Decision Trees for submitting Medical Record Review Research

Are you conducting human subjects research as defined by DHHS and FDA? Decision Trees provided by the Office for Human Subject Research Protections will help you determine if an activity is research involving human subjects that must be reviewed by the IRB.

These charts are general, and not specific to many situations. They also do not address requirements from other agencies, such as the Food and Drug Administration (FDA), The National Institutes of Health (NIH) or other state and local governments.

Guidance is available through the Office of Research Support Services at the College of Medicine at Rockford.

Chart A: Is Activity Research Involving Human Subjects?

Chart B: Is the Human Subjects Research Eligible for Exemption?

Chart C: May the IRB Review be done in by Expedited Procedures?

Chart D: May the IRB Continuing Review be done by Expedited Procedures?