HRPP has a One Application Policy in accordance with Title 45 CFR 46.115 (Health and Human Services, IRB Records) and Title 21 CFR 56.115 (Food and Drug Administration, IRB Records).
All new initial studies (Exempt/Expedited/Full Board) reviewed by the IRB/HRPP after May 1, 2022 will be subject to the One Application Policy. Studies that receive IRB approval or an Exempt Determination will receive documents stamped with IRB/HRPP Approval that must be retained in their study record. HRPP will issue an updated version of the IRB/HRPP Approved stamped documents with each subsequent submission approval.
Studies that fall under the One Application Policy will maintain a single, active application that reflects current study procedures and incorporates all IRB-approved amendments and HRPP-accepted modifications. Stamped documents will be issued to the PI along with the Approval Memo for all initial approvals. The IRB/HRPP Approved stamp will be located in the footer of the document. The stamped document must be retained in your study records.
Future submissions must include updates to all applicable documents to maintain a single, active application that incorporates all IRB/HRPP approved revisions. Revisions should be made to applicable documents using Microsoft Word with tracked changes to indicate the requested revisions. Individual revised documents should be submitted along with the Revision Request Form and any new material to [email protected] for review and approval. HRPP will issue an updated version of the IRB/HRPP Approved stamped documents with each submission approval.
Effective November 14, 2022, this process reflects the following changes from previous submission requirements:
Use Word with tracked changes
Submit only those documents being revised or added.
- Submit individual Word documents of the materials being changed with tracked changes in Word.
- The original protocol with tracked changes in Word.
- New documents being added as individual Word documents.
Alternate formats may be accepted, but will require the submission of clean copies prior to final approval.
Final IRB/HRPP Approved Materials will be issued as a pdf with a single stamp in the bottom left corner of the document.