The Human Research Protections FLASH IRB Series is a collection of brief, pre-recorded educational modules designed to provide practical guidance on key topics related to human subjects research and IRB processes. Each presentation is less than 10 minutes in length and includes closed captioning, a transcript, and a companion guide with screenshots to support learning and reference.
The FLASH IRB Series is intended for researchers, study coordinators, faculty, and staff involved in human subjects research who are looking for convenient, on-demand training to enhance their understanding of IRB requirements, regulatory expectations, and WRG-HS processes.
Watch for additional FLASH modules covering a variety of human research protections topics as we continue to expand the series.
This guide provides step-by-step instructions for creating and submitting a Human Research Determination Form (RDF) in WRG-HS. It includes screenshots and troubleshooting tips to help investigators and study teams successfully complete the submission process.
This guide provides step-by-step instructions for creating and submitting an Intake for an Initial IRB Application in WRG-HS. It includes screenshots, submission tips, and troubleshooting guidance to help investigators and study teams successfully initiate the IRB review process.
This guide provides step-by-step instructions for creating and submitting an Initial IRB Application in WRG-HS following completion of the Intake Form. It includes screenshots, submission guidance, and troubleshooting tips to help investigators and study teams successfully submit their application for IRB review.
This guide provides step-by-step instructions for creating and submitting an Administrative Amendment in WRG-HS for eligible administrative changes, such as updates to study personnel or submission of translated documents. It includes screenshots, submission instructions, troubleshooting guidance, and appendices covering alternate navigation methods, reopening in-progress submissions, and resolving incomplete application errors to support successful submission.
This guide provides step-by-step instructions for creating and submitting an Amendment in WRG-HS. It walks users through initiating an amendment, completing the Amendment Questionnaire, revising the IRB application, uploading tracked changes, submitting the amendment for PI certification (when applicable), and verifying successful submission. The guide also includes troubleshooting tips and appendices covering alternative navigation methods, reopening in-progress amendments, resolving incomplete application errors, using Forms History to compare application versions, and documenting revisions using tracked changes.
This guide provides step-by-step instructions for creating and submitting a Continuing Review in WRG-HS. It walks users through initiating a Continuing Review, completing the Continuing Review questionnaire, documenting study progress and enrollment, uploading any required supporting documentation, completing the IRB application, submitting the review for PI certification (when applicable), and verifying successful submission. The guide also includes troubleshooting tips and appendices covering alternative navigation methods, reopening in-progress Continuing Reviews, addressing incomplete application errors, providing additional study information, and using the Forms History feature to compare current and previous IRB application versions.
This guide provides step-by-step instructions for submitting a Closure Report in WRG-HS. It walks users through locating an approved protocol, initiating a Closure Report, completing the Closure Report questionnaire, addressing study closure requirements, completing the IRB application, submitting the Closure Report for PI certification (when applicable), and verifying successful submission. The guide also includes important considerations for study closure, such as requirements related to identifiable data analysis, repositories, ClinicalTrials.gov reporting, and cumulative enrollment reporting, as well as troubleshooting tips and appendices covering alternative navigation methods, reopening an in-progress Closure Report, and resolving incomplete application errors.
