Course

Unit 1:
Introduction to Ethics in Translational Research, Overview of ethical principles and theories, Historical perspective on research ethics, Importance of ethical considerations in translational research
Unit 2:
Ethical Considerations in Study Design and Conduct, Risk-benefit assessment and study feasibility, Selection of study populations and recruitment strategies, Data management and integrity in translational research
Unit 3:
Informed Consent and Participant Protection, Elements of informed consent, Capacity to consent and decision-making capacity, Consent issues in vulnerable populations
Unit 4:
Ethical Issues in Preclinical Research, Animal welfare and ethical considerations in animal studies, Reduction, refinement, and replacement principles, Translation of preclinical findings to clinical research
Unit 5:
Ethical Challenges in Clinical Trials, Randomization and equipoise, Placebo-controlled trials and standard of care, Monitoring and reporting adverse events
Unit 6:
Ethical Implications of Emerging Technologies, Gene editing and genetic modification, Stem cell research and regenerative medicine, Artificial intelligence and big data in translational research
Unit 7:
Research Integrity and Publication Ethics, Authorship and contributorship, Plagiarism and research misconduct, Peer review and responsible publication practices
Unit 8:
Ethical Issues in Translating Research into Practice, Access to investigational therapies, Commercialization and conflicts of interest, Health disparities and global health equity
Unit 9:
Basic understanding of GLP, GMP and GCP

Preamble

Ethics and Quality Systems in Translational Research is a graduate-level course designed to provide students with an in-depth understanding of ethical principles, considerations, and challenges as well as the need for quality systems needed toin the conduct of translational research. The course will explore quality systems (Lab Accreditation, GLP, GCP, GMP) and ethical issues related to human subjects research, preclinical studies, clinical trials, and the translation of research findings into clinical practice. Through lectures, case studies, discussions, and guest speakers, students will critically examine ethical dilemmas and develop skills in ethical decision-making in the context of translational research.

Course outcome

CO1: To understand foundational ethical principles and theories relevant to translational research
CO2: To explore ethical considerations in the design, conduct, and dissemination of translational research studies.
CO3: To analyze case studies and real-world examples of ethical challenges in translational research.
CO4: To examine the roles and responsibilities of researchers, institutional review boards (IRBs), and regulatory bodies in ensuring ethical conduct.
CO5: To discuss ethical issues related to informed consent, risk-benefit assessment, and vulnerable populations in translational research.
CO6: To understand the basic quality systems needed for laboratories (GLP), biomanufacturing (GMP) and clinical trial (GCP).
CO7: To develop skills in ethical decision-making and critical thinking through class discussions and assignments.

Program outcome (PO)

PO1: Utilize scientific principles and methodologies to design innovative solutions for data analysis, experimentation, and product development for challenges in translational research.
PO2: Recognize the importance of environmental sustainability in translational research and strive to minimize adverse environmental impacts.
PO3: Engage in ethical conduct, leadership, active listening, constructive feedback, and interpersonal communication to facilitate productive collaborations and knowledge exchange.
PO4: Acquire fundamental and advanced knowledge and skills in project management, financial planning, and entrepreneurship relevant to translational research ventures and initiatives.
3 = High Affinity, 2 = Medium Affinity, 1 = Low Affinity, – = No Affinity

Program Specific Outcome (PSO)

PSO1: Addresses the complexity of interdisciplinary sciences in biological and medical contexts.
PSO2: Deals with regulatory affairs in medicine, covering topics such as ethical considerations and regulatory frameworks.
PSO3: Covers compounds as drugs and their efficacy, involving pharmacology and drug development.
PSO4: Explores the intersection of bioinformatics and artificial intelligence in biology and medicine.
PSO5: Deals with technology in personalizing medicine, involving precision medicine approaches.
PSO6: Focuses on communicating and disseminating science and medicine to the public, involving science communication and public outreach efforts.

Oliver, P., 2010. The student’s guide to research ethics. McGraw-Hill Education (UK).