Course

Preamble

The recent advances in the field of biotechnology/biomedical technologies have brought into focus several ethical issues. The inventions in the field of genetic engineering, molecular medicine and related fields of molecular biology not only affect us but also the plants, microorganisms, animals and the entire environment and the way we practice agriculture, medicine and food processing. An increase in our ability to change life forms in recent years has given rise to the new science of bioethics. The present course focus on the bioethical issues the modern society confronts. Topics such as biomedical technologies its health and human rights perspectives, Clinical ethics, emerging trends in biomedical and genetic technologies and regulatory frame works, legal and ethical implications of cryonics, cloning and its ethical legal and scientific aspects, regulation of biobanks and responsible conduct of biomedical research will be discussed in the curriculum.

Unit 1

Foundation of Bioethics: Definition, historic evolution, codes and guidelines, universal principles.

Clinical ethics: Describe the sanctity of human life and the need to preserve human life, what makes research involving human subjects ethical, explain about issues related to prenatal screening, clinical trials (Phase I/II/III/IV) studies. Biomedical ethics.

Unit 2

Clinical ethics: Describe the sanctity of human life and the need to preserve human life, what makes research involving human subjects ethical, explain about issues related to prenatal screening, clinical trials (Phase I/II/III/IV) studies. Biomedical ethics.

Unit 3

Legal and ethical implications of cryonics: Introduction, origin of cryonic preservation in humans, procedure, meaning of death, its suspension and legal implications, its position in India.

Unit 4

CRISPER Revolution, its future and legal issues: Introduction, advances in genomic research and its legal aspects, ethical and human rights issues in human DNA editing, genome editing technology its legal and regulatory challenges

Unit 5

Ethics and regulation of biobanks: Introduction, types of biobanks, barriers of biobanking, biobanking framework in India, ethical issues of biobanks

Unit 6

Biomedical research: Introduction to responsible conduct of research, advising and mentoring, treatment of data, data falsification, fabrication and plagiarism, competing interests, commitments and values.

Unit 7

Ethical use of animals in the laboratory: Introduction to animal ethics, bioethics and animals, animal rights, animal use in biological research

Unit 8

Identifying a scientific problem and collecting data to address the problem, development of a hypothesis, addressing the hypothesis with research question driven experiment strategy, experiment design, choosing appropriate controls, adoption of experimental techniques to address the hypothesis, sample collection and processing strategies with examples.

(1) The Cambridge Textbook of Bioethics, 1st edition (2008), Peter A. Singer and A. M. Viens; Cambridge University Press, ISBN-13: 978-0511545566.
(2) Foundation of Bioethics, 2nd edition (1996), E. H Tristram; Oxford University Press, ISBN-13: 9780195057362.