{"id":919,"date":"2011-03-18T09:52:34","date_gmt":"2011-03-18T13:52:34","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/irb\/?page_id=919"},"modified":"2011-05-04T08:37:47","modified_gmt":"2011-05-04T12:37:47","slug":"amendment-and-progress-report-issues","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/irb\/amendment-and-progress-report-issues\/","title":{"rendered":"Amendment and Progress Report Issues"},"content":{"rendered":"

***Start reading from the bottom. New items will be added to the top of this list.<\/span><\/strong>\u00a0\u00a0<\/p>\n

\n

FAQ- added 3\/22\/11<\/span><\/strong>\u00a0<\/p>\n

Q.4.<\/span><\/strong> <\/span>I am confused about making changes to study staff.\u00a0 What kind of amendment do I use?<\/span>\u00a0<\/span><\/p>\n

A.4.<\/strong><\/span> There are actually two types of options for amendments;\u00a0 the standard <\/strong>amendment form (as in INSPIR I ) and the \u201cchange internal study staff\u201d (short) amendment<\/strong> form.\u00a0<\/span><\/p>\n

Adding study personnel<\/span><\/strong>
\n\u00a0<\/span><\/strong>The only way <\/span>internal staff (BUMC staff) can be ADDED <\/strong><\/span>to a study is by an \u201cinternal staff change\u201d (short) amendment.\u00a0 The research personnel\/investigators\/research staff must be added to Section 3 of INSPIR. \u00a0(To be added, all study personnel must have a BU user name and Kerberos password).<\/span><\/span>\u00a0<\/span>The only way external (non-BUMC staff)<\/strong> <\/span>can be Added to a study is through a STANDARD amendment (long form) where they are added to Section 4 (external investigators).<\/span><\/p>\n

\u00a0<\/span>To Add a new internal (BU\/BMC) investigator<\/strong> and amend another part of the protocol<\/strong>, 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).<\/span><\/p>\n

\u00a0<\/span>If you want to add an ADMINISTRATIVE\u00a0ASSISTANT(s)<\/strong> (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.\u00a0 You can go to \u201cstudy management\u201d section of the protocol and make the change to the protocol. \u00a0\u00a0The persons listed as Admin\u00a0Assistant should not have contact with subjects or their identifiable data or be otherwise engaged in human subjects research.<\/strong><\/span><\/p>\n

The Study Contact section<\/strong> (Section 3.3) is used to indicate those who will receive email notification about the study.\u00a0 You can add people to this section via Study Management without submitting either kind of amendment to the IRB.\u00a0 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.<\/span><\/strong><\/span><\/p>\n

\u00a0<\/strong><\/span>No internal or external investigators should be added to INSPIR protocols under Section 5 (this is for removing study staff only).<\/span><\/p>\n

Removing study personnel<\/span><\/strong><\/p>\n

\u00a0<\/strong>Investigators are asked at this time \u00a0to NOT submit an amendment simply to remove study staff from a study.<\/span><\/p>\n

Study staff can be removed from a study at the time of the next Progress Report.\u00a0<\/span><\/p>\n

If investigators are listed in Section 3.1 (PI) and\/or 3.2 (co-investigators and research staff)\u00a0 then a \u201cchange internal study staff\u201d (short form) \u00a0amendment will be needed to remove them from Section 3..\u00a0\u00a0 If a \u201cchange internal study staff\u201d (short) amendment is being done to add study staff then study staff can be removed from Section 3 with the same \u201cshort\u201d amendment.\u00a0<\/span><\/p>\n

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.\u00a0\u00a0 Investigators should be asked NOT to submit a standard amendment simply to remove someone from the protocol under Sections 4.0 or 5.0.\u00a0 This is unnecessary.<\/span>\u00a0<\/p>\n

\n

Q.3. <\/strong>Is there a way to delete a draft of an amendment<\/strong>?\u00a0 I had drafted an amendment to change the PI, but the PI hadn\u2019t submitted prior to the conversion.\u00a0 Now, I don\u2019t need to do that as an amendment, so I want to withdraw\/delete\/cancel the amendment.\u00a0 It appears to only allow me to revise or submit.\u00a0\u00a0<\/p>\n

A.3.\u00a0\u00a0\u00a0 <\/strong>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 \u201coutstanding submissions\u201d the amendment and there will be a green button on the right of that action that says RETRACT SUBMISSION. Retract it then delete it.\u00a0\u00a0<\/p>\n

\n

Q.2. <\/strong>I was told by my Departmental \u201cSuper User\u201d that there is a staff-specific amendment, is that true?\u00a0<\/strong>\u00a0\u00a0<\/p>\n

A.2.<\/strong> <\/strong>If you would like to add BU\/BMC and affiliated study staff, then yes, you are talking about \u201cInternal Study Personnel Changes\u201d amendment. You cannot make these changes if the study has never been approved.\u00a0 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)\u00a0\u00a0<\/p>\n

\n

Q.1.<\/strong> <\/strong>I would like to submit an amendment and do not see how to do that.\u00a0 I would think that I need an approved protocol to submit an amendment \u2013 correct?\u00a0\u00a0<\/p>\n

A.1.<\/strong> <\/strong>Yes, you need to have an approved protocol before you can amend the protocol.\u00a0\u00a0 There are two types of \u201camendments\u201d\u00a0\u00a0<\/p>\n

    \n
  1. Standard amendments<\/li>\n
  2. Amendment to change internal investigators<\/li>\n<\/ol>\n

    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).\u00a0\u00a0\u00a0<\/p>\n

    You CAN NOT submit a \u201cstandard\u201d amendment while another \u201cstandard\u201d amendment is pending. \u00a0\u00a0You cannot submit a standard amendment while there is a PR (continuing review) pending.\u00a0\u00a0<\/p>\n

    Once you have an approved version of the protocol,\u00a0\u00a0<\/p>\n

      \n
    • Open up the protocol to the Study Management page for the protocol.<\/li>\n
    • In the \u201ccenter column\u201d select\u00a0\u00a0 \u201cchange requests and amendment\u201d for a standard amendment OR \u201cInternal Study Personnel Changes\u201d to add study staff.\u00a0\u00a0\u00a0 (If you need to delete study staff from a migrated study you will need to complete a standard amendment.)<\/li>\n
    • This will bring you to a page showing the history of previous amendments.\u00a0<\/li>\n
    • *** 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. <\/strong><\/li>\n<\/ul>\n

      If you go to the IRB website and click on INSTRUCTIONS FOR INVESTIGATORS and you will see a link \u201cHow to Add Internal Investigators\u201d with power-point slides w\/instructions.<\/p>\n","protected":false},"excerpt":{"rendered":"

      ***Start reading from the bottom. New items will be added to the top of this list.\u00a0\u00a0 FAQ- added 3\/22\/11\u00a0 Q.4. I am confused about making changes to study staff.\u00a0 What kind of amendment do I use?\u00a0 A.4. There are actually two types of options for amendments;\u00a0 the standard amendment form (as in INSPIR I ) […]<\/p>\n","protected":false},"author":874,"featured_media":0,"parent":0,"menu_order":34,"comment_status":"closed","ping_status":"open","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/919"}],"collection":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/users\/874"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/comments?post=919"}],"version-history":[{"count":15,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/919\/revisions"}],"predecessor-version":[{"id":937,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/919\/revisions\/937"}],"wp:attachment":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/media?parent=919"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}