Baylor uses its BRAAN to improve IRB operations
Two years ago, Baylor College of Medicine had a dilemma: double its staff to accommodate the increase in study protocols being submitted to its IRB or find an electronic solution to its problem.
"A strategic decision was made to develop a comprehensive electronic web-based animal- and human-subject protocol system that would provide electronic capabilities to address every aspect of the IRB function," says Addison Taylor, MD, PhD, associate dean for clinical research at the Houston-based medical college.
Baylor had downloadable IRB forms on the web for four years and had begun to accept on-line protocol review comments from IRB members, but the college wanted a system that would provide a more comprehensive compliance solution.
"We could not identify a product at that time that provided more than a document tracking capability," explains Taylor.
Therefore, BRAAN, the Baylor Research and Assurance Network system, was developed by end users. BRAAN is a web-based application that allows investigators and IRB members to do everything from submitting protocols to tracking and reviewing studies on-line to training investigators on human subject protections.
The application is menu driven, providing pull-down selections for users in every aspect of protocol creation, submission and review. From the home page, administrators and investigators can select the appropriate path — animal or human protocol, existing or new protocol — and they then will be directed step-by-step through the program to supply information that must be included in the protocol application.
BRAAN is divided into sections, with each containing questions or prompts designed to gather pertinent information about the protocol. For example, investigators creating a new protocol must answer questions such as "What is the purpose of the protocol?" or "Will research data be tied to individual’s names or record number?" They also will be asked to provide specific information on inclusion and inclusion criteria, sample size, potential risks or discomforts, and consent procedures (e.g., who will be recruiting subjects, how research population will be identified, and how consent will be obtained). Investigators can generate a preliminary informed consent form that contains autopopulated information provided in previous answers.
Required fields, such as risk categorization or a series of questions to determine whether a protocol qualifies for expedited review, are highlighted in red. The system will not allow investigators to move forward if those fields are left blank. There also is a "Review for Completeness" section that will list areas that require more information before submission.
If investigators would like to use information from an existing study, they can select the study from a drop-down menu, and all pertinent information will autopopulate in upcoming screens. Investigators then may revise or update autopopulated fields as they go along. Additionally, personnel information can be autopopulated with data provided by the human resources department.
IRB administrators can use the program to schedule meetings and report findings using templated memos. IRB board members can access protocols on-line and provide comments that can be viewed later by investigators. "One example of a BRAAN feature that has made life easier is as an investigator, I have access to the protocol and all documents related to the protocol," Taylor says. "These are stored on-line and can be printed for regulatory authorities or clinical monitors wherever needed. Also, as an IRB member, I can now review protocols off-line by downloading them to my laptop for review away from the office. I can access protocols from anywhere in the world as long as there is Internet access."
BRAAN contains education modules on research ethics; investigator responsibility; the role of the IRB; and special topics, such as informed consent and scientific integrity.
"I have evaluated most of the other IRB support products currently available," says Taylor. "BRAAN is the only comprehensive software suite developed by clinical investigators, IRB administrators, IRB board members, and IRB staff that provides a complete electronic IRB solution, form web-based investigator submission to adverse event reporting."
The application won the 2002 Award for Excellence in Human Research Protection given by the Bethesda, MD-based Health Improvement Institute and sponsored by the Office of Human Research Protections.
Baylor so believes in BRAAN that last year the college decided to go public, making the program available to other universities and independent IRBs. The Academic Performance Institute (API) is handling the commercial sale of the application. You can visit the API web site and request more information or access to the BRAAN demo at www.api.md/buyers/index.cfm.
Two years ago, Baylor College of Medicine had a dilemma: double its staff to accommodate the increase in study protocols being submitted to its IRB or find an electronic solution to its problem. They chose the latter.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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