IRBNet General Submission Instructions for CUNY
1.Accessing IRB Net (New Registration)
2.ACCESSING IRBNET (Existing Registration)
3.Adding your Training Credentials to IRBNet (CITI)
4.Creating a New Project in IRBNET
5.Continuing Review or Amendment Request for a protocol that was never in IRBNet (previously in IRB Manager, or paper format)
6.Continuing Review or Modification for a protocol which has previous submissions via IRBNet
7.Submitting your Project Package to the HRPP Office for Review
8.Unlocked Packages - Responding to Modification / Information Requests
8.1.Retrieve letter issued by the HRPP or UI-IRB Office.
8.2.Revise your Project’s Package – Missing Application Part I (unlocked Packages)
8.3.Revise your project package – Other Missing Documents (unlocked packages)
8.4.Revise your project package – Modifying Initial Application Part I (unlocked packages)
8.5.Revise your project package – Modifying Other Documents (unlocked packages)
8.6.Re-Submitting your Project Package (unlocked packages)
9.Locked Packages - Responding to Modification / Information Requests
9.1.Retrieve letter issued by the HRPP or UI-IRB Office.
9.2.Revise your project by creating a new package
9.3.Revise Application Part I (from a Locked Package)
9.4.Revise Other Previously Submitted Documents (from a Locked Package)
9.5.Add Other Previously Submitted Documents (from a Locked Package)
9.6.Linking your training materials to a new (from a Locked Package)
9.7.Submitting your Revised Project Package
10.Accessing IRB Approved/Published Documents
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1.Accessing IRB Net (New Registration)
1.1.Visit:
1.1.1.New users: Click on “New Registration” in the top right corner
1.1.2.Fill-out the registration form following the on-screen prompts
1.1.3.You will receive an account validation email from IRBNet, using the validation link provided, log into IRBNet for the first time.
1.2.Once registered, add your training credentials (CITI “Human Research Curriculum” Completion Report – Not “Responsible Conduct of Research”) to your profile as follows:
1.2.1.Click “User Profile” (link at top of screen once logged-in) and attach your CITI Human Subjects Certification by clicking “Add New Record”.
1.2.2.On the Training & Credentials Record page, select the document type from the drop-down menu.
1.2.3.Enter the date the document was effective
1.2.4.Click “Browse” to locate the document that you plan to attach (once found click “Open”).
1.2.5.Next, click “Attach”
1.2.6.You should now find yourself on the “User Profile” page. Submit your training certificate to the IRB by clicking “Submit” highlighted in blue next to the document you just added.
1.2.7.You will now be on the “Submit Training & Credentials” page. Type in your campus name in the blank and click “Search”
1.2.8.One you locate your campus name click on it and then click “Continue”
1.2.9.On the new page that opens, click “Submit”
Your document has now been submitted.
2.ACCESSING IRBNET (Existing Registration)
2.1.Visit:
2.2.Existing users: Enter your user Name and Password in the top right corner and click “log-in” (if you forgot your username or password select “Forgot your Password”, an email will sent to the email address indicated in your account with your username/password information.)
2.3.Once you log-in you will see the “My Projects” screen
3.Adding your Training Credentials to IRBNet (CITI)
3.1.After logging in click “User Profile” (link at top of screen once logged-in) and attach your CITI Human Subjects Certification by clicking “Add New Record” (DoNot Responsible Conduct of Research)
3.2.On the “Training & Credentials Record” page, select the document type from the drop-down menu.
3.3.Enter the date the document was effective
3.4.Click “Browse” to locate the document that you plan to attach (once found click “Open”).
3.5.Next, click “Attach”
3.6.You should now find yourself on the “User Profile” page. Submit your training certificate to the IRB by clicking “Submit” highlighted in blue next to the document you just added.
3.7.You will now be on the “Submit Training & Credentials” page. Type in your campus name in the blank and click “Search”
3.8.One you locate your campus name click on it and then click “Continue”
3.9.On the new page that opens, click “Submit”
Your document has now been submitted.
4.Creating a New Project in IRBNET
4.1.After logging in, click “CREATE NEW PACKAGE” on left side of the page
4.2.Enter the title of the project, the principle investigators first and last name. (if entering degree, only enter degrees the PI has already obtained)
4.3.Then click “Continue”
4.4.Now you will find yourself on the “Designer” page
4.5.Click “Add New Document” (Located under Step 2 of the “Designer” page)
4.6.On the “Attach Document” page, next to “On-Line Document” (bottom of the page), select “CUNY Application for Approval to use Human Subjects – Part I” and click “Add”
4.6.1.The IRB Document Wizard will open. When this happens you will have two choices a) cloning or b) not cloning:
a)cloning-If you have previously submitted a “CUNY Application for Approval to use Human Subjects – Part I” on ANY previous protocol submitted through IRBNet, cloning may be an option for you (if not, go to step 4.6.3.) Cloning creates an exact copy of your existing wizard and can be useful if a lot of the information already contained in your existing wizard will also be needed in your new wizard. When cloning you should always review every answer copied from your existing wizard to make sure it applies to your new wizard and make changes where necessary.
b)not cloning - You can only clone a form if you have previously created a form. If you have not, you must create a new one. To create a new form go to step 4.6.3.:
4.6.2.Cloning:
4.6.2.1.Select “Clone one of my existing wizards”
4.6.2.2.When a list of previous documents appears at the bottom of the page, select which one you would like to clone and click Continue. Note: You can preview each document by clicking the Paper icon to the right of the document title.
4.6.2.3.Read the instructions and then click Next.
4.6.2.4.Continue through each page making sure your answers apply to your current project.
4.6.2.5.When you arrive at the page that says “Form Complete”, take note of the supplements that you will be required to fill out (if any) before submitting your application.
4.6.2.6.You can preview the attachment before saving and exiting by clicking on “Preview” (close the newly opened window when done with your preview).
4.6.2.7.When you are ready to save the document click “Save & Exit” and your document will be saved and automatically attached to your project (you will be taken to the “Designer Page”).
4.6.3.Not cloning:
4.6.3.1.Select “Create a new wizard from scratch”
4.6.3.2.Read the instructions, then click “Next”
4.6.3.3.Continue through all the pages by answering the questions and clicking “Next” on each page.
4.6.3.4.When you arrive at the page that says “Form Complete”, take note of the supplements that you will be required to fill out (if any) before submitting your application.
4.6.3.5.You can preview the attachment before saving and exiting by clicking on “Preview” (close the newly opened window when done with your preview).
4.6.3.6.When you are ready to save the document click “Save & Exit” and your document will be saved and automatically attached to your project (you will be taken to the “Designer Page”).
4.7.Next, under Step 1 of the “Designer” page, click on “Select a Library” and choose “CUNY Institutional Review Board” from the drop-down menu.
4.7.1.From the “Select Document” drop-down menu choose “Initial Application Part II” (if submitting for Exempt Review, select “Request for Exemption” instead of “Initial Application Part II”) and click “Download”
4.7.2.Save the document to your PC. Repeat steps under 4.7. until you have downloaded all the documentsyou need for your application (i.e. sample consents, supplements, etc…)
4.7.3.Once you have downloaded all of the necessary documents, locate them and begin filling them out forms and altering consents to meet the needs of your project (if applicable).
4.8.When you have completely finished filling out and saving your documents, return to the Designerpage for your project and click “Add New Document”
4.8.1.You will then see the Attach Document page, where you will select an “Attachment Type” from the drop down menu for whatever it is you plan to attach (example, Application Form for the “Initial Application Part II” or the “Request for Exemption”)
4.8.2.Click “Browse” to locate the document that you plan to attach (once found click “Open”)
4.8.3.Then Click “Attach”
4.8.4.Your document is now attached to the project package (Repeat steps under section 4.8. for each item you wish to attach – such as forms you have completed, copy of your grant if receiving funding, consents, supplements, external institutional approval, or any other document you need to attach).
4.9.On the designer page, link your training documents to the project by clicking “link / un-link records”, selecting your training certificate, and clicking save. (if you cannot locate your CITI documentation, it is possible you did not add it to IRBNet. Visit your User Profile to verify).
4.10.Go to Section 7 of this document for submission instructions
5.Continuing Review or Amendment Request for a protocol that was never in IRBNet (previously in IRB Manager, or paper format)
(If your project has previously been submitted via IRBNet, do not follow these instructions – Instead go to section 6)
5.1.After logging in, click “CREATE NEW PACKAGE” on left side of the page
5.2.Enter the title of the project, the principle investigators first and last name. (if entering degree, only enter degrees the PI has already obtained)
5.3.Then click “Continue”
5.4.Now you will find yourself on the Designer page
5.5.Click “Add New Document” (Located under Step 2 of the Designer page)
5.6.On the “Attach Document” page, next to “On-Line Document” (bottom of the page), select “CUNY Application for Approval to use Human Subjects – Part I” and click “Add”
5.6.1.The IRB Document Wizard will open. When this happens you will have two choices a) cloning or b) not cloning:
a)cloning - If you have previously submitted a “CUNY Application for Approval to use Human Subjects – Part I” on ANY previous protocol submitted through IRBNet, cloning may be an option for you (if not, go to step 5.6.3.) Cloning creates an exact copy of your existing wizard and can be useful if a lot of the information already contained in your existing wizard will also be needed in your new wizard. When cloning you should always review every answer copied from your existing wizard to make sure it applies to your new wizard and make changes where necessary.
b)notcloning - You can only clone a form if you have previously created a form. If you have not, you must create a new one. To create a new form go to step 5.6.3.:
5.6.2.Cloning:
5.6.2.1.Select “Clone one of my existing wizards”
5.6.2.2.When a list of previous documents appears at the bottom of the page, select which one you would like to clone and click Continue. Note: You can preview each document by clicking the Paper icon to the right of the document title.
5.6.2.3.Read the instructions and then click Next.
5.6.2.4.Continue through each page making sure your answers apply to your current project.
5.6.2.5.When you arrive at the page that says “FormComplete”, take note of the supplements that you will be required to fill out (if any) before submitting your application.
5.6.2.6.You can preview the attachment before saving and exiting by clicking on “Preview” (close the newly opened window when done with your preview).
5.6.2.7.When you are ready to save the document click “Save & Exit” and your document will be saved and automatically attached to your project (you will be taken to the Designerpage).
5.6.3.Not cloning:
5.6.3.1.Select “Create a new wizard from scratch”
5.6.3.2.Read the instructions, then click “Next”
5.6.3.3.Continue through all the pages by answering the questions and clicking “Next” on each page.
5.6.3.4.When you arrive at the page that says “Form Complete”, take note of the supplements that you will be required to fill out (if any) before submitting your application.
5.6.3.5.You can preview the attachment before saving and exiting by clicking on “Preview” (close the newly opened window when done with your preview).
5.6.3.6.When you are ready to save the document click “Save & Exit” and your document will be saved and automatically attached to your project (you will be taken to the Designerpage).
5.7.Next, under “Step 1” of the Designer page, click on “Select a Library” and choose “CUNY Institutional Review Board” from the drop-down menu.
5.7.1.From the “Select Document” drop-down menu choose “Continuing Review Report” (if submitting a amendment, select “Modification/Amendment Request”) and click “Download”.
5.7.2.Save the document to your PC. Repeat steps under 5.7. until you have downloaded all the documents you need for your application (i.e. sample consents, supplements, etc…)
5.7.3.Once you have downloaded all of the necessary documents, locate them and begin filling them out.
5.8.When you have completely finished filling out and saving your documents, return to the Designer Page for your project and click “Add New Document”
5.8.1.You will then see the Attach Document page, where you will select an “Attachment Type” from the drop down menu for whatever it is you plan to attach (eg. Continuing Review form for the “Continuing Review Request”)
5.8.2.Click “Browse” to locate the document that you plan to attach (once found click “Open”)
5.8.3.Then Click “Attach”
5.8.4.Your document is now attached to the project package (Repeat steps under section 5.8.for each item you wish to attach – e.g. consents, previously approved protocol, prior approval letter, previously stamped/approved consent, unstamped consent, data collection instruments, grant application or status report –if receiving funding – and any other document related to the protocol since this is the first time you are using IRBNet for this study).
5.9.On the designer page, link your training documents to the project by clicking “link / un-link records”, selecting your training certificate, and clicking save. (if you cannot locate your CITI documentation, it is possible you did not add it to IRBNet. Visit your User Profile to verify).
5.10.Go to Section 7 of this document for submission instructions
6.Continuing Review or Modification for a protocol which has previous submissions via IRBNet
(If your project has NOT previously been submitted via IRBNet, do not follow these instructions – Instead go to section 5)
6.1.After logging in, access your project from the “My Projects” tab (left side of the page).
6.1.1.Click on the title of the project.
6.2.Now you will find yourself on the Designer page.
6.2.1.Click the “Add New Document”
6.3.After clicking “Add New Document” you will be taken to a page that informs you that the “Package is Locked”
6.3.1.On the “Package is Locked” page, click “Create New Package”
6.4.You will now be on the “Project History” page, where a red arrow will be visible next to the new package you just created.
6.4.1.Click on the title of the words “New Document Package” highlighted in Blue.
6.5.You will now be on the “Designer” page for the New Package you just created.
6.5.1.Under “Step 1” of the Designer page, click on “Select a Library” and choose “CUNY Institutional Review Board” from the drop-down menu.
6.5.2.From the “Select Document” drop-down menu choose “Continuing Review Request” (if submitting a modification, select “Modification/Amendment Request”) and click “Download”
6.5.3.Save the document to your PC. Repeat steps under section 6.5 until you have downloaded all the documents you need for your application (i.e. sample consents, supplements, etc…)
6.5.4.Once you have downloaded all of the necessary documents, locate them and begin filling them out.
6.6.When you have completely finished filling out and saving your documents, return to the Designer Page for your project and click “Add New Document”
6.6.1.You will then see the “Attach Document” page, where you will select an “Attachment Type” from the drop down menu for whatever it is you plan to attach (example, Continuing Review form for the “Continuing Review Report”)
6.6.2.Click “Browse” to locate the document that you plan to attach (once found click “Open”)
6.6.3.Then Click “Attach”
6.6.4.Your document is now attached to the project package (Repeat steps under section 6.6. for each item you wish to attach – e.g. consents).
6.7.On the designer page, link your training documents to the project by clicking “link / un-link records”, selecting your training certificate, and clicking save. (if you cannot locate your CITI documentation, it is possible you did not add it to IRBNet. Visit your User Profile to verify).
6.8.Go to Section 7 of this document for submission instructions
7.Submitting your Project Package to the HRPP Office for Review
7.1.Share your project - only necessary if one of the following examples applies…
a) If you are a student, you must share the project with your faculty advisor so that they can sign the protocol (your faculty advisor must be registered with IRBNET).
b) If you are completing the application on behalf of the PI you must share the project with the PI so they can sign it.