Mary A. Banks Director, BUMC IRB March, 2011 Training for IRB Board Members Session 1

Upcoming System Changes As of 6pm on March 10 the INSPIR system will “be down” for all users (IRB & IACUC) Before midnight on March 10 th INSPIR I will be back up  IACUC will be back to “business as usual”  IRB protocols will be “read only” Investigators and IRB will be able to open, read, and print INSPIR I  Protocols  Consent forms  Attachments  Mod memos /Approval letters  No processing of ANY IRB actions by anyone 3/10-3/15 !

The Next IRB Meeting will be run on INSPIR II Training for Board Members for INSPIR II will be in multiple parts 1) Part I : The Basics (Investigator role) 2) Part II: Board Member role (IRB Assistant) 3) Part III: Board member access to Test Server 4) Part IV : Locating Analyst pre-reviews and giving Reviewer Feedback 5) Part V (optional) Board member “mini-session” training on March 11 and March 14 th ( details to follow)

Part I :The Basics The Basics of your training : For background and overview: Please read the Feb CR Times feature article : 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 Member Study application Consent forms Study attachments

How To Log In to INSPIR II

www. not yet.com/inspir 2 1 On 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 15 th - doing so could disrupt the migration. Do NOT give out URL for test server to others

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

This is your HOMEPAGE Each person has his/her own homepage Red arrow points to your “name” (This person’s name is Board Member)

From Your HOMEPAGE From 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 Arrow Study Assistant ( your own IRB protocols) Blue Arrow IRB Assistant (your IRB protocols for review) Red Arrow

Training about the “Roles” On the “investigator “training video and Power-point slides you will find instructions about the first two roles My Assistant Study 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” Role You will see multiple options : Meeting agenda- to view upcoming agenda “Find 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 Arrow Items for review by category- Blue arrow Meeting 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 You will see “general info” Study number, PI, study status, study (lay) summary (yellow arrows) From here Click on Study Components (red arrow) to OPEN the protocol, consents and attachment s PI name

From this “submission components” page you will see: The submission form The Application The 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 You can view it Section by Section (red arrow) or Look at it in its entirety (Blue Arrow)

Access to the INSPIR Test Server Access 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 15 th – this could negatively impact the institution wide migration

Access to the Test Server We will 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 password You can go into Study Assistant Create a new protocol –just to play around and get familiar with the application We 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 we will tell you that IRB number You 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 )

Parts IV and V You will receive s regarding the rest of the Board Member slides (how to see the Analysts pre-reviews and how to “give feedback” You will also receive s about “mini-sessions” for Board Member Training These Board Member Training Slides will be posted on the IRB website

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.