FDA Series – Using Drugs in Human Subjects Research

Although OHRP and FDA regulations are similar, differences exist based on FDA’s unique scope and requirements. The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering an FDA series. This first session will focus on research involving drugs and how to navigate the IRB approval process. By the end of the session, participants will be able to:

• Explain common regulatory terms in the context of FDA-regulated drug studies
• Assess which regulations apply to clinical investigations involving drugs or biologics, including when an Investigational New Drug Application (IND) is required
• Identify and complete Buck-IRB application sections and documents required for FDA-regulated drug research
• Recognize how and when to consult the FDA

Please note, this intermediate-level session assumes a basic familiarity with the IRB review process and Buck-IRB, and will not cover emergency use or expanded access protocols. While the session will be tailored to medical researchers and research staff, anyone preparing IRB submissions is welcome.