COURSE OBJECTIVES
Ø To understand importance of bioethics and biosafety. To understand legal social and economic impacts of biotechnology. To understand regulatory guidelines and their importance. To understand importance of patent.
Ø To understand procedure to apply for patent.
Ø To understand procedure of assessment of biosafety for biotech foods. To understand ethical implications of biotechnology.
UNIT 1 INTRODUCTION TO BIOSAFETY
Definition of ethics and Bioethics, Ethics in Biotechnology(positive and negative effects with classical examples – Rice with Vitamin A, No-till Agriculture, cotton without insecticide, reduced need for fertilizer, biological pest control , slow ripening fruits and controlled ripening, fast growing trees and fishes.
UNIT 2 GMO
Guidelines for research with transgenic organisms. Environmental impact of genetically modified organisms (beneficial and hazardous impact), Field trials with GMO, Containment levels. Biosafety protocol, Cartagena Biosafety protocol, Mechanism of implementation of biosafety guidelines. Biosafety and politics. Biosafety database.
UNIT 3 IMPLICATIONS OF BIOSAFETY
Awareness education on genetically engineered organism.-Transgene instability, gene flow, resistance/ tolerance of target organism, increase weedlessness, risks and uncertainty associated with Biotechnology. Containment levels and their impact on Environment- Containment- definition, types of containment, summary of recommended Biosafety levels for infectious agents, detail checklist–premises and lab equipment, Animal facilities, environment.
UNIT 4 GLP AND PATENTS
Gene technology laboratory. GLP and Bioethics- introduction, national Good Laboratory Practices (GLP), the GLP authority functions, Good Laboratory Practices- necessity, aspiration and responsibility. Procedure to apply patent, other intellectual properties viz copy rights, Rights, Plant breeder’s rights, trade secrets/ trade symbol etc. WTO, TRIPS, PCT and GATT. IPR problems and its hindrance.
UNIT 5 ETHICS.
Ethics in clinical trials and Good Clinical Practices (GCP) – Definition of clinical trials and GCP, general information about clinical trials, need to conduct clinical trials, faces ofclinical trials, institutional set ups for conducting clinical trials, ethics in clinical Biotechnology
TEXT / REFERENCE BOOKS
1. Safety Assessment by Thomas, J.A., Fuch, R.L. (2002), Academic Press.
2. Biological safety Principles and practices) by Fleming, D.A., Hunt, D.L., (2000). ASMPress.
3. Biotechnology - A comprehensive treatise. Legal economic and ethical dimensions VCH.Bioethics by Ben Mepham, Oxford University Press, 2005.
4. Bioethics & Biosafety by R Rallapalli & Geetha Bali, APH Publication, 2007
5. Bioethics & Biosaftey By Sateesh Mk (2008), Ik Publishers
6. Biosafety And Bioethics Rajmohan Joshi Publishers