Biotechnology and the Law

  • BRAIN Initiative
  • Bayh-Dole Act
  • nanotechnology
  • Stevenson-Wydler Act
  • rDNA
  • synthetic biology
  • precautionary principle
  • RAC
  • Coordinated Framework
  • genetic engineering
  • GMO
  • dual use

Learn to:


  1. Interpret relevant statutes, case law, and regulations pertaining to biotechnology

  2. Assess incentives for innovation, such as federal funding, licensing, and patents

  3. Evaluate broad ethical considerations and mechanisms for bioethical assessment of biotechnology

  4. Identify legal and policy issues resulting from “dual use” research


This biotechnology law course gives students the opportunity to assess the scope of federal administrative agency oversight of biotechnology in agriculture, industry, and healthcare. Course topics include examination of foundational technologies such as recombinant DNA technology; current applications, including nanobiotechnology and synthetic biology; academic-industry relationships; protection of human subjects in research and institutional review of clinical trials; data privacy and security issues; and protection of intellectual property. Class activities include group and individual analysis of biotechnology case studies, including problems raised by synthetic biology and rDNA in agriculture. Upon completion of this course, students will appreciate the variety of legal, policy, scientific, social, and ethical issues in the realm of biotechnology.

Division of Online Learning

[email protected] | 973-642-8747 or 973-761-9000 ext. 8747