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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 PI Instructions · 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

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Page 1: IRBNet PI Instructions · 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

IRBNet PI Instructions

IRBNet General Submission Instructions for CUNY

CITY UNIVERSITY OF NEW YORK

January 17, 2013

Authored by: Angela Cartmell & Keisha Peterson

Page 2: IRBNet PI Instructions · 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

IRBNet General Submission Instructions for CUNY

Page 2 of 29 Last update: 01.17.2013 ACM KP

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

Page 3: IRBNet PI Instructions · 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

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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