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Sathyabama Institute of Science and Technology B.Sc - BioChemistry SBB1615 Bioethics, Biosafety and IPR Syllabus

SATHYABAMA INSTITUTE OF SCIENCE AND TECHNOLOGY SCHOOL OF BIO AND CHEMICAL ENGINEERING

SBB1615 BIOETHICS, BIOSAFETY AND IPR
L T P CREDITS TOTAL MARKS
4 0 0 4 100

Unit 1 INTRODUCTION TO BIOETHICS 12 Hrs.
Definition of ethics and Bioethics, Ethics in Biotechnology(positive and negative effects withclassical 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 LEVELS OF BIOSAFETY 12 Hrs.
Awareness education on genetically engineered organism.-Transgene instability, gene flow,resistance/ tolerance of
target organism, increase weedlessness, risks and uncertainity associatedwith Biotechnology.Containment levels and
their impact on Environment- Containment- definition, types ofcontainment, summary of recommended Biosafety levels
for infectious agents, detail checklist–premises and lab equipment, Animal facilities, environment.

Unit 3 GLP AND BIOETHICS 12 Hrs.
Gene technology laboratory. GLP and Bioethics- introduction, national Good Laboratory Practices (GLP), the GLP
authority functions, Good Laboratory Practices- necessity, aspirationand 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 4 GCP 12 Hrs.
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
Max Hours.60

TEXT / REFERENCE BOOK
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

END SEMESTER EXAMINATION QUESTION PAPER PATTERN
Max. Marks : 100 Exam Duration : 3 Hrs.
PART A : 10 questions of 2 marks each - No choice 20 Marks
PART B : 2 questions from each unit of internal choice; each carrying 16 marks 80 Marks