mary a. banks director, bumc irb march, 2011 training for irb board members session 1

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  • Mary A. Banks Director, BUMC IRB

    March, 2011Training for IRB Board Members Session 1

  • Upcoming System ChangesAs of 6pm on March 10 the INSPIR system will be down for all users (IRB & IACUC)Before midnight on March 10th INSPIR I will be back up IACUC will be back to business as usualIRB protocols will be read only

    Investigators and IRB will be able to open, read, and print INSPIR IProtocols Consent formsAttachments Mod memos /Approval lettersNo processing of ANY IRB actions by anyone 3/10-3/15 !

  • The Next IRB Meeting will be run on INSPIR IITraining for Board Members for INSPIR II will be in multiple partsPart I : The Basics (Investigator role)Part II: Board Member role (IRB Assistant)Part III: Board member access to Test Server Part IV : Locating Analyst pre-reviews and giving Reviewer FeedbackPart V (optional) Board member mini-session training on March 11 and March 14th ( details to follow)

  • Part I :The BasicsThe Basics of your training :

    For background and overview: Please read the Feb. 2011 CR Times feature article : www.bu.edu/crtimes

    Please take the time to watch the training video (with Power-Point slides) posted on the IRB website as Investigator Training. It provides a lot of information about the protocols themselves, their structure, how protocols are created and migrated, etc.

  • Click here to link to video

  • Part II: Board Member role

    How to log into INSPIR II How to locate your homepage Board Member : IRB Assistant How to find a sample protocol (to read) as a Board MemberStudy applicationConsent formsStudy attachments

  • How To Log In to INSPIR II

  • www. not yet.com/inspir 2 1On March 15, 2011 the URL for INSPIR II Production Server will be posted and the site will go live As Board members we will give you the URL for the Test Server

    Clicking on the URL will bring you to this INSPIR II log-in page Please do not attempt to log in to production for INSPIR II before March 15th - doing so could disrupt the migration.Do NOT give out URL for test server to others

  • 2You must Log-in using your BU user name (xxx.bu.edu) and Kerberos password

  • This is your HOMEPAGEEach person has his/her own homepageRed arrow points to your name (This persons name is Board Member)

  • From Your HOMEPAGEFrom your homepage you will have 3 major options

    My Assistant this is where you update your personal profile & contact information about YOU (all about YOU!)

    Study Assistant this is where you find and update all YOUR STUDIES (if you have any)- including studies where you are a PI or co-investigator or study staff. Here is where you would also create a new protocol.

    IRB Assistant- this is where you find materials assigned to you for your IRB review as a Board Member

  • This is Your Home-Page

    My Assistant (personal profile) Purple ArrowStudy Assistant ( your own IRB protocols) Blue ArrowIRB Assistant (your IRB protocols for review) Red Arrow

  • Training about the RolesOn the investigator training video and Power-point slides you will find instructions about the first two rolesMy AssistantStudy Assistant

    IRB Assistant The rest of these slides relate specifically to the IRB Assistant role It is here that you will find all the materials you need for your IRB reviews of protocols as Board Members

  • Back on your Home-Page Under IRB Assistant RoleYou will see multiple options :Meeting agenda- to view upcoming agendaFind a study to locate a specific study (other options will be discussed later)

  • Make sure that you verify that you have selected the correct IRB Panel from the drop-down menu (see red arrow) Select Panel here

  • Correct Panel Once you have verified that you have the correct IRB Panel Click on Meeting Agenda (under the IRB Assistant Role )(red arrow)

  • On this page you will see

    Panel Name- Green Arrow Meeting Date: Red ArrowItems for review by category- Blue arrowMeeting Chair Purple arrow

    This will bring you to the Meeting Agenda Page

    Use right hand scroll bar to scroll down (yellow arrow)

  • Red Arrow points to how protocols will be listed

    Click where it says click to open to OPEN the protocol

  • This opens the cover page for this study H-30025

    You will see general infoStudy number , PI, study status, study (lay) summary (yellow arrows)

    From here Click on Study Components (red arrow) to OPEN the protocol , consents and attachment sPI name

  • From this submission components page you will see: The submission form The ApplicationThe consent forms Other study docs (= attachments)

    Click on the icon next to each item to OPEN it

  • This will open up the IRB Application for H-30025

    You can view it Section by Section (red arrow) or Look at it in its entirety (Blue Arrow)

  • Access to the INSPIR Test ServerAccess to the Test Server will be limited to IRB staff, Board Chairs and Board Members, super-users, CRRO and a few support people

    Please do NOT give the test server URL to others we cannot have hundreds of users logging into the test server

    Under NO circumstances should anyone try to log into the PRODUCTION SERVER before March 15th this could negatively impact the institution wide migration

  • Access to the Test ServerWe will email you the URL for the test server by the end of the day today and then you will be able to log-in using your BU user-name and Kerberos passwordYou can go into Study Assistant Create a new protocol just to play around and get familiar with the applicationWe will list you as a co-investigator on a test protocol so that you can go in and look at a dummy protocol that was created in INSPIR II in the email we will tell you that IRB numberYou can go into IRB Assistant and look under a meeting date and see a new protocol, an amendment and a PR waiting for full board review (details of the meeting date will be in the email)

  • Parts IV and VYou will receive emails regarding the rest of the Board Member slides (how to see the Analysts pre-reviews and how to give feedbackYou will also receive emails about mini-sessions for Board Member Training These Board Member Training Slides will be posted on the IRB website www.bumc.bu.edu/irb

  • Final Thought

    Change has a considerable psychological impact on the human mind. To the fearful it is threatening because it means that things may get worse. To the hopeful it is encouraging because things may get better.

    ~King Whitney Jr.