Course

Unit 1

Unit 1:

Ethical Considerations in Study Design and Conduct, Overview and historical perspective of ethical principles and theories, Importance of ethical considerations in stem cell research, Risk-benefit assessment and study feasibility, Selection of study populations and recruitment strategies

Unit 2

Unit 2:

Informed Consent and Participant Protection, Elements of informed consent, Capacity to consent and decision-making capacity, Consent issues in vulnerable populations

Unit 3

Unit 3:

Ethical Issues in Preclinical Stem Cell Research and Clinical Trials Involving Stem Cells, Preclinical studies: Reduction, refinement, and replacement principles in Animal models, Translation of preclinical findings to clinical research, Clinical trials: Randomization, equipoise and Placebo-controlled trials and standard of care, Monitoring and reporting adverse events

Unit 4

Unit 4:

Ethical Implications of Emerging Stem Cell Technologies, Gene editing and genetic modification, Stem cell research and regenerative medicine, Artificial intelligence and big data in stem cell research

Unit 5

Unit 5:

Research Integrity and Publication Ethics, Authorship and contributorship, Plagiarism and research misconduct, Peer review and responsible publication practices

Unit 6

Unit 6:

Ethical Issues in Translating Stem Cell Research into Practice, Access to investigational therapies, Commercialization and conflicts of interest, Health disparities and global health equity

(30 classes)

Preamble:

This course provides a comprehensive exploration of the ethical, legal, and social implications of stem cell research and its clinical applications. Topics include the moral status of the embryo, consent in biobanking, ethical frameworks governing embryonic and adult stem cell use, and international regulatory standards. Through case studies and discussions, students will critically evaluate controversies and responsible practices in the field.

Course Outcomes:

CO1: Describe the foundational concepts and therapeutic strategies of cell and gene therapy, including in vivo and ex vivo approaches.

CO2: Explain the design, types, and safety considerations of viral and non-viral vectors used in gene delivery.

CO3: Analyze various delivery methods and targeting strategies, and evaluate challenges in effective gene transfer.

CO4: Distinguish between different cell therapy types and discuss their clinical applications in disease treatment.

CO5: Interpret clinical trial data and approved cell and gene therapy products, assessing challenges in efficacy and safety.

CO6: Identify key ethical, regulatory, and commercial considerations involved in the development and deployment of advanced therapies.

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 cell therapy

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 – Advanced techniques in cell culture, gene editing, and bioprocessing

PSO 7 – Statistical methods to interpret and validate diagnostic results

PSO 8 – Integrate cell therapy into personalized medicine

PSO 9 – GMP and regulatory practices in cell therapy production

PSO 10 – Bioinformatics and biological data use

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

Textbook

Black, C. (2006). The Stem Cell Debate: The Ethics and Science Behind the Research. Enslow Publishers.

Reference

Kahn, J. (2019). Ethics and Stem Cell Research. Johns Hopkins Berman Institute of Bioethics.