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Module 1: Lesson 1
Ethics Committees and Regulatory Authorities
How IRBs, IECs, and regulatory agencies work together to protect research participants and ensure the integrity of clinical trial data.
What you will learn
By the end of this lesson, you will be able to:
Ethics committees: the participant's advocate
Before any clinical trial can begin, an independent ethics committee must review and approve the research. In the United States, this committee is called an Institutional Review Board, or IRB. In Europe and many other regions, it is called an Independent Ethics Committee, or IEC. The names differ, but the purpose is identical: to protect the rights, safety, and well-being of human research participants.
The concept of independent ethics review emerged from historical tragedies. Before the mid-twentieth century, researchers largely governed themselves. Some conducted experiments that would be unthinkable today: deliberately infecting people with diseases, withholding effective treatments, experimenting on vulnerable populations without consent. The Nuremberg Code, the Declaration of Helsinki, and the Belmont Report all called for independent review of research before it could proceed.
Today, ethics committee review is not optional. Federal regulations in the United States require IRB approval for all federally funded research involving human subjects. The International Council for Harmonisation mandates ethics committee approval for all clinical trials of investigational medicinal products. This requirement exists because researchers, however well-intentioned, are not the best judges of whether their own studies are ethical.
Good Clinical Practice (GCP)
Full course · Clinical Research Foundations