Mary A. Banks BS, BSN
“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.
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.
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:
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.
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:
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.
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.
This Quiz applies to the recertification period from July 1, 2009 to June 30, 2011.