Respond to Formal IRB Communication

HRP-214: Response to PPHS Required to Secure Approval Form – Instruction Guide 

Use this form when responding to IRB determinations such as a “Deferral” of approval or “Response Required to Secure Approval”. This form is for use during the formal IRB review process, and is not necessary in response to screening or analyst pre-review comments. 

HRP-214 Response to PPHS (2/1/11)

Section A should be completed as a list of direct responses to each of the points in the IRB Findings and Determinations correspondence. 

Section B serves as a checklist for other materials that may need to be submitted along with this form, as applicable. 

Section C must be signed by the PI as an attestation that the PI acknowledges and authorizes the submission.