Submitting a new IRB application involves the following steps: Creating a New Project in IRBNet Using the “Designer” to attach all relevant forms and documents and create a Registration Form. Sharing the submission with others. Obtaining SRC review and approval. Obtaining any necessary ancillary reviews and approvals. Obtaining e-signatures Submitting the package to the IRB. Each step is described in more detail below. On the “My Projects” page, click on the “Create New Project” button on the left area to start creating your IRB submission. This will bring you to the “Project Information” page where you can begin inputting your information for your submission. Please follow the online instructions as indicated. The items with the red asterisk (*) must be filled out Click “Continue” to move to the next section of the submission, which brings you to the “Designer” page (see next section) The “Designer” Page is where you will locate all the forms and templates to be used with your submission. Click on “Designer” on left menu.
Search for user, select type of access, then enter a comment to the user, for example, to request e-signature. NOTE: If a particular user’s name does not come up, contact that user. It is possible they have not yet registered with IRBNet or they did not complete the registration process for IRBNet. The Scientific Review Committee must submit their review in the following manner: Log into IRBNet at with the Username and Password Click on “My Projects” in the blue-shaded area on the left-hand side of the webpage and click on the project title When the project opens, click on Designer on the left menu Choosing “Need Forms? Show Form Libraries” will allow you to download blank forms, templates, or reference materials. In the section “Select a Library,” choose the location of the IRB which would be “SUNY Downstate Medical Center, IRB Office, Brooklyn, NY” The section labeled “Select a Document” is where all the most updated DMC/IRB forms and templates will be located. Please download the SRC Reviewer Form to your desktop so that you can begin editing as needed. Attach the completed form by returning to the “Designer” page and clicking “Attach New Document” and upload the document. Contact the study team if revisions are needed, before e-signing the submission. If revisions are not required, see section below on “Electronic Signatures” for instructions on how to e-sign the submission. The package should be electronically signed, preferably in the following order, before submitting the package to the IRB: E-signed by the PI E-signed by the Scientific Review Committee Reviewer E-signed by the Department Chair
once you submitted your review, the heading was change to Update your comments and reviewer documents:” Click on the “Committee Messages” link. The “Committee Messages” page will show you all the emails associated with the submission under review. Messages sent with a red flag next to them will also appear in your “My Reminders” page. Click on the red flag to silence that message once you have completed your review. This will also remove this message from the “My Reminder” page. This is a good way for you to keep track of your workload. If there are no reminders left then you have completed all reviews for that agenda IRB Policy IRB-01 Angela Cartmell, PhD, CIP Kevin L. Nellis, MS, CIP Nakih Gonzales Danielle Lewis, MD, MPH Original Issue Date: 11.04.2016 Revision Date: 2.10.2017 Replaces previous documents: IRB Application Guidance (updated and combined with this guidance on 12/27/2016) Date Reviewed & Approved Revision Required Responsible Staff Name and Title Yes No 11.04.2016 X Kevin Nellis, Executive Director Human Research Protections and Quality Assurance 12.27.2016 X Kevin Nellis, Executive Director Human Research Protections and Quality Assurance 02.10.2017 X Kevin Nellis, Executive Director Human Research Protections and Quality Assurance