Regulatory Coordinator
Full course · Regulatory Submissions & Stakeholder Management
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Maps the five major IRB models as operational realities the RC must navigate simultaneously, analyzing their distinct characteristics and building a reference guide for portfolio-level IRB management.
There was a time -- and it was not so long ago -- when the question "Which IRB reviews your studies?" had a simple answer. The institution had its own IRB, or the site used a single commercial board, and that was the universe. Every protocol went to the same body, following the same forms, on the same timeline, through the same portal. A coordinator could master one set of procedures and apply them uniformly.
That world no longer exists. The 2018 revised Common Rule's single IRB mandate for federally funded multi-site research, the explosive growth of commercial central IRBs like WCG and Advarra, the persistence of institutional IRBs for certain categories of research, the VA's separate Central IRB system, and the emergence of academic institutions serving as the single IRB of record for cooperative group studies -- these developments have created an environment where a single site may simultaneously submit to three, four, or even five different IRBs for different studies in the same portfolio.
And here is the operational reality that matters for this lesson: each of those IRBs operates differently. Different portals. Different form sets. Different submission timelines. Different reviewer expectations. Different fee structures. Different communication preferences. The RC who treats them interchangeably will discover -- through rejected submissions, missed deadlines, and exasperated IRB administrators -- that the IRB ecosystem in 2025 is not a taxonomy to memorize. It is an operational landscape to navigate.
What you will learn3 objectives
By the end of this lesson, you will be able to:
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