September 23, 2019
For the Record: A Special Six-Month Series, September 23, 2019
This is the second issue in a special six-month series of bi-weekly newsletters about two pending major changes. Each issue will focus on one or two specific topics related to each change. All issues will be archived in the usual HSD Announcements section of our webpage.
- Expanded Single IRB policy (effective January 20, 2020)
- Major Zipline eIRB system upgrade (at the end of the calendar year)
You’ve been doing it all along!
UW researchers and the UW IRB have been doing and talking about Single IRB arrangements for years, using different names and words.
- Cooperative agreements with regional institutions that describe which institution’s IRB does the review when both institutions are involved.
- Industry multi-site clinical trials have been required by industry sponsors to obtain review from one or a few independent IRBs for many years. Examples: WIRB, Advarra.
- National Cancer Institute’s Central IRB provides the review for all sites participating in many NCI-funded oncology trials.
- Dual review: The UW IRB has actively tried for many years to help researchers avoid dual review – for example, by allowing a collaborating institution working with a UW researcher to rely on the UW IRB instead of obtaining their own review.
- IRB authorization agreements have commonly been used to document the reliance of a collaborating investigator on the UW IRB review.
These are all examples of Single IRB arrangements.
So what’s new?
- Required. The use of a single IRB will now be required for all federally-funded research involving more than one domestic institution, beginning January 20, 2020. Previously, it was almost always an elective or optional arrangement. See the figure below showing how the current NIH Single IRB policy is being expanded.
- Vocabulary. A consistent vocabulary has emerged nationally, which will help promote understanding.
Refers to the one IRB that is conducting the review for multiple institutions involved in a study. Other commonly used terms: reviewing IRB; central IRB; lead IRB.
Refers to the written, legally-binding, agreement by which one institution agrees to rely upon the IRB at another institution. Must be signed by an institutional authority, cannot be signed by the researcher. Other commonly used terms: cooperative agreement; master agreement.
User Experience Changes
Zipline’s user interface will be modernized and simplified after the upgrade. The biggest changes will be to the SmartForm, or the electronic forms that are completed as part of an IRB application. Here are a few of the most significant improvements.
- A Left Navigator will replace the current Jump To menu. The Left Navigator will persist on screen and can be collapsed or opened while you complete the SmartForm pages, depending on your preference. The page you are currently on will always be highlighted in orange to make it easy to see where you are and what you have left.
- The Save, Exit, and Continue buttons will be enlarged and relocated to maintain a fixed position in the bottom right corner of the screen as users scroll through the form. No more searching for the Save button!
- New slide-in windows replace pop ups when you add a document or person to the SmartForm, helping you focus on the step that needs to be completed before returning to the SmartForm page.