UAMS.EDU

Is your study subject to FDA review? Edit documents accordingly

The Food and Drug Administration (FDA) has oversight over some, but by no means all, of the research that comes through the UAMS IRB. When submitting studies, please confirm that your consent and HIPAA authorization forms correctly reflect whether the FDA will have access to study records. Projects that involve FDA-regulated products such as investigational drugs and devices are subject to FDA review, and the FDA must be listed as an entity that may review records for those types of studies. However, if your study is not subject to FDA oversight, you can delete any mention of the FDA reviewing records from the consent and HIPAA authorization forms. Note that studies that involve approved drugs and devices may also be subject to FDA oversight in some cases, depending on study particulars. The IRB and the Office of Research Regulatory Affairs can help you determine if you need to mention the FDA in a particular study’s consent and HIPAA authorization forms.