About
Biological research in India is regulated by various guidelines and rules published by Central/State agencies to safeguard ethical, moral, ecological, medical, and environmental interests. These regulations offer structured instructions, principles, and mechanisms to ensure the safe and ethical conduct of research within the country. Compliance with regulatory guidelines is crucial in research and constitutes an important aspect of modern biological research.
The Regulatory Compliance Office (RCO) at the Bangalore Life Sciences Cluster [BLiSC] educates and advises campus researchers about regulatory requirements and facilitates the process of obtaining required approvals from statutory committees. The office also assists in ensuring that the campus facilities and research infrastructures are in line with regulatory guidelines and have Environment, Health, and Safety protocols in place.
Research at the Bangalore Life Science Cluster, that includes inStem, NCBS and C-CAMP, is in diverse areas of animal, plant and human biology, including cell and molecular biology, developmental biology, genetics, genomics, stem cells and regenerative biology, ecological systems, disease models and therapeutics. Therefore, the research on campus is regulated by different Institutional Statutory Committees including the Institutional Biosafety Committee (IBSC), Institutional Human Ethics Committee (IHEC), Institutional Animal Ethics Committee (IAEC), and Institutional Committee for Stem Cell Research (IC-SCR). Approvals from national statutory agencies such as the Review Committee on Genetic Manipulation (RCGM), National Biodiversity Authority (NBA), Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT), Health Ministry’s Screening Committee (HMSC), Atomic Energy Regulatory Board (AERB), etc. are obtained as required.
Resources
- Biosafety and Containment- Rules, Acts, and Guidelines (RCGM and IBSC): https://biorrap.gov.in/Home/RegulatoryDocuments, https://ibkp.dbtindia.gov.in/Content/Rules
- ICMR National Ethical Guidelines (IEC): https://ethics.ncdirindia.org/ICMR_Ethical_Guidelines.aspx
- Stem Cell Research and Therapy (ICSCR and NAC-SCRT):https://nacscrt.icmr.org.in/download.php
- Supervision of Experiments on Animals (IAEC and CPCSEA): https://cpcsea.nic.in/Content/55_1_GUIDELINES.aspx
- Health Ministry’s Screening Committee (HMSC) (for international cooperation involving human subjects/ samples/ data): https://hmsc.dhr.gov.in/hmscguidelines
- Biological Diversity Act 2002, Rules 2004 & Notifications: http://nbaindia.org/content/18/21/1/notifications.html
People
Ketan Thorat
Fellow ‘E’/ Scientist ‘D’- Regulatory Compliance Officer
Email: ketant@instem.res.in
