IRB Protocol & Submissions

On this page you will find specific instructions about submitting human subjects research protocols to Georgia Tech’s IRB. Depending on your institute status, certain requirements may apply. Click on the appropriate tabs at the left to verify the requirements that apply specifically to you. Once you familiarize yourself with the protocol submission process, you may return to this page and click on the IRBWISE button to go directly to the protocol submission system. If you have any questions, please email irb@gatech.edu.

• Faculty/Staff
• Administrative Assistants
• Students
• NonGT-Employees
• Sign-off
• Amendments
• Continuing Review
• HIPAA De-Identification Certification Form

If I am Georgia Tech Faculty/Staff, how do I submit an application?

To use IRBWISE you will first need a username and password. You may now login to IRBWISE using your campus-wide GT Account (a.k.a. GT number, e-mail, spectrum, kerberos). For help with your GT Account, please contact OIT. If you are a GT student or employee, you may login now and do NOT need to request an account.

If you have an existing WebWISE or IRBWISE account, you may continue to use it, or you may switch to your GT account—all of your accounts are linked.

At the end of this section you will see the link that will take you directly to the sign in page for IRBWISE. Once you click that link you will be asked for your username and password.

You will be taken your “Home” page. On this page you will see your “Alerts” and your “My Protocols”. It is also on this page that you will find the option of “Submit new Protocol”.

You will find the option of “Submit New Protocol” in the dropdown menu of the “Tasks” box in the upper right hand corner of the screen. Once you choose “Submit New Protocol” you will be taken to the IRB application.

Following are things you should know about the IRB process and submitting an application.

You must complete Human Subjects Training. If you have not already done so you can read the instructions for completing required human subjects training.

Next:

You will see on the application several sections with the word “required”. These sections must be completed in order for the system to allow your application to be submitted. If a section is not applicable answer it as N/A. Do not leave it unanswered.

Another important thing to remember is to upload all your required documents. These include consent forms, study protocol, dissertation, any advertisements, all survey instruments, interview questions, etc. If your research is funded you will also need to upload your grant.

Georgia Tech has a required consent format. There are consent templates that must be followed when writing your consent forms. There are also templates for parental permission and assent (used for minors) forms. These templates can be accessed by clicking on the Informed Consent link at the left of this page.

Very Important: Once you have completed all sections of the application and you are ready to submit you must forward it to your Chair* or Dean* or Director* for sign off. Who you send it to, will depend on how your department is organized. Your Chair/Dean/Director will then submit it to the IRB for you. Do not submit your application directly to the IRB. If you do so, it will be returned to you with instructions to forward to your Chair*/Dean*/Director* for sign off.

*Note: If you are a Chair/Dean/Director you may submit your application directly to the IRB.

I have admin access and am preparing an application for the PI, what do I need to do?

If you are not the PI but are preparing the application for the PI you must remember that you cannot submit the application directly to the IRB. You must first forward the application to the PI for review and sign off. The PI will then be responsible for forwarding the application to the appropriate individual (Chair, Dean, Director) for signatures. It is then the responsibility of the Chair/Dean/Director to forward on the IRB.

• You will see on the application several sections with the word “required”. These sections must be completed in order for the system to allow your application to be submitted. If a section is not applicable answer it as N/A. Do not leave it unanswered.
• Another important thing to remember is to upload all your required documents. These include consent forms, study protocol, dissertation, any advertisements, all survey instruments, interview questions, etc. If your research is funded you will also need to upload your grant.
• Georgia Tech has a required consent format. There are consent templates that must be followed when writing your consent forms. There are also templates for parental permission and assent (used for minors) forms. These templates can be accessed by clicking on the Informed Consent link at the left of this page.

If I am a student, how do I submit an application?

You may now login to IRBWISE using your campus-wide GT Account (a.k.a. GT number, e-mail, spectrum, kerberos). For help with your GT Account, please contact OIT.

At the end of this section you will see the link that will take you directly to the sign in page for IRBWISE. Once you click that link you will be asked for your username and password. You will be taken your “Home” page. On this page you will see your “Alerts” and your “My Protocols”. It is also on this page that you will find the option of “Submit New Protocol”.

You will find the option of “Submit New Protocol” in the dropdown menu of the “Tasks” box in the upper right hand corner of the screen. Once you choose “Submit New Protocol” you will be taken to the IRB application.

If you are a student, you should list your advisor as the “Principal Investigator” and list yourself as a “Co-investigator”.

Following are things you should know about the IRB process and submitting an application. First: You must complete Human Subjects Training. If you have not already done this, please read instructions for completing training.

Next:

• You will see on the application several sections with the word “required”. These sections must be completed in order for the system to allow your application to be submitted. If a section is not applicable, answer it as N/A. Do not leave it unanswered.
• Another important thing to remember is to upload all your required documents. These include consent forms, study protocol, dissertation, any advertisements, all survey instruments, interview questions, etc. If your research is funded, you will also need to upload your grant.
• Georgia Tech has a required consent format. There are consent templates that must be followed when writing your consent forms. There are also templates for parental permission and assent (used for minors) forms. These templates can also be accessed by clicking on the Informed Consent link at the left of this page.

Please Note: Once you have completed all sections of the application and you are ready to submit you must forward it to your advisor for sign off. Your advisor will then submit it to the Chair or Dean or Director of the department. Do not submit your application directly to the IRB. If you do so, it will be returned to you with instructions to forward to your advisor for sign off.

If I am not an employee or student at Georgia Tech, how do I submit an application?

In order to conduct research using Georgia Tech faculty, staff or students you will need approval from the Georgia Tech IRB. You will also need a faculty sponsor here on campus to act as your Principal Investigator on the IRB application. You should list yourself as a Co-investigator on the application. The Georgia Tech IRB application, called IRBWise, is an online submission. Instructions on how to use this system are as follows:

To use IRBWise you will first need a username and password. You will need to request a username and password from Melanie Clark at melanie.clark@gtrc.gatech.edu.

At the end of these instructions you will see the link that will take you directly to the sign in page for IRBWise. Once you click that link you will be asked for your username and password.

You will be taken your “Home” page. On this page you will see your “Alerts” and your “My Protocols”. It is also on this page that you will find the option of “Submit new Protocol”.

You will find the option of “Submit New Protocol” in the dropdown menu of the “Tasks” box in the upper right hand corner of the screen. Once you choose “Submit New Protocol” you will be taken to the IRB application.

Following are things you should know about the IRB process and submitting an application.

You must complete Human Subjects Training. If you have not already done, please read the instructions for completing training.

Next:

• You will see on the application several sections with the word “required”. These sections must be completed in order for the system to allow your application to be submitted. If a section is not applicable answer it as N/A. Do not leave it unanswered.
• Another important thing to remember is to upload all your required documents. These include consent forms, study protocol, dissertation, any advertisements, all survey instruments, interview questions, etc. If your research is funded you will also need to upload your grant.
• Georgia Tech has a required consent format. There are consent templates that must be followed when writing your consent forms. There are also templates for parental permission and assent (used for minors) forms. These templates can be accessed on the Informed Consent page.

Very Important: Once you have completed all sections of the application and you are ready to submit you must forward it to your Faculty Sponsor (Principal Investigator) for sign off. Your Faculty Sponsor will then submit it to the IRB for you. Do not submit your application directly to the IRB. If you do so, it will be returned to you with instructions to forward to your Faculty Sponsor for sign off.

How do I sign off on this protocol?

If you received an email asking you to sign off you can accomplish that in two ways: either through the link in the email you received or by going to your “Home” in IRBWISE.

You may login to IRBWISE using your campus-wide GT Account (a.k.a. GT number, e-mail, spectrum, kerberos). For help with your GT Account, please contact OIT.

If you have an existing WebWISE or IRBWISE account, you may continue to use it, or you may switch to your GT account–all of your accounts are linked.

If you use the link in the email:
You may choose to access the protocol through the link in the email. If you do so, you will be taken directly into the protocol. At the top of the page you should see instructions in green. At the bottom of the page you will see a “Continue” button. If you click on the “Continue” button you will be taken to a new screen where you will be asked to re-enter your password. You will also see the 3 options. The First option is to return it to the PI. The second is to send it to another person for signatures and the last option is to submit it to the IRB. At the very bottom of the screen you will see the button for “Submit”. If you are unable to sign off please see “Troubleshooting”.
If you go through your “Home” page:
The link at the end of these instructions will take you directly to the IRBWISE sign in page. It is here that you will enter your username and password. Once inside you will see your “Home” page. It is on this page that you will be able to see what is in your “Submissions to Sign off”. If you click on the “Submissions to Sign off” tab you will see a list of studies needing your sign off. If you click on the protocol you will be taken into the application requiring your signature. Once there the procedures are the same as above. To access your “Home” page, click on the link at the end of this section. You will need your username and password to enter.

Trouble Shooting

If you are asked to sign off on a protocol but the system is not giving you the option of “Sign Off” there may be several reasons.

*Remember: if for some reason the link in the email is not working you can always access your protocols from your “Home” page.

Following are some typical reasons that you may not be able to sign off:

• The student researcher may have listed you as PI or certified research personnel. The system will not allow you to “sign off” on your own work. In this case the PI will need to remove you from the protocol as any type of certified personnel.
• The PI may have chosen the option of “Forward to PI” rather than “Forward for Signatures”. If this is the case you will probably see the option to “Submit” the application but not the option of “Sign off Submission”. “Submitting” the application is not the same thing as “Signing off” on it. In this case the application will need to be returned to the PI and he/she will need to re-send it for sign off.
• The PI may have not actually forwarded the application to you for sign off in the system.
• There may be a bug in the system over which you have no control. If the above reasons are not the cause this may be the case. In this case you will need to report this to the IRB Administrator.

If you experience difficulty in signing off on a protocol please call or email Melanie Clark at 404-894-6942 for assistance.

How do I submit an amendment?

When you wish to change anything on your IRB approved study you must first submit an amendment to the IRB for review and approval prior to implementation of the change. To submit an IRB protocol or to modify an existing protocol, click on the IRBWISE link either at the end of this section or in the menu on the left side of this window. You will need your username and password to enter.

In order to submit an amendment on your study you will need to find your study in your “My Protocols” list. Once you see the study you wish to amend simply click on it. You will be taken into the application. You will need to choose “Request amendment” from the “Tasks” drop down menu. The appropriate screen will open.

If you are adding personnel: All personnel must complete human subjects training. Approval will not be issued until the requirement for training has been satisfied.

For instructions on how to complete training please go to: www.compliance.gatech.edu/IRB/training.shtml

Important things to remember when submitting an amendment:

• Please answer all applicable sections of the form.
• You must include a justification for the amendment.
• You must upload all documents that accompany the amendment, i.e. consent forms, ads, etc.

How do I submit a continuing review?

When your study is about to expire you will receive an email from our office 60 days out and then again 30 days out reminding you to submit your Continuing review.

There are two ways to submit a continuing review:

1. You can access your study through the link at the bottom of the email you receive. Once you click on the link you will be asked for your username and password. You may login to IRBWISE using your campus-wide GT Account (a.k.a. GT number, e-mail, spectrum, kerberos). For help with your GT Account, please contact OIT. If you are a GT student or employee, you may login now and do NOT need to request an account. If you have an existing WebWISE or IRBWISE account, you may continue to use it, or you may switch to your GT account–all of your accounts are linked. After you enter your username and password you will taken to your study. You should select “Request continuing review” from the drop down menu of the “Tasks” box in the upper right hand corner of the screen. Once you do this you will see the continuing review form.
2. If you are submitting a Continuing Review through your “My Protocols” page you will simple need to find the study in your list, click on it and once inside your protocol chose from the “Tasks” drop down menu the option of “Request Continuing Review”. The appropriate screen will open.

Important things to remember:

• Please be sure to fill out all sections of the application.
• If you have completed your study and would like to close it, you must still complete the form and submit as a final report.
• You will need to state the status of the protocol. This option is found in the “Subjects” section. So even if you do not have direct interaction with subjects (for example, you are doing a record review) you will need to click “Yes” on that question in order to answer the “protocol status” questions.
• If your research is continuing you must upload the consent form, advertisements, survey instruments, interview protocols, etc. that you wish to use in the upcoming approval period.