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IRB Library

The IRB Library houses submission documents, guidance, and policies for the research community to access and download.

  • Forms - IRB application documents
  • Templates - sample documents for an IRB submission
  • Guidance - information on important topics such as FERPA and data security
  • Policies - standard operating procedures (SOPs) for the review of human subjects research
  • PAM - post approval monitoring, documents to assist researchers with ongoing monitoring of research
Document Category Document File Document Description Version Date
Forms File Amendment Application Request changes to IRB approved documents or change in PI 01/19/2018
Forms File Closure Application Request project closure 01/19/2018
Forms File Continuing Review Application Request continuing review of active study 01/19/2018
Forms File Deferred Projects Annual Report Provide status update of project deferred to external IRB 08/04/2017
Forms File Device Form Provide information related to use of an investigational device 04/27/2016
Forms File Event Report Provide information related to adverse event or unanticipated problem 08/04/2017
Forms File HIPAA Waiver Request Request a waiver of HIPAA Authorization 06/12/2017
Forms File Individual Investigator Agreement For External Partner PIs whose institution does not have an FWA 10/16/2017
Forms File PI Eligibility Request Form Request an exception to PI Eligibility policy 08/08/2017
Forms File Project Information Form Provide information on a new project 01/19/2018
Forms File Project Team Form List active research team members and associated role 01/19/2018
Forms File Protocol Deviations Report Provide information on protocol deviations that occurred since last review 09/16/2015
Forms File Request for External IRB Review Request for deferral of oversight to external IRB 06/09/2016
Forms File Scientific Validity Review Form Provide documentation of review of scientific validity 04/24/2017
Forms File Translation Certification Form Certify the qualifications of the translator used for research documents 12/02/2015