The Value of Early Engagement with Your IRB
It’s no secret that in clinical research, everything moves at a quick pace – and that doesn’t stop when working with outside vendors. Typically established to make research operations flow smoother, your vendor relationships often can either make or break a research study. Institutional review board (IRB) partners are no exception. As a sponsor, how can you make the most of your relationship with your IRB?
As you’re beginning your partnership with your IRB, setting clear expectations for each organization will be beneficial during study startup and will also help maintain the relationship for many studies to come.
Setting up a study kickoff call can ensure any key milestones or special requirements are understood. Scheduling this conversation upfront with an IRB will save both the sponsor and IRB time when it comes to review time. At a kickoff call, sponsor and IRB representatives may discuss things such as:
- When first patient in (FPI) is scheduled and how it will affect IRB submission
- Unique recruitment plans or complex trial design so questions can be addressed prior to IRB review
- The number of sites relying on central IRB review
- Any priority sites the IRB should be aware of
- If the study product will contain recombinant DNA or other such genetically modified materials that may also require institutional biosafety committee (IBC) review
- Special considerations such as multiple informed consent forms (ICFs), translated documents, or other external vendor partnerships impacting IRB review
Communicate Early and Often
Providing your IRB with advance notice regarding study plans allows them to be a better partner and can smooth the review process. However, this involves advanced planning on the sponsor’s behalf.
Giving the IRB visibility into your study pipeline and your intended submission schedule allows the IRB time to gather the appropriate resources and expertise for the study. Should additional expertise be required, advanced visibility lets the IRB engage those experts early so their insights can be included in the formal review discussion. Otherwise, the IRB will not know to contact outside experts until they receive your submission, and review may need to be tabled until that additional input is available. This also allows you to discuss any preliminary questions you or the IRB may have about the study without delaying the formal review process.
Additionally, if you are working with sites using a local IRB, ask if they can instead rely on the study’s central IRB. Often sites already have an agreement in place; sponsors may be able to start this process by sending the central IRB a list of sites they intend to work with, and the IRB can review to determine which sites have previously relied on the IRB. In a case study, Advarra found sites relying on the central IRB could activate twice as fast as opposed to those only relying on local IRBs.
Embrace the Partnership
Setting up communication lines and expectations for the sponsor-IRB relationship provide the basis for a solid partnership. Some ways to maintain the partnership may include:
- Schedule regular check-in or governance meetings. These are typically used to discuss upcoming studies in the pipeline, as well as review any recent issues or updated IRB processes or policies. This will help prepare the IRB and address any questions either side may have.
- Establish a master services agreement to formalize the working relationship and responsibilities.
- Establish an ICF template for similar studies or a program so the basic content is already IRB approved. This makes the review process more efficient, as the already approved template only needs study-specific information updates.
- Arrange trainings with IRB professionals to educate teams on key IRB issues, trending topics, or IRB processes.
Ultimately, the more effort going into a sponsor-IRB partnership early on, the more solid and collaborative the relationship can be. With the many moving parts of a study, staying organized and consistently communication with your IRB will benefit both individual trials, as well as your entire development program.