The Brown University IRB/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).

Effective November 1, 2018, the IRB/HRPP implemented the One Application Policy for new Full Board studies only.

Beginning May 1, 2022, this Policy will expand. All new studies - Full Board, Expedited and Exempt - will be subject to the One Application Policy.

New Submissions

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 after May 1, 2022. The IRB/HRPP Approval stamp will be located in the footer of the document and will include separate and continuous approval dates.

Example:

Example IRB Approval Stamp

Revisions

IRB/HRPP stamped documents must be submitted for all future amendments or modifications. Revisions must be integrated directly into the protocol document using tracked changes, strikethrough or highlighting to indicate the changes being requested. Complete IRB/HRPP Approval stamped documents should be submitted along with the Revision Request Form and any new material as a single PDF to [email protected] for review and approval. 

Example Stamped Tracked Changes

 

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