Course Description
Ethical issues in biomedical engineering: responsible conduct of research, concepts of good lab and clinical practices, ethical issues, and case studies. Food and Drug Administration (FDA) regulatory pathways and approval procedures. Commercialization and technology transfer.
Additional Requirements for Graduate Students:
Graduate students will be required to complete a written
assignment and oral presentation describing the regulatory
pathway and testing requirements for a hypothetical product
based on their current research or a field of research they are
interested in.
Athena Title
Regulations and Ethics in BME
Prerequisite
(BCMB 3100 or BCMB 3100E or BCMB 4010/6010) and BCHE 3520
Semester Course Offered
Offered every year.
Grading System
A - F (Traditional)
Course Objectives
Upon successful completion of the course, students will understand: 1. Concepts related to responsible conduct of research, such as plagiarism, authorship, research misconduct, and financial conflicts of interest 2. Protection of human beings and welfare of laboratory animals when research involves human participants and animal subjects 3. FDA regulatory pathways and approval procedures 4. Technology transfer, commercialization, and legal aspects in biomedical engineering
Topical Outline
1. Responsible conduct of research, such as plagiarism, authorship, research misconduct, and financial conflicts of interest 2. Ethics case studies in biomedical engineering 3. Laws and regulations of animal use and human subject protection 4. FDA regulatory pathways and approval procedures 5. Commercialization, technology transfer, and legal aspects
Syllabus