Ethical Aspects of conducting a Clinical Trial


The goal of clinical research is to develop generalizable knowledge that improves human health or increases understanding of human biology. People who participate in clinical research make it possible to secure that knowledge. The path to finding out if a new drug or treatment is safe or effective, for example, is to test it on patient volunteers. But by placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science.

In this course, you will be introduced to ethical principles and ethical aspects involved in the conduct of clinical trials and what happens in the absence of compliance with the Ethical principles. You will also get to know the difference between audit and inspection, and how those activities are conducted.

What will I learn?

  • Definition and role of Ethics in Clinical trials
  • Review of the development of research Ethics through various triggers for tougher regulations
  • Ethical principles of the ICH
  • Review of International Legislation
  • Types and function of Independent Ethics Committees – constitution, membership, procedures and documentation required
  • Responsibilities of Investigators towards Ethics Committees
  • Distinction between Independent Data Monitoring Committees and Ethics Committees
  • Informed Consent Form – definition, elements, exceptions to the informed consent principles, revisions, protection of vulnerable subjects
  • Research fraud and misconduct – definition, prevention, fabrication and falsification
  • Inspections vs Audits – definition, requirements, processes