Amendment and Progress Report Issues

***Start reading from the bottom. New items will be added to the top of this list.  

FAQ- added 3/22/11 

Q.4. I am confused about making changes to study staff.  What kind of amendment do I use? 

A.4. There are actually two types of options for amendments;  the standard amendment form (as in INSPIR I ) and the “change internal study staff” (short) amendment form. 

Adding study personnel
 The only way internal staff (BUMC staff) can be ADDED to a study is by an “internal staff change” (short) amendment.  The research personnel/investigators/research staff must be added to Section 3 of INSPIR.  (To be added, all study personnel must have a BU user name and Kerberos password). The only way external (non-BUMC staff) can be Added to a study is through a STANDARD amendment (long form) where they are added to Section 4 (external investigators).

 To Add a new internal (BU/BMC) investigator and amend another part of the protocol, you must submit 2 different amendments; one short amendment (to modify study staff) and one standard amendment (to change another part of the IRB application).

 If you want to add an ADMINISTRATIVE ASSISTANT(s) (Section 3.6) as someone who ONLY will have access to the INSPIR protocol but will not be engaged in human subjects research then you do NOT have to submit either kind of amendment to the IRB.  You can go to “study management” section of the protocol and make the change to the protocol.   The persons listed as Admin Assistant should not have contact with subjects or their identifiable data or be otherwise engaged in human subjects research.

The Study Contact section (Section 3.3) is used to indicate those who will receive email notification about the study.  You can add people to this section via Study Management without submitting either kind of amendment to the IRB.  However, study Contact is not a role per se, so anyone listed as the Study Contact should also be listed somewhere else according to their role in the study. So if the study contact is also someone engaged in research, having contact with subjects or their identifiable data (e.g. PI, co-investigator, coordinator, project manager, statistician, other research staff) then they need to be listed also in Section 3.1 or 3.2. And if they are not engaged in research, they should also be listed in 3.6 Administrative Assistant.

 No internal or external investigators should be added to INSPIR protocols under Section 5 (this is for removing study staff only).

Removing study personnel

 Investigators are asked at this time  to NOT submit an amendment simply to remove study staff from a study.

Study staff can be removed from a study at the time of the next Progress Report. 

If investigators are listed in Section 3.1 (PI) and/or 3.2 (co-investigators and research staff)  then a “change internal study staff” (short form)  amendment will be needed to remove them from Section 3..   If a “change internal study staff” (short) amendment is being done to add study staff then study staff can be removed from Section 3 with the same “short” amendment. 

To remove investigators from migrated studies (migrated Section 4.0 or converted section 5.0)- this can only be done either with a standard amendment or with a progress report. This should be done optimally at the time of the Progress Report. It can be done if a standard amendment is being submitted for another reason.   Investigators should be asked NOT to submit a standard amendment simply to remove someone from the protocol under Sections 4.0 or 5.0.  This is unnecessary. 

Q.3. Is there a way to delete a draft of an amendment?  I had drafted an amendment to change the PI, but the PI hadn’t submitted prior to the conversion.  Now, I don’t need to do that as an amendment, so I want to withdraw/delete/cancel the amendment.  It appears to only allow me to revise or submit.  

A.3.    If none of the IRB analysts have picked up the amendment then yes you can go to the submission page of the study and see in your “outstanding submissions” the amendment and there will be a green button on the right of that action that says RETRACT SUBMISSION. Retract it then delete it.  

Q.2. I was told by my Departmental “Super User” that there is a staff-specific amendment, is that true?   

A.2. If you would like to add BU/BMC and affiliated study staff, then yes, you are talking about “Internal Study Personnel Changes” amendment. You cannot make these changes if the study has never been approved.  You can however add new study staff if the study has previously been approved but now there is a standard amendment or PR pending. (see Q.1. above for instructions)  

Q.1. I would like to submit an amendment and do not see how to do that.  I would think that I need an approved protocol to submit an amendment – correct?  

A.1. Yes, you need to have an approved protocol before you can amend the protocol.   There are two types of “amendments”  

  1. Standard amendments
  2. Amendment to change internal investigators

You can submit an amendment to change internal investigators at any time (e.g. while a standard amendment is pending or in draft, while a PR is pending or in draft, while another amendment to change internal investigators is pending).   

You CAN NOT submit a “standard” amendment while another “standard” amendment is pending.   You cannot submit a standard amendment while there is a PR (continuing review) pending.  

Once you have an approved version of the protocol,  

  • Open up the protocol to the Study Management page for the protocol.
  • In the “center column” select   “change requests and amendment” for a standard amendment OR “Internal Study Personnel Changes” to add study staff.    (If you need to delete study staff from a migrated study you will need to complete a standard amendment.)
  • This will bring you to a page showing the history of previous amendments. 
  • *** Then you need to click on the button that says ADD NEW FORM to create a new amendment request or internal study personnel change request.

If you go to the IRB website and click on INSTRUCTIONS FOR INVESTIGATORS and you will see a link “How to Add Internal Investigators” with power-point slides w/instructions.