The NINDS Topics in Clinical Research Seminar Series Lecture Presents, Behind Closed Doors: What Is the IRB and How Do I Get My Studies Approved?

Wednesday, May 17, 2023 | 1:00 - 2:00 PM

Would you like to learn more from the following objectives:

a. Overarching goal of the IRB is ensuring research subject safety – all reviews are done with this in mind.

b. IRBs are required and regulated by OHRP and the FDA, which dictate the types of reviews. IRBs are thus subject to FDA audit.

c. Leading issues that hold up approval: discrepancies between the protocol and the Informed Consent (ICF), poorly written or unclear ICFs, unclear distinction between the study and the standard of care.

Then please join us as we host Dr. Jennifer Berkeley, Director of Neurocritical Care, Vice Chair, Department of Neurology and Chair, LifeBridge Health IRB, Sinai Hospital of Baltimore.

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