Last month, NIH released the “Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research”. They have coined this process as the “sIRB”, making it sound somewhat fashionable . The policy requires that only one IRB hold the responsibility for multi-site projects, leaving the oversight of the study to one site only. While there are indications that the sIRB will be part of the revisions to the Common Rule later this year, the NIH is the first government agency to mandate this policy for all of its funded research.
At my institution, I happily sign reliance agreements and am always agreeable to naming my institution the IRB of record; signing a reliance agreement over to another site is my preferred method since oversight of one study is taken care of by someone else. For institutions that handle large numbers of clinical trials with the accompanying complex research compliance record keeping, this seems like a daunting task; especially if they haven’t been doing it (could this say “using a single review board”) consistently. The NIH is framing this as a way of reducing administrative burden. In some respects this may be true but it can also be viewed as putting a larger burden on one administrator.
While there is support for the idea that an sIRB can reduce paperwork, speed up studies, and make things easier for all parties, there are some very important things that could potentially be overlooked with a single site IRB. Since this process will likely soon be dripping into all IRB protocols, regardless of NIH funding in the future, an institution needs to think about the way they keep multi-site studies organized. The key is for a professional research administrator prepare for the potential of not being as aware of what is happening in a study as she might have been the new NIH rules. Here are some important steps to ensure that everything is in order:
- Get it in writing: Make your Reliance agreement clear and complete. It should clearly spell out to the free access of information related to the study and all issues related to liability. I had one reliance agreement come across my desk with the words “million dollars” written in it and immediately sent it to Legal to make sure we could agree to that language. There were some red lines in revisions, of course. The Reliance agreement with another institution is a legal document. Make sure the collaboration is transparent and be sure to get it signed.
- SOPs for the administrative process: Make sure to capture all those little details about who will do what and when and place that in the appendix of the agreement. This will ensure that there is a clear process on how information related to the single IRB will be stored and cover any guidelines you may require. Make sure you also follow-up on a regular basis and distribute important timelines for everyone involved in these studies. Remember to share those requirements in your Reliance agreement as an Appendix too!
- Record-keeping excellence: Keep a record of all modifications, adverse events, expiration dates and all personnel involved. An electronic IRB submission system is an essential tool for good record keeping. If the system can keep track of external IRB approvals, than that certainly can help minimize administrative burden literally.
- Join the other site’s IRB: A good way of staying in the loop, even if it’s just for matters related to your shared protocol.
Transparency and pro-activity are the best ways to maintain any agreement, especially one that is all about Reliance. Don’t forget, trust is what all research administration professionals are striving for, and so are the participants, principle investigators and everyone else who is striving for good, solid research.