| Course Name | Ethics in Diagnostics |
| Course Code | 25CLG504 |
| Program | M. Sc. Clinical Genomics |
| Semester | 1 |
| Credits | 1 |
| Campus | Kochi |
(Lectures 05)
Foundations of Biomedical Ethics, Introduction to bioethics and key principles (autonomy, beneficence, non-maleficence, justice), Historical milestones and cases in biomedical ethics, Ethical frameworks and decision-making models. Informed Consent in Diagnostics, Definition and importance of informed consent, Legal and ethical standards, Challenges in obtaining informed consent in different diagnostic contexts (e.g., genetic testing),
(Lectures 02)
Patient Privacy and Confidentiality, Concepts of privacy, confidentiality, and data protection, HIPAA and other relevant regulations (context-specific), Risks of data breaches and ethical implications of health data sharing, Genetic data and family disclosure dilemmas.
(Lectures 03)
Responsible Conduct of Research in Diagnostics, Research integrity and misconduct (fabrication, falsification, plagiarism), Ethics in publishing and peer review, Conflict of interest and transparency, Ethical considerations in diagnostic trials and clinical validation.
(Lectures 05)
Ethical Challenges with Emerging Technologies. The ethics of predictive diagnostics and incidental findings, Balancing innovation with patient rights. Case Studies and Ethical Decision-Making, Integrative analysis of real-world diagnostic dilemmas, Applying ethical frameworks to complex cases, Developing and presenting ethical arguments, Preparing ethical review proposals for diagnostic protocols.
Total number of classes: 15
Preamble
This course provides a comprehensive overview of ethical principles in biomedical research and clinical diagnostics. Topics include informed consent, patient confidentiality, responsible conduct of research, and ethical use of emerging technologies. Students will engage with case studies to analyze ethical dilemmas in diagnostics and therapeutic interventions.
Course outcomes:
CO1: Understand key bioethical principles and their application in diagnostics.
CO2: Evaluate informed consent, addressing legal, ethical, and cultural aspects.
CO3: Assess privacy, confidentiality, and data protection in diagnostics.
CO4: Recognize research integrity, conflicts of interest, and transparency in diagnostics.
CO5: Analyze ethical challenges with emerging diagnostic technologies.
CO6: Apply ethical decision-making frameworks to real-world diagnostic dilemmas.
Program outcome
PO1: Bioscience Knowledge
PO2: Problem Analysis
PO3: Design/Development of Solutions
PO4: Conduct Investigations of complex problems
PO5: Modern tools usage
PO6: Bioscientist and Society
PO7: Environment and Sustainability
PO8: Ethics
PO9: Individual & Team work
PO10: Communication
PO11: Project management & Finance
PO12: Lifelong learning
0 – No affinity; 1 – low affinity; 2 – Medium affinity; 3 – High affinity
CO–PO Mapping Table:
| COs | PO1 | PO2 | PO3 | PO4 | PO5 | PO6 | PO7 | PO8 | PO9 | PO10 | PO11 | PO12 |
| CO1 | 2 | 2 | 2 | – | – | 3 | 2 | 3 | 1 | 2 | – | 2 |
| CO2 | 2 | 2 | 2 | – | – | 3 | 1 | 3 | – | 2 | – | 2 |
| CO3 | 2 | 2 | 1 | – | 2 | 3 | – | 3 | – | 2 | – | 2 |
| CO4 | 2 | 2 | – | 1 | – | 3 | – | 3 | – | 2 | – | 2 |
| CO5 | 2 | 3 | 2 | 1 | 2 | 3 | 2 | 3 | – | 2 | – | 3 |
| CO6 | 3 | 3 | 2 | 2 | – | 3 | – | 3 | 1 | 2 | – | 3 |
Program Specific Outcomes (PSO):
PSO1. Apply fundamental molecular biology principles to interpret clinical genomic data.
PSO2. Use molecular techniques (e.g., PCR, RT-PCR, sequencing) to detect genetic mutations and biomarkers.
PSO3. Analyze genotype-phenotype correlations in inherited and acquired disorders.
PSO4. Identify pathogenic variants from NGS data and interpret their clinical relevance.
PSO5. Correlate molecular pathways with disease mechanisms and therapeutic targets.
PSO6. Develop and validate diagnostic assays based on molecular biology principles.
PSO7. Utilize molecular biology to support pharmacogenomic profiling and therapy optimization.
PSO8. Integrate multi-omic data (genomic, transcriptomic, epigenomic) for personalized health solutions.
PSO9. Apply molecular knowledge to cancer genomics, infectious diseases, and rare genetic disorders.
PSO10. Translate molecular discoveries into clinical interventions through evidence-based practice.
0 – No affinity; 1 – low affinity; 2 – Medium affinity; 3 – High affinity
CO–PSO Mapping Table:
| COs | PSO1 | PSO2 | PSO3 | PSO4 | PSO5 | PSO6 | PSO7 | PSO8 | PSO9 | PSO10 |
| CO1 | 2 | – | – | – | – | – | 2 | 1 | – | 3 |
| CO2 | 2 | – | – | – | – | – | – | – | – | 3 |
| CO3 | 2 | – | – | – | – | – | – | – | – | 3 |
| CO4 | 2 | – | – | – | – | – | – | – | – | 3 |
| CO5 | 2 | – | – | – | – | 1 | 2 | – | – | 3 |
| CO6 | 3 | – | – | – | – | 2 | 2 | – | – | 3 |
Evaluation Pattern: 50+50 = 100
| Internal Assessment – 50% | ||
| Periodical 1 | Exam | 20% |
| Periodical 2 | Exam | 20% |
| Continuous Assessment | Assignment/Test/Quiz | 10% |
| 50% | ||
| End Semester Examination- 50% | ||
| Theory Exam | 50% | |
| 50% | ||
| Total | 100% | |
Textbook:
Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 7th ed. New York (NY): Oxford University Press; 2013.
Reference Book:
Chadwick R, ten Have H, Meslin EM. The SAGE Handbook of Health Care Ethics: Core and Emerging Issues. London (UK): SAGE Publications; 2011.
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