Module 1: Foundations of Biomedical Research Ethics

• Evolution of biomedical ethics: from Nuremberg Code to the Belmont Report

• Core ethical principles: respect for persons, beneficence, and justice

• The role of international guidelines and declarations (Helsinki, CIOMS)

• Hands-on Exercise: Analyzing historical ethical violations and their modern implications

Module 2: Ethical Review and Institutional Oversight

• Structure and responsibilities of Institutional Review Boards (IRBs)

• Review processes for biomedical research proposals

• Risk–benefit assessment and participant protection

• Hands-on Exercise: Simulated review of a clinical trial proposal

Module 3: Informed Consent and Participant Rights

• Designing culturally appropriate informed consent procedures

• Special populations: minors, vulnerable groups, and cognitively impaired participants

• Data privacy and confidentiality obligations under GDPR and HIPAA

• Hands-on Exercise: Developing an informed consent form for a human study

Module 4: Research Misconduct, Data Integrity, and Compliance

• Understanding research misconduct: fabrication, falsification, and plagiarism

• Responsibilities in data management, authorship, and reporting

• Compliance audits and corrective actions

• Hands-on Exercise: Conducting an ethics audit for a simulated research project

Module 5: Case Study – Ethical Dilemmas in Biomedical Research

• Integrative review of real-world ethical breaches in biomedical settings

• Role-playing ethical decision-making in controversial research situations

• Developing compliance improvement plans for institutions

• Hands-on Exercise: Group presentation on ethical resolution and institutional response