What is an IRB?
An Institutional Review Board (IRB) is an independent committee responsible for reviewing and approving clinical research involving human subjects. Its primary role is to ensure the rights, safety, and welfare of participants are protected.
IRBs are required by U.S. federal regulations, including:
- FDA regulations (21 CFR Part 56)
- HHS regulations (45 CFR Part 46, also known as the Common Rule)
IRBs ensure:
- The study protocol is ethically and scientifically sound
- Informed consent forms (ICFs) are clear, complete, and compliant
- Risks to participants are minimized and justified
- Adverse events and protocol deviations are reported and addressed
IRBs must be registered with the FDA and operate under written procedures. They are also subject to audits and inspections by federal agencies. Increasingly, IRBs seek accreditation from organizations like AAHRPP (Association for the Accreditation of Human Research Protection Programs) to demonstrate compliance with high ethical standards.
Central vs. Local IRBs
In the world of clinical research, especially for medical devices, the choice between using a central IRB or a local IRB can significantly impact timelines, costs, and compliance.
What is a Central IRB?
A central IRB (also known as a commercial IRB) is an independent board that provides ethical review services for multiple research sites. It is often used in multicenter clinical trials to streamline the review process.
Key Features:
- One IRB oversees all participating sites
- Standardized processes and documentation
- Online portal for submissions, tracking, approvals and sharing documents (i.e. study level repository)
- Faster review timelines for expediated review (typically 5–10 business days from submission); For full board Review (typically 30 business days)
What is a Local IRB?
A local IRB is affiliated with a specific institution, such as a hospital or university. It reviews studies conducted at that institution and considers local context, such as community standards and institutional policies.
Key Features:
- Tailored to the institution’s needs
- Often includes local experts
- May require pre-review and additional documentation
- Review timelines vary (often 2–4 weeks or more)
Choosing Between Central and Local IRBs: Strategic Considerations for Multi-Site Trials
When planning a clinical trial—especially one involving multiple sites—Sponsors must decide whether to use a central IRB or local IRB. While both serve the same fundamental purpose of protecting human subjects, their operational models, timelines, and institutional relationships differ significantly. Understanding these differences is crucial for optimizing study efficiency, compliance, operational fees, and cost-effectiveness.
Efficiency and Timelines
One of the most cited advantages of a central IRB is speed. Central IRBs typically offer review timelines of 5 to 10 business days for expedited and exempt reviews, thanks to their streamlined processes and dedicated infrastructure, staff, and digital infrastructure. For more complex studies requiring full board review, timelines may extend to 30 business days. These timelines are often published and predictable, making them attractive for Sponsors aiming to accelerate study startup and maintain consistent compliance across multiple sites
In contrast, local IRBs often operate on fixed meeting schedules, such as monthly or biweekly. However, review dates are not always guaranteed. The timing of a local IRB review can be heavily influenced by the volume and complexity of submissions already in the queue. If earlier submissions require extended discussion or revisions, subsequent applications may be delayed or pushed to a later meeting, even if submitted on time. This unpredictability can significantly impact study timelines, especially in multicenter trials where multiple local IRBs are involved. Additionally, local IRBs may require pre-reviews, which can further extend the timeline before full board review is even scheduled.
Standardization vs. Customization
Central IRBs provide a standardized approach to submissions, documentation, and informed consent templates. This is particularly beneficial in multicenter trials, where consistency across sites is essential. Central IRBs often use digital portals that simplify document uploads, version control, and communication. This standardization is especially beneficial in multicenter trials, where consistency across sites is critical for compliance and efficiency.
Local IRBs often require site-specific submissions tailored to their institutional policies. Each site may have its own informed consent form (ICF) template, submission checklist, and reporting requirements. While this allows for greater alignment with the local context, it also increases the administrative burden on Sponsors and CROs.
Cost Considerations
While central IRBs are often perceived as more cost-effective due to their efficiency, the reality can be more nuanced. Central IRBs typically charge a study-level fee plus per-site fee. However, if a site insists on a “seeded” submission (i.e., an initial local review before deferring to the central IRB) or requires a reliance agreement to be in place before transferring oversight to another IRB, Sponsors may end up paying both central and local IRB fees—doubling the cost.
Local IRBs usually charge a flat fee per site but may also include hidden costs related to extended timelines and additional administrative work.
Shared Renewal Dates and Their Financial Impact in Central IRBs
Another important financial nuance when working with central IRBs is how they manage continuing review through a shared study renewal date. In most cases, all participating sites are aligned to a single annual review cycle, regardless of when each site joins the study. While this simplifies oversight and documentation for the IRB, it can create budgeting challenges for Sponsors. If a site is added several months after the study’s initial approval, its IRB coverage will only extend until the next shared study renewal date—not for a full 12 months. This means that newly activated sites may receive only a partial year of IRB coverage before being required to undergo continuing review and pay the associated renewal fees. As a result, Sponsors may find themselves paying full IRB fees for shorter approval periods, leading to higher cumulative costs over time, especially in studies with staggered site activations. This dynamic adds complexity to financial planning and should be carefully considered when budgeting for central IRB services.
Cost-Effectiveness Considerations
Although central IRBs often have higher upfront fees, their efficiency—through faster reviews and streamlined processes—can make them more cost-effective for multicenter studies. In contrast, local IRBs may appear more economical, but longer timelines and added administrative work can lead to hidden costs. The most cost-effective option depends on the study’s size, complexity, and the Sponsor’s internal resources.
Institutional Preferences and Control
Large academic institutions often prefer to use their own IRBs to maintain control over the ethical review process and retain associated revenue. Even when they agree to defer to a central IRB, they may still require a local review of the protocol and ICF, which can undermine the efficiency gains of centralization.
In contrast, private practices and smaller research sites without their own IRBs tend to favor central IRBs, as they offload the regulatory burden and simplify compliance.
Regulatory and Strategic Alignment
The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have both issued guidance encouraging the use of single Institutional Review Boards (sIRBs) for multicenter studies to reduce redundancy and improve oversight consistency. Central IRBs are well-positioned to meet these expectations, offering transparency, published policies, and centralized documentation.
However, Sponsors must still ensure that all participating sites are willing and able to rely on Central IRBs, which may require negotiation and formal reliance agreements.
Operational Burden and Infrastructure
Using a central IRB often shifts the submission and document management burden to the Sponsor or CRO. This includes managing access to IRB portals, uploading documents, tracking approvals, safety events, and major protocol deviation reporting, and responding to inquiries. While this can be efficient with the right infrastructure, it may be overwhelming for smaller Sponsors or those unfamiliar with the process.
Local IRBs, by contrast, place more responsibility on the site staff, which can be advantageous if the Sponsor lacks internal resources. However, this also means less control and visibility for the Sponsor.
| Criteria | Central IRB | Local IRB |
|---|---|---|
| Review Speed | 5–10 business days for expedited review (published timelines) 30 business days complex studies | 2–4 weeks or more; depends on meeting schedules |
| Cost | More Expensive (Study-level + per-site fees) | More economic |
| Standardization | High – one protocol, one ICF template, one process | Low – each site may require its own templates and processes |
| Submission Complexity | Centralized portal; streamlined documentation | Varies by institution; less automation |
| Local Context Consideration | Limited | Strong – considers local policies and community needs |
| Site Preference | Preferred by private practices or sites without IRBs | Required by large academic institutions |
| Reliance Agreements | Often required when local IRB defers to central | Not applicable |
| Operational Burden | On sponsor or CRO to manage submissions | On site to manage submissions |
| Document Management | Centralized portal | Institution-specific systems |
| Flexibility | Less flexible with templates and policies | More adaptable to site-specific needs |
Table 1. Central vs. Local IRBs
Management Challenges: Central vs. Local IRBs
Dual Submissions and Costs
While central IRBs are designed to save time and money, dual submissions can negate these benefits. For example, a site may require a “seeded” submission or reliance agreement before deferring to a central IRB—adding both time and cost. In some cases, Sponsors end up paying double: once to the central IRB and again to the local IRB.
Institutional Resistance
Large academic institutions often prefer to use their own IRBs to retain control and revenue. Even when they agree to use a central IRB, they may still require local review of the protocol, monitoring investigator training in human subject protects to assure it meets institutional and best practices standards, overseeing university Financial Conflict of Interest, and informed consent form (ICF), leading to delays.
Operational Complexity
Managing submissions through central IRB portal can be efficient but also technically demanding. Sponsors must:
- Track multiple submissions
- Manage user access
- Handle multiple document versions
Adding users, tracking submissions, and separate submissions for different study updates can be challenging and time consuming.
Informed Consent Customization
Even with a central IRB, sites may insist on using customized ICFs that align with their institutional templates. This undermines the standardization benefit and adds to the workload.
Frequently Asked Questions (FAQ)
How do I decide between a central vs. local IRB for my clinical trial?
Choosing between a central IRB and a local IRB is not a one-size-fits-all decision. The best option depends on several factors, including:
- Study Design (e.g., single site vs. multicenter)
- Budget and internal resources
- Site preferences and institutional requirements
- Regulatory obligations
For smaller companies or startups with limited funding, local IRBs may be more cost-effective and easier to manage. In contrast, for large multicenter trials, central IRBs often provide greater efficiency through faster reviews and standardized processes. In many cases, a hybrid approach becomes necessary, particularly when certain institutions require local IRB oversight despite the broader use of a central IRB.
Can I use both central and local IRBs in the same clinical trial?
Yes, it is possible—and sometimes necessary—to use a hybrid model where some sites rely on a central IRB while others insist on using their local IRB. This often happens in multicenter studies involving large academic institutions that require local oversight. However, managing both types of IRBs increases operational complexity, requiring careful coordination of submissions, approvals, and reporting requirements across different systems.
Are central IRBs always faster than local IRBs?
Generally, yes—central IRBs are faster due to their streamlined processes and dedicated review schedules. Most central IRBs offer review timelines of 5 to 10 business days for expedited review, 30 business days for full board review. However, speed can vary depending on the completeness of the submission and the IRB’s workload. Local IRBs often operate on fixed meeting schedules and may delay reviews if earlier submissions require extended discussion, making their timelines less predictable.
Does the FDA require the use of a central IRB?
No, the FDA does not mandate the use of a central IRB. However, it encourages their use in multicenter trials to reduce duplicative reviews and improve efficiency. The NIH, on the other hand, requires the use of a single IRB (sIRB) for most federally funded multisite studies. Sponsors should evaluate regulatory requirements, site preferences, and study complexity when deciding between central and local IRBs.
