminar to discuss the HST graduate program from two important perspectives: How students found out about the program and chose to apply to HST, and how the graduate qualifying exams were designed and administered.
4	Case Studies on Funding Ethical Issues in Academia and the Clinic Speaker Dr. John Parrish, Chairman of Dermatology for the Harvard Teaching Hospitals, Founder and Former Director of the Wellman Labs for PhotoMedicine, and Founder and Director of the Center for the Integration of Medicine and Innovative Technology (CIMIT)	Dr. Parrish presented three compelling personal case studies exploring the ethical issues related to funding research within the academic and clinical setting. How much influence on research direction should companies providing sponsored research funding be allowed? Under what circumstances should research be conducted with Department of Defense funding? Should research support be accepted for projects with very high risk of failure? Dr. Parrish used the hierarchal strategies offered through the seminar series to show how new options for optimum decision outcomes can be developed.
5	Ethical Dilemmas Associated with Drug Development for Small Target Groups Speaker Dave Fleming, Senior VP of Genzyme	Dave Fleming spoke about the ethical dilemmas associated with developing new drugs for small targeted groups of patients. As one of the first employees at Genzyme, Mr. Fleming has observed and participated in the major decisions that the company has made since its inception. He shared with the class some of the complex decisions related to clinical testing, patient support, shareholder responsibilities, and regulatory compliance with world-wide patient populations of less than 5000. Genzyme has build a successful biotech company around these principles and is now providing care to patients on a world-wide basis.
6	Ethical Issues Related to Clinical Research in High Stress Environments Speaker Kris Olson, MD	Dr. Olson, an infectious disease physician specializing in providing care in extremely high stress environments, including conflict zones, refugee camps, and disaster relief sites, described some of the ethical issues related to conducting clinical research in these highly stressed environments and explored how the definitions for ‘patient safety’, ‘informed consent’, enrollment incentives, and protocol compliance are challenged in these settings.
Spring 2006
7	Ethics of Closed-loop Medical Control Systems Speaker Prof. John Guttag, Senior Professor of Electrical Engineering and Computer Science at MIT	Dr. John Guttag served as the Chair of his department for over ten years before leaving that post to take a sabbatical to study medical applications of his control systems and signal analysis strategies. Dr. Guttag discussed how these control systems could help to reduce medical errors, improve outcomes, and reduce costs in the healthcare system. He also presented several ethical dilemmas related to the clinician-machine interface, to closed-loop systems designs, and to data interpretation and analysis.
8	Ethics of Pharmaceutical Post-market Surveillance Speaker Dr. Frank Douglas, Executive Director of the Center for Biomedical Innovation Management, MIT	Dr. Frank Douglas created and serves as Executive Director of the Center for Biomedical Innovation Management at the Massachusetts Institute of Technology. He is a Professor of Practice for the MIT School of Engineering, the MIT Sloan School of Management, the MIT School of Science and the Harvard-MIT Division of Health Sciences and Technology. Before joining MIT, Dr. Douglas was the Executive Vice President, Drug Innovation and Approval, and Chief Scientific Officer for a developer of pharmaceuticals and human vaccines. Dr. Douglas described several ethical dilemmas he faced during his pharmaceutical development career, how he created acceptable new options for a successful outcome, and the lessons he learned from these complex experiences.
9	Ethical Considerations in Accelerating Medical Technologies Speaker Dr. Wendy Everett, President of the New England Healthcare Institute (NEHI)	Dr. Wendy Everett described the ethical issues around the rapid adoption of new and innovative drugs and devices into clinical practice. Dr. Everett described several examples of medical advances that have been fully approved by the FDA, shown to be safe and effective, and even cost-effective, and still have not become the standard of clinical care. She explored the concept of barriers to access in this context. Dr. Everett also showed several examples of the risks of releasing new technologies too early to the market and discussed the ethical dilemmas associated with the risk-benefit concept.
10	Ethics of Live-sustaining Biomedical Engineering Design Speaker Dr. David Lederman, Founder and Former Chairman of ABIOMED	Dr. David Lederman, founder and former Chairman of ABIOMED, will describe his 30 year quest for a safe and effective implantable mechanical heart system. He will describe some of the challenging issues he and his colleagues faced in the design of the engineering system, the design of the clinical trials to test the system, and the regulatory and legal hurtles they faced as the system finally moved into human clinical care.
11	The Good Works Project and Ethical Conduct of Research Speaker Dr. Howard Gardner, John H. and Elisabeth A. Hobbs Professor of Cognition and Education at the Harvard Graduate School of Education	Dr. Howard Gardner is the John H. and Elisabeth A. Hobbs Professor of Cognition and Education at the Harvard Graduate School of Education. He also holds positions as Adjunct Professor of Psychology at Harvard University and Senior Director of Harvard Project Zero. In 2004 he was named an Honorary Professor at East China Normal University in Shanghai. Author of twenty books and hundreds of article, Dr. Gardner’s latest project is called the GoodWorks Project. “GoodWork” is work that is both excellent in quality and also exhibits a sense of responsibility with respect to implications and applications. Researchers are examining how individuals who wish to carry out good work succeed in doing so during a time when conditions are changing very quickly, market forces are very powerful, and our sense of time and space is being radically altered by technologies, such as the web. Dr. Gardner will discuss how the identification, analysis, and resolution of ethical dilemmas is incorporated into the definition and practice of GoodWork.
12	The Ethics of Genetic Screening for Therapeutic Procedures