NEW! Harvard IRBs Master Agreement

January 10, 2020

Are you a Harvard University Area researcher who is collaborating with a Harvard Medical School researcher?  Have you ever wondered why a reliance agreement is needed when you work with another Harvard researcher?  It’s almost like we are two separate institutions!  Well, we are, or at least in regard to how the Harvard IRBs are set up. Since the Harvard IRBs work independently of each other, if a Harvard University Area researcher (Cambridge and Allston campus) is working with a Harvard Longwood Campus Area researcher, it is like being at separate institutions.  When you are working across two separate institutions, each collaborator may either seek IRB review from their home institution or have their institution “rely” on another institution’s IRB review.

Here at Harvard, we seek to prevent duplication of effort (really, it’s true!). In order to achieve this, your Harvard IRB would request that you into enter what is called a “reliance agreement”. This agreement allows one IRB to provide review for another IRB. In the case of Harvard collaborations, a researcher would need to create an IRB submission in ESTR as well as request a reliance agreement in the online IRB reliance system, SmartIRB. Yes, that’s right, two separate submissions!

For some time now, the Harvard IRBs have been working to find a way to simplify this process. While it is a requirement to have Harvard researchers complete an IRB submission in ESTR, we have uncovered a way to bypass the SmartIRB reliance request process.

May we introduce to you, the Harvard IRB Master Agreement. So, what is the Master Agreement?  The Master Agreement is a standing document between the Harvard IRBs that acts like a permanent reliance agreement: it outlines the conditions for reliance, the responsibilities for each researcher, as well as the general terms and conditions of the reliance. But the best part about the Master Agreement is that you do not need to create a separate reliance request. Just submit your respective ESTR submission and that’s it - no need for a separate SmartIRB reliance request submission.

The Harvard Master Agreement and process will become effective on Monday, January 20, 2020. But what if you forget about this brand-new process when submitting to a Harvard IRB? Or maybe you go ahead and complete a SmartIRB request? Don’t worry, the folks at the Harvard IRB office will let you know and guide you to the right path.