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GIR Member Viewpoint - January 2011

Lightening the Burden of Research Administration Through System Integration

Sharon A. Bowser, M.B.A., Assistant Dean for Information Services
University of Maryland School of Medicine

In September 2008, the University of Maryland School of Medicine went live with a new electronic application that integrates the research administration activities of the IRB, the General Clinical Research Center (GCRC), the University’s Institutional Biosafety Committee (IBC) and Radiation Safety Committee (RSC). An electronic IRB application was not new for the UMB Campus. The School of Medicine introduced the first electronic IRB application to the UMB Campus in 2003; five years later, web-based applications were de facto. What was not, however, was a web-based application that completely integrated the modules, eliminating the redundant data-entry efforts previously required when creating an IRB protocol that involved the VA, recombinant DNA, bloodborne pathogens, and/or that utilized the services of the GCRC.

CICERO (Comprehensive Institutional Collaborative Evaluation of Research On-Line), allows our investigators and study coordinators to create an IRB “parent” protocol. During the process, questions are asked about the use of biohazards and radioactive materials, the areas in which the research is being conducted, and the clinical services being requested. If answers provided indicate the protocol will use biohazards or radioactive material, involve VA funding or space, or utilize the services of the GCRC, a notice that the answers will require submission of one or more child protocols is provided. When the PI begins the child protocol he or she fills out the questions that pertain specifically to that module. The specific questions that were already answered as the IRB protocol was being composed appear on the child protocol(s).

In addition to the benefit of not having to spend time doing redundant data entry, the faculty members and study team have one workspace to log into where the status of every application can readily be ascertained. If during IRB administrative review additional information is needed from the PI, the reviewer can send a note to the PI and study coordinator, who will see the note when the protocol is viewed; an e-mail is also sent to the PI’s and Study Coordinator’s e-mail accounts.  Business rules can be enforced that have challenged the Human Research Protections Office (HRPO) for years – a PI cannot initiate more than one modification if a continuing review is in process; the protocol cannot be submitted if conflict of interest (COI) disclosures have not been submitted by everyone on the study, the IRB will not review a new protocol if there is an existing protocol in an expired state.

The University’s Institutional Biosafety Committee can quickly identify the number of IRB protocol in draft form that will generate a child protocol. The HRPO monitors the IBC progress and the application automatically schedules an IRB protocol to a meeting after the IBC has initiated a motion to approve the child protocol. The VA IRB office concurrently reviews IRB protocols involving VA resources and can send notes to the PI asking for a modification to the protocol while it is still in draft form. This capability has significantly reduced the number of IRB modifications the VA previously required when they didn’t have access to the protocol until after it was approved by the IRB.

Information Services at the University of Maryland School of Medicine, in partnership with the research administration offices on campus, has plans for future enhancements that will continue to make the onerous, increasingly complex and regulatory-intense area of research administration as streamlined as possible. Current development initiatives include expanding the workflow for the VA to further automate their oversight committees and developing the IACUC committee module.  COI disclosures are an institutional priority. Tying disclosures to protocol submissions will be undertaken soon.  Once completed, faculty and staff will submit one annual disclosure rather than one-per-protocol as is currently required.

Internal and external pressures for compliance and regulatory accountability have complicated research administration and contributed to an increase in the approval times of research protocols. Technology enables the development of tightly integrated research administration systems. Extensive business analysis turned into effective business rules and cooperation across the research administration offices of the UMB campus allows Information Services in the School of Medicine to make the oversight of research activities less burdensome for all involved.

Member Viewpoints

Featured in issues of the GIR Newsletter and the GIR website, these articles are contributed by GIR representatives on current IT-related issues, challenge solutions, and technological innovations in academic medical institutions.