eIRB Tips for HS IRB Studies

The following tip sheets and detailed instructions are for Health Sciences Institutional Review Board (HS IRB) studies. For more information reach out to the HS IRB.

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Frequently Asked Questions (FAQs) about electronic IRB (eIRB)  

Where can I find the link to the eIRB?

The link to eIRB can be found on our website or by visiting https://eirb.tuftsmedicalcenter.org/

Now that everything is electronic, do I still need to sign IRB Forms?

We have updated many of our forms for eIRB. The Research Financial Disclosure Form (also known as the COI – Conflict of Interest (COI) form) and Form 10B are the only forms where a signature is still required.

We accept the following types of signatures on the Research Financial Disclosure Form:

  • An original ink signature (and scanned for upload)
  • A Watermarked Adobe Signature
  • A signature drawn with the “pencil” tool

Be sure to download the latest forms and templates directly from the eIRB library for every submission to ensure you are using the latest version of each. For guidance on which Forms may be required and where to upload them in the eIRB, refer to Documents and Forms to Upload in eIRB.

How do I find a study in eIRB?

When searching for a study in eIRB, an easy way to find it is to first click the ellipsis (…) symbol underneath the IRB tab and select “All Submissions”. Then use the Wildcard (%) symbol before typing in the study number, PI Name or part of the study name. You can change the search type in “Filter by”.

How do I check the status of my eIRB submission? What do the different statuses mean?

The big orange box in the top left corner of the study page will tell you the current status of your study. For continuing reviews and modifications, you must be in the specific continuing review or modification submission to check the status.

  • Pre-Submission – The submission has NOT been submitted to the IRB. The PI still needs to review the submission & click ‘Submit’
  • Dept/Div Review – Department Chair / Division Chief needs to Submit Department / Division Review
  • Pre-review – IRB staff is currently reviewing
  • Clarification Requested – IRB has requested clarifications or changes from the PI
  • Acknowledged – Reportable New Information (RNI) has been acknowledged
  • Active – The study is active
  • Approved – The submission has been approved by the IRB
  • Closed – The study team closed the study
  • Discarded – The study team discarded the submission
  • External IRB – This study was approved by another IRB
  • Human Research, Not Engaged – IRB determined Tufts is not engaged for this project; no further review needed
  • Lapsed – IRB approval for the study has expired
  • Modifications Required – Reviewer determined that changes are needed for submission to be approved
  • Non-Committee Review – The submission is being reviewed by a Designated Reviewer (IRB Chair/Vice-Chair)
  • Committee Review – The submission is being reviewed by the convened IRB Board
  • Not Human Research – The project is not human subjects research (NHSR); no further review needed
  • Pending sIRB Review – External IRB study awaiting external IRB’s approval

My submission has been stuck in Department/Division review for a while – who do I contact to check on this?

Department/Division sign-off is needed before a new study is submitted to the IRB. When you click the blue “Edit Study” or “View Study” bar on the left side of the study workspace, you will see the tab at the top with “Jump To”. Click “Jump To” for a drop down menu and select “Study Department/Division.” Under “*Study Department/Division”, your Department/Division will appear in blue text – click this and you’ll be brought to the department information page. Click the “Properties” tab. Scroll down until you see “IRB Ancillary Reviewers” and you will see the contact information for your Department/Division Reviewer.  If you have chosen the wrong Department/Division Reviewer, contact the IRB office for assistance.

How do I navigate back to the Main Study page from a modification or Continuing Review?

Click on the double arrow icon (also referred to as the “breadcrumb trail”) at the top left hand side of your screen. This will display a dropdown menu where you can click on the Main Study title. This will take you back to the Main Study page.

eIRB website menu

How do I find the option to Submit, Assign a Primary Contact and/or a PI Proxy?

The PI or PI Proxy are the only ones who can officially “Submit” a submission to the IRB. On the left hand side of the study workspace, underneath “Next Steps”, the PI and/or PI Proxy has the ability to “Submit”, Assign a Primary Contact, and/or Assign a PI Proxy.  The Primary Contact can access the study in eIRB and will receive eIRB notifications for the study. The Primary Contact also has the ability to create a submission on behalf of the PI. The PI Proxy, however, is the only research team member that can officially submit items on behalf of the PI. In order to assign a PI Proxy, the member must already be part of the research team. This option will not be available until the change in research team has officially been processed by the IRB.

Make sure you are on the main study page when you do this.

How do I reply to pre-review comments and requests for revisions?

Once you are ready to submit your response to IRB comments:

  1. Click Edit Study (or Edit Modification/CR) on the left side of the workspace.
  2. Use the “Continue” and “Jump To” buttons to navigate through the smart form.
  3. Use the Add button to add a new document.
  4. Use the Update button to replace an older version of a document with a revised version. The outdated version will still be accessible in the document history.
    1. Use Tracked Changes for every document you revise.
    2. Name documents to clearly show what they are (i.e. Protocol, ICF tracked). However they are titled, will be how they are referenced in the IRB Approval Letter.
  5. Click “Save” at the top or bottom of the screen before you click “Exit”
  6. Click “Submit Response” on the left side of the workspace, under all the blue buttons.
    1. The “Submit Response” option will only be visible to the PI (or PI Proxy, if one is assigned).
    2. In the Notes box, type in any responses to comments that aren’t reflected in your revised documents.
    3. Then, click “OK”.

Who should I check the box to notify when I add a Comment?

  1. Checking “PI /PI Proxy / Primary Contact” sends an e-mail to the PI, PI Proxy, and Primary Contact
  2. Checking “Study Team” sends an e-mail to all of the research team members listed in eIRB
  3. Checking “IRB Coordinator” sends an e-mail to IRB office staff. (Please note that this is not the research coordinator)

Can I upload password-protected documents to the eIRB?

Avoid uploading password-protected documents to eIRB. If you have to, please provide the password to access the document in the form of a comment on the Main Study page. You may do so by selecting “Add Comment” on the left hand side of the submission workspace, under Next Steps.

How do I submit Continuing Review for a WIRB/external IRB study?

You do not need to submit Continuing Review to Tufts HS IRB for studies under an external IRB. You may get automated Continuing Review Deadline Reminders from eIRB for these studies, but there is nothing you need to do in eIRB. Continuing Review, when required, will be conducted by the external IRB.

On the Basic Study Information page, it asks me if this study is a single-site study or a multi-site/collaborative study. My study involves other sites, but how do I know which to pick?

Multi-Site / Collaborative Study: A study in which two or more institutions coordinate, regardless of whether Tufts will serve as the IRB of record for other institutions.

Single-Site Study: A study in which only one institution completes all research activities outlined in a specific protocol.

This will be my first time submitting a Continuing Review in eIRB, how do I make sure I do it correctly?

If you are submitting a continuing review of your study in the eIRB for the first time, you will need to complete the study “shell” of basic study information in eIRB:

  1. On the Main Study page, select “Create Modification/CR”
  2. Under “What is the purpose of this submission”, select “Modification and Continuing Review”, regardless if you are including any changes to the study.
  3. Under “Modification Scope”, select both “Study Team Member Information” and “Other Parts of the Study” options
    1. This will allow you to 1) upload all of your current study documents and 2) update your current list of research team members (regardless if any changes in research team are being made at this time). If both “Study Team Member Information” and “Other parts of the Study” are not selected, you will be asked to discard your submission and start over.
  4. When the smart form prompts you to summarize the modification, please state “Filling out the shell of this study in eIRB for the first time”/“Updating Study Shell” if no other changes are being made at the time of continuing review.
  5. In the future, you will choose this “Modification and Continuing Review” option only if you have a continuing review plus a modification (amendment) to submit.