The Association of Clinical Research Professionals
Ethics and Human Subject Protection: An Introduction with ICH E6(R3) Guidance
Ethical conduct protects your reputation, research outcomes, and the safety of your participants.
Now updated to reflect the latest guidance from ICH E6(R3), this on-demand training is a must for clinical research professionals at any stage of their career—whether you’re just starting out or looking to reinforce your foundational knowledge.
Through a compelling exploration of the history and evolution of ethics in clinical trials, this course reveals why ethical conduct is not just a regulatory requirement. You’ll gain an understanding of the principles that guide ethical decision-making and learn how to apply them to protect human subjects and maintain the integrity of your work.
The course addresses how to identify and prevent unethical behavior before it escalates, and how to respond effectively when ethical concerns arise. By examining key guidelines and their core elements, you’ll see how missteps can impact not only trial outcomes but also public trust and organizational reputation.
At the end of this course, participants should be able to:
Define the concept of ethics and distinguish its application within the context of clinical research.
Summarize key historical events that shape ethical standards in clinical trials.
Identify and classify major ethical guidelines and codes used in clinical research.
Explain the role of ethical conduct in protecting participants and ensuring research integrity.
Analyze the consequences of unethical decisions and evaluate their impact on stakeholders.
Apply ethical decision-making strategies to address concerns and respond to potential misconduct in clinical trials.