Ethical Considerations in Clinical Research: Protecting Human Subjects
Ethical considerations, Clinical research ethics, Human subjects protection, Balancing scientific advancement and ethical principles, Ethical implications of dissemination of research findings
About Program:
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.
Program Objectives:
What you will learn?
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
Week 2: Informed Consent and Participant Autonomy
- Importance of informed consent and its elements
- Consent process, capacity assessment, and participant autonomy
Week 3: Ethical Considerations in Study Design
- Ethical challenges in study design and participant selection
- Balancing scientific rigor and ethical requirements
Week 4: Privacy, Confidentiality, and Data Protection
- Maintaining privacy and confidentiality of research participants
- Ethical considerations in data collection, storage, and sharing
Week 5: Vulnerable Populations and Research Ethics
- Ethical considerations when involving vulnerable populations
- Special protections for children, pregnant women, and other vulnerable groups
Week 6: Research Ethics Committees and Institutional Review Boards
- Role and functions of research ethics committees
- Ethical review process and criteria for research approval
Week 7: Risk-Benefit Assessment and Minimization
- Ethical considerations in risk assessment and management
- Balancing potential benefits and risks for research participants
Week 8: Reporting Adverse Events and Safety Monitoring
- Ethical responsibilities in adverse event reporting
- Safety monitoring and pharmacovigilance in clinical research
Week 9: Publication Ethics and Responsible Conduct of Research
- Ensuring integrity and transparency in research reporting
- Avoiding plagiarism, data fabrication, and research misconduct
Week 10: International Ethical Guidelines and Cultural Considerations
- Ethical guidelines and cultural diversity in clinical research
- Navigating ethical challenges in global research collaborations
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
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
Intended For :
Graduates, Post Graduates, Research Scholars, Academicians, Industry Professionals of Healthcare and Medical Research Sector
Career Supporting Skills
Program 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.
