WIRB Frequently Asked Questions

What is the procedure for requesting changes in previously approved consent forms?

Effective January 1, 2009, WIRB will require all requests for changes in previously approved consent forms to be submitted in one of two ways:

1. The changes can be submitted using the currently approved WIRB consent form with only the new changes tracked in redline format or handwritten on the form.
2. The changes can be detailed in a document specifying the requested changes.

In general, a statement justifying changes is very helpful and can reduce the need for WIRB to contact sites for explanations. Whenever revisions are requested to previously Board-approved language, the submission must include a rationale.

After January 1, 2009, whenever WIRB receives a request for a revised consent form in any format other than the two formats described above the submission will be returned to the submitter with a request that the changes be sent to WIRB as described above.

If the changes are to be submitted for a multi-site study, the same changes might have already been approved by WIRB for another site. If you agree to accept the changes already approved, the review will take place more quickly. You can contact WIRB Client Services to determine if pre-approved language exists for this change in research at the following toll free number: 800-562-4789.

An industry sponsor asked me if I could use a different central IRB – the one that they contract with for all their other sites. Do we have to use WIRB for review of all industry-sponsored research? What is the U of R’s policy on this?

The only external IRB the University uses is Western IRB. WIRB is the University of Rochester’s IRB of record for FDA-regulated, industry-initiated drug and device trials involving greater than minimal risk. This is mandated by an agreement between the University and the U.S. Department of Health and Human Services (DHHS) Office of Human Research Protection (OHRP). The agreement builds in reciprocal visitation, policy reviews, joint training efforts and other activities to ensure the collaboration between the University and its external review board are compliant with federal regulation, State law and University policy.

If I have amendments, adverse events reports or continuing review reports for my WIRB-reviewed and approved study do I need to submit them to your office?

No. Only the initial WIRB submission needs to be reviewed by our office to ensure that the study is entered into our tracking system and proper University policies and procedures have been followed. If everything is in order, we send out the submission by express mail within 24 hours – often even on the day the submission is received.

As a service, we will send out any other documents you want to go to WIRB by express mail. Our office does not review these documents. They usually will go out within one to two days of receipt in our office.

I have a study I am submitting to WIRB. Because we are required to submit the application through your office and we are not able to submit the application electronically, can we provide the information on a CD?

Yes. We will review the information on the CD and print-off any documents that we require for OHSP hardcopy files.