Five Common IRB Challenges in Clinical Trials and How to Address Them

The ethical principles that inform Institutional Review Board (IRB) oversight have remained anchored by the Belmont Report since 1979, with the purpose of protecting participants, upholding scientific integrity, and informing the regulatory framework that governs human subjects research. What has changed, however, is the scale, speed, and complexity of modern clinical research.

Multi-site trials, gene transfer studies, evolving Food and Drug Administration (FDA) guidance, and growing site workloads have all placed new demands on the IRB process. And while the core ethical principles remain stable, the systems built to support those standards haven’t always kept pace. The result is a set of persistent operational gaps that affect sponsors, sites, and, ultimately, the patients waiting for new therapies.

Here are five of the most common IRB challenges and what research teams can do to address them.

Why Is Submission Transparency So Important in the IRB Process?

When sponsors and sites can’t clearly see where their IRB submission stands, planning becomes guesswork. Without real-time visibility into key milestones, such as intake, pre-review, board review, determination, and document delivery, teams may spend valuable time chasing updates instead of managing next steps.

The absence of transparent, predictable turnaround times creates downstream uncertainty. A sponsor who doesn’t know when protocol approval will arrive can’t confidently schedule site activation, enrollment readiness, or additional milestones.

How to address it: Work with an IRB partner that measures and publishes actual turnaround data, not just target goals. For example, WCG IRB delivers new protocol determinations in fewer than six days and new site determinations in fewer than two days, measured from submission to document delivery. Clear benchmarks like these allow research teams to plan with confidence and help ensure that patients are not left waiting in the wings.

How Does Fragmented Communication Slow the IRB Review Process?

Disorganized or redundant communication during the review process is one of the most common, and most avoidable, sources of delay. When sponsors manage multiple contacts across different departments, messages get lost, instructions get repeated, and clarifications take longer than they should.

This is particularly disruptive for lean biotech teams navigating the IRB process for the first time, where the cost of miscommunication isn’t just time – it’s organizational momentum.

How to address it: A single point of contact model directly addresses this challenge. When one dedicated expert owns the relationship from submission to closeout, communication is cleaner, accountability is clearer, and teams spend less time coordinating and more time executing. Structured portfolio meetings and governance check-ins further reinforce alignment between IRB teams and sponsors throughout the life of a study.

What Delays Arise from Siloed IRB and IBC Reviews?

Studies involving gene transfer or biological agents often require both IRB and Institutional Biosafety Committee (IBC) review. When these are managed separately and sequentially, the combined wait time can add weeks or months to the start-up process.

This is a well-documented challenge for emerging biotech sponsors, many of whom may not immediately recognize the need for IBC review or understand how to coordinate the two processes in parallel.

How to address it: Coordinate IRB and IBC reviews through a single provider capable of managing both concurrently. Organizations that can handle parallel review can reduce the compounding delays that come from treating these as separate workstreams. Identifying IBC requirements early in the planning phase, including assessing site readiness and registration status, helps sponsors avoid surprises that derail enrollment timelines.

What Administrative Burdens Are Most Commonly Placed on Site Staff?

Site staff are often asked to manage complex submission requirements, consent form version control, recruitment material reviews, and reporting obligations, all while running active trials. When these tasks aren’t streamlined, the burden falls on already-stretched teams and can contribute to avoidable delays or errors.

Common pain points include redundant data entry, unclear or inconsistent submission expectations, and the challenge of keeping up with ongoing protocol changes across multiple sites.

How to address it: Technology and training together make a meaningful difference. Smart submission workflows that reduce redundant data entry, real-time tracking dashboards, and customized staff training all help sites operate more efficiently. According to WCG’s internal data, checklists and targeted training have reduced human errors by roughly 25 percent and process errors by as much as 75 percent for clients who hadn’t previously used them systematically, as observed in selected client workflows.

How Do Submission Errors Extend Trial Timelines?

In multi-site trials, timeline delays can compound when sites submit individually to different IRBs or follow inconsistent submission pathways. Each separate review process may introduce its own requirements, questions, documentation gaps, and approval timelines. As the number of sites increases, even small delays at the individual site level can create substantial downstream effects on study start-up, enrollment readiness, and overall trial times. For example, an internal WCG analysis, comparing a standard multi-site submission model to a centralized review approach, found a difference of 456 days (607 days versus 151 days with WCG) in total time under review.

How to address it: Pre-review processes that catch errors before a submission reaches the board, combined with a concurrent review model that covers all sites under a single protocol, help prevent the most common sources of delay. Training teams on submission requirements upfront, rather than correcting errors after the fact, keeps studies on track.

What IRB Support Options Can Help Research Teams Move Faster?

Addressing these challenges requires more than good intentions. It requires a partner with the infrastructure, expertise, and commitment to make ethical review both rigorous and efficient.

WCG IRB has led the field of independent ethical review for nearly 60 years, holding ISO 9001 certification and the Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation, with a board of nearly 200 members and a team operating seven days a week. If the study requires an accelerated review timeline or white-glove service, WCG’s IRB+ can expedite the process without sacrificing quality or integrity.

The goal isn’t speed for its own sake. It’s predictability, quality, and a partnership model built to protect both participants and timelines.

Frequently Asked Questions

Avoid Common IRB Challenges by Starting with the Right Partner

Whatever your ethical or scientific review needs are, WCG has the expertise to help you move through the review process with confidence. WCG has served as the trusted partner for ethical review for nearly 60 years, helping researchers, sponsors, and institutions navigate every type of review determination with accuracy and efficiency.

Get in touch with our IRB experts using the form below to discuss your study’s needs and learn how we can best support you.