When should the Principal Investigator (PI) begin the application process?
It is best to apply before the study begins enrollment. An application can be submitted once the Institutional Review Board (IRB) has approved the study. This application must be submitted by the PI who is a faculty member or official of the research institution. See below for steps that should be taken if the Certificate of Confidentiality is obtained after enrollment and data collection has begun. What should the PI do if the IRB will not issue its final approval until the project has been issued a Certificate of Confidentiality? The PI may submit an IRB approval conditioned only upon the issuance of the Certificate of Confidentiality. What if the research includes multiple protocols and/or sites? The National Heart, Lung, and Blood Institute (NHLBI) supports many multi-site and networked clinical studies and trials. A single Certificate of Confidentiality can be issued where the same or overlapping subjects will be enrolled, and/or where one or more protocols will be carried out at
