Feature Article

Coming Soon to an IRB Near You ... INSPIR II
February 2011 Issue

Mary A. Banks BS, BSN
Director, BU/BMC IRB
Author has nothing to disclose with regards to commercial support.

PRINT | CLOSE WINDOW

Introduction

?Beware the Ides of March.? ~ William Shakespeare, Julius Caesar, Act 1, Scene 2

On March 15, 2004, the IRB component of BUMC’s electronic system named INSPIR (Integrated Network for Subject Protection In Research) was launched.  For the past seven years, this system has been used by both IRB and IACUC for all human and animal research submissions.

On March 15, 2011, the IRB will be launching a new software application which has been customized for BUMC and which will be called, “INSPIR II”.  INSPIR II will replace INSPIR I as the electronic system used only by the IRB for managing all human subjects research protocols, past and future.  Animal protocols and IACUC documents will remain on INSPIR I at this time, and will eventually be transitioned to RIMS.

The purpose of this article is to provide an overview of the new system, note some of the features and benefits of INSPIR II, describe the migration plan and transition process, and to identify the variety of training options for investigators and study staff to learn about INSPIR II.


Overview

INSPIR II is a commercial software product purchased by BUMC from a California-based company called, “iMedRIS”.  One of the key features of the iMedRIS software is its flexibility and its ability to be customized to suit the unique needs of each institution.  For over a year, the BUMC IRB Application Specialist and the BU IT Department have been working with the IT staff at iMedRIS to create INSPIR II forms and processes that are similar/compatible with INSPIR I; and to write the code necessary to migrate ALL the data, reports, letters, etc. from INSPIR I  to INSPIR II.    There are approximately 6,000 investigators, 7,000 protocols, 40,000 consent forms,  50,000 letters, and over 65,000 attachments in INSPIR I that must be migrated--so writing the code was no small feat! The “conversion” from INSPIR I to INSPIR II will take place as an electronic migration so that when INSPIR II goes live on March 15th, all studies will have been transferred from INSPIR I to INSPIR II and will retain their same status.  For example, a study that was a draft in INSPIR I on March 10th will be in draft form on March 15th in INSPIR II.  A study that was conditionally approved awaiting review by the IRB on March 10th in INSPIR I will retain that same status on March 15th in INSPIR II.

Features and Benefits

INSPIR II offers numerous features and benefits, many of which were identified by investigators as “wishes” during focus groups held last year.  Here is a summary of a few of the key positive features: 

  • INSPIR II will run on Macs as well as PCs.  Almost all common browsers can be used.
  • INSPIR II will support the use of Word with Rich Text Format (RTF).  Therefore, such features as spell check, bold text, highlighting, changing font size, etc. will be available for the IRB application as well as for consent forms.  This will eliminate those pesky upside down question marks!
  • INSPIR II utilizes a navigation menu which builds a “smart” IRB application, based on how an investigator answers key questions at the beginning of the application.   If a study does not include such activities as investigational drugs, devices, repositories, specimen collection, etc., then the investigator will not have to complete those sections of the IRB application.  This function allows each IRB application to be much more customized to the type of research being presented.
  • Consent forms will be “separate” from IRB applications.  In INSPIR II, new versions of consent forms will only be created by investigators when necessary--unlike INSPIR I where   new versions of consent forms were automatically created with each IRB submission.
  • The action to modify internal (BU/BMC) study staff is a separate function from creating amendments and progress reports.  An amendment to modify study staff can be created and processed while another amendment and/or progress report is pending.
  • The system allows for multiple consent form templates to be created.  Investigators will have the opportunity to “build” various types of consent forms (i.e., screening consent forms, pediatric assent forms, survey consents, etc.) using a consent form builder instead of having to rely on the single consent form template.
  • It will not be necessary to re-enter all the information about each investigator for each new protocol that is created. Instead, each BUMC investigator will maintain a “profile” in INSPIR II which only needs to be updated once, and then that information can be referenced for each protocol in which that investigator participates.
  • Anyone who has a BU username and Kerberos password can immediately log in and be added to a protocol without having to “register” with INSPIR.  (Users with bmc.org accounts or from other institutions will still need to register with INSPIR to get a BU username and Kerberos password.)
  • Translated consent forms will be electronically validated within the system.

Migration Plan and Transition Process

Historical data (pre-January 31, 2011) are already being migrated from INSPIR I to INSPIR II.  This process will actually take several weeks (which is why the migration is being done in two steps).    On Thursday, March 10, 2011, the INSPIR system will “go down” for a few hours so that the IT staff can begin the work of migrating the “current” data to the new system.  By midnight, INSPIR I will be brought back up, but the IRB human subjects research protocols will be in a READ-ONLY format.   (The IACUC protocols will not be affected as they will remain in INSPIR I.)  From March 10, 2011, until the new system goes live on March 15th, neither investigators nor the IRB staff will be able to make any changes to their IRB human research protocols within INSPIR I.

During the migration period (March 10th to March 15th), investigators will be able to open, read, and print all materials in INSPIR I including the protocols, letters, mod memos, consent forms, attachments, etc.    Even after INSPIR II goes live, INSPIR I will be available for “read only” purposes.

During the migration period, the IRB staff will be working on training and preparations for the “go live” date.  Just as for investigators, the IRB staff will not be able to open any protocols to make any changes or approvals, or do any processing.   Investigators who have any protocols which will expire during this downtime should have already submitted their progress reports to the IRB so they can be renewed and not expire during this downtime.

INSPIR II Training

While all protocols, data, and documents from INSPIR I will be moved to INSPIR II, the “look” of INSPIR II is different; so investigators and study staff will require some training in order to be able to locate their study documents, make any changes, or create new protocols. The IRB staff held some focus groups with investigators and surveyed others to find out their recommendations for how to best provide training and support to the hundreds of investigators who will need training on the new system.  Based on their suggestions and the recommendations of others experienced in this type of large scale training process, here are some of the training plans:
 

  • Super-Users: Approximately 30 people from a wide variety of departments and sections at BUMC have been identified as very heavy and frequent users of INSPIR I.  These people have graciously agreed to participate in high intensity INSPIR II training, and then to serve as “go to” people within their sections/departments/large study groups who have questions or need help with the INSPIR II application.  The IRB will be posting more information about these “Super-Users” on the IRB website within the next few weeks.
  • General training sessions (large group): These sessions will be held on February 28th and March 1st and will provide a general introduction and overview for investigators about the system. Pre-registration is required.  These sessions are open to all members of the study staff. The PowerPoint slides from these sessions will be posted on the IRB website following the sessions.
  • Smaller group introductory sessions: Members of the Clinical Research Resources Office (CRRO) will also be providing introductory sessions. Pre-registration is also required for these sessions.
  • On-line training: The IRB will post training materials, including a link to a training video, on the IRB website for investigators and study staff who are unable to attend the above sessions or who prefer to learn “independently”. 
  • Manuals:  iMedRIS provides software training manuals for investigators and study staff who prefer to learn new software by reading the manual.  Links to these manuals will be posted on the IRB website.  
  • Department level training:  For departments or study groups with a minimum of 10 to 12 participants, the IRB staff will schedule departmental level training to follow up on the introductory sessions.   The IRB will post directions on the website the week of March 15th for scheduling these sessions.   Unfortunately, these sessions cannot be scheduled prior to the “go live” date.
  • Specialized training for “Other Users”:   Besides study personnel and the IRB staff, there are multiple other groups who use INSPIR as part of their departmental processes including:  IRB Board Members and Chairs, Office of Sponsored Programs (OSP-med), Office of Grants Administration (OGA), the Conflict of Interest Committee, Internal Audit, Institutional Biosafety Committee, and Investigational Drug Pharmacy.  The IRB staff will be conducting specialized training (different than investigator training) for all of these groups.

A Few Key Points

INSPIR II will only be used for human subjects research.  Animal protocols and IACUC documents will remain on INSPIR I at this time.  There are no plans to move IACUC to INSPIR II.

In the upcoming weeks, there will be many communications, notices, and directives coming from the IRB related to INSPIR II.   The BUMC IRB website will be the best single source of information related to the transition.  Please refer to it often for the “latest” information.

After March 15th, a notice will be sent to PIs of all studies asking them to contact all members of their study staff to request that they log into INSPIR II with their BU username and Kerberos password and update their individual “profile” within INSPIR II.  Each person must personally update his/her own profile because doing so requires the use of his /her BU username and Kerberos password (which is private and should never be shared with others).  The updating process will take only 2 minutes and only needs to be done once (not for each protocol).   This updating CANNOT be started until after March 15th when the INSPIR II production server is up and running.    Instructions for how to update the user “profile” will be posted on the IRB website, and this process will also be demonstrated as part of investigator training.  At this time, if there are members of your BUMC study staff who have never obtained a BU username and Kerberos password, then they should go to http://www.bumc.bu.edu/inspir/ and click on “Getting Started” to request a BU username and Kerberos password. All BUMC study staff will be required to have these in order to be listed on the INSPIR protocol. 

Investigators have asked what they should be doing to “prepare” their protocols for the transition to INSPIR II. There is nothing that must be done to protocols in order to prepare them for the move.  It will not serve any purpose to prematurely submit new protocols and/or amendments between now and March 10th (before the system goes down). As previously stated, all protocols that are migrated over to INSPIR II will retain their same status from INSPIR I.

Summary

INSPIR II, the new and improved BUMC IRB electronic system, will “go live” on March 15, 2011.  INSPIR II has many features and benefits.  While all protocols, data, and documents from INSPIR I will be moved to INSPIR II, the “look” of INSPIR II is different; so investigators and study staff will require some training in order to be able to locate their study documents and make any changes or create new protocols. Training sessions for INSPIR II are currently underway and will continue through March and April.


Quiz

This Quiz applies to the recertification period from July 1, 2009 to June 30, 2011.

Click here, close this window, and login to My Account if you are
a BUMC researcher and would like to take the quiz now.

Close Window