Biomedical Engineering Seminar Series: Topics in Medical Ethics and Responsible Conduct in Research
Ethical dilemmas in biomedical research and healthcare: authorship, funding, drug and device development, clinical research and genetic screening.
Healthcare professionals and biomedical researchers face ethical dilemmas in a highly regulated environment, such as who deserves authorship or how safe a new device must be. This seminar series explores techniques for recognizing, analyzing and resolving those dilemmas through talks by practicing clinicians, technologists, researchers and industry leaders, each built around case studies, small-group discussion and role-playing. Topics include authorship, research funding, drug development for small patient groups, clinical research in conflict zones, post-market surveillance, life-sustaining devices and genetic screening.
What You Will Achieve
- Recognize ethical dilemmas in biomedical research and clinical practice
- Analyze questions of authorship, conflicts of interest and research funding
- Weigh safety, consent and access in the development of drugs and medical devices
- Discuss responsible conduct of research using real case studies
Program Overview
Research Conduct and Funding
Authorship, funding and the research enterprise.
- Authorship from a journal editor’s view
- Funding ethics in academia and the clinic
- The Good Works Project and ethical conduct of research
Drugs, Devices and Clinical Research
Bringing new treatments to patients.
- Engineering breakthrough medical technologies
- Drug development for small patient groups
- Clinical research in high-stress environments
- Post-market surveillance and accelerating adoption
Emerging Technologies
New capabilities and the questions they raise.
- Closed-loop medical control systems
- Life-sustaining biomedical engineering design
- Genetic screening for therapeutic procedures
Course Completion
Job Outlook
These questions arise in biomedical research, medical device and pharmaceutical development, clinical practice and research administration.
Good for: Biomedical engineers, clinicians and researchers who want real cases of the ethical choices in their field.
Keep in mind: A 2005-2006 seminar series whose materials are summaries of each guest talk and the in-class activity format; the discussions and voting happened live, and the regulatory examples date from then.
Bottom line: Medical and research ethics taught through the experiences of people who built companies, journals and treatments.
Frequently Asked Questions
Who were the speakers?
Among them Julie Ingelfinger of the New England Journal of Medicine, John Abele of Boston Scientific, Dave Fleming of Genzyme, David Lederman of ABIOMED, John Guttag, Frank Douglas, Wendy Everett and Howard Gardner.
How were sessions run?
Each talk came with pre-seminar questions, anonymous class voting, role-playing scenarios and breakout groups on the day's topic.
Does it cover clinical research in crisis settings?
Yes. An infectious disease physician discussed research in conflict zones, refugee camps and disaster sites, and how patient safety and informed consent apply there.
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