Bioethics and Biosafety

Bioethics: Moral implications of life sciences.
Biosafety: Measures to prevent harm from biological agents.
Autonomy: Patient's right to choose.
Beneficence: Do good.
Non-maleficence: Do no harm.
Justice: Fair distribution of benefits/burdens.
BSL-1: Minimal risk, standard practices.
BSL-2: Moderate hazard, limited access, biosafety cabinets.
BSL-3: Serious/lethal disease via inhalation, negative air pressure.
BSL-4: High risk, life-threatening, positive-pressure suits.
Cartagena Protocol: 2000, Biosafety of LMOs.
Nagoya Protocol: 2010, Access & Benefit-Sharing (ABS).
GEAC: Apex body for environmental release of GMOs (MoEFCC).
RCGM: Monitors research, approves field trials (DBT).
IBSC: Institutional level biosafety review.
DBT: Department of Biotechnology, promotes biotech, issues guidelines.
ICMR: Regulates clinical trials, ethical guidelines.
Rules, 1989: Statutory basis for GMO regulation (EPA, 1986).
BRAI: Proposed unified regulatory body (not enacted).
LMO: Living Modified Organism (Cartagena term).
GMO: Genetically Modified Organism.
AIA: Advance Informed Agreement (Cartagena).
DURC: Dual-Use Research of Concern.
Germline Editing: Heritable changes, highly controversial.
Somatic Editing: Non-heritable changes, therapeutic focus.
Biopiracy: Unauthorized use of genetic resources/traditional knowledge.
Puttaswamy Judgment: Right to Privacy (implications for genomic data).
Aruna Shanbaug Case: Passive euthanasia, living wills (2011).
Common Cause Case: Liberalized living wills (2018).
GM Mustard (DMH-11): GEAC approved environmental release (2022), ongoing debate.
WHO Genome Editing: Recommendations for responsible governance (2021).
New Drugs & Clinical Trials Rules: 2019, strengthened patient safety.
Environmental Ethics: Moral relation to nature, biotech impact.
Research Ethics: Ethical conduct of research, human/animal subjects.
Medical Ethics: Ethics in clinical practice, patient care.
Precautionary Principle: Act to prevent harm even with scientific uncertainty.
Gene Flow: Transfer of genes from GMOs to wild relatives.
Biodiversity Act, 2002: Implements Nagoya Protocol in India.
Biosafety Clearing-House (BCH): Information exchange mechanism.
Ethical Review Boards (IECs): Oversee research ethics.

Vyyuha Quick Recall Mnemonic: SAFE-BIO

Safety Levels (BSLs 1-4, containment)
Autonomy & ABS (Nagoya Protocol, patient rights)
Frameworks (Indian: GEAC, RCGM, ICMR; International: Cartagena)
Ethics (Principles: Beneficence, Non-maleficence, Justice)
Biosafety Protocols (Cartagena Protocol, LMOs)
Indian Regulations (Rules 1989, DBT Guidelines, BRAI debate)
Outstanding Dilemmas (Germline editing, Biopiracy, Data Privacy)

How to use it in 5-minute revision: When reviewing, pick a letter from SAFE-BIO. For 'F' (Frameworks), quickly list GEAC, RCGM, ICMR, and their functions. For 'O' (Outstanding Dilemmas), recall germline editing, biopiracy, and genomic data privacy, and briefly state the core ethical issue for each. This mnemonic helps ensure comprehensive coverage of key areas under timed pressure.