Protocols: Frequently Asked Questions

Outlined below are specific instructions for submitting research protocols involving human subjects to Georgia Tech's Central IRB for review. Requirements differ depending on your GT status (i.e., faculty members, student, administrative assistant), so review these items carefully to identify the requirements that apply to you. When you are ready to begin the process, go to IRBWISE to enter the protocol submission system. If you have questions, contact the IRB team

Frequently Asked Questions

I am a Georgia Tech faculty or staff member. How do I submit a protocol for review?

To access IRBWISE, log in with your campus-wide GT Account (e.g., GT number, e-mail, spectrum, Kerberos). For help with your GT Account, contact the Office of Information Technology (OIT). If you already have an existing IRBWISE or WebWISE account, you may continue to use it, or you may switch to your GT account—all of your accounts are linked.

After entering your username and password, your “Home” page will appear. Select “Submit New Protocol” (located in the dropdown menu of the "Tasks" box in the upper right corner) to begin a new protocol application. (Your IRBWISE Home Page will display a list of your protocols and any related messages.

Within the protocol application, items identified as "required" must be completed in order to submit your protocol to the IRBWISE system. If any of these required sections are not applicable to your protocol, answer "N/A." Do not leave them unanswered.

Be sure to upload all required documents. These include study protocol, dissertation, consent forms, any advertisements, all survey instruments, interview questions, etc. If your research is funded, you will also need to upload the statement of work or project description from the proposal grant or contract. Consent document templates are available on the ORIA website.

When you have completed all sections of the protocol application and are ready to submit, select the “Forward for Signatures” option for your role.

FACULTY MEMBERS: Forward the protocol application to your Department Chair, Dean, or Director for sign off and final submission. This individual will receive an emailed request to sign off on the protocol application and submit it to the IRB. If you submit the protocol application directly to the IRB, it will be returned to you with instructions to forward to your Department Chair, Dean, Director for sign off.

DEPARTMENT CHAIRS, DEANS, AND LABORATORY DIRECTORS: Submit the protocol application directly to the IRB.

I am a Georgia Tech student. How do I submit an application?

Follow the directions above to begin a new protocol application. Identify your advisor as the "Principal Investigator" and yourself as a "Co-Investigator." The completed application must be forwarded to your advisor for review. Your advisor is responsible for forwarding the protocol application to the appropriate Department Chair, Dean, or Director for signoff and final submission to the IRB.

I am a staff member (such as administrative assistants with admin access to the protocol). How do I prepare an application for a Principal Investigator?

Follow the directions above to begin a new protocol application. After preparing the application, select the “Forward to PI” option in IRBWISE to forward it to the PI for review. The PI is then responsible for forwarding the protocol application to the appropriate Department Chair, Dean, or Director for sign off and final submission.

I am not an employee or student at Georgia Tech. How do I submit an application?

Contact the Office of Research Integrity Assurance for a determination as to whether Georgia Tech is engaged in your proposed research. You will be advised on a case-by-case basis.

I am a Department Chair, Dean, or Director. How do I sign off on a protocol application that has been forwarded for my signoff and submission to the IRB for review?

If you have received an email asking you to sign off on an application, you can either click on the protocol link in the email or sign in to IRBWISE.

From the link in the email:

Click on the email link to access the protocol. At the top of the page, instructions will appear in green.  Click on the “Continue” button at the bottom of the screen. You will enter your password on the next screen and then select from three options:

  1. Return the application to the PI for modifications.
  2. Send the application to another person for signature.
  3. Submit the application to the IRB.

The SUBMIT button is at the bottom of the screen.  If the system does not allow you to submit the application to the IRB, please see Troubleshooting Suggestions below.

From your IRBWISE Home page:

Click on the "Submissions to Sign Off" tab to see a list of protocol applications that require your sign off. If you click on the specific protocol, you will be taken into the application requiring your signature. Follow the procedures above to submit the application to the IRB.

Troubleshooting Suggestions

Here are a few typical reasons that Department Chairs, Deans, or Directors are unable to sign off on a protocol application:

  • The same individual cannot be identified as both the PI or certified research personnel and the Department Chair, Dean, or Director, as the system will not allow you to “sign off” on your own work. If this is the case, the PI or student researcher 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.” Within the IRBWISE system, “Submitting” an application is not the same thing as “Signing off” on it. The application will need to be returned to the PI (select “Return to PI” option) so that the PI can resend for sign off.
  • The PI may not actually have forwarded the application to you for sign off. In this case, report the problem to the IRB Administrator. Send a request to irb@gatech.edu or call the Office of Research Integrity Assurance at 404.894.6944 or 404.894.6942.

Protocols awaiting your review are also accessible from your IRBWISE “Home” page.

How do I submit an amendment to an approved study?

Prior to implementing any changes to a study,  an amendment must be submitted and approved by the IRB. To amend an existing protocol, select the pertinent study in the "My Protocols" list, then select "Request amendment" from the "Tasks" dropdown menu. Complete and submit the amendment via IRBWISE.

All personnel being added to a protocol must complete Human Subjects Training before being approved.  For information on required training, visit IRB Required Training.

Important items to remember when submitting an amendment:

  • Answer all applicable sections of the form.
  • Include a justification for the amendment.
  • Upload all documents that accompany the amendment, such as consent forms, ads, etc.

How do I submit a "Request for Continuing Review When the Study Is About to Expire?"

Expiration notices are automatically emailed by IRBWISE to Principal Investigators 60 days and 30 days prior to expiration of a study approval period. If the study will continue, a request for continuing review must be submitted via IRBWISE.  

There are two ways to submit a Continuing Review Request:

  1. Click on the link to IRBWISE in the expiration notice email
  2. Select the expiring protocol from your IRBWISE account

To submit a Continuing Review Request from the email link:

Clink on the link at the bottom of the email. Log in to IRBWISE and select  “Request Continuing Review” from the drop down menu of the “Tasks” box in the upper right hand corner of the screen. Complete and submit the Continuing Review form.

To submit a Continuing Review from your IRBWISE account:

Select the study from the list on the "My Protocols" page.  From the protocol, select "Request Continuing Review" from the "Task" dropdown menu.  Complete and submit the Continuing Review form.

If you want continuing approval of the study, you must upload the consent form, advertisements, survey instruments, interview protocols, and any other documents that you wish to use in the upcoming approval period, even if you uploaded these same forms in the initial application.

I am a Georgia Tech faculty or staff member. How do I submit a protocol for review?

To access IRBWISE, log in with your campus-wide GT Account (e.g., GT number, e-mail, spectrum, Kerberos). For help with your GT Account, contact the Office of Information Technology (OIT). If you already have an existing IRBWISE or WebWISE account, you may continue to use it, or you may switch to your GT account—all of your accounts are linked.

After entering your username and password, your “Home” page will appear. Select “Submit New Protocol” (located in the dropdown menu of the "Tasks" box in the upper right corner) to begin a new protocol application. (Your IRBWISE Home Page will display a list of your protocols and any related messages.

Within the protocol application, items identified as "required" must be completed in order to submit your protocol to the IRBWISE system. If any of these required sections are not applicable to your protocol, answer "N/A." Do not leave them unanswered.

Be sure to upload all required documents. These include study protocol, dissertation, consent forms, any advertisements, all survey instruments, interview questions, etc. If your research is funded, you will also need to upload the statement of work or project description from the proposal grant or contract. Consent document templates are available on the ORIA website.

When you have completed all sections of the protocol application and are ready to submit, select the “Forward for Signatures” option for your role.

FACULTY MEMBERS: Forward the protocol application to your Department Chair, Dean, or Director for sign off and final submission. This individual will receive an emailed request to sign off on the protocol application and submit it to the IRB. If you submit the protocol application directly to the IRB, it will be returned to you with instructions to forward to your Department Chair, Dean, Director for sign off.

DEPARTMENT CHAIRS, DEANS, AND LABORATORY DIRECTORS: Submit the protocol application directly to the IRB.

I am a Georgia Tech student. How do I submit an application?

Follow the directions above to begin a new protocol application. Identify your advisor as the "Principal Investigator" and yourself as a "Co-Investigator." The completed application must be forwarded to your advisor for review. Your advisor is responsible for forwarding the protocol application to the appropriate Department Chair, Dean, or Director for signoff and final submission to the IRB.

I am a staff member (such as administrative assistants with admin access to the protocol). How do I prepare an application for a Principal Investigator?

Follow the directions above to begin a new protocol application. After preparing the application, select the “Forward to PI” option in IRBWISE to forward it to the PI for review. The PI is then responsible for forwarding the protocol application to the appropriate Department Chair, Dean, or Director for sign off and final submission.

I am not an employee or student at Georgia Tech. How do I submit an application?

Contact the Office of Research Integrity Assurance for a determination as to whether Georgia Tech is engaged in your proposed research. You will be advised on a case-by-case basis.

I am a Department Chair, Dean, or Director. How do I sign off on a protocol application that has been forwarded for my signoff and submission to the IRB for review?

If you have received an email asking you to sign off on an application, you can either click on the protocol link in the email or sign in to IRBWISE.

From the link in the email:

Click on the email link to access the protocol. At the top of the page, instructions will appear in green.  Click on the “Continue” button at the bottom of the screen. You will enter your password on the next screen and then select from three options:

  1. Return the application to the PI for modifications.
  2. Send the application to another person for signature.
  3. Submit the application to the IRB.

The SUBMIT button is at the bottom of the screen.  If the system does not allow you to submit the application to the IRB, please see Troubleshooting Suggestions below.

From your IRBWISE Home page:

Click on the "Submissions to Sign Off" tab to see a list of protocol applications that require your sign off. If you click on the specific protocol, you will be taken into the application requiring your signature. Follow the procedures above to submit the application to the IRB.

Troubleshooting Suggestions

Here are a few typical reasons that Department Chairs, Deans, or Directors are unable to sign off on a protocol application:

  • The same individual cannot be identified as both the PI or certified research personnel and the Department Chair, Dean, or Director, as the system will not allow you to “sign off” on your own work. If this is the case, the PI or student researcher 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.” Within the IRBWISE system, “Submitting” an application is not the same thing as “Signing off” on it. The application will need to be returned to the PI (select “Return to PI” option) so that the PI can resend for sign off.
  • The PI may not actually have forwarded the application to you for sign off. In this case, report the problem to the IRB Administrator. Send a request to irb@gatech.edu or call the Office of Research Integrity Assurance at 404.894.6944 or 404.894.6942.

Protocols awaiting your review are also accessible from your IRBWISE “Home” page.

How do I submit an amendment to an approved study?

Prior to implementing any changes to a study,  an amendment must be submitted and approved by the IRB. To amend an existing protocol, select the pertinent study in the "My Protocols" list, then select "Request amendment" from the "Tasks" dropdown menu. Complete and submit the amendment via IRBWISE.

All personnel being added to a protocol must complete Human Subjects Training before being approved.  For information on required training, visit IRB Required Training.

Important items to remember when submitting an amendment:

  • Answer all applicable sections of the form.
  • Include a justification for the amendment.
  • Upload all documents that accompany the amendment, such as consent forms, ads, etc.

How do I submit a "Request for Continuing Review When the Study Is About to Expire?"

Expiration notices are automatically emailed by IRBWISE to Principal Investigators 60 days and 30 days prior to expiration of a study approval period. If the study will continue, a request for continuing review must be submitted via IRBWISE.  

There are two ways to submit a Continuing Review Request:

  1. Click on the link to IRBWISE in the expiration notice email
  2. Select the expiring protocol from your IRBWISE account

To submit a Continuing Review Request from the email link:

Clink on the link at the bottom of the email. Log in to IRBWISE and select  “Request Continuing Review” from the drop down menu of the “Tasks” box in the upper right hand corner of the screen. Complete and submit the Continuing Review form.

To submit a Continuing Review from your IRBWISE account:

Select the study from the list on the "My Protocols" page.  From the protocol, select "Request Continuing Review" from the "Task" dropdown menu.  Complete and submit the Continuing Review form.

If you want continuing approval of the study, you must upload the consent form, advertisements, survey instruments, interview protocols, and any other documents that you wish to use in the upcoming approval period, even if you uploaded these same forms in the initial application.