How To's


The Emory IRB's concise & illustrated "How To" guide may be found here. Step-by-step instructions for specific topics are below.  Additionally, instructional videos can be found under the eIRB Training tab.

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How To Get an eIRB Account - With an E.U. or Emory Healthcare Account

Users with an Emory NetID can log into eIRB using their netID and password. Upon first log-in, an eIRB account will automatically be created, using information from PeopleSoft. Users should verify account information is correct by clicking on their name on the top right of the screen (next to the "My Home" link). In some cases, your departmental may appear as "Undefined." This will not have any impact on your work other than that you'll be required to choose your correct department for Departmental REview on new study submissions.

Please note that eIRB will only send notifications to the email address listed on your account properties page. 

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How To Get an eIRB Account - No E.U. or Emory Healthcare Account

New University Employees/students without an Emory Account:

After you attend employee orientation you can obtain an Emory NetID.   Once you have an Emory NetID, follow the above steps for those who have an EU/EHC account to log into eIRB.

If you are in the process of being hired as an Emory University employee and do not yet have your NetID, DO NOT request a sponsored account. Please contact your HR department and have them start the process for creating your university credentials. Once those have been established, please follow the instructions for those who have an EU/EHC account to log into eIRB. More information about Sponsored Accounts and who is eligible can be found at https://emory.service-now.com/kb_view.do?sysparm_article=KB00188.

Sponsored Accounts for Non-Emory University or Non-Emory-Healthcare Users:

Sponsored accounts are ONLY for non-Emory study staff who need access to eIRB in order to view or edit submissions. All other non-Emory staff may be added manually under the "non-Emory" section. Please note, the addition of non-Emory staff to an Emory IRB reviewed protocol may require additional steps, such as those found on our collaborative research page.

For VA Personnel: Please note that all VA personnel must have their accounts sponsored by Tony Laracuente (Antonio.Laracuente03@va.gov). Please contact him with the pertinent information so he can sponsor your account.

For non-VA Personnel: In order to obtain a sponsored account (the first step in getting access to eIRB) the PI, one of the study coordinators, or someone else on the PI’s staff will need to sponsor the account. The sponsor must be a full time Emory employee. 

You must provide the sponsor with the following information: First NameMiddle NameLast Namecontact phone numbercontact e-mail address, and full date of birth (MM/DD/YYYY). Without this information they will not be able to sponsor your account.

The Sponsor will need to follow the instructions below:

  1. The sponsor should go to http://help.emory.edu and login
  2. Click on the “Request a Service” link
  3. Click on the "Sponsored: Account Request" link
  4. Provide the required information
  5. In the "Additional Services" area please check "eResearch" so the request is routed correctly after the account is created.

Once the account is established, which may take 2-3 business days, the sponsor will receive your account information to send to you. Once you have your Emory account information (Emory NetID and Password) please follow the instructions above for those who have an EU/EHC account to log into eIRB (i.e., simply log into eIRB with your Emory netID and password).

All e-mail from the University system will be forwarded to the contact e-mail address supplied when the sponsored account is created. If you need to change your contact e-mail, please contact the Emory University Helpdesk at 404-727-7777. They can provide instructions on how to forward your Emory e-mail to another address.

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Submit a study in eIRB (see also, the New Study Guide)

To submit a study in eIRB:

  • Go to http://eresearch.emory.edu/emory and log in using your eIRB username and password (tip: these may be different from your regular Emory username and password)
  • Click "My Home" at top right
  • Click "New Study"

The application space for your study will open:

  • Answer all required questions and respond to prompts
  • Application consists of numerous pages. Click "Continue" at top right to move to next page
  • Click the "Finish" button at the top right
  • Study workspace will appear
  • Click "Submit Study" at left.
Note: the PI is the only person (or role) who can submit the study in eIRB.

Remember:

  • A departmental approver who has been given a special role is the only person who can give departmental approval in eIRB. If you don’t know who yours is, please contact irb@emory.edu to ask
  • For all consent/assent/HIPAA documents that require IRB approval "stamping," please refer to the templates under the Forms & Guidance tab
  • If you receive notice that changes are requested, edit the application and click "Submit Changes" at left in study workspace. A co-I or Coordinator, not just the PI, may make the change and submit them.
  • If your study needs approval by other committees besides the IRB (such as Radiation Safety), eIRB will notify them if you:
    • Check the appropriate box on page 2 of application, “Required Reviews”
    • Environmental Health and Safety Office (Radiation, Chemical, Biological safety), the Cancer Trials Research Committee, and the Conflict of Interest Committee will register their approval in eIRB after their review is complete
    • You must also submit applications directly to those offices, which can be done in parallel with your eIRB submission (it does not matter which application you start with). See their websites for details - all are linked to from http://www.or.emory.edu/
  • To save your entries on one page and move to the next, click "Continue" (which will also highlight any required questions you may have missed)
  • To save your entries and stay on the same page, click "Save" at top in gray bar
  • Only the listed PI, Co-Is and Coordinators can create and edit a study. Only the PI can submit the initial application.
  • You do not need to complete the application in one session. You can save your work and return later.

To re-open a study to continue editing:

  • Login to eIRB
  • Studies in pre-submission studies will appear in your Inbox
  • Your Inbox will also show studies sent back to you by the IRB for changes
  • All of your studies (active and closed/withdrawn) will appear on your "IRB" tab

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New Study Guide

create   New studies in eIRB can be created by clicking the "New IRB Study" button on the left hand side of the eIRB home page. Doing this will bring up the first page of the eIRB application smartform. The smartform will adjust which questions you are asked depending on your answers.

id   The first page asks for general information such as:
  • The full and short study title
  • The expected start and end dates
  • The study staff

The various schools and departments at Emory have differing rules on who can serve as Principal Investigator. Researchers should check with their department for specific information or consult the IRB P&Ps which deal with Investigator Qualifications and Student Research.


reviews  

The next page deals with required Departmental and Faculty Advisor reviews. Again, specific departments have their own rules regarding Department approval and what role an Advisor must take in student research.

Question 1 defaults to the PI's department. REVISE this if needed to ensure that the listed departments starts with an ASTERISK (*) (removing any other departments), as those are the only ones with associated Approvers. For further guidance on this see our FAQs: 

Approval will be required from any department listed. If you are unclear about who your Departmental Approver is, contact either your department manager or the IRB.


Bio Med Research

 

If the study has any type of medical intervention or procedure, the Biomedical Research Page will be triggered in eIRB. In addition to asking about Emergency Use and other special considerations (e.g. HDEs and Treatment INDs), this eIRB page will also ask about specific medical procedures to be used in the study (see the list to the left).

This page will also ask how data will be collected and whether there will be any banking of specimens or data.

Certain procedures may require ancillary review by other offices. Selecting certain procedures will trigger the appropriate page in eIRB. Radiation Safety Committee (RSC) approval, for example, is generally required for research using radiation, and selecting "Radiation Exposure" will trigger the Radiation Safety page in eIRB.

Note: Selecting any kind of genetic testing or banking will trigger the Institutional Health and Biosafety Committee (IHBC) review page. IHBC approval is not required for genetic testing unless recombinant DNA is being used.


From here the eIRB smartfom will diverge depending on the type and design of the study. While some pages in eIRB will ask general questions about the research, others may be ask about specific parts of the research. Some of the pages that follow will not be relevant for all researchers. Only a few specific areas of concern will be covered here.

enroll  

The study population page will ask for basic information about what subjects will be recruited, as well as the expected enrollment for the study.

Note: The Emory IRB considers any subject who gives consent to be "enrolled," whether or not they subsequently fail screening tests or drop out of the study. This means that only entering the target accrual number may result in over-enrollment and a subsequent non-compliance review. Researchers should keep this in mind and account for some level of loss when entering the number of subjects to be enrolled at Emory.


 

All consent forms, HIPAA authorization forms, and revocation letters must be stamped with the IRB approval period and study number. Emory IRB uses a header called the "Document Stamping Template" to do this. Researchers should ensure that all the forms listed above are on an unaltered version of this header. Changing the header in any way will prevent proper date and protocol number stamping.

The Document Stamping Template is linked in eIRB, but can also be found here.


Once you have finished filling out the eIRB smartform, you will have successfully created a new IRB study. The next part of this page will lead you through getting any Co-Investigators to accept their roles and getting departmental approval. These are required before the study can be reviewed by the IRB.
     

     
Getting from Pre-Submission to IRB Review  
presubacticities  

Back on the study home page, the list of activities under the "My Activities" toolbar should resemble the one to the left. The current state of the study should be "Pre-Submission."

The most important options now are "Send Email Notifications to Co-Investigators," "Submit study to Dept or FA for approval," and "Contact IRB Staff." At this point, no analyst has been assigned to the study, so any comments logged to the IRB will go the the IRB listserv.

The next step in the submission process is to notify any Co-Investigators and get them to accept their roles.

     

     
deptsevstate  

The next step is to submit the study to the PI's department (or faculty advisor, for students) for review. Each Department in Emory chooses their own Departmental Reviewer, or Reviewers. By clicking on "Submit study to Dept or FA for approval," The Department Reviewer will automatically be notified.

Your study will now be in the state, "Department Review." 

   
deptrevsubmit  
     

     
deptapproval  

Once the Departmental Reviewer gives his or her approval, the study will return to the IRB in the state "Protocol Analyst Assignment."

The IRB will assign a Research Protocol Analyst to review the study prior to Full Board or Expedited review.

   
rpaassign  
     

     
staff review  

Congratulations!

Your study has now been submitted to the IRB and is being reviewed by an IRB staff member. If no further changes are required, your study will be sent for review by the full board or a designated reviewer.  (For information about the various levels of review, please refer to our page on IRB Review Types)

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Submit an amendment

At times in the course of a study, you may need to change the plans or consent materials. You must get IRB approval before making these changes. In eIRB, this means you must “create an amendment request.”

The Amendment application will open:
  • Please answer all questions
  • To move from page to page click "Continue" at top right
  • After you complete the Amendment request, you will see a link to modify the existing study. Sometimes one change affects other parts of the study file. Please edit the study in eIRB to reflect implications of the amendment.
  • Click "Go to the forms for the Study being amended" to edit the study
  • Click "Finish" at top right
  • You will return to “workspace”
  • PI must click "Submit Amendment" at left (only the PI can do this in eIRB)
Remember:
  • To save your entries and move to the next page, clicking "Continue" will save your information if all required answers are complete on that page
  • To save your entries and stay on the same page, click "Save" at top in gray bar
  • While the listed PI, Co-Is and Coordinators can create and edit an amendment, only the PI can click “Submit”
  • You do not need to edit the questions in one session. You can save your work and return later.
To re-open a Amendment request:
  • Login
  • The pre-submission Amendment request will appear in your Inbox
  • Click on "IRB" tab to open the relevant study. Click on Amendment workspace link in the “history.”
  • Or click on "IRB" tab and open the study, click "AM-CR-RE-Term" tab, and click title of the Amendment.

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How To Submit a Reportable Event in eIRB

For general information about which sort of occurences are reportable, and when, please consult the IRB's page on Reportable Events.

To submit a Reportable Event in eIRB:

  • Go to http://eresearch.emory.edu/emory and log in
  • Click "My Home" at top right
  • Click "IRB" tab at center
  • Click title of relevant study
  • Click "New Reportable Event"
This will open the Reportable Event application:
  • Please answer all questions and respond to prompts
  • To move from page to page click "Continue" at top right
  • Click "Finish" at top right
  • You will return to “workspace”
  • PI must click "Submit Reportable Event" at left (only the PI can do this)
    • Until the PI submits the Reportable Event, the IRB will not see it
Remember:
  • To save your entries and move to the next page, clicking "Continue" will save your information if all required answers are complete on that page
  • To save your entries and stay on the same page, click "Save" at top in gray bar
  • While the listed PI, Co-Is and Coordinators can all create and edit an Amendment, only the PI can click “Submit”
  • You do not need to edit the questions in one session. You can save your work and return later
To re-open a Reportable Event request:
  • The pre-submission Reportable Event request will appear in your Inbox
  • Click on "IRB" tab and open the study, then click on the Reportable Event Workspace link in the “history”
  • Or click "IRB" tab and open the study, click on "AM-CR-RE-Term" tab, and click on title of Reportable Event.

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How To Submit a Continuing Review Application in eIRB

To submit a continuing review/renewal/re-approval application

  • Go to http://eresearch.emory.edu/emory and log in
  • Click "My Home" at top right
  • Click "IRB" tab at center
  • Click on title of relevant study
  • Click "New Continuing Review"

The renewal application will appear:

  • Please answer all questions and respond to prompts
  • To move from page to page click "Continue" at top right
  • Click "Finish" at top right
  • You will return to "workspace”
  • PI must click "Submit Continuing Review" at left (only the PI can do this)

Remember:

  • To save your entries and move to the next page, clicking "Continue" will save your information if all required answers are complete on that page
  • To save your entries and stay on the same page, click "Save" at top in gray bar
  • While the listed PI, Co-Is and Coordinators can all create and edit an Amendment, only the PI can click "Submit”
  • You do not need to edit the questions in one session. You can save your work and return later
  • Please use the newest IRB document stamping template (located under Forms & Guidance/Consent Toolkit) for all consent/assent/HIPAA documents that require IRB approval "stamping”

To re-open a Continuing Review request:

  • Log in
  • The pre-submission Continuing Review request will appear in your Inbox
  • Click "IRB" tab and open the study, then click the Continuing Review Workspace link in the "history”
  • Or click "IRB" tab and open the study, click "AM-CR-RE-Term" tab, then click on title of the Continuing Review

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How to Close-Out or Terminate a Study in eIRB

If all human subjects research activities have concluded, including analysis of identifiable data, you may close out/terminate a study in eIRB. To do this, you must "create a Close-Out request ” in eIRB.

  • Go to http://eresearch.emory.edu/emory and log in
  • Click "My Home" at top right
  • Click "IRB" tab at center
  • Click title of relevant study
  • Click "New Close-Out"

The Close-Out application will open:

  • Please answer all questions and respond to prompts
  • To move from page to page click "Continue" at top right
  • Click "Finish" at top right
  • You will return to the "workspace”
  • PI must click "Submit Close-Out" at left (only the PI can do this)

Remember:

  • To save your entries and move to the next page, clicking "Continue" will save your information if all required answers are complete on that page
  • To save your entries and stay on the same page, click "Save" at top in gray bar
  • While the listed PI, Co-Is and Coordinators can all create and edit an Amendment, only the PI can click "Submit”
  • You do not need to edit the questions in one session. You can save your work and return later

To re-open a Close-Out request:

  • The pre submission Close-Out request will appear in you Inbox
  • You can click on the "IRB" tab and open the study. You can then click on the Close-Out Workspace link in the history.
  • You can click on the "IRB" tab and open the study. You can then click on the "AM-CR-RE-Term" tab. Then click on the title of the Close-Out.

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