Approvals

Researchers will need approval from the SRC and DCC IRB

Scientific Review Committee (SRC) approval:

            The investigator submits the completed proposal to the Scientific Review Committee (SRC) Chairs (Ronn Tanel, Sonali Patel) and the PAC3 Project Specialist (Margaret Graupe). Two-three reviewers will be assigned to review the proposal, and their suggestions will be compiled and sent back to the investigator within 4 weeks of submission. This review will indicate whether the proposal has been accepted with minor revisions, requires major revisions for reconsideration, or is rejected. The author can request a meeting with the SRC chairs to discuss the outcome of the proposal and how the proposal can be strengthened. Proposal revisions should be submitted within six weeks of the review or meeting with the chairs.

            Please note, if the proposal includes fields from another registry within Cardiac Networks United, it will need to be approved by that collaborative’s Scientific Review Committee as well. Approval from another registry’s SRC will be coordinated by the PAC3 SRC.

IRB Approval:

            The Data Coordinating Center at Michigan has an overarching IRB to house the registry in Michigan but requires an IRB submission for each research project requesting data to be sent out of the registry. It will streamline the IRB process significantly if the investigator reviews and thoroughly understands the Data Flow for Research document. Send the completed Registry IRB form to the PAC3 Project Specialist (Margaret Graupe). Approval can usually be obtained in 1-2 weeks, but the IRB may come back with questions, so it will be up to the author to answer the questions promptly to ensure timely approval.

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