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IRBNet PI Instructions
IRBNet General Submission Instructions for CUNY
CITY UNIVERSITY OF NEW YORK
January 17, 2013
Authored by: Angela Cartmell & Keisha Peterson
IRBNet General Submission Instructions for CUNY
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1. Accessing IRBNet (New Registration) ............................................................................................................ 3
2. Accessing IRBNet (Existing Registration) ........................................................................................................ 4
3. Adding your Training Credentials to IRBNet (CITI) ......................................................................................... 4
4. Creating a New Project in IRBNet .................................................................................................................. 5
5. Creating a Research with Human Subject Determination Package in IRBNet ................................................. 8
6. Continuing Review/Final Report/Amendment Request for a protocol that was never in IRBNet (previously
in IRB Manager or paper format) .................................................................................................................. 9
7. Continuing Review/Final Report/Amendment Request for a protocol which has previous submissions via
IRBNet ......................................................................................................................................................... 12
8. Submitting your Project Package to the HRPP Office for Review ................................................................. 14
9. Unlocked Packages - Responding to Modification / Information Requests .................................................. 16
9.1. Retrieve letter issued by the HRPP or UI-IRB Office. ................................................................................... 16
9.2. Revise your project package – Missing Application Part I (unlocked Packages) ........................................ 16
9.3. Revise your project package – Other Missing Documents (unlocked packages) ........................................ 18
9.4. Revise your project package – Modifying Initial Application Part I (unlocked packages) .......................... 20
9.5. Revise your project package – Modifying Other Documents (unlocked packages) .................................... 20
9.6. Re-Submitting your project package (unlocked packages) ........................................................................ 21
10. Locked Packages - Responding to Modification / Information Requests ...................................................... 23
10.1. Retrieve letter issued by the HRPP or UI-IRB Office. ................................................................................... 23
10.2. Revise your project by creating a new package ......................................................................................... 23
10.3. Revise Application Part I (from a Locked Package) .................................................................................... 24
10.4. Revise Other Previously Submitted Documents (from a Locked Package) ................................................. 24
10.5. Add Documents (to a Locked Package) ...................................................................................................... 25
10.6. Linking your training materials to a new package ..................................................................................... 26
10.7. Submitting your Revised Project Package .................................................................................................. 27
11. Accessing IRB Approved/Published Documents ........................................................................................... 29
12. IRBNet Symbols ........................................................................................................................................... 29
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1. Accessing IRB Net (New Registration) 1.1. Visit: https://www.irbnet.org/release/index.html
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.
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2. ACCESSING IRBNET (Existing Registration) 2.1. Visit: https://www.irbnet.org/release/index.html
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” (Do Not
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.
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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.
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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”
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4.7.2. Save the document to your PC. Repeat steps under 4.7. until you have
downloaded all the documents you 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 Designer page 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 8 of this document for submission instructions
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5. Creating a Research with Human Subject Determination Package in
IRBNET
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. Next, under Step 1 of the “Designer” page, click on “Select a Library” and choose
“CUNY Institutional Review Board” from the drop-down menu.
5.5.1. From the “Select Document” drop-down menu choose “Submission Form -
Research with Human Subject Determination ” and click “Download”
5.6. When you have completely finished filling out and saving your documents, return to
the Designer page for your project and click “Add New Document”
5.6.1. 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, Application Form for the “Initial Application Part II” or the
“Request for Exemption”)
5.6.2. Click “Browse” to locate the document that you plan to attach (once found click
“Open”)
5.6.3. Then Click “Attach”
5.6.4. Your document is now attached to the project package (Repeat steps under
section 5.6. 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).
5.7. Once you’ve completed uploading all documents (i.e. research determination form,
grant proposal, data collection instruments, etc.), go to Section 8 of this document for
submission instructions
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6. Continuing Review, Final Report, 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 7)
6.1. After logging in, click “CREATE NEW PACKAGE” on left side of the page
6.2. Enter the title of the project, the principle investigators first and last name. (if entering
degree, only enter degrees the PI has already obtained)
6.3. Then click “Continue”
6.4. Now you will find yourself on the Designer page
6.5. Click “Add New Document” (Located under Step 2 of the Designer page)
6.6. 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”
6.6.1. 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) 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
5.6.3.:
6.6.2. Cloning:
6.6.2.1. Select “Clone one of my existing wizards”
6.6.2.2. 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
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preview each document by clicking the Paper icon to the right of the
document title.
6.6.2.3. Read the instructions and then click Next.
6.6.2.4. Continue through each page making sure your answers apply to your
current project.
6.6.2.5. 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.
6.6.2.6. You can preview the attachment before saving and exiting by clicking on
“Preview” (close the newly opened window when done with your
preview).
6.6.2.7. 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).
6.6.3. Not cloning:
6.6.3.1. Select “Create a new wizard from scratch”
6.6.3.2. Read the instructions, then click “Next”
6.6.3.3. Continue through all the pages by answering the questions and clicking
“Next” on each page.
6.6.3.4. 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.
6.6.3.5. You can preview the attachment before saving and exiting by clicking on
“Preview” (close the newly opened window when done with your
preview).
6.6.3.6. 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).
6.7. Next, under “Step 1” of the Designer page, click on “Select a Library” and choose
“CUNY Institutional Review Board” from the drop-down menu.
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6.7.1. From the “Select Document” drop-down menu choose “Continuing Review
Report” (if you are only submitting an amendment, select
“Modification/Amendment Request” instead of “Continuing Review Report” –
same applies to Final Report) and click “Download”.
6.7.2. Save the document to your PC. Repeat steps under 6.7. until you have
downloaded all the documents you need for your application (i.e. sample consents,
supplements, etc…)
6.7.3. Once you have downloaded all of the necessary documents, locate them and
begin filling them out.
6.8. When you have completely finished filling out and saving your documents, return to
the Designer Page for your project and click “Add New Document”
6.8.1. 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
(e.g. Continuing Review form for the “Continuing Review Request”, Final Report
form for the “Final Report”, Amendment or Modification for the “Amendment”.)
6.8.2. Click “Browse” to locate the document that you plan to attach (once found click
“Open”)
6.8.3. Then Click “Attach”
6.8.4. Your document is now attached to the project package (Repeat steps under
section 6.8. 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).
6.9. 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).
6.10. Go to Section 8 of this document for submission instructions
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7. Continuing Review, Final Report, or Amendment request 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 6)
7.1. After logging in, access your project from the “My Projects” tab (left side of the page).
7.1.1. Click on the title of the project.
7.2. Now you will find yourself on the Designer page.
7.2.1. Click the “Add New Document”
7.3. After clicking “Add New Document” you will be taken to a page that informs you that
the “Package is Locked”
7.3.1. On the “Package is Locked” page, click “Create New Package”
7.4. You will now be on the “Project History” page, where a red arrow will be visible next
to the new package you just created.
7.4.1. Click on the title of the words “New Document Package” highlighted in Blue.
7.5. You will now be on the “Designer” page for the New Package you just created.
7.5.1. Under “Step 1” of the Designer page, click on “Select a Library” and choose
“CUNY Institutional Review Board” from the drop-down menu.
7.5.2. From the “Select Document” drop-down menu choose “Continuing Review
Request” (if only submitting a modification, select “Modification/Amendment
Request” instead of “Continuing Review Request” – same applies if only submitting
a “Final Report”) and click “Download”
7.5.3. Save the document to your PC. Repeat steps under section 7.5 until you have
downloaded all the documents you need for your application (i.e. sample consents,
supplements, etc…)
7.5.4. Once you have downloaded all of the necessary documents, locate them and
begin filling them out.
7.6. When you have completely finished filling out and saving your documents, return to
the Designer Page for your project and click “Add New Document”
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7.6.1. 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
(e.g. Continuing Review form for the “Continuing Review Request”, Final Report
form for the “Final Report”, Amendment or Modification for the “Amendment”)
7.6.2. Click “Browse” to locate the document that you plan to attach (once found click
“Open”)
7.6.3. Then Click “Attach”
7.6.4. Your document is now attached to the project package (Repeat steps under
section 7.6. for each item you wish to attach – e.g. consents).
7.7. 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).
7.8. Go to Section 8 of this document for submission instructions
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8. Submitting your Project Package to the HRPP Office for Review 8.1. 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.
c) If you have additional key personnel (Co-PIs, Research Assistants, or other project
related staff) you must share the project with your research team. These steps can be
used (each person you share the project with must be registered with IRBNet).
If none apply, go to 7.2. Otherwise go to 7.1.1.
8.1.1. Click “Share this project” on the left side of the page.
8.1.2. Select “Share” (highlighted in BLUE) in the center of the page
8.1.3. Select the Institution the individual is affiliated with and click “Select
Organization” (default will be your primary institution. However, if the individual is
at another CUNY campus, search for that CUNY campus)
8.1.4. Locate the individual from a list of names and choose which type of access you
are giving them – definitions are on this page (if a specific name is not there, you
either selected the wrong institution or the individual is not registered with IRBNet
yet - Researchers and students should contact their research personnel or Faculty
Advisor to verify their affiliation.)
8.1.5. You can enter comments to the individual(s) in the “Comment” field, then select
“Save”
8.2. Sign your Package – Packages must be signed by all Faculty Advisors and PIs. Select
“Sign this Package” from the left side of the page.
8.2.1. On the Sign Package page, select your role in the project from the drop-down
menu.
8.2.2. Then click “Sign”
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8.3. Submit your Package - When package has been completely reviewed and it has been
signed by the PI and Faculty Advisor (when applicable), select “Submit this Package”
from the left side of the page.
8.3.1. Select your primary campus affiliation (that is the board that will do the review –
for student’s this is the Faculty Advisor’s primary campus affiliation). This should
default to the correct campus. Researchers and students should contact their
research personnel or Faculty Advisor to verify their affiliation.
8.3.2. Then select “Continue”
8.3.3. Select your “Submission Type” from the drop-down menu and click “Submit”
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9. Unlocked Packages - Responding to Modification / Information
Requests
9.1. Retrieve letter issued by the HRPP or UI-IRB Office.
9.1.1. After logging in, access your project from the “My Projects” tab (left side of the
page).
9.1.2. Click on the title of the project.
9.1.3. Now you will find yourself on the Designer page.
9.1.4. On the Designer page click “Review Details”
9.1.5. You will now find yourself on the Review Detail page where you will find all
letters, as well as approved and/or stamped documents published by the HRPP or
UI-IRB office.
9.1.6. Click on the “Document Type” highlighted in Blue for the Item you wish to
access.
9.1.7. Be sure to read the instructions in the letter carefully.
9.2. Revise your Project’s Package – Missing Application Part I (unlocked
Packages)
If the HRPP / IRB Office has asked you to add the “CUNY - Application for Approval to Use
Human Participants in Research, Part I” (because it was not included in any previous
packages), and the package has been unlocked, follow these instructions
9.2.1. After logging in, access your project from the “My Projects” tab (left side of the
page).
9.2.2. Click on the title of the project.
9.2.3. Now you will find yourself on the Designer page.
9.2.4. Under Step 2 click “Add New Document.”
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9.2.5. 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”
from the drop-down menu and click “Add”.
9.2.6. 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 8.2.8.) 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
8.2.8.:
9.2.7. Cloning:
9.2.7.1. Select “Clone one of my existing wizards”
9.2.7.2. 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.
9.2.7.3. Read the instructions and then click Next.
9.2.7.4. Continue through each page making sure your answers apply to your
current project.
9.2.7.5. 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.
9.2.7.6. You can preview the attachment before saving and exiting by clicking on
“Preview” (close the newly opened window when done with your
preview).
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9.2.7.7. 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).
9.2.8. Not cloning:
9.2.8.1. Select “Create a new wizard from scratch”
9.2.8.2. Read the instructions, then click “Next”
9.2.8.3. Continue through all the pages by answering the questions and clicking
“Next” on each page.
9.2.8.4. 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.
9.2.8.5. You can preview the attachment before saving and exiting by clicking on
“Preview” (close the newly opened window when done with your
preview).
9.2.8.6. 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).
9.3. Revise your project package – Other Missing Documents (unlocked
packages)
9.3.1. If the item is a form or consent that CUNY has a template for:
9.3.1.1. From the Designer page, click on “Select a Library” and choose “CUNY
Institutional Review Board” from the drop-down menu.
9.3.1.2. From the “Select Document” drop-down menu choose “Initial
Application Part II” (if submitting for Exempt Review, select “Exempt
Determination” instead of “Initial Application Part II”) and click
“Download”
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9.3.1.3. Save the document to your PC. Repeat steps under section 9.3.1. until
you have downloaded all the documents you need for your application
(i.e. sample consents, supplements, etc…)
9.3.1.4. Once you have downloaded all of the necessary documents, locate them
and begin filling them out.
9.3.2. When you have completely finished filling out and saving your documents,
return to the Designer page for your project and click “Add New Document”
9.3.2.1. 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 (e.g. Application Form for the “Initial Application Part II”)
9.3.2.2. Click “Browse” to locate the document that you plan to attach (once
found click “Open”)
9.3.2.3. Then Click “Attach”
9.3.2.4. Your document is now attached to the project package (Repeat steps
under section 9.3.2. for each item that CUNY has a template for and you
wish to attach).
9.3.3. If the item is a survey, set of interview questions, flyer, recruitment script, or
other item that CUNY DOES NOT have a template for:
9.3.3.1. From the “Designer” page, click on “Add New Document”
9.3.3.2. 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 (e.g. Application Form for the “Initial Application Part II”)
9.3.3.3. Click “Browse” to locate the document that you plan to attach (once
found click “Open”)
9.3.3.4. Then Click “Attach”
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9.3.3.5. Your document is now attached to the project package (Repeat under
section 9.3.3. for each item that you need to attach and CUNY does not
have a template for).
9.4. Revise your project package – Modifying Initial Application Part I
(unlocked packages)
If the HRPP / IRB Office has asked you to modify the “CUNY - Application for Approval to Use
Human Participants in Research, Part I” and the package has been unlocked, follow the below
instructions:
9.4.1. After logging in, access your project from the “My Projects” tab (left side of the
page).
9.4.2. Click on the title of the project.
9.4.3. Now you will find yourself on the Designer page.
9.4.4. Under “Step 2” click on the pencil icon next to the “CUNY - Application for
Approval to Use Human Participants in Research, Part I”.
9.4.5. After clicking the pencil icon you will be taken to the “IRBNet Document
Wizard” page where you can make changes to the “CUNY - Application for
Approval to Use Human Participants in Research, Part I”.
9.4.6. Once you have finished your changes, click “Save and Exit”.
You have revised your “CUNY - Application for Approval to Use Human Participants in
Research, Part I”.
9.5. Revise your project package – Modifying Other Documents (unlocked
packages)
If the HRPP / IRB Office has asked you to modify a document you already submitted, find it in
the list of documents on the “Designer” page (NOT including “CUNY - Application for Approval
to Use Human Participants in Research, Part I”; for those steps go to previous section):
9.5.1. After logging in, access your project from the “My Projects” tab (left side of the
page).
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9.5.2. Click on the title of the project.
9.5.3. Now you will find yourself on the Designer page.
9.5.4. Click on the paper icon next to the document you plan to modify. Doing this
will open the document up for editing.
9.5.5. Do your edits and save the document to your PC.
9.5.6. Return to the Designer page and click on the pencil icon next to the document
you just updated.
9.5.7. After clicking the pencil icon you will be taken to the Attach Documents page
9.5.8. Click “Browse” to locate the document that you plan to attach. Click the
document and click “Open”.
9.5.9. Then Click “Attach.”
9.5.10. Your document is now attached to the project package (Repeat steps in section
9.5. for each document you have been asked to revise).
9.6. Re-Submitting your Project Package (unlocked packages)
Before re-submitting your project package, please make sure EACH item in the letter from
the HRPP or UI-IRB Office is addressed adequately. Please include a response letter to the
HRPP or UI-IRB Office outlining how EACH item was addressed in the project package. For
example, if the HRPP/UI-IRB Office letter requests changes to the CUNY Application Part II or
the informed consent form, please indicate what changes were made and where on the form
the changes were made. This response letter must be attached in the “Designer” page of
the package (see section 9.3.3 for instructions).
9.6.1. Share your project – You must share your project if one of the following 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.
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c) If you have additional key personnel (Co-PIs, Research Assistants, or other project
related staff) you must share the project with your research team. These steps can be
used (each person you share the project with must be registered with IRBNet).
*If none apply go to 9.6.2. Otherwise go to 9.6.1.1.
9.6.1.1. Click “Share this Project” on the left side of the page.
9.6.1.2. Select “Share” (highlighted in BLUE) in the center of the page
9.6.1.3. Select the Institution in which the individual is affiliated with and click
“Select Organization” (default will be your primary institution). If the
individual is at another CUNY campus, search for and click that CUNY
campus.
9.6.1.4. Locate the individual from a list of names and choose which type of
access you are giving them – definitions are on this page (if a specific
name is not there, you either selected the wrong institution or the
individual is not registered with IRBNet). You can enter comments to the
individual(s) in the “Your Comments” field, then select “Save.”
9.6.2. Sign your Package – Packages must be signed by all Faculty Advisors and PIs.
9.6.2.1. Select “Sign this Package” from the left side of the page.
9.6.2.2. On the Sign Package page, select your role in the project from the drop-
down menu.
9.6.2.3. Then click “Sign.”
9.6.3. Re-Submit - When package has been completely reviewed and it has been
signed, click the "Mark Revisions Complete" link at the top of the Designer page.
Doing so will automatically notify the HRPP Office that your revisions are
complete.
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10. Locked Packages - Responding to Modification / Information
Requests
10.1. Retrieve letter issued by the HRPP or UI-IRB Office.
10.1.1. After logging in, access your project from the “My Projects” tab (left side of the
page).
10.1.2. Click on the title of the project.
10.1.3. Now you will find yourself on the Designer page.
10.1.4. On the Designer page click “Review Details”
10.1.5. You will now find yourself on the Review Detail page where you will find all
letters, as well as approved and/or stamped documents published by the HRPP or
UI-IRB office.
10.1.6. Click on the “Document Type” highlighted in Blue for the Item you wish to
access.
10.1.7. Be sure to read the instructions in the letter carefully.
10.2. Revise your project by creating a new package
10.2.1. After logging in, access your project from the “My Projects” tab (left side of the
page).
10.2.2. Click on the title of the project.
10.2.3. Now you will find yourself on the Designer page.
10.2.4. Click the “Add New Document”
10.2.5. After clicking “Add New Document” you will be taken to a page that informs you
that the “Package is Locked”
10.2.6. On the “Package is Locked” page, click “Create New Package”
10.2.7. You will now be on the “Project History” page, where a red arrow will be
visible next to the new package you just created.
10.2.8. Click on the title of the words “New Document Package” highlighted in Blue.
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10.2.9. You will now be on the Designer page for the New Package you just created.
10.3. Revise Application Part I (from a Locked Package)
These instructions refer to the attaching of documents for subsequent packages see Section
10.2. for instructions on how to create subsequent packages. If the HRPP / IRB Office has asked
you to modify the “CUNY - Application for Approval to Use Human Participants in Research,
Part I” you already submitted, find it in the list of documents under the words “Documents
from Previous Packages that you can Revise”.
10.3.1. Once you have located the document, click on the pencil icon next to the
“CUNY - Application for Approval to Use Human Participants in Research, Part I”.
10.3.2. After clicking the pencil icon you will be taken to the IRBNet Document
Wizard page where you can make changes to the “CUNY - Application for
Approval to Use Human Participants in Research, Part I”.
10.3.3. Once you have finished your changes, click “Save and Exit”.
10.3.4. Your revised “CUNY - Application for Approval to Use Human Participants in
Research, Part I” is now attached to the project package.
10.4. Revise Other Previously Submitted Documents (from a Locked
Package)
These instructions refer to the attaching of documents for subsequent packages see Section
10.2. for instructions on how to create subsequent packages. If the HRPP / IRB Office has asked
you to modify a document you already submitted, follow the instructions below (NOT including
“CUNY - Application for Approval to Use Human Participants in Research, Part I”; for those steps
go to previous section):
10.4.1. Find it in the list of documents under the words “Documents from Previous
Packages that you can Revise”.
10.4.2. Once you have located the document, click on the paper icon next to the
document you plan to modify. Doing this will open the document up for editing.
10.4.3. Do your edits and save the document to your PC.
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10.4.4. Return to the Designer page and click on the pencil icon next to the document
you just updated.
10.4.5. After clicking the pencil icon you will be taken to the Attach Documents page
10.4.6. Click “Browse” to locate the document that you plan to attach. Click the
document and click “Open”.
10.4.7. Then Click “Attach.”
10.4.8. Your document is now attached to the project package (Repeat steps in section
9.4. for each document you have been asked to revise).
10.5. Add Documents (to a Locked Package)
10.5.1. These instructions refer to the attaching of documents for subsequent packages
see Section 10.2. for instructions on how to create subsequent packages. If the
HRPP / IRB Office has asked you to add a document you did not attach previously,
and the item is a form or consent that CUNY has a template for do the following
(otherwise skip to section 10.5.3.):
10.5.1.1. From the Designer page, click on “Select a Library” and choose “CUNY
Institutional Review Board” from the drop-down menu.
10.5.1.2. From the “Select Document” drop-down menu choose “Initial
Application Part II” (if submitting for Exempt Review, select “Exempt
Determination” instead of “Initial Application Part II”) and click
“Download”
10.5.1.3. Save the document to your PC. Repeat steps under 10.5.1.1. and
10.5.1.2. until you have downloaded all the documents you need for your
application (i.e. sample consents, supplements, etc…)
10.5.1.4. Once you have downloaded all the necessary documents, locate them
and begin filling them out.
10.5.2. When you have completely finished filling out and saving your documents,
return to the Designer Page for your project and click “Add New Document”
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10.5.2.1. 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 (e.g. Application Form for the “Initial Application Part II”)
10.5.2.2. Click “Browse” to locate the document that you plan to attach (once
found click “Open”)
10.5.2.3. Then Click “Attach”
10.5.2.4. Your document is now attached to the project package (Repeat steps a
through i for each item that CUNY has a template for and you wish to
attach).
10.5.3. If the item is a survey, set of interview questions, flyer, recruitment script, or
other item that CUNY DOES NOT have a template for:
10.5.3.1. From the Designer page, click on “Add New Document”
10.5.3.2. 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 (e.g. Application Form for the “Initial Application Part II”)
10.5.3.3. Click “Browse” to locate the document that you plan to attach (once
found click “Open”)
10.5.3.4. Then Click “Attach”
10.5.3.5. Your document is now attached to the project package (Repeat steps
under section 10.5.3. for each item that you need to attach and CUNY
does not have a template for).
10.6. Linking your training materials to a new package
10.6.1. On the designer page, link your training documents to the project by clicking
“link / un-link records”
10.6.2. Select your training certificate
10.6.3. Click save.
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10.6.4. If you cannot locate your CITI documentation, it is possible you did not add it to
IRBNet. Visit your User Profile to verify.
10.7. Submitting your Revised Project Package
Before submitting your revised project package (response package), please make sure EACH
item in the letter from the HRPP or UI-IRB Office is addressed adequately. Please include a
response letter to the HRPP or UI-IRB Office outlining how EACH item was addressed in the
revised project package (response package). For example, if the HRPP/UI-IRB Office letter
requests changes to the CUNY Application Part II or the informed consent form, please
indicate what changes were made and where on the form the changes were made. This
response letter must be attached in the “Designer” page of the response package (see
section 10.5.3 for instructions).
10.7.1. Sharing your project. You must share your project if one of the following 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.
c) If you have additional key personnel (Co-PIs, Research Assistants, or other project
related staff) you must share the project with your research team. These steps can be
used (each person you share the project with must be registered with IRBNet).
*If none apply go to 10.7.2. Otherwise go to 10.7.1.1.
10.7.1.1. Click “Share this Project” on the left side of the page.
10.7.1.2. Select “Share” (highlighted in BLUE) in the center of the page
10.7.1.3. Select the Institution in which the individual is affiliated with and click
“Select Organization” (default will be your primary institution). If the
individual is at another CUNY campus, search for and click that CUNY
campus. Researchers and students should contact their research
personnel or Faculty Advisor to verify their affiliation.
10.7.1.4. Locate the individual from a list of names and choose which type of
access you are giving them – definitions are on this page (if a specific
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name is not there, you either selected the wrong institution or the
individual is not registered with IRBNet).
10.7.1.5. You can enter comments to the individual(s) in the “Your Comments”
field, then select “Save.”
10.7.2. Sign your Package – Packages must be signed by all Faculty Advisors and PIs.
10.7.2.1. Select “Sign this Package” from the left side of the page.
10.7.2.2. On the Sign Package page, select your role in the project from the drop-
down menu.
10.7.2.3. Then click “Sign.”
10.7.3. Submit the revised package - When package has been completely reviewed and
it has been signed by the PI and Faculty Advisor (when applicable), select
“Submit this Package” from the left side of the page.
10.7.3.1. Select your primary campus affiliation (that is the board that will do the
review – for student’s this is the Faculty Advisor’s primary campus
affiliation - Researchers and students should contact their research
personnel or Faculty Advisor to verify their affiliation.)
10.7.3.2. Then select “Continue”
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11. Accessing IRB Approved/Published Documents
11.1. After logging in, access your project from the “My Projects” tab (left side of the
page).
11.2. Click on the title of the project.
11.3. Now you will find yourself on the “Designer” page.
11.4. On the “Designer” page click “Review Details”
11.5. You will now find yourself on the “Review Details” page where you will find all
letters, as well as approved and/or stamped documents published by the HRPP
or UI-IRB office.
11.6. Click on the “Document Type” highlighted in Blue for the Item you wish to
access.
12. IRB Net Symbols
- Package is locked and is in the hands of the HRPP Office or IRB.
- Package is un-locked pending changes by PI.
- Package has been re-locked by the PI and is pending review by the HRPP Office .
- Delete
- View a document
- Edit or replace a document
* - Required field
- You have pending project reminders
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