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>  News Releases >   2003 >   May

Web project will offer more consistency in human-subject research review

Posted 05/05/03, by Susan Knapp

The web project IRBNet will allow institutional review boards to standardize their practices. The Dartmouth group that helped develop the project includes Dan Rockmore (left), Professor of Mathematics and Computer Science; Alison S. Fanelli, IRBNet Project Manager; Derek J. Mulcahy, Senior Programmer; and Elizabeth Bankert, Director of the Committee for the Protection of Human Subjects. (photo by Joe Mehling '69)
Database will house protocols and standards used by institutional review boards

Research on human subjects, regardless of the field of study, deserves a high level of scrutiny. Every project must be carried out within a framework of appropriate ethical and scientific design standards. Federal law mandates that each institution that conducts research on humans convene an Institutional Review Board, or IRB, to review each study and to develop policies, procedures and consent forms.

In order to standardize this process and enhance IRB communication, faculty and staff members at Dartmouth in collaboration with the Children's Hospital of Philadelphia (CHOP) are establishing a national, centralized and secure web-based IRB database, called IRBNet.

"The goal of this project is twofold," says Elizabeth Bankert, Director, Committee for the Protection of Human Subjects at Dartmouth. "First, we want to assist in the education of researchers towards the development of a study, and second, we want to allow IRBs across the nation to communicate with each other."

The IRBNet project began last September with funding from the National Institutes of Health. According to Bankert, IRBNet should cultivate a more effective and efficient means of education and communication among IRB researchers and sponsors.

In addition to Bankert, the Dartmouth team includes Alison Fanelli, IRBNet Project Manager; Dan Rockmore, professor of mathematics and computer science; Derek Mulcahy, senior programmer; and Robert Parrott, programmer. The team at CHOP is headed by Robert Nelson, associate professor of anesthesia and pediatrics and chair of the Committees for the Protection of Human Subjects at CHOP and at the University of Pennsylvania; and Marsha C. Wallace, CHOP Manager of Clinical Trials Quality Assurance.

"We've made terrific progress, and the database should be ready in September," says Bankert.

IRBNet will allow for the distribution and review of protocols and consent forms used in multiple institutions. It will also be a system for coordinating activities of multiple IRBs when they are participating in multi-center trials, and users will be prompted to register when they first visit the site. It will take about a day to verify users' information before they become a full access member of the IRBNet.

There are two modules to IRBNet. The Study Builder Module serves as an educational resource. Experts in the field of biomedical and social science research are creating a content-rich resource to assist researchers as they design study protocol and consent forms. This module will provide an interactive tool to develop a protocol and consent form which will not only adhere to federal regulations but will also guide the researcher with information and links on topics of specific interest. The Communication Module will provide real time information to IRBs in order to enhance local review. IRB administrators may chose to review or update the status of a study, enter new studies for review at a local level, and communicate with other IRBs about their review decisions.

Once the IRBNet is completed, institutions across the country will be invited to register via the web.

-Susan Knapp

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