How Single IRB Review Mandates Help Research Sponsors
The Food and Drug Administration’s (FDA’s) proposed single institutional review board (sIRB) mandates are in part designed to support greater efficiencies and consistencies when conducting multisite research. This change has the potential for a substantial impact on sponsors and contract research organizations (CROs), as well as institutions conducting multisite research.
A Brief Overview of the Proposed FDA Single IRB Mandate
On September 28, 2022, FDA released two proposed new rules, also known as Notices of Proposed Rule Making (NPRM). Each of these proposed rules is intended to harmonize certain current regulations with the Department of Health and Human Services (HHS) regulations, also known as the Common Rule. Specifically, one NPRM identifies specific provisions regarding IRB review and the informed consent process; the other focuses on how cooperative research and the single IRB intersect.
Over the past decade, single IRB mandates were established for federally funded multisite research. Broadly speaking, most industry-sponsored trials haven’t needed to comply with these requirements, giving institutions flexibility to identify what their local IRB would review, versus what a single IRB would review centrally.
If the FDA’s proposed single IRB mandate becomes law, most multisite human research, with few exceptions, will require single IRB review. FDA oversight of clinical trials is typically determined by the type of research being conducted, rather than who is funding the study – with this in mind, it opens the door for more multisite studies requiring single IRB review.
Benefits to Using a Single IRB
How does this impact the industry as a whole? Industry sponsors have always had the option to require sites to rely on the study’s single IRB, but some sites have historically been able to opt out and rely on local review instead. Mandated single IRB review will help sponsors by removing local IRB review as an option in most cases and necessitating all sites rely on the same IRB for the study. There are many benefits to moving from a local IRB to a single IRB.
Consistent Study Conduct Across all Sites
In order for trials to get to their endpoints, it’s critical to conduct research the same way at every single site. One site can’t do something slightly different – they won’t get the consistent data to submit to the FDA for approval. By using a single IRB, this allows the same research to be conducted at every single site involved in the study. This also ensures the regulations are consistently applied for every single site.
During initial review, an IRB may request modifications to the protocol, informed consent form (ICF), and other materials to ensure participants’ rights and welfare are protected. With multiple IRBs reviewing a single study, that could mean multiple versions of the protocol, ICF, etc. in use with participants. This can lead to inconsistent participant protections as well as inconsistent study data. With a single IRB overseeing all sites, everything is much more consistent.
Additionally, required single IRB review would enable organizations to better streamline changes to the protocol. Say a particular study has 100 sites, and five or six of those sites’ local IRBs require specific changes to the protocol as a condition of approval. For sponsors and CROs, it’s burdensome and time-consuming to figure out which site materials to update and only update those. It’s also a task to keep track of who’s conducting which version of the protocol. Or, if the sponsor wants to simplify things and apply one IRB’s changes to the entire study, staff must go back through and communicate the changes to all those other various IRBs. With a central IRB, updates are streamlined since they are submitted just once centrally and apply for all sites at the same time, which leads to minimal disruption at the site level.
Working Together to Understand Processes
Working with a single IRB can enable sponsors to identify sites for a particular study, which also helps sites get studies up and running quickly and efficiently. The single IRB may also be able to help sponsor and CRO teams understand what needs to be in place (i.e., reliance agreement, items in the consent form) in order to move forward with a particular site. Even though the NPRM is not yet final, by communicating with your single IRB up front, it’ll help pave the way for an overall successful process.