IRB Presentation: Checklists and Guidance Documents Galore!

Event Date: 

Wed, Oct 05, 2022 - 9:00am to 10:30am

Event Location: 


The Human Subjects Office (HSO) offers a variety of checklists and documents that we hope the research community will use for various types of circumstances and scenarios. In this lecture, HSO staff will provide an overview of the following checklists and when to use them:

  • Exemption Tool – about the eight categories of research that qualify for Exempt Status
  • Two Informed Consent Document checklists – for biomedical research and social/behavioral researchers to make sure consent documents are consistent with the HawkIRB application
  • checklist (NEW!) – incorporates all previous and Applicable Clinical Trial (ACT) checklists
  • Investigational New Drug (IND) or Investigational Device Exemption (IDS) Checklists – about the reporting and record keeping responsibilities of researchers who hold an IND or IDE with the Food and Drug Administration (FDA)
  • FDA Site Inspection Guide – for when the FDA comes to inspect a study
  • Course Related Student Project Checklist – for student projects conducted as a course assignment
  • PI Departure Checklists – for the Human Research Protection Program and for funded research (external or internal funding)

Pre-registration is recommended.