This web page, and our new forms!

This page was designed to help investigators understand the often arcane federal regulations for the determination of exempt status. To improve the submission process and reduce the amount of additional correspondence between the investigator and the IRB, we have not only provided a detailed set of criteria for each of the 7 broad exempt categories that the University of Pittsburgh IRB reviews, but we have developed integrated submission forms, each of which includes a study-appropriate cover sheet, protocol questions, investigator assurances, mentor/faculty sponsor assurances (if applicable) and ‘honest broker’ assurances (if applicable).

Each Word-based form is ‘locked,’ and investigators can type (or paste materials) into text form fields, and click check boxes with the left mouse button. For descriptive materials, links to relevant federal regulations or guidance documents are provided.