Campus begins using eResearch
to submit human subject applications
All Ann Arbor campus Institutional Review Boards (IRBs)behavioral science, health and medicalare accepting applications for new studies involving human subjects via a new Web-based system called eResearch.
eResearch replaces the previous IRBWebapp system and provides a single, unified online application for all studies involving human subjects research at the University. IRB-Flint and IRB-Dearborn will accept new studies beginning July 1.
"eResearch is designed to standardize the application and approval process by providing a unified application," says Marvin Parnes, associate vice president for research. The application is an online smart form that delivers only the questions relative to the study. "The application is longer and more detailed than previous applications," Parnes says, "but the information collected in the application will enhance the researcher's compliance with federal requirements and guidelines for research involving human participants."
During early June, Michigan Administrative Information Services converted the studies from the IRBWebapp into eResearch. Beginning June 20, all new studies, renewals, amendments and adverse event reporting for IRB-behavioral science and IRB-health will be submitted using eResearch.
For IRBMED, new study applications will be accepted until July 17 in their current format or through eResearch. After that date, all new study applications must be submitted using eResearch.
IRBMED studies initiated using the old system will be converted to eResearch between Oct. 1-Dec. 1. Amendments, adverse events and renewals for existing studies should continue to be submitted in the current format until the study is converted and the study team has been contacted by IRBMED staff. IRBMED staff will communicate directly with each research team to provide information about conversion dates and procedures.
A variety of training opportunities are available to investigators and their teams. eResearch provides an environment called the "Sandbox" where users can practice completing an application and navigate the new system. MAIS and the IRBs also are providing lecture/demo presentations, hands-on and online training and documentation.
There also are open labs scheduled where principal investigators, study coordinators and other team members can drop in to use the system or practice in Sandbox. Registration for labs is required. Details and registration information are available in the training section at http://eresearch.umich.edu.
The eResearch Web site provides many resources for research teams, including a pre-application checklist that will help them prepare for using the system. There are tips for working with uploads, determining appropriate file size and successful scanning. The FAQ section explains many facets of the eResearch process, including an overview of the study review process, where to get help and training and which browser/operating system will deliver the best results.