IRB Application Issues
Q.15. Do I have to submit an internal staff change amendment to add an administrative person to my protocol ? If not, then how do I add them?
A.15. All investigators engaged in human subjects research, including co-investigators, participating clinicians and research staff, must be listed in Sections 3.1 or 3.2 of this protocol, they must be in compliance with the BUMC requirements for human subjects training certification and recertification and they must also comply with the institutional policies for submitting Project Specific Conflict of Interest Disclosures (COI-PSDs).
- Open the study in INSPIR II to the STUDY MANAGEMENT page.
- On this page you will see two tabs near the top of the page above the blue line; SUBMISSIONS and STUDY MANAGEMENT
- Click on the STUDY MANAGEMENT tab
- Under the STUDY MANAGEMENT tab- locate the third button down called KEY STUDY PERSONNEL and click on that
- Scroll down to locate the STUDY CONTACT or ADMINISTRATIVE ASSISTANT sections
- Click on the “ADD” bar to open the directories. From the directories locate the name of the person you wish to add.
- Once you find the name on the list, click the check mark to select that user.
- This will bring you back to the Key Study Personnel page and you should see the person’s name added to the correct section .
- Click on “Save Access to the Study”.
Q.14 a. (previously Q.8.) If you need to submit an amendment to a single section of the application (e.g. the confidentiality section) but with no other changes to protocol or consent, do you need to go through all the sections of the application and copy/paste text that migrated from INSPIR I?…or can you change on the confidentiality section?
Q.14.b. (previously Q.8.a.) If there was a protocol (example H12345) that was deferred prior to the migration, is it possible to redo the protocol into the new format?
A.14 a. & b. After reviewing multiple protocols and running into challenges with migrated data, the IRB is changing its directions about using the new versions of the application forms when submitting protocols. To streamline directions, effective immediately, whenever you get the Pop-up that says “Convert to a new version” (see below) you should follow the directions in the pop-up. (This includes when you get the pop-up for amendments forms, progress reports AND FOR NEW VERSIONS OF THE IRB APPLICATION.)
|A new version of the form has been published.Please click on the button CONVERT TO THE NEW VERSIONThen click through the wizard to verify that the application is complete.
By following the directions, a new version of the form (amendment, progress report, or IRB application) will be created. For the actual Amendments forms themselves and the Progress Reports themselves, just go through them and answer all the questions.
New Versions of the IRB Application attached to Amendments and Progress Reports
When you create the new version of the IRB application – you will need to go through the application section by section to “rebuild” the application. When the application appears on the screen initially, it will look like parts of the application have been lost. They have not. You will just need to go through the application, section by section, clicking on SAVE AND CONTINUE in the upper right hand corner. As you do this for each section of the application, that section will “reappear” with your previous answers migrated over from INSPIR I.
- In the new application there will be some fields /questions that will be new. It is ok to leave these “new” sections and questions blank. We have removed the message that forces you to answer all the questions before moving forward.
For new versions of the IRB Application that are for new submissions (never previously approved by the IRB)
**If this is a new application (never submitted to the IRB), even if it was drafted in INSPIR I, you will need to complete all the questions on each page. (The system will not force you to answer all questions but the protocol will be sent back as incomplete.)
Q.14 c. (previously question 9) One thing that is really unclear is if our protocols will be rejected if all the new information is not completed when we are just trying to submit an amendment.
A.14 c. For amendments and Progress Reports – you will be required to create a new published version of the IRB application. It is in the new published version that you will see the new questions.
- For Progress Reports you are required to submit a revision of the application (in the updated published version) with the PR (even if there are no changes to the IRB application). You will not be required to answer all the “new” questions. .
- For amendments, in most cases you will need to submit a revision of the IRB application with the updated published version but you are not required to answer all the new questions in each section. (You will be required to answer the new questions in the section that relates to your amendment.)
- The IRB will not “reject” amendments that come in with the new version of the application, but with the new questions unanswered. (In a very rare case the IRB may send it back asking you to answer some of the new questions, but that will only be in situations where extensive changes have been made to the application or the application in its current state is not clear.
For new protocols (where drafts were created in INSPIR I) and the draft was migrated, you will need to convert to the new version, go through the application, and answer all the questions before it is submitted to the IRB or it will be returned.
Q.13. I did have problems with the drop down menu for the departments. So, I just chose one from the few that were available.
A.13. The drop-down list of departments will definitely have some duplication. If you see an option that matches your needs you can select it.If you don’t see any option to match your department please email the IRB at firstname.lastname@example.org and it will be added. Please note that Community Health Sciences was recently added to the department list.
Q.12. Department and Special Routing signoff. I see a section for Department Chair sign-off but I do not see where we indicate special routing sign-off (e.g. IDS Pharmacy). What if I don’t know who is supposed to sign off for certain special routing?
A.12. All special routing signatories need to be listed in the same section as the Department Chairs. An updated list of all the special routing roles and the people associated with the roles has been added to the HELP section under Department Chair sign-off. Click on the ? [help icon] to the right of this section to see the listing, then Add the appropriate person’s name to the application (by clicking the ADD button), then select the associated role.
Q.11. New protocols: What about new protocols- those that were migrated from INSPIR I in draft form (never submitted to the IRB) and those that were created in INSPIR II after the migration.
A.11. If a NEW protocol was migrated over in draft form and now you pick it up to work on it you are going to get this same “convert to new version” message. FOR NEW PROTOCOLS, that have not been submitted yet to the IRB we are going to require that you convert to the new version, go through the updated application again and answer all the “new” questions. For new protocols that you STARTED after the migration (they were not started in INSPIR I)- you will not see the Convert to New Version button- the system will automatically take you to the latest published version when you start creating a new application.
****Questions and answers to previous questions 8, 8.a., 9, and 10, have been removed because the instructions have been modified. See Question 14 above for the revised instructions.
Q.7. Navigation menu question (Section 10.0) If you change an application enough so that a subsection is no longer needed, should that subsection no longer appear and the data deleted? I went back and changed BUMC from Institution A to Institution B and still get the “BUMC is Institution A” questions in 11.0.
A.7. Changing the application to indicate that BUMC is Institution B (from Institution A) would “change this” into an Exempt application. You would need to go back to the Navigation Page (Section 10) and check all your answers again on that page, making sure that question 10.4 is changed to “no” and that you saved the answers.
Q.6. Optional page: BUMC is Institution A -Could the Institution B list be alphabetized? What do we do if the institution isn’t on the list?
A.6. The Institution B list was migrated over from INSPIR I. We will see if it can be alphabetized during the next version of the form but it will not be alphabetized for the migration. If you cannot find an Institution on the list then contact the IRB office (email email@example.com) and that institution can be added.
Q.5. If “Dept/Internally Funded” was selected in 7.1, should we add the department as a sponsor in 7.2?
A.5. At this time it is not necessary to add details about departmentally funded or internally funded studies.
Q.4. Section 3.5 Department Review on a new application: Can you add Section Chief or Other in the drop down for title? (I got an error message if I let it stay as none)
A.4. The dropdown menu was changed to read Depart. Chair/Section Chief. You can use this drop-down for anyone signing on behalf of the Department Chair (for example, if the PI is the Department Chair then the signatory official will be the Dean).
Q.3. Section 4 External Personnel on a new application: How do I add external personnel? I see the button “Click here to add any External Personnel”, but no place to enter information.
A.3. When you “click to add External Personnel” this will bring you to the page where you add people’s name and information. Click on the “button” at the top that says “Add External Personnel to the Study”. This will pop up a page with 5 questions. Answer the 5 questions- then CLICK ON SAVE EXTERNAL PERSONNEL INFO (upper right hand corner). This will bring you back to the “add External Personnel page” where you can add someone else or go back to the protocol application.
Q.2. Section 3.6 on a new application - What does the text “Administrative Assistant” refer to?
A.2. The Section for Administrative Assistant is where you add anyone who is NOT an investigator or member of the study staff (not engaged in the research), but just needs to be added so that they can read the protocol. The text “Administrative Assistant” is just “software artifact” that we could not remove on this version. Please just ignore.
Q.1. Submission: Problems with submitting the application. Is there a way of finding out which sections are not complete?
A.1. As you move from Section to Section the system should prompt you to answer certain “required” questions. Not all questions have “forced” answers in order for the application to be submitted. So, some questions may be incomplete when the application is submitted.