- Direct your browser to This is the homepage for the IRB application.

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1 I. Logging on/setting up an account. - Direct your browser to This is the homepage for the IRB application. - First time applicants will have to create a new account. Click on the Click Here link that appears on the right hand side of the screen. This will take you to the form to set up and create a new account - Once on this page, provide all of the requested information. This includes providing your name, address, city, state, phone number, zip code, position, affiliation, and department 1

2 - Note that all boxes must be filled in or you will not be able to go on to the next page. 2

3 - On the second page, set up your username and password for the account. Remember these and write them down, you will need them to access the system. - When setting your password, it is advised that you use the same log-in as your Kean address (what appears before in your ) - On this page, you will also need to provide a valid Kean address as well as set up a security question and answer. - Once you have provided the requested information, hit create user to move on. Note that all fields must be populated before you are able to move on and go back to the home page 3

4 - On the homepage, enter the system by typing in your username and password. These should have been set-up upon your first registration with the IRB system. 4

5 II. Opening and Creating a New Application. - On the log in page, enter your username and password - Upon successful entry in to the system you will come to the home page. The home page for every user shows all of the applications that they currently have open. First time users will see a blank screen with no applications. 5

6 (FIRST TIME USER VIEW) - To start writing a new application, select the create project option in the top menu 6

7 - On the left hand side of the create project page, under select type, you can the access the type of application you need to fill out. - The links in the center of the page will take you to the descriptions of the exempt and expedited categories - Clicking any of the links will take you to the corresponding application on another screen 7

8 Application - The application form can be accessed at this point. - TIP: Download and Complete the application template on the ORSP webpage prior to opening up an application. - Using this document, cut and paste your responses into the online system. This will make navigation in and around the system easier for applicants 8

9 - When all of the fields have been completed, click on the view and save button at the bottom of the screen. This will take you to a screen that will allow you to check your document one more time prior to submission - Make sure to fill out all fields marked with a *. Failure to do so will result in an error message. The error message will pop-up on your screen, indicating what has to be fixed. 9

10 - When all fields are filled in, on the view and save page you will able to review your application. At the bottom of the page, you will see the save button. - If you are satisfied with the application select save. III. Uploading Attachments and Submission - Once you save the application, you will go to the maintenance page. The maintenance page allows applicants to edit their applications. Before submission can occur, all required documents such as consent, assent, and debriefing forms have to be uploaded from this page. 10

11 - From this page will be able to upload all your required documents. Select the type of document from the pull down menu and enter a brief description of it. You can select it by clicking on the browse button. After you have located the document, hit upload file. - Consent and debriefing forms are a requirement and must be entered before you are allowed to submit. o It is recommended that applicants combine all their attachments into one file. o When uploading the consent form combine in one document the consent form with the rest of your attachments o You will still have to upload your debriefing form separately. Combining files will help you manage your uploads - Once the required forms have been submitted, the submit button will appear at the bottom of the screen. Click it once you are ready to submit. 11

12 - If you are ready to submit at that point, take a minute to read the statement on the screen. If you are satisfied with the application check the signature button if you agree, and click the submit button. - You will be taken to the project status page, where you should receive notification that your study has been submitted to the advisor if one is there. 12

13 - This is applicable only to student applicants. Faculty applicants without advisors will see Submitted to IRB under the Status column 13

14 IV. Modification of Applications for Students - FOR STUDENTS: After your advisor reviews your application, you will receive an notifying you of their decision. o When your application is approved, it will be uploaded and entered into the system for that month s review o If the application is denied by your advisor, you will receive an notifying you of their decision - If your application is rejected by your advisor, you have to go back into the system, fix the application and resubmit it for approval - The first thing you will need to do is log back into the system. From the home page, you will be able to see all of the applications you currently have opened and check on their status. Advisor decisions will be highlighted in the column labeled status 14

15 - All comments can be accessed and reviewed by clicking on the column labeled Advisor/IRB comments - On this page all of the comments will be laid out for review and you can see exactly what has to be changed. 15

16 - After you read the comments, go back to the main menu via the go to home button at the bottom of the page - From the home page, you will be able to go back into the application and make the requested edits via the view project column. By clicking the icon in this column, you will be taken back into the application 16

17 - After reviewing the application, at the bottom of the page, there is an edit button. Clicking on this button will open the application in edit mode, allowing you to make any edits/changes 17

18 - Once you have made all of the edits/changes, click on the update button at the bottom of the page - From there you will be asked if you want to upload any additional documents. This is where you can delete older versions of your forms and upload newer copies. Once all of your changes are made, click on submit 18

19 - You will then be taken to the signature page. Be sure to click the signature button before clicking on submit. Failure to do so will result in an error. - You will receive an notifying you of your submission. Starting the process all over again 19

20 V. AFTER IRB REVIEW - Applicants will be notified via of the status of their application. The IRB administrator will notify them of the status via . Comments regarding their application will be conveyed via . - To make any changes download a copy of the provisional form from the IRB website. - Indicate on the form how all of the provisions were dealt with and provide detail as to their changes. - Submit a copy of the provisional form with a hard copy of the IRB application to IRB@kean.edu and to the IRB office. 20