The Office of
Announcement of New IRB Web Site and Forms
The merger integrates the expertise of more than 100 IRB members and administrative staff across eight IRB committees. We can more readily call on expertise across campus, make best use of shared staffing, and standardize many best practices. These include common application forms, web site, and standard operating procedures. The integrated operation will be better able to ensure both the protection of human subjects and University compliance with complex regulations that govern this area. Multiple IRB committees will continue to ensure that we can provide appropriate oversite of diverse research across our large campus.
Changes at the level of individual investigators or research teams will depend on which IRB was used previously; some may see few changes, others more. But in all cases applicants will continue to submit protocols as they have in the past: The submission should be directed to the IRB that serves your home department. In rare cases the review may be handled by another IRB if it is determined that a particular project is best reviewed there.
The application and review process are largely unchanged. You will still submit an application to the same IRB (Behavioral, Biomedical, Dentistry [part of Biomedical IRB starting July 2005], Nursing, or Public Health), and the review process has not changed. However, there are new application forms and consent templates--one set of forms for all applicants and IRBs. There are grandfathering provisions for use of new forms for existing IRB-approved projects--see below.
New application and consent forms will be required for all new projects being submitted for initial IRB approval after March 15, 2005. The new application and consent forms are available for immediate use.
Existing projects that were approved before March 15, 2005 and are now being submitted for continuing review (e.g., modification or renewal) are usually grandfathered. However, if the IRB finds that the information on the old initial application form is inadequate, you may be requested to update to the new initial application form. Use the new (and brief) submission sheets (IRB Forms) for modifications or renewals, but you may attach the existing approved description of the study (IRB application) and consent forms. Application and consent forms may be reformatted if the investigator prefers to use the new templates, but this is not required for previously approved studies.
No. Existing IRB-approved projects may continue to use the existing consent forms approved earlier. The existing consent forms also may serve as the basis for modified consent forms to accompany an Application for Modification of Approved Human Subjects Research form.
All new submissions to the IRB for initial approval are required to use the new consent form templates after March 15, 2005.
The criteria for which IRB will review your application remains as it was. The usual determinant is home department of the applicant. OHRE administrative staff may route your application to a different committee if the review would benefit from different expertise. See Submission Instructions.
The length of time it takes to review your application usually will not change. In some circumstances, such as the review of complex protocols requiring special expertise, or ones that cross several organizations, the review time ought to decrease. This is because one IRB can more easily call on resources from all the other IRBs. In addition, pooling of staff permits specialization. For instance, OHRE now has a compliance specialist to help navigate complex regulatory matters.
The constitution of the committees (there are eight--four for the Biomedical IRB, one for each of the other IRBs) has not changed. The IRBs are still located in the same places, although we expect to consolidate locations in the future. All addresses and phone numbers remain the same. See Contact Information.