Create and Submit a New (First Time) Project Submission in IRBNet

  • Depending on an individual’s access level, the PI can delegate (through sharing) to a co-investigator, or a study coordinator, the task of helping to create the study. Higher levels of sharing (ability to submit a study, as an example) should be granted to as few individuals as possible (e.g., PI and study coordinator).
  • In addition to the documents addressed below, BNL investigators should obtain additional BNL-specific forms for completion at http://www.bnl.gov/ora/ORA.asp
  • Consent forms should be submitted in Microsoft word, and should not be submitted on letterhead.

To begin: Log on, choose ‘Create New Project’ (on the left), and fill out all initial required fields (and non-required fields as you wish for your own ‘search’ requirements).

Complete the Registration Form for Expedited or Full CORIHS Review:
  • Go to your project’s Designer
  • Select ‘Add New Document’
  • In the lower shaded ‘On-Line Document’ box, select ‘Registration Form for Expedited or Full Committee Review’, then hit the ‘Add’ button
  • Begin completing the Registration Form. You do not need to complete the whole form in one sitting; you can ‘save and exit’, and then go back and update the document by clicking the pencil icon next to the document listed in the designer.
  • When you are done completing the registration form, click “Preview” to see what the completed form looks like, and confirm that all the information provided is accurate. Once you are satisfied in this regard,

 

Click "Save and Exit", and then continue constructing your project package to completion:

  • Download and complete the "Application for Expedited or Full CORIHS Review", a downloadable document located in the project’s in the Document Library (found on Designer page, step one) that will capture more detail about the answers you provided in the Registration Form.
  • Download and complete other required, downloadable forms (found on Designer page, step one), in accordance with the requirements outlined in the CORIHS Submission Requirements for New, First Time Submissions , which is available in the project’s Library. Examples of such forms are the consent templates for customization to your study, ‘Application for Approval to Conduct Research at University Hospital’, and Supplemental forms (if your project is proposing use of questionably viable or nonviable neonates, international sites, prisoners, or must comply with ICH-GCP). Once completed, you will upload the completed forms from your computer. You will need to supply a ‘document type’: select the descriptor that best describes what you are uploading. If unsure, select ‘other’ and provide the description you want in the field called ‘description’. Then browse and find the document for uploading from your computer by clicking on ‘Add New Document’ in the Designer, and using the top shaded area on the next screen.
  • Upload other documents from your computer to complete the submission, such as sponsor protocol, investigator brochures, advertisements etc, by clicking on ‘Add New Document’, and using the top shaded area.
  • Share with your project team members
  • Obtain appropriate signatures
  • Submit the package to the Stony Brook University Human Subjects Committee (IRB) by clicking the ‘Submit this Project ’ button on the left. You will be submitting to the Stony Brook University Human Research Committee (IRB). The first time you submit a brand new project, you will choose the submission type ‘New Project’.

 


 

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