About

This comprehensive program is designed to provide participants with a deep understanding of the ethical principles, guidelines, and best practices essential in clinical research. It aims to equip healthcare professionals, researchers, and academicians with the knowledge and skills required to ensure the protection of human subjects while maintaining research integrity.

Aim

This program aims to familiarize participants with the ethical principles and considerations involved in conducting clinical research. Participants will learn about the ethical framework, guidelines, and regulations governing human subjects’ protection, informed consent, and research integrity.

Curriculum

1. Week 1: Introduction to Medical Ethics in Clinical Research

   • Overview of medical ethics and its relevance to clinical research
   • Ethical principles and frameworks for research involving human subjects

2. Week 2: Informed Consent and Participant Autonomy

   • Importance of informed consent and its elements
   • Consent process, capacity assessment, and participant autonomy

3. Week 3: Ethical Considerations in Study Design

   • Ethical challenges in study design and participant selection
   • Balancing scientific rigor and ethical requirements

4. Week 4: Privacy, Confidentiality, and Data Protection

   • Maintaining privacy and confidentiality of research participants
   • Ethical considerations in data collection, storage, and sharing

5. Week 5: Vulnerable Populations and Research Ethics

   • Ethical considerations when involving vulnerable populations
   • Special protections for children, pregnant women, and other vulnerable groups

6. Week 6: Research Ethics Committees and Institutional Review Boards

   • Role and functions of research ethics committees
   • Ethical review process and criteria for research approval

7. Week 7: Risk-Benefit Assessment and Minimization

   • Ethical considerations in risk assessment and management
   • Balancing potential benefits and risks for research participants

8. Week 8: Reporting Adverse Events and Safety Monitoring

   • Ethical responsibilities in adverse event reporting
   • Safety monitoring and pharmacovigilance in clinical research

9. Week 9: Publication Ethics and Responsible Conduct of Research

   • Ensuring integrity and transparency in research reporting
   • Avoiding plagiarism, data fabrication, and research misconduct

10. Week 10: International Ethical Guidelines and Cultural Considerations

    • Ethical guidelines and cultural diversity in clinical research
    • Navigating ethical challenges in global research collaborations

11. Week 11: Ethical Issues in Multi-Center Trials and Data Sharing

    • Ethical considerations in multi-center trials and data sharing
    • Collaboration, authorship, and ownership of research data

12. Week 12: Ethics in Post-Trial Activities and Dissemination of Results

    • Ethical responsibilities in post-trial activities and long-term follow-up
    • Dissemination of research findings and public engagement

Outcomes

• Understanding of ethical principles and guidelines in clinical research.
• Proficiency in obtaining informed consent and ensuring participant confidentiality.
• Knowledge of ethical considerations in vulnerable populations.
• Awareness of research integrity and responsible conduct of research.
• Competence in ethical decision-making and resolving ethical dilemmas.