March 2005, Issue 4

New Computer-based IRB Protocol Management System

The Office for Research Integrity and the Institutional Review Board (ORI/IRB) of the Tufts Health Sciences Campus and Tufts-New England Medical Center (Tufts-NEMC) are on the verge of launching a computer-based IRB protocol management system called BRAAN (pronounced “brain”), which stands for biomedical research and assurance network. The current version of BRAAN has been implemented at Baylor University, Boston University, and the University of Maryland. Working with BRAAN representatives for the past year, the ORI/IRB has been acting as a beta site for an updated version called BRAAN 2, as well as a BRAAN 2 version customized for Tufts University/Tufts-NEMC. Kate-Louise Gottfried, director of research integrity, has advocated bringing BRAAN to Tufts/Tufts-NEMC. She believes the system will be ready for testing by faculty and staff in the second quarter of 2005. The ORI/IRB seeks the help of study coordinators, statisticians, and research assistants. Those interested in testing BRAAN should contact the ORI/IRB at (617) 636-7512 or by email at IRBOFFICE@tufts-nemc.org.

Ease of Submission

The BRAAN system is designed to expedite the IRB protocol submission process. Rather than filling out multiple forms, the investigator will answer questions within the BRAAN website and the software will automatically populate the system in all the appropriate places. “The system is extremely user friendly, like doing online banking or shopping,” says Gottfried. Investigators or other authorized personnel will complete the protocol information online within the BRAAN system and hit "Submit." This simple keystroke will electronically send the protocol to the department chair or designate, eliminating the need to make a special trip to get the chair’s signature. After reviewing the protocol, the chair will hit "Submit" signaling the BRAAN system to search the protocol for certain criteria that will designate one of the following destinations:

  • If a protocol is within the National Institutes of Health-funded General Clinical Research Center (GCRC), the submission will be forwarded to the GCRC for review before going to the IRB. Upon successful review, the GCRC will attach an approval to the protocol electronically and submit it back into the BRAAN system to continue on track to the IRB for committee review.
  • If the protocol triggers criteria indicating that it may need Scientific Review Committee (SRC) attention, such as an obvious lack of peer review, it is flagged and sent to an IRB staff member who will either send it to the SRC or submit it back into the BRAAN system to continue on track to the IRB for committee review.
  • If neither GCRC nor SRC review is required, the protocol proceeds to the IRB for committee review.

Ease of Review

BRAAN is also geared toward increasing the ease and efficiency of IRB committee meetings. “IRB committee members will have an opportunity to look at upcoming protocols in advance and at their convenience, 24 hours a day,” says Gottfried. “They’ll be able to log comments onto the BRAAN website for other committee members to read and respond to, allowing an interactive dialogue that will enable them to be more informed about the protocols they need to discuss at the next committee meeting.”

Ease of Management

Principal investigators and other authorized personnel will be able to log on to the BRAAN system, put in the necessary identifiers, and obtain access to all protocol information from the time of initial submission. “The system will retain every single version of your submission, so if it’s time for renewal and you want to see the initial submission, you can easily look it up in the system,” says Gottfried.

Another benefit of BRAAN is the range of reports that users and the ORI/IRB staff will be able to create. Investigators will be able to generate routine reports for research areas to which they have access. Investigators will also be able to ask the ORI/IRB to generate unique reports drawing on information that is only available to ORI/IRB personnel, such as a report on the number of accruals in oncology studies per month or a report on whether a drug in one study is being used in other protocols.

The ORI/IRB will conduct training seminars to familiarize investigators and staff with the new system. Please be assured that no members of the research community will be left out on their own in cyberspace. “The system is fabulous – it does a tremendous amount – but the human element is not eliminated,” says Gottfried. “There will always be someone at the IRB office during normal working hours for investigators to call for assistance.”

 

Tufts University, Office of the Vice Provost
Health Sciences Campus: (617) 636-6550
Medford Campus: (617) 627-3417
Copyright 2005 Tufts University. All Rights Reserved.

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