Course Title: Regulatory, Ethical and Legal Issues in Biotechnology

Part A: Course Overview

Course Title: Regulatory, Ethical and Legal Issues in Biotechnology

Credit Points: 12.00

Course Code




Learning Mode

Teaching Period(s)


City Campus


135H Applied Sciences


Sem 2 2006,
Sem 2 2007,
Sem 2 2008,
Sem 2 2009,
Sem 2 2010,
Sem 2 2011,
Sem 2 2012

Course Coordinator: Assoc.Prof. Gina Nicoletti

Course Coordinator Phone: +61 3 9925 2133

Course Coordinator Email:

Course Coordinator Location: 3.2.06

Pre-requisite Courses and Assumed Knowledge and Capabilities

Background knowledge and practical skills in molecular biology, as provided by, for example, BIOL2262/BIOL2263 Genetics and Molecular Biology, an equivalent course or evidence of equivalent capabilities.

Course Description

Students will learn about significant issues in the local and international regulation of biotechnology as it applies to research and to the development of biotechnology products and services.   Students will also explore the ethical and social issues arising from research and development, manufacture and use of biotechnology products.

Objectives/Learning Outcomes/Capability Development

This course will develop knowledge of current regulatory, legal and ethical issues relevant to the conduct of biotechnology research and development.  Students will learn to source and interpret regulatory and legal material, apply the information to typical issues in research and product development and write pertinent and concise reports to support organisational decisions.

Students should be able to
• understand current national and international legislation and regulations relevant to the conduct of biotechnology research and product development
• apply this knowledge to typical problems arising in research and development
• appreciate the ethical and social issues relevant to biotechnology activities and apply this to professional conduct

Overview of Learning Activities

The learning activities comprise
• attendance at lectures where topic areas will be presented and explained
• attendance at tutorial sessions where study guides and case studies will illustrate topics presented in lectures
• completion of tests, case study-based assignments and a final examination to demonstrate an integrated understanding of topic areas and their application to the solving of typical industrial problems
• private study and independent research on issues of significance in biotechnology

Overview of Learning Resources

Students will be provided with relevant online and library resources.   The course is supported by material on the DLS.

Overview of Assessment

This course is assessed by short tests, case study based business reports and an end of semester examination.