Adding/Removing Internal Investigators From An Already .

Adding/Removing InternalInvestigators from an AlreadyApproved Study (Section 3.0)1

Internal Investigators These are BU/BMC faculty and staff Boston Public Health Commission and Boston HealthnetCommunity Health Center investigators are also “internal”investigators for BUMC IRB protocols Internal investigators must be listed in Section 3 of theIRB application In order to be listed, all internal investigators and studystaff MUST have a BU or a BMC username and passwordand had previously logged in to INSPIR (at least once). Investigators from other locations and other institutionsare not listed under Internal investigators (they are addedin the External Investigators table)2

Internal Investigators An “Internal Study Personnel Change Form” can be made toadd/remove internal investigators from Section 3 at any time. An “Internal Study Personnel Change Form” can be made While another “Internal Study Personnel Change Form” is pending While another “standard amendment” is pending While a Progress Report (Continuing Review) is pending An “Internal Study Personnel Change Form” cannot be used to addExternal Investigators – a standard amendment called “Change Requestand Amendments Form” must be submitted3

Login into INSPIR and from yourHome page, click on “My Studies”to list all the studies that you haveaccess to4

This is my personal “My Studies” pageYou can use the filter or the“Find by ” feature to locatethe study or draft. Or you canjust scroll down.Once you locate the study ordraft, click on “Open”.5

Click on “Internal Study PersonnelChanges)- blue arrow6

This will bring you to the Internal Study Personnel Changes page. (blue arrow)Here you will see any previous personnel changes (yellow arrow)To open a new “Internal Study Personnel Change” form – click on the Add New Formbutton (red arrow)7

This will bring you to the Amendment information page. In section 1.2 describe thechanges requested (e.g. We want to add Dr. Jane Doe as a Co-Investigator)Then scroll down to complete the next section (1.3) of the form. (yellow arrow)8

In section 1.3, check the box(es) for one or more options: To replace the current PI with someone else, check “Changing Principal Investigator”box. To replace the Supervising PI with someone else, check the “Changing SupervisingPrincipal Investigator (formerly known as Faculty Sponsor)” box. To add new study personnel (other than the PI or Supervising PI), check the “Addingstudy personnel” box. To remove an existing study personnel, check the “Removing study personnel” box.Depending on what boxes you have checked, the corresponding section will appear in thisform to be completed. Scroll down in the form to address the next section.9

Note: If you did not check the “Changing Principal Investigator” box in section 1.3 of theform, skip the next instructions to slide # 29.Changing Principal Investigator10

In section 1.4, describe the reason for the requested PI change (blue arrow). Then scrolldown. (green arrow)11

Next, you need to download the “Principal Investigator Responsibilities” document, have the new PI sign it, andattach it to this submission:1. Click on “see PDF Document” link to open this document.2. Save the document to your Desktop3. If you have Adobe, the new PI can e-sign it and save it again to your Desktop. If you don’t have Adobe, you canprint it out, have the new PI sign the printout, and then scan the signed document and save it to your Desktop.Alternatively, you can use a PDF of an email listing these responsibilities and the new Principal Investigatorresponding and acknowledging them.Once you have a signed “Principal Investigator Responsibilities” document saved on yourDesktop, click on “Add a New Document” to attach it to this submission.12

Clicking on the “Add a New document”, will display the “Study Document Add:” popup.1. Give this document a title (blue arrow)2. Click on the “Browse” button (green arrow)13

This will display the “File Upload” popup (or similar popup depending on which webbrowser you are using).1. Navigate to where you saved the signed document (i.e. Desktop)(blue arrow)2. Select the signed document (green arrow)3. Click on the “Open” button (Grey arrow)14

This will bring you back to the “Study Document Add:” popup. Notice the uploaded document’s name is now appearing in the popup (blue arrow)1. Change the “Version Date” to today’s date (green arrow)2. Select “Signed PI or Supervising PI Responsibilies” for the “Category” (red arrow)3. Click on the “Save Document” button (Grey arrow)15

This will bring you back to the “Internal Study Personnel Change Form”. Notice that the PI Responsibilities document is now appearing in this form (blue arrow)Next, you need to select one of the options under “Please select the status of the study”. If you selected option 1, “Additional subjects will be consented”, section 1.5 needs to becompleted. Proceed to the next slide. If you selected any of the remaining four options (other than “Additional subjects willbe consented”), skip the next instructions and go to slide # 29.16

If you selected option 1, “Additional subjects will be consented”, section 1.5 will appear. In this section you need to revise any approved consent forms to include the new PI’sname and contact information. To revise a consent form, click on the “Select or ReviseExisting” button. (blue arrow)17

Clicking on the “Select or Revise Existing” button, will display a popup similar to the oneshown below.1. Scroll down and find the consent form that you want to revise, then click on the “CreateRevision” icon that correspond to that consent form (same row)18

Clicking on the “Create Revision” icon, will open the “Study Consent Revision” popupdisplaying the selected consent form cover sheet.1. Click on the “Check-out Document” button to download a copy of the consent form inWord that you can modify.19

You should get a “File open” prompt similar to the one shown below. Select “Open with” and click “OK” (this prompt might look different if you are using adifferent web browser)20

The consent form should open in Microsoft Word.1. Make all the changes necessary to the PI’s name and contact information to reflectthose of the new PI. In this step, you should not make any other changes at all to theconsent form.2. Save this consent form on your Desktop.21

Once you have the consent form revised and saved to your Desktop, go back to the INSPIRsystem where you left off. It should look like the screenshot below.1. Click on the “Complete Checkout” button in order for the system to give you the optionto check-in (upload) the revised consent form.122

This will bring you back to the consent form’s cover sheet. But this time you have the“Check-in Document” button available to upload the revised consent form.1. Click on the “Check-in Document” button to check-in (upload) the revised consentform.123

You will get this popup to browse for that document.1. Click on the “Browse” button to look for and select your document.124

You will get this popup for File Upload (this popup might look different depending on yoursystem and web browser used).1. Click on “Desktop” in the left column, and in the right column, click on the documentname that you want to upload to highlight it.2. Click on the “Open” icon.11225

This will take you back to this popup but you will see that the selected document nameappears here (blue arrow).1. If you have the correct document listed, then you can proceed and click on the “SaveSelected Document” button to upload your document (green arrow).126

This will take you back to the “Study Consent Revision:” popup.1. Change the Version Date to today’s date (blue arrow) and change any other field in thisscreen, if needed.2. Click on the “Save Consent” button (green arrow).1227

This will take you back to the “Internal Study Personnel Changes” Form.The revised consent form should appear in the table in section 1.5 (blue arrow).11- Scroll down to the next section (green arrow).28

Note: If you did not check the “Changing Supervising Principal Investigator (formerlyknown as Faculty Sponsor)” box in section 1.3 of the form, skip the next instructions to slide# 32.Changing Supervising PrincipalInvestigator (formerly known asFaculty Sponsor)29

In section 1.6, describe the reason for the requested Supervising PI change (blue arrow).Then scroll down. (green arrow)30

For this section, you can use slides 12 to 16 to download a copy of the PI’s ResponsibilitiesPDF file, and have the new Supervising PI sign it, and then uploaded here.Once you have executed instructions in slides 12-16, return to this slide.31

Note: If you did not check the “Adding study personnel” box in section 1.3 of the form, skipthe next instructions to slide # 37.Adding New Internal Investigatorsto a Study32

One of the sections that you will visit is the “Personnel to be added or removed”. In thissection, locate the appropriate section/role; and using the Add buttons (yellow arrow), addthe personnel to the application.Clicking on the Add button will bring you to the INSPIR Directory where you can search forthe investigators by name.33

When you get to the “Search User Directory” page (blue arrow)1- Enter the last name (green arrow)2- Click on the “Find” button (yellow arrow) to search for the person.1Banks2Tip – If you can’t find this person in INSPIR, ask that person to login to INSPIR for thefirst time and their INSPIR account will be created. They can use the step-by-stepinstructions in the link below to login and create their INSPIR ccess-to-INSPIR.pdf34

A list of people in INSPIR with that last name will be displayed. Locate the person you’relooking to add and click on the check symbol ( ) (red arrow) to add this person to theapplication. This will take you back to the Internal Study personnel changes form.Note: Here, you can check the training status of the person you areadding by clicking on the head icon ( green arrow)35

The person that you just added should show up now (yellow arrow).Some sections, requires that you select the user’s role in the study from a drop-down menu(green arrow). Select the user’s role when required.To add more staff, repeat the instructions in the previous three screens.36

Notes for adding New Investigators If the new investigator(s) that you add will need to receiveemail notifications about the protocol and be assignedtasks in their “Incomplete Tasks”, you will also have to addtheir name(s) under “Add a Study Contact”. “Study Contact” is not a study role. So anyone that is listedas a Study Contact will also need to be listed under anotherstudy role such as “A) Additional Investigators” or “B)Research Staff”, if they are not already listed there.37

Note: If you did not check the “Removing study personnel” box in section 1.3 of the form,skip the next instructions to slide # 42.Requesting the Removal of ExistingInternal Investigators from theStudy38

To request for someone to be removed from the study, scrolldown to the section titled “Please select any existingPersonnel you wish to remove:”, and click on “Select”. Thiswill take you to the next screen with the list of all personnelthat are currently listed on the study.39

Select the one(s) that you want to remove by clicking on thecheck box(es) next to their name(s). Then click on “SaveSelections”40

The list of people that you want removedfrom the study should appear in thissection.Note: If you make a mistake, you can unselect someone by clicking on the check box nextto the name and then on “De-select” to remove that person from this list. If you de-selectsomeone, that person will no longer be included in the list of people that you want41removed from the study, and thus, will remain on the study.