Full course description
(Formerly known as "REd Online: Institutional Review Board (IRB) and Human Subject Research")
Participants will develop a basis for understanding the background and regulations for the protection of human research subjects. The Human Research Protection Program (HRPP) will be discussed including the informed consent process, vulnerable populations, Serious Adverse Event (SAE) reporting, inclusion and exclusion criteria, HIPAA authorization, and protocol applications. The Electronic Research Integrity Compliance Administration (ERICA) program will be presented and IRB documentation standards will be explained.
At the conclusion of this class, you should be able to:
- Describe the background and events that lead to the development of ethical principles and regulations for the conduct of human subject research
- Summarize the Human Research Protection Program (HRPP) with accompanying regulations
- Identify regulations and processes for the protection of research participants using informed consent
- List vulnerable human subject populations and explain why they are vulnerable
- Describe how to use online IRB resources and portal.