Strategies for Single IRB Success

We recently had the pleasure of hosting a webinar around the complexities of multi-site research and strategies for working with a single IRB (Institutional Review Board).

Joining us were two IRB experts: Lauren Vacardo, a senior IRB coordinator at Pearl IRB (under Versiti Clinical Trials), and Steven Mueller, an IRB Reliance Analyst at Thomas Jefferson University. Lauren and Steven used to work together on the reliance team at TJU, and proudly call themselves “IRB nerds” — a well-earned title as shown throughout the webinar in their thorough IRB expertise!

In this webinar, we covered quite a bit, from the fundamental differences between reviewing and ceding, to the latest updates on FDA regulations and some key strategies on how to prepare your institution for a single IRB. If you missed the live session, you can view the on-demand recording here.

If you don’t have time to listen to the full webinar, read on for a recap of the biggest takeaways from Lauren and Steven’s discussion!

What exactly is a single IRB?

A single IRB comes into play with multi-site research (also called cooperative research): studies conducted at more than one institution, site, or location under a common research protocol. Participants might be enrolled at several different sites, but everyone is following the same study procedures, objectives, and protocol.

Traditionally, each of those sites would send the same study through its own IRB. With a single IRB model, however, one IRB takes the lead as the reviewing IRB, and the other sites rely on its review. This helps reduce duplicative reviews and supports consistent determinations across sites without reducing protections for participants.

Contrary to what some may believe, a single IRB does not get rid of local context. Depending on where the research is actually happening, local context review is still an important part of the process. 

Institutional IRBs can work with other institutional IRBs, commercial IRBs like WCG or Advarra, or independent IRBs like Pearl IRB. Which one takes the lead really depends on the study and the resources available at each institution. Lauren noted that independent IRBs typically don’t conduct research themselves, so they would never be in the position of ceding review.

Why do single IRBs matter?

To illustrate why a single IRB can be valuable, imagine an investigator-initiated study with five sites, each reporting to its own local IRB. Because IRB has its own personality and every reviewer brings their own background, the study team can end up with a pile of comments that might conflict, requring a significant amount of work to untable before completing the submission. In this scenario, a single IRB would help alleviate that extra work by ensuring a consistent IRB review process.

With multi-site research expanding, a single IRB review can save institutions, organizations, and sponsors a lot of time and money by decreasing delays and improving coordination with one central point of contact for IRB communications. Single IRBs are useful for multi-site studies of any scale, from as few as two institutions collaborating to industry-sponsored pharmaceutical trials involving collaboration between hundreds of sites across the world. 

When wouldn’t you want (or need) to participate in a single IRB?

It’s important to understand when a single IRB might not be desirable or necessary. During the discussion, Steven detailed a few common scenarios where a single IRB is required, should be strongly considered, or may not be necessary.

When a single IRB is required

If a study is federally funded and non-exempt under the Common Rule (45 CFR 46), a single IRB is required. You don’t have a choice in this case.

When you should strongly consider a single IRB

Steven recommends strongly considering a single IRB for multi-site research where two or more sites are following the same protocol and interacting with participants. 

When you should rethink reliance

For exempt research, or a secondary data analysis where no participants are involved, each site can do its own local review. In those cases, a data sharing agreement between institutions may be all you need.

Ceding review vs serving as the IRB of record

After deciding that a study will use a single IRB, the participating teams will need to determine who will serve as the IRB of record and which institutions will cede revivew. 

As Steven pointed out, ceding review to an IRB of recod does not absolve your institution of its ethical research responsibilities. The ceding institution must still handle investigator qualifications, local training, communicating local context, and any local ancillary reviews (like radiology or radiation), the same as they would if they were the reviewing board. 

Alternatively, if your institution is serving as the IRB of record, your IRB will be responsible for conducting the regulatory review and provide ongoing oversight for all participating sites covered under the reliance agreement. 

Single IRB challenges

As with most research processes, working with a single IRB is not without its challenges. Steven outlined several common challenges that should not necessarily deter a team from using a single IRB, but should always be taken into consideration and planned around.

Lack of standardized processes 

Every institution has its own forms, processes, and workflows, which can be a struggle to navigate, especially as the institutions who participate grow.

Duplicative reviews still happen 

Some institutions want to keep a local review process, which can undermine the efficiencies a  single IRB is supposed to create.

Confusion about responsibilities 

Reliance agreements lay out things like who handles reportable events or consent form updates, but as an industry, we’re still working out some of the ongoing oversight questions, so this isn’t a perfect solution.

Communication across sites 

Making sure everyone knows when amendments are approved or continuing reviews have happened can be tricky.

Technology limitations 

If you’re working with a commercial IRB and your local IRB, those systems probably don’t talk to each other, so teams end up entering the same information multiple times.

Should my organization be the IRB of record?

Whether or not an organization should serve as the IRB of record or cede review to another institution’s IRB will depend on the study, the sponsor, the participants, and a host of other variables all play a role. 

Your team may not have control over the decision of who serves as the IRB of record. In the most common example, a study’s sponsors might require the use of a specific single IRB. 

Teams that do have a say in the final decision of who will serve as the IRB of record and who will cede review should consider which institutional IRB is the best situated to provide the review. This can come down to which IRB has the most thorough review requirements, which has more efficient processes in place, and which has the most available resources to handle the review. 

The role of AAHRPP accreditation

During the webinar, Steven highlighted the importance of AAHRPP (Association for the Accreditation of Human Research Protection Programs) accreditation. AAHRPP is an independent nonprofit organization that provides voluntary accreditation through peer review of human research protection programs. 

This accreditation acts as an independent measure of quality and provides a “vote of confidence” in single IRB reliance relationships, ensuring an institution has rigorous policies in place and actively follows them.

However, if your institution is not AAHRPP-accredited, that doesn’t mean you are automatically disqualified from participating in a single IRB. Unaccredited programs might simply be asked to complete an assessment form to ensure they meet industry standards and have proper protections in place for research subjects. 

The FDA’s proposed rule and operation trailblazer

Single IRB requirements are not a brand new concept. The NIH first published a draft policy requiring a single IRB back in 2014, and single IRBs have been mandated for NIH-funded research since 2018 and for federally funded research under the revised Common Rule since 2020.

Operation Trailblazer is a renewed initiative launched earlier this year by the Department of Health and Human Services aimed at accelerating clinical trials and reducing administrative delays. A major focus of this initiative is expanding the single IRB mandate to align with FDA regulations.

We expect the FDA rule to look pretty similar to the current Common Rule and NIH requirements. While the target publication date for this proposed FDA rule is on the agenda for December 2026, our experts noted that these timelines can occasionally shift and institutions can use this time now to prepare.

Preparing your institution for a single IRB

While the timeline for the FDA’s proposed rule continues to shift, institutions conducting research that could benefit from using a single IRB and teams actively approaching research that will require a single IRB should take several steps to prepare for doing so.

Embrace flexibility

Clinical research is always changing, so flexibility is the most important tool you have to navigate new processes. What is true today may change in the future, so staying up to date on your team’s IRB processes and keeping teams involved and aware of changing regulations is more important than ever. 

Reexamine current policies

Take time to review outdated policies and ensure you clearly delineate the roles of the IRB versus the Human Research Protection Program (HRPP). For example, you must decide who handles emerging topics like AI governance so those responsibilities don’t get lost when ceding review.

Establish master service agreements within your institutions 

For industry-sponsored trials that may soon mandate a commercial IRB, exploring master service agreements now ensures that external IRBs know your institution’s specific preferences and policies ahead of time.

Utilize SMART IRB (Version 3)

Over 1,500 institutions use SMART IRB, a national initiative that provides a master reliance agreement to reduce administrative burden. Upgrading to Version 3 offers flexibility clauses, such as easily deciding which institution handles HIPAA privacy reviews.

Create a statement of work

Lauren and Steven recommended developing a Statement of Work document prior to IRB submission. This helps clearly define which site is doing what (e.g., consenting participants vs. just sharing data), streamlining the initial review process and avoiding back-and-forth confusion.

Ask the right questions early

Before agreeing to collaborate on a single IRB, always ask potential collaborators what the investigators are actually doing, who is funding the study, and how local context (such as state-specific HIPAA laws or experimental subject bills of rights in places like California) will be collected. 

As Steven explained, once you know what the investigators are doing and who’s funding the study, you can figure out which regulations apply and whether reliance makes sense, all without reviewing the full protocol.

Lauren shared a great example of local context: in California, HIPAA language in consent forms must be in 14-point font, and an experimental subject’s bill of rights may be required for medical experiments. A local context survey or questionnaire is an easy way to capture these details from each site.

Keep in mind that size doesn’t determine readiness

When asked whether larger and smaller institutions should prepare for a single IRB differently, the presenters noted a few significant differences. Steven shared that smaller institutions sometimes worry about giving up control, but if you have a strong HRPP, all of your core responsibilities for protecting participants are still there. Ceding the ethical and regulatory review shouldn’t change that, as long as you have confidence in your partner. Lauren agreed that being a smaller institution doesn’t mean you can’t be prepared, and the same goes for larger ones. The collaborative nature of this field means you can always learn from what has worked for others.

Final takeaways

Lauren and Steven concluded their discussion by emphasizing the most important takeaways the audience should leave with.

Steven encouraged everyone to keep the end goal in mind: bringing innovations, treatments, and generalizable knowledge to the communities that need them, while ensuring ethical research and protecting human subjects. His challenge to everyone was to look at current policies, procedures, and even any biases we hold against a single IRB, and ask, “Does this contribute to the protection of participants?” If not, consider why it’s still in place.

Lauren reminded the audience that while most don’t love change at first, many of the improvements teams rely on today once felt unfamiliar too. Single IRBs aren’t brand new; NIH-funded studies have used this model successfully for years. Her hope is that teams keep supporting IRBs through this transition so multi-site research can be reviewed ethically and efficiently for the people who participate in it.

It was amazing to learn so much from Lauren and Steven about streamlining research to bring innovations to our communities faster and safer. For those who want to continue learning, Lauren and Steven suggested joining the incredibly supportive IRB community on LinkedIn, seeking educational resources through SMART IRB, PRIM&R, and AAHRPP conferences, and reviewing guidance documents from HHS and the FDA. One of our attendees also recommended IRB Exchange, an NIH-funded tool for tracking reliance agreements, cede decisions, and sign-offs across multiple sites. 

Additionally, when it comes time to prepare your actual submission packet, be sure to review our helpful IRB application checklist to ensure you have all the necessary documentation ready to go.