IRB Presentation: Checklists and Guidance Documents Galore!

Oct 5, 2022

09:00 AM - 10:30 AM

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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

ClinicalTrials.gov checklist (NEW!) – incorporates all previous ClinicalTrials.gov 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)

Individuals with disabilities are encouraged to attend all University of Iowa–sponsored events. If you are a person with a disability who requires a reasonable accommodation in order to participate in this program, please contact in advance at