Institutional review goes online

Science Article
February 5, 2004

Institutional Review Board committees soon will conduct evaluations of human-subjects research electronically

Joe Simpson, IRB analyst (right), troubleshoots and provides feedback for the new e-Review network developed by programmer-analyst Ralph Eickhof. photo by Todd McNaught

By BARBARA BERG

For the dedicated volunteers who make sure that the center's human-subjects research meets federal requirements, the days of toting around thousands of pages of grant applications and administrative forms to monthly meetings soon will end.

In the next few weeks, one of Fred Hutchinson's two institutional review boards (IRBs) will transition to an on-line evaluation process of research projects. Committee B will be the first to switch to the new system. Once the system is up and running smoothly, the electronic-review, or e-Review, process will become the norm for both committees, which each meet once a month. The second IRB, committee A, is expected to begin electronic review in the next few months. Investigators may contact the Institutional Review Office (IRO) to determine which committee is reviewing their study.

Only the review part of the process will be affected initially. Investigators who submit proposals for review must still turn in paper copies to the IRB, although the number of copies will drop from about 15 to four. During the third quarter of calendar year 2004, the Institutional Review Office (IRO) will begin planning for electronic-forms submission. The planning process will include significant involvement of investigators, study staff and division directors to ensure that electronic submission would not result in unnecessary complexity or additional effort for researchers.

IRB-reviewed research

IRBs are federally mandated committees charged with overseeing all new and ongoing research that involves human subjects. Each of the center's two IRBs are made up of about a dozen center doctors, nurses and researchers as well as community members. IRB-reviewed research includes clinical trials that provide cancer patients with access to experimental therapies, cancer-prevention studies that examine effect of diet and any other type of study in which humans take part, even if it involves only answering questions on a form. An IRB's role is to ensure that such studies are conducted ethically and safely.

The implementation of the new e-Review for committee members was driven by several factors, said Karen Hansen, IRO director.

"Each year, hundreds of thousands of pieces of paper are generated from IRB submissions," she said. "Not only will the shift to e-Review result in a substantial savings in copying costs over the long term, but it will also make it much easier on the IRB committee members."

Instead of wheeling dollies with heavy stacks of paper to and from meetings, each IRB committee member will be provided with a laptop computer to use for the evaluation process. The computers will enable them to review the submissions at home and have access to the documents during the monthly meetings. The forms committee members use to evaluate submissions will also be filled out on the computer. As committee members change, the laptops will be passed along to new members.

The e-Review system

Once an investigator completes an IRB submission packet, he or she will send the original and three copies to the IRO. These documents will be scanned to create PDF (portable document format) files. Committee members will be able to submit their comments online, and those comments will be available to other committee members prior to the review meeting. All comments and documents will also be available to committee members in subsequent review cycles.

The e-Review system is based on a similar one now in use at the University of California at San Diego. Ralph Eickhof, a programmer-analyst in Clinical Data Systems, developed the Web-based application and enhanced the Protocol-IRO database to support it.

Derek Walker, the project manager of the e-Review transition, said the system's performance has been excellent and is designed to ensure that the information is secure. "The e-Review application will be hosted on the CORE site, a secure web portal hosted by the Clinical Systems Group, and access to study documents will be limited to members of the committee reviewing the study."

Tanna MacReynold, IRO manager, conducted orientation sessions about the e-Review process for faculty and research staff last month. For questions or additional information, contact MacReynold at tmacreyn@fhcrc.org or 206-667-6567.

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E-Review transition team members include:

• Linda Glockling, manager, Data Abstraction
• Rick Ramsey, manager, Clinical Systems Group
• Geoff Hirschi, programmer analyst, Clinical Data Systems
• Joe Simpson, IRB analyst, Institutional Review Office
• Bret Dodson, project coordinator, Information Technology

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