1. Will there be a single document to recapitulate the original HSP as well as subsequent amendments, allowing a clear current description of the approved study?

Yes, the ePortfolio will be the single document and serve as a replacement for the HSP and other IRB submission forms. At each amendment, we ask that you update the appropriate sections of the ePortfolio with the changes.

2. Can I submit an amendment to an existing protocol (approved prior to August 28, 2020) using the ePortfolio?

Separate Amendment and Continuing Review forms have been developed for existing protocols. The ePortfolio will not allow Amendment or Continuing Review submissions for protocols not initiated on the ePortfolio.

3. How will department scientific review (i.e., PORF) work? Is that electronic or will it be still submitted on paper from IRAP?

Currently, there are no changes to Departmental Scientific Review processes; however, in the future, there may be an opportunity to upgrade the scientific review process.

4. Can we wait until the form goes live to submit?

Yes, you may wait until the ePortfolio goes live to submit, or you may submit the protocol using the current suite of applications. Note: The HSP and current suite of forms may be submitted until September 30, 2020, and the IPR and PRAF will still be accepted until November 30, 2020.

5. Will the Personnel eForm be integrated into the ePortfolio?

The Personnel eForm will remain a standalone document so it can be independent of the ePortfolio. No significant changes are being made to the Personnel eForm at this time.

6. Will the PI be required to sign the ePortfolio?

No signatures on IRB eForms are required, but the PI will receive an email confirming submission of applications. Note that the Protocol Oversight Review Form must be signed.

7. Will this apply to any changes in the consent, or will we still need to submit a clean and tracked consent for any amendments?

Consent forms will continue to be uploaded as Microsoft Word documents, with tracked and clean copies submitted when changes are requested.

8. Will the PI be notified a submission has been generated in his/her name?

The PI will receive an automatic notice when an IRAP submission has been submitted to the IRB.

9. How will this new approach work for student researchers for theses and dissertations?

Students will submit their applications to the IRB using the ePortfolio.

10. Will ancillary approvals be incorporated into the ePortfolio or will they still be separate document uploads?

Ancillary approvals will be submitted as an attachment within the ePortfolio.

11. How will the process of submitting a response to IRB questions on an HSP change?

Responses to communications to the ePortfolio will look somewhat different. Administrative Pre-Review letters and Determination Letters will be formatted in a table with a cell for your response. When you complete your response, please upload the Response as an attachment to the ePortfolio.

12. Will turnaround times be shortened?

The ePortfolio is projected to reduce turnaround times, and automating current manual processes will allow redeployment of IRB staff to more value-added tasks.

13. Did UAB build the ePortfolio or buy the software from a vendor?

InfoEd, the commercial vendor that designed IRAP, uses an eForm builder, so the software was immediately available; however, UAB partnered with another institution that uses InfoEd to obtain the basic structure of the ePortfolio.

14. Will documents that have to be submitted require a naming convention?

Anything uploaded within an eForm (e.g., the ePortfolio, Amendment eForm, or Continuing Review eForm) will not require a naming convention. Applications uploaded prior to September 30 using the HSP or Continuing Reviews and Amendments uploaded prior to November 30 using the Microsoft Word suite of applications will require naming conventions.

15. Is there a save feature where you can start the ePortfolio and come back to it later before submitting?

Yes, there is a save feature, so you may leave the ePortfolio and complete later. It is recommended that you save often to avoid timing out and losing work. You will need to remember the protocol number so you can find the submission again.

16. Is there a feature that lets you print out the ePortfolio as a document?

Yes, you can save the ePortfolio as a PDF and print the document.

17. Who will have access to one study via the ePortfolio?

Any investigator listed on the protocol as well as the PI’s delegates have access to the ePortfolio.

18. Will the ePortfolio be an editable document?

Yes, amendments are made directly to the ePortfolio. You will not have to start over each time.

19. Will we need to set up new delegates, or will those already in IRAP carry forward to ePortfolio?

Your existing IRAP delegates will remain unchanged.

20. Will there be any guidance when choosing exempt or expedited categories as we begin the ePortfolio?

There are definitions of each expedited or exempt category inside the ePortfolio and you may select the appropriate category or categories.

21. Will completion of the ePortfolio be required for existing protocols?

Not at this time. If you have an existing protocol, we are asking you not to complete the ePortfolio until further notice.

22. How will the department reviewer complete his/her review to sign the Protocol Oversight Review Form (PORF)?

You can save the ePortfolio as a PDF and send it to your department reviewer along with an unsigned copy of the PORF.

23. Will delegates have the ability to complete the ePortfolio and save it for the PI to submit?

Delegates can complete the ePortfolio, click save, and notify the PI the ePortfolio draft is complete for him/her to review and submit.

24. Regarding the IRB submission distribution system, will IRB staff “pull” the same types of protocols that are more in his/her area of expertise or experience or pull the next one in line?

IRB staff will pull the next in line for the submission type that is in their area of expertise.

25. Will a copy of the training presentation be available?

A copy of the training presentation is available HERE.

26. If we have a specific question about a submission, can we email the IRB staff who reviewed it or do we have to email the general IRB email?

If the pre-review has been initiated, you can email the IRB staff reviewer who completed your pre-review for that submission.

27. Will new expiration dates be less than a year away if reviewed prior to expiration date like is currently the process?

No changes to the expiration date process is occurring.

28. Can I submit multiple protocols at the same time?

Yes, you can submit multiple applications for different IRB protocols; however, you may only have one open Continuing Review or Amendment submission in a single protocol at a time.

29. When will the HSP become obsolete?

The OIRB will stop accepting the HSP on September 30, 2020.

30. Can you skip questions and move on and then come back to earlier questions you skipped?

Because the form uses branching logic, questions must be answered in the order they are presented.

31. Will we get a notification that our study material has been pulled by an IRB staff member or will the status change in IRAP?

You will not receive a notification until the IRB staff member has completed the pre-review.

32. Is this form similar to the WIRB Smart Forms?

Yes, the form is similar.

33. Can multiple investigators work on the same form at the same time?

No, only one investigator can work in the same form at the same time. If multiple investigators use the form simultaneously, the form may lose data for one or more investigators. However, multiple users may contribute to the same form when logged in at different times.