Biosafety and Bioethics

Advances in biotechnology are almost always accompanied by controversy, mainly because so much of modern biotechnology involves manipulating genetic material directly. ELSI - the Ethical, Legal and Social Implications of biotechnology - is the umbrella term for this relationship between biotechnology and society, and it underlies both of the two concepts covered in this section: biosafety and bioethics. Biosafety is the prevention of large-scale loss of biological integrity, with a focus on both ecological and human health, and is enforced through regular laboratory safety reviews, strict operating guidelines and ongoing risk-management processes wherever biohazards are handled; failures in these protocols, often traceable to human error or poor technique, are what actually lead to exposure incidents. Specific risks biosafety guards against include the pathogenicity of natural or genetically modified organisms and viruses, toxicity or allergy risk from microbial products, the rise of antibiotic-resistant pathogenic microorganisms, safe disposal of spent microbial biomass and effluent, and contamination, infection or mutation risk in process strains or in industrial use of recombinant microorganisms. In India, biosafety guidelines are implemented through a tiered system of statutory bodies: Institutional Bio-safety Committees (IBSCs) monitor research activity at the level of individual institutions; the Review Committee on Genetic Manipulation (RCGM), functioning under the Department of Biotechnology (DBT), monitors higher-risk research activities in laboratories; and the Genetic Engineering Approval Committee (GEAC), under the Ministry of Environment, Forest and Climate Change, is the apex body with the power to permit commercial-scale use of Genetically Modified Organisms (GMOs) and open-field trials of transgenic material, including agricultural crops, industrial products and healthcare products - covering both Biosafety Research Level trials, BRL-I and BRL-II. Bioethics, by contrast, is the study of the ethical issues that emerge from advances in biology and medicine - covering cloning, gene therapy, life extension, human genetic engineering and the manipulation of DNA, RNA and proteins - and is closely tied to moral discernment in medical policy and practice. The ELSI programme itself was founded in 1990 as a formal part of the Human Genome Project, with a share of that project's funding at the US National Institutes of Health and Departm …