Course

Unit 1

Unit 1:

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.

Unit 2

Unit 2:

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), Special populations: children, cognitively impaired, non-native speakers.

Unit 3

Unit 3:

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.

Unit 4

Unit 4:

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.

Unit 5

Unit 5:

Ethical Challenges with Emerging Technologies, AI and machine learning in diagnostics: biases and transparency, CRISPR, genetic screening, and direct-to-consumer tests, The ethics of predictive diagnostics and incidental findings, Balancing innovation with patient rights.

Unit 6

Unit 6:

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.

(30 classes)

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

Program-specific outcome

PSO 1 – Emerging technologies in clinical diagnostics

PSO 2 – Biomolecules in Medicine

PSO 3 – Molecular dysregulation in diseases

PSO 4 – Molecular technology in diagnosis and therapy

PSO 5 – Applying lab discoveries to clinical practice

PSO 6 – Microorganisms in Medicine

PSO 7 – Statistical methods to interpret and validate diagnostic results

PSO 8 – Integrate molecular diagnostics into personalized medicine

PSO 9 – Compounds as biomarkers and its specificity

PSO 10 – Bioinformatics and biological data use

0 – No affinity; 1 – low affinity; 2 – Medium affinity; 3 – High affinity

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.